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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
• viewing the posterior segment of the eye, including two- and three- dimensional imaging
• cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• fundus imaging
• fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management of various ocular diseases, including:
• age-related macular degeneration
• macular edema
• diabetic retinopathy
• retinal and choroidal vascular diseases
• glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.
A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared super-luminescent diode and a spectral interferometer are used to create the cross-sectional images.
The following modifications have been applied to the device subject of this 510(k):

• Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 250 kHz
• Update of the default contrast display setting from 1:4 to 1:2 for the Superficial Vascular Complex (SVC) and the Deep Vascular Complex (DVC) for the acquisition speeds of 125 kHz and 250 kHz

Acceptance Criteria and Study for SPECTRALIS HRA+OCT

The provided FDA clearance letter for the SPECTRALIS HRA+OCT and variants (K250868) describes a retrospective image grading case study (S-2023-1) performed to demonstrate substantial equivalence for modifications to the device. The modifications include the addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 250 kHz and an update of the default contrast display setting from 1:4 to 1:2 for the Superficial Vascular Complex (SVC) and the Deep Vascular Complex (DVC) for 125 kHz and 250 kHz acquisition speeds.

The study aimed to show that the investigational SPECTRALIS scan types (with 250 kHz acquisition and updated contrast settings) performed similarly to the predicate SPECTRALIS HRA+OCT with OCTA Angiography Module scan types (HR10 @ 85 kHz, HS20 @ 85 kHz) in terms of image quality, visualization of key anatomical vascular structures, and identification of pathologies.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly define specific numerical acceptance criteria in the format of a table with pass/fail thresholds. Instead, it reports performance metrics and concludes on "similarity" and "sufficiency" relative to clinical needs and the predicate device. Based on the provided text, the implied acceptance criteria were that the investigational device's performance should be similar to or sufficient for clinical assessment compared to the predicate device.

Here's a summary of the reported device performance, interpreted as meeting these implied criteria:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): The effectiveness analysis population from the S-2020-5 study consisted of 79 subjects. All 25 Normal subjects and 54 Pathology subjects were included in this retrospective study. However, the exact count for direct comparison between the predicate and investigational device ranged from 74 to 78 subjects depending on the scan type.
• Data Provenance:
  • Country of Origin: United States
  • Retrospective/Prospective: The S-2023-1 image grading case study was retrospective, using clinical data that was collected prospectively in a previous study (S-2020-5). Data was collected at a single clinical site.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Three independent reviewers from a Reading Center.
• Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., "radiologist with 10 years of experience") of these reviewers. It only identifies them as "independent reviewers from the Reading Center."

4. Adjudication Method for the Test Set

• The document states that the performance metrics for image quality were "summarized based on the percentage of images graded better than Poor (i.e., Good or Average) on consensus." This indicates that some form of consensus method was used for image quality grading. However, the specific adjudication method (e.g., 2+1, 3+1, majority rule, etc.) for achieving this consensus is not detailed. For visualization of key anatomical structures and identification of pathologies, it indicates agreement analysis between predicate and investigational scan types but does not explicitly describe an adjudication method to establish a single "ground truth" before comparison; rather, it assesses agreement between the two device types.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The study described is an image grading study involving multiple readers (three independent reviewers) evaluating multiple cases, comparing an investigational device's performance to a predicate device. While it aligns with elements of a comparative effectiveness study, it's not explicitly labeled as a "Multi Reader Multi Case (MRMC) comparative effectiveness study" in the statistical sense (e.g., for ROC analysis). Instead, it focuses on agreement rates, PPA, and NPA.
• Effect Size of Human Readers' Improvement with AI vs. without AI: This study does not involve AI assistance for human readers. The device in question is a medical imaging device (OCTA), not an AI-powered diagnostic tool providing automated interpretations or assisting human readers. Therefore, there is no reported effect size for human readers improving with AI vs. without AI assistance. The study compares two versions of the imaging device.

6. Standalone Performance Study

• Yes, a standalone performance assessment was conducted for the investigational scan types. The reported metrics for "Overall Image Quality" and "Visualization of Key Anatomic Structures" are measures of the algorithm's output (images from the investigational scan types) as graded by experts, independent of a human-in-the-loop scenario for diagnostic decision-making. The agreement analysis is essentially comparing the standalone performance of the investigational scans against the standalone performance of the predicate scans.

