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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.

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 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.

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.

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 non-contact ophthalmic 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 OCT Angiography (OCTA) as an optional, add-on functionality to the SPECTRALIS HRA+OCT. Based on OCT imaging, OCTA is a non-invasive method to visualize the retinal and choroidal vasculature without the need for injection of intravenous dyes. The device generates OCTA images from analysis of temporal changes in the intensity of reflected light caused by moving particles, such as erythrocytes flowing through vessels. These changes in the OCT signal are detected by repeatedly capturing OCT images on the retina to allow for the creation of an image contrast between the perfused vessels and the static surrounding tissues.

OCTA volume scans allow for the visualization of en-face images generated from predefined or user-customizable slabs. OCT Angiography is intended for qualitative use only. No quantitative measurements are provided by the OCTA functionality.

Besides the addition of OCT Angiography, the SPECTRALIS device is unchanged. The unmodified device is the predicate device for