7. Type of Ground Truth Used

• The "ground truth" for the test set was primarily established through expert consensus/grading by three independent reviewers.
• The "Normal population" was defined by clinical examination showing no retinal conditions or abnormalities.
• The "Pathology population" had specific retinal conditions (e.g., wet age-related macular degeneration, diabetic retinopathy) and abnormalities (e.g., microaneurysm, choroidal neovascularization, retinal neovascularization) that were identified. This implies medical record review and possibly other diagnostic findings contributed to classifying these subjects, but the direct "truth" for the study's performance metrics (image quality, structure visualization, abnormality identification) came from the expert grading of the OCTA scans.

8. Sample Size for the Training Set

• The document does not specify a sample size for a training set. The study primarily focuses on the validation of modifications to an existing device, and the data listed is related to its verification and clinical evaluation (test set). It is possible that the underlying algorithms within the SPECTRALIS were trained on a separate, unmentioned dataset prior to this 510(k) submission, but this information is not provided in the clearance letter.

9. How the Ground Truth for the Training Set Was Established

• As the document does not provide information about a training set, it does not describe how the ground truth for any training set was established.

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The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.
The analysis covers:

• · Cornea Thickness
• · Anterior Segment
  o Anterior chamber width, depth, volume and angle parameters
  o Lens Thickness
• · Axial Length

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:
· ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
• ANTERION Software (V.1.5) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.
The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).
For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.
The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.
The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.
The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eve.
The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App. (2) the Cornea App. (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements for the patient´s individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.
The following modification has been applied to the device, subject of this 510(k):

• · Addition of the Epithelial Thickness Module (separate License in the Cornea App) with maps and parameters of the corneal epithelial and stromal thickness.
  To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes a comparative study, implying that the acceptance criteria for the "ANTERION" device's new Epithelial Thickness Module were based on its precision (repeatability and reproducibility) and agreement with an existing legally marketed device, the "Cirrus HD-OCT 5000 with Anterior Segment Premier Module."

The acceptance criteria are implicitly defined by demonstrating similar or better precision and general agreement with the predicate device across various corneal epithelial thickness measurements and patient populations.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Total Subjects: 115 subjects
     • 32 in Normal Cornea population (Group A)
     • 82 in Abnormal Cornea population (Group B), further divided into:
       • 25 Keratoconus subgroup
       • 20 Contact Lens Wearer subgroup
       • 18 Status Post-Keratorefractive Surgery subgroup
       • 19 Dry Eye Disease subgroup
   • Data from 32 Group A and 81 Group B participants were included in precision analyses.
   • Data from 32 Group A and 80 Group B participants were included in agreement analyses.
   • Provenance: Prospective, randomized precision and agreement clinical study conducted at one diverse clinical site in the United States.
   • Scans per parameter/population: Vary (e.g., 285 scans for most Normal Cornea parameters, 725 for most Abnormal Cornea parameters). Each participant had 3 replicates per acquisition type, per configuration from three device-operator configurations.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This study does not establish ground truth using experts in the traditional sense (e.g., radiologists interpreting images). Instead, it's a comparative effectiveness study where the ANTERION device's measurements are compared to those of a legally marketed predicate device (CIRRUS HD-OCT 5000). The "ground truth" implicitly refers to the measurements obtained by the predicate device, or rather, the comparison is made between the measurements of the two devices, not against an external expert-derived truth. Expertise was involved in operating the devices and assessing image quality by the operator, but not in establishing a separate "ground truth" for the measurements themselves.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not explicitly stated for the test set measurements. The study design involved "three replicates per acquisition type, per configuration" and "image quality was assessed by the operator after each acquisition." This suggests that the operators evaluated the quality of the individual scans, but there is no mention of an independent adjudication process for the actual thickness measurements or a consensus method for defining "ground truth" between multiple readers.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This was a comparative effectiveness study involving multiple operators ("three operators") and multiple cases (115 subjects / ~114 study eyes). However, it was not an MRMC study focused on human reader improvement with/without AI assistance. This study compared measurements from one device (ANTERION) to another (CIRRUS HD-OCT 5000) for precision and agreement. The "ANTERION" device is an ophthalmic imaging and analysis device, and while it has "Apps" that perform analysis, the study focuses on the device's measurement performance rather than an AI component assisting human readers in diagnosis.
   • Therefore, there is no effect size reported regarding human readers improving with/without AI assistance in this context.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the study primarily evaluates the standalone performance of the ANTERION device's measurement capabilities (specifically the Epithelial Thickness Module) against a predicate device. While human operators collected the images, the reported precision (repeatability and reproducibility) and agreement data are quantifications of the device's algorithmic measurement outputs. The "Cornea App" and its Epithelial Thickness Module perform the thickness calculations.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The study uses the measurements from a legally marketed predicate device (CIRRUS HD-OCT 5000) as the reference for comparison, rather than an independent "ground truth" like pathology or expert consensus. The aim is to show that the new device's measurements are sufficiently precise and agree with those from an established device.

7. The sample size for the training set:

   • The document does not provide information on the training set for the ANTERION device's algorithms. The study described is entirely focused on the clinical performance testing (test set) of the device.

8. How the ground truth for the training set was established:

   • As no information on the training set is provided, how its "ground truth" was established is also not available in this document.

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The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Device Name: SPECTRALIS with Flex Module
Predicate Device: SPECTRALIS HRA+OCT (K223557)

• 100% of OCT images were assessed as having sufficient overall image quality.
• 100% of IR cSLO images were assessed as having sufficient overall image quality.
• 97.2% of OCTA images were assessed as having sufficient overall image quality. (Page 14) |
  | Visibility of Key Anatomic Structures | Key anatomic structures should be clinically acceptably visualized. | In the effectiveness population (All Eyes):
• Clinically acceptable visualization of key anatomic structures was achieved on OCT in 100% of assessments.
• On OCTA, clinically acceptable visualization was achieved in 94.4% to 97.2% of assessments. (Page 14)
  The results generally demonstrate that investigational SPECTRALIS with Flex images provide similar visualization as compared to the predicate SPECTRALIS. (Page 14-15) |
  | Identification of Pre-specified Abnormalities | The device should have comparable ability to identify pre-specified abnormalities (structural via OCT, vascular via OCTA) compared to the predicate device. | - Agreement rates (between investigational device and predicate for same result):
  • Structural abnormalities on OCT: ≥ 84.3%.
  • Vascular abnormalities on OCTA: ≥ 85.1%.
• Negative Percent Agreement (NPA) in All Eyes for all pre-specified abnormalities:
  • On OCT: at least 87.8%.
  • On OCTA: at least 92.6%.
• Positive Percent Agreement (PPA) for All Eyes for all pre-specified abnormalities (with more than 2 cases identified on the predicate):
  • On OCT: at least 75%.
  • On OCTA: at least 75%.
    These results indicate the ability to identify each pre-specified abnormality is similar between devices. (Page 15) |
    | Safety | The device should not introduce new safety concerns. | No adverse events occurred during the course of the study. (Page 14) |
    | Substantial Equivalence (General) | The device should be as safe and effective as the predicate devices. | The study concludes that the SPECTRALIS with Flex Module is substantially equivalent to the predicate SPECTRALIS with regards to image quality, visibility of key anatomic structures, and identification of structural and vascular abnormalities, and supports its safety. (Page 15) |
    | Supine & Pediatric Patients | Demonstrate effective and safe imaging for pediatric and adult patients in the supine position. | The clinical study included adult patients (22 years or older) and the literature review provides evidence for safe and effective use in pediatric conscious or unconscious patients in the supine position. The device shares the patient profile (conscious/unconscious pediatrics and adults in supine position) with the secondary predicate device (Bioptigen ENVISU). (Page 15-16) |

Study Details

1. Sample size used for the test set and the data provenance:

   • Subjects Enrolled: 88
   • Subjects Completed Study: 84
   • Effectiveness Analysis Population: 76 participants (25 Normal subjects, 51 Posterior Segment Abnormality subjects). The exact count varied slightly for each image type based on abnormalities of interest and acceptable acquisitions.
   • Data Provenance: Single clinical site, located in the United States. The study was prospective and observational.
   • Patient Demographics:
     • Mean age: 57.3 ± 19.2 years (overall)
     • Gender: 59.2% female, 40.8% male
     • Ethnicity: 96.1% did not identify as Hispanic or Latino
     • Race: 80% White, 18.4% Black/African American, 2.6% Asian
   • Study Populations:
     • Adult Normal Eyes (no posterior segment abnormalities)
     • Adult Posterior Segment Abnormality Eyes (structural and/or vascular posterior segment abnormalities)

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Three independent readers.
   • Qualifications: Referred to as "independent readers from a reading center." No specific qualifications (e.g., years of experience, subspecialty) are provided in this extract.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The text states that the "proportion of images graded better than Poor on consensus" was used. For abnormality identification, "agreement rates (based on the abnormalities identified by the reading center on the predicate, percentage of eyes with the same result on the investigational device)" were utilized. This implies that the three readers likely had a consensus process for the overall image quality and visibility assessments, and for abnormality identification, agreement with the predicate's findings by the reading center was important. The specific 2+1 or 3+1 method is not explicitly mentioned, but the term "consensus" suggests an agreed-upon finding among the readers.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This was not an MRMC comparative effectiveness study involving AI assistance. The study was designed to show substantial equivalence between the investigational device (SPECTRALIS with Flex Module) and its predicate (SPECTRALIS HRA+OCT) regarding image quality and ability to identify abnormalities. There is no mention of AI or its impact on human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, this was not a standalone (algorithm-only) study. The study involved human readers (three independent readers) to grade images obtained from the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for image quality, visibility of structures, and identification of abnormalities was established through expert grading by three independent readers from a reading center, likely using expert consensus to interpret findings. The predicate device's findings also served as a reference for agreement in abnormality detection.

7. The sample size for the training set:

   • The provided text does not contain information about a training set size. The clinical study described is for validation and comparison to a predicate, not for training a new algorithm.

8. How the ground truth for the training set was established:

   • As no training set is mentioned, this information is not applicable based on the provided document.

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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• · viewing the posterior segment of the eye, including two- and three- dimensional imaging
• · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• fundus imaqinq
• · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• · performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• · diabetic retinopathy
• retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser- scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the crosssectional images.

The following modifications have been applied to the device subject of this 510(k):

• . Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 125 kH
• Addition of a General-Purpose Graphics Processing Unit (GPGPU)

Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:

Device: SPECTRALIS HRA+OCT and variants

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a pass/fail. Instead, it demonstrates similarity and non-inferiority to a predicate device. The performance metrics reported serve as evidence that the new modifications do not negatively impact the device's functionality compared to the predicate.

Overall Conclusion from Study: The investigational SPECTRALIS OCTA images provide similar visibility as compared to the predicate (85 kHz) and the ability to identify each pre-specified vascular abnormality is similar between the predicate and investigational scan types.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Effectiveness Analysis Population): 79 subjects. However, the exact count for direct comparison between the predicate and investigational device varied depending on the scan type.
• Data Provenance:
  • Country of Origin: United States
  • Retrospective or Prospective: Prospective
  • Study Design: Observational Case Study (S-2020-5)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Three independent reviewers.
• Qualifications of Experts: The document states they were "from a reading center" but does not specify their individual qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document explicitly states that the analyses were based on "the grading results from the effectiveness analysis population," and imagery was "graded better than Poor on consensus." This implies a consensus-based adjudication method for image quality and visualization of structures, and agreement analysis for vascular abnormalities. It does not specify a 2+1 or 3+1 rule, but highlights the "consensus" aspect.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a typical MRMC comparative effectiveness study, designed to measure how much human readers improve with AI vs. without AI assistance, was not conducted. This study's primary goal was to demonstrate that modifications to an existing device (adding new scan acquisitions, increasing scan speed, and GPU processing) did not negatively impact its performance compared to its predicate. It assesses the similarity of the device's output (images) between the investigational and predicate versions.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Since the device in question is an imaging device (OCT) that captures and processes images for clinical evaluation by a human, and the study involves human graders assessing image quality and identifying pathologies, a "standalone algorithm-only" performance evaluation (without human-in-the-loop) in terms of clinical interpretation was not the primary focus or design of this particular study. The assessment revolves around the quality of the device's output for human interpretation.

7. Type of Ground Truth Used

The ground truth was established by expert consensus from the three independent reviewers from a reading center, who graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies.

8. Sample Size for the Training Set

The document does not provide information about a training set. This study is a clinical performance evaluation of an updated imaging device, not typically a machine learning model that requires a discrete training set for its core function. The modifications involve hardware (scan speed, GPU) and an investigational scan type, and the performance assessment is against a predicate device.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this type of device modification study, this information is not applicable.

Ask a specific question about this device

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• · viewing the posterior segment of the eye, including two- and three-dimensional imaging
• · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• · fundus imaging
• · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• · performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• · diabetic retinopathy
• · retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• · a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• · a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.

The following changes have been applied to the device subject of this 510(k):

• Widefield Reflectance mode for artifacts suppression
• Regression analysis in Glaucoma Module Premium Edition
• Thunderbolt 3 interface
• Thunderbolt cable fan
• Process separation of acquisition software module
• Windows 11 Support

The provided text describes a 510(k) summary for the SPECTRALIS HRA+OCT and variants, which is a non-contact ophthalmic diagnostic imaging device. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K201252) through non-clinical performance testing and a comparison of technological characteristics.

Therefore, I cannot provide the requested table and information based on the given text.

Here's what the document does provide regarding non-clinical performance testing:

Non-Clinical Performance Testing:

The modified SPECTRALIS device underwent non-clinical performance testing to ensure its safety and efficacy. This testing was guided by several FDA-recognized consensus standards:

• ISO 14971: 2019: Medical Devices - Application of Risk Management to Medical Devices.
• AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 62304 Edition 1.1 2015-06: Medical Device Software Software Life Cycle Processes.

The testing found that the device met the requirements of these applicable standards, demonstrating that the safety and efficacy of the modified device are comparable to the predicate.

Additionally, the following documentation was provided and verification/validation conducted:

• Software documentation, verification, and validation: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Cybersecurity documentation: Submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

Changes from the Predicate Device:

The modifications to the device since its previous clearance (K201252) include:

• Widefield Reflectance mode for artifact suppression.
• Regression analysis in Glaucoma Module Premium Edition.
• Thunderbolt 3 interface.
• Thunderbolt cable fan.
• Process separation of acquisition software module.
• Windows 11 Support.

The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the modified SPECTRALIS HRA+OCT and variants with the cleared SPECTRALIS device (K201252)." This indicates that a clinical study with acceptance criteria for device performance as typically understood (e.g., sensitivity, specificity, accuracy against a ground truth) was not performed or provided in this submission to support these specific modifications. The substantial equivalence is based on the claim that these modifications do not change the fundamental technology, acquired images, patient populations, or aid to clinical evaluation, and are supported by non-clinical verification.

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The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.

The analysis covers:

• · Cornea Thickness
• · Anterior Segment
  • o Anterior chamber width, depth, volume and angle parameters
  • o Lens Thickness
• · Axial Length

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:

• ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The . hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
• . ANTERION Software (V.1.2.4) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.

The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).

For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.

The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.

The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.

The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eye.

The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for the cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.

This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.

To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the ANTERION device (K230897).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific thresholds for each parameter. Instead, it presents extensive "Repeatability and Reproducibility" data (precision analyses) from two clinical studies (B-2018-3 and B-2018-5). The implication is that the demonstrated precision values meet the internal acceptance criteria for the device's performance.

Therefore, the table below will present the reported device performance, which is implicitly what the device "met" to achieve clearance. It's important to note that specific numerical acceptance thresholds are not explicitly defined in the provided text. The reported values are the performance demonstrated by the device in the studies.

Table 1: Reported Device Performance (Repeatability and Reproducibility)

Note regarding Acceptance Criteria: The document states, "The device met all pre-determined acceptance criteria" under "Non-Clinical Performance Testing". For clinical performance, it states, "Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence." This implies that the demonstrated repeatability and reproducibility values, as detailed in the tables, were considered acceptable for the device's intended use. Specific numerical thresholds for each parameter are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The provided text details the sample sizes for the clinical studies which serve as the test sets for the device's performance.

• Study Protocol B-2018-3:

  • Sample Size:
    • Group A (open angle): 29 participants completed, data from 25 for precision analyses (225 scans). 27 for agreement analyses.
    • Group B (narrow angle): 27 participants completed, data from 27 for precision analyses (234 scans). 26 for agreement analyses.
    • Total enrolled: 30 Group A, 28 Group B.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

• Study Protocol B-2018-5:

  • Sample Size: 176 participants enrolled, 172 completed.
    • Group A (normal anterior segment): 27 participants.
    • Group B (cataract): 33 participants.
    • Group C (corneal abnormalities): 45 participants (38-43 for specific parameters in precision analysis tables).
    • Group D (post-keratorefractive surgery): 29 participants (28-29 for specific parameters).
    • Group E (pseudophakic/aphakic eyes): 41 participants (39-40 for specific parameters).
    • Scans: Varied per parameter and group, ranging from ~243 to 378 scans for precision analysis.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set.

It mentions:

• "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" for Protocol B-2018-3.
• "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed" for Protocol B-2018-5.

While it mentions manual correction and an "independent reading center," it does not specify the number of experts, their specialty (e.g., ophthalmologists, optometrists, or technicians), or their years of experience for establishing this ground truth.

4. Adjudication Method for the Test Set

The document mentions "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" and "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed."

However, it does not describe a formal adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements among multiple readers or for establishing the final "ground truth" if multiple experts were involved in these manual corrections. It implies that a single "manual correction" was applied, but the process for achieving a single corrected state from potentially multiple reviewers or iterations is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a standard MRMC comparative effectiveness study was not performed as described for AI assistance.

The studies compared the ANTERION device's measurements not to human readers' performance, but to other devices (CIRRUS HD-OCT 5000 and Pentacam AXL) for accuracy and to itself for precision (repeatability and reproducibility). The ANTERION is an imaging and measurement device, not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, a study of how human readers improve with AI vs without AI assistance is not applicable in the context described.

The studies assessed the ANTERION's ability to consistently and accurately measure ophthalmological parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance results presented (Repeatability and Reproducibility) for the ANTERION device represent its standalone performance as a measurement device. The reported CV% values reflect the device's inherent precision in generating these measurements.

While manual corrections of ANTERION segmentation were performed in the studies, this was described as a step in processing the acquired images to enable measurements, rather than human "interpretation" of the algorithm's output for diagnostic purposes in a human-in-the-loop scenario. The repeatability and reproducibility are derived from the measurements produced by the device, sometimes after such manual adjustments. The overall goal was to demonstrate the consistent and accurate measurement capability of the device rather than a diagnosis assistance system.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment appears to be based on:

• Comparison to legally marketed devices: The studies performed "agreement analyses" with CIRRUS HD-OCT 5000 and Pentacam AXL, implying these served as reference or comparative ground truth for measurement accuracy. The details of these agreement analyses (e.g., Bland-Altman, Deming regression) are mentioned, but the specific numerical outcomes of these agreement analyses are not provided in the excerpt.
• Manual correction by experts/independent reading center: For measurements derived from image segmentation (e.g., angle parameters, corneal thickness, chamber depth), "manual correction of ANTERION segmentation" and "manual placement of the angle recess points" were performed. This suggests that the ground truth for these segmented features was established by manual review, presumably by qualified personnel, even though their qualifications are not specified.

Therefore, the ground truth is a combination of comparison to established ophthalmic devices and expert manual correction/review of segmented images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

The provided document describes the clinical studies for device validation/testing. It does not provide information on the sample size used for the training set of the ANTERION's algorithms. As a measurement device rather than an AI diagnostic algorithm in the typical sense, it's possible that its internal algorithms rely on established physical/optical models and calibration, not necessarily a large-scale "training set" of images in the machine learning context. However, if machine learning was used for segmentation, the training set details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a "training set" or the use of machine learning for its algorithms, there is no information on how the ground truth for any hypothetical training set was established.

Ask a specific question about this device

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization of the anterior segment.

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:

• . ANTERION Hardware (Imager/Basis) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
• ANTERION Software (PC): The ANTERION Software includes the main user . interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The PC software additionally stores, receives, and displays the acquired data.

The ANTERION hardware is separated in three parts: the Basis (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).

For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Basis and controlled via a ioystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.

The Basis mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.

The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.

The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging, while the IR camera allows for en-face imaging of a patient's eye.

The Imaging App, the subject of this submission, is the foundation of the ANTERION platform, and focuses on the high-resolution visualization of the entire anterior segment, from the anterior surface of the cornea to the posterior surface of the lens.

The Imaging App delivers swept-source OCT images that allow visualization of anterior segment pathologies and evidence of surgical interventions, e.g. keratoplasty, LASIK, implanted IOLs, and phakic lenses.

Here's a breakdown of the acceptance criteria and study details for the ANTERION device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document focuses on establishing substantial equivalence rather than explicit quantitative acceptance criteria with pass/fail thresholds. However, the study aims to demonstrate that the ANTERION's performance is similar to or better than the predicate and reference devices in key areas.

Here's a table summarizing the implicit acceptance criteria (demonstrated similarity or superiority) and the reported device performance:

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 87 participants (34 in "Normal Anterior Segment group", 53 in "Abnormal Anterior Segment group"). One eye per subject was selected.
   • Data Provenance: Prospective, single clinical site in the United States.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Number of Experts: Three independent graders were used for image quality and abnormality identification.
   • Qualifications: "Qualified graders" are mentioned. No specific experience (e.g., "radiologist with 10 years of experience") is provided, but they were described as "masked" and "independent."

3. Adjudication Method for the Test Set:

   • Method: Majority rule was applied to get consensus from the three independent graders.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done? Yes, effectively. The study compared the ANTERION device to the CIRRUS HD-OCT 5000 device using multiple graders and multiple cases, assessing both image quality and abnormality identification.
   • Effect size of human readers improve with AI vs. without AI assistance: This study does not directly measure the improvement of human readers with AI assistance. Instead, it compares the device's performance (ANTERION) against a comparator device (CIRRUS) for diagnostic imaging purposes. Human graders (experts) were used to evaluate the output of both devices and establish ground truth, not to assess AI assistance to human readers.

5. Standalone (Algorithm Only) Performance:

   • The study evaluates the ANTERION imaging app as a diagnostic device, which produces images and potentially analyses thereof. The assessment of image quality and abnormality identification was performed by human graders viewing the images produced by the device. It is not explicitly stated whether the ANTERION has an "algorithm only" mode that provides automated diagnoses without human review, but the clinical evaluation method suggests a focus on the quality of the images provided for human interpretation rather than fully automated standalone performance.

6. Type of Ground Truth Used:

   • For Abnormality Identification: The slit lamp examination performed by the investigator was used as the reference (ground truth) for identifying abnormalities.
   • For Image Quality and Visibility of Structures: Expert consensus (majority rule of three masked graders) was used to grade image quality and visibility of structures on the OCT images from both devices.

7. Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set for the ANTERION device's algorithms or software. The clinical study described is a test set evaluation.

8. How the Ground Truth for the Training Set Was Established:

   • The document does not provide this information. The clinical study details focus solely on the evaluation of the device's performance using a test set.

Ask a specific question about this device

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• · viewing the posterior segment of the eye, including two- and three-dimensional imaging
• · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• · fundus imaging
• · fluorescence imaging (fluorescein angiography, indocyanine green angiography, SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• · performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• · diabetic retinopathy
• · retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared super-luminescent diode and a spectral interferometer are used to create the cross-sectional images.

The provided text is a 510(k) summary for the Heidelberg Engineering SPECTRALIS HRA+OCT and variants, a non-contact ophthalmic diagnostic imaging device. The submission outlines modifications to an existing cleared device (K192391).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in a dedicated table format. Instead, it uses a "TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART" to compare the modified device against its predicate (K192391). The "Discussion" column in this chart implicitly indicates whether performance is considered equivalent ("Same") or if differences are minor and do not impact safety/effectiveness.

The implied acceptance criterion for most characteristics is "Same as predicate device" or that any differences do not introduce new safety or effectiveness concerns.

Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria is described as non-clinical performance testing, including bench testing of OCT imaging properties, validation and verification activities, and ongoing quality control. These tests confirmed that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The study described is entirely non-clinical bench testing, not a human reader study or clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study was non-clinical bench testing. There were no human experts establishing ground truth for a test set in the context of diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "The changes applied to the SPECTRALIS since the clearance in K192391 do not change the intended patient populations, the type of acquired images, or that the SPECTRALIS may be used as an aid to clinical evaluation." This implies that the device is an imaging tool, not one that directly interacts with human readers for diagnostic interpretation (i.e., no AI assistance component or comparative effectiveness with human readers is mentioned).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The device is an imaging hardware system, not an algorithm, and the modifications are to hardware and software features that enhance image acquisition and scanning patterns, not an AI or standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench testing, the "ground truth" would be established by objective physical measurements, engineering specifications, and validated measurement standards to assess optical properties, scanner linearity, light exposure, and image quality parameters. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The document does not describe the development or training of an algorithm or AI model.

9. How the ground truth for the training set was established

Not applicable. The document does not describe the development or training of an algorithm or AI model.

Ask a specific question about this device

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• · viewing the posterior segment of the eye, including two- and three-dimensional imaging
• · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• · fundus imaging
  · fluorescence imaging (fluorescein angiography, indocyanine green angiography, SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• · performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• · diabetic retinopathy
• · retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.

Because of discontinuation of device components, the following changes have been applied to the device:

• . Replacement of the OCT line camera in the spectrometer with an equivalent camera from the same manufacturer, and comparable specifications;
• . Update of the digital device interface from Thunderbolt to Thunderbolt 2;
• With the update of the TDI, the device complies with electromagnetic compatibility standard IEC 60601-1-2 Edition 4.0.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• viewing the posterior segment of the eye, including two- and three-dimensional imaging
• cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• fundus imaging
• fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• diabetic retinopathy
• retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.

The purpose of this premarket notification [510(k)] is to add the High Magnification Module (HMM) as an optional, exchangeable accessory objective lens to the SPECTRALIS HRA+OCT.

The HMM is offering an 8° field of view (FOV) and allows for cSLO imaging only. It offers a magnified view of parts of the retina with improved resolution. Compared to the standard objective with 30° FOV, it has an approximately 4 times increased digital resolution, with optical resolution approximately 25% improved compared to the standard objective. With the new HMM objective, the digital resolution for a FOV of 8° is 1536x1536 pixels for High Resolution imaging, and 768x768 pixels for High Speed imaging. The functionality for averaging images with the proprietary automatic real-time (ART) eye tracking is still maintained.

cSLO imaging with the HMM is only intended for qualitative use.

• No quantitative automatic measurements are performed on HMM images. -
• No classifications against reference data are performed on HMM images -

Besides the addition of the optional High Magnification Module, the SPECTRALIS device is unchanged.

The provided document describes a 510(k) premarket notification for a SPECTRALIS HRA+OCT device with a High Magnification Module (HMM). The notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (K181594).

The acceptance criteria and study detailed pertain to the High Magnification Module (HMM), an optional accessory objective lens, and its impact on the existing SPECTRALIS HRA+OCT. The primary goal was to ensure the modified device (with HMM) is as safe and effective as the unmodified predicate device.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify a separate "test set" in the context of patient data or a clinical study for the HMM's performance. The evaluation was primarily based on non-clinical performance testing, simulations (ray tracing), and bench testing. There is no mention of patient data (retrospective or prospective) used specifically to validate the HMM.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth, in this context, was established through engineering simulations (ray tracing) and bench test measurements against predefined technical specifications and comparisons to the standard objective. There were no human experts establishing ground truth from clinical data for the HMM's performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring expert adjudication was described for the HMM.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device described (Spectralis HRA+OCT with HMM) is an ophthalmic diagnostic imaging device. The High Magnification Module (HMM) is an accessory objective lens for cSLO imaging only, intended for qualitative use, and specifically states:

• "No quantitative automatic measurements are performed on HMM images."
• "No classifications against reference data are performed on HMM images."
  This indicates that the HMM is not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance for human readers would not have been performed or relevant for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The HMM is a hardware component (an objective lens) for an imaging device, not a standalone algorithm. Its function is to provide magnified cSLO images with improved resolution for qualitative viewing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the HMM's performance was based on:

• Theoretical values derived from ray tracing simulations for optical parameters.
• Measurements from bench testing to verify physical parameters like field of view, image geometry, lateral resolution, and image quality, against the standard objective.
• Compliance with FDA recognized consensus standards (ISO, AAMI, IEC standards).

8. The sample size for the training set:

Not applicable. The HMM is a hardware accessory; there is no "training set" in the context of machine learning or algorithms.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set mentioned, this question is not relevant to the provided information.

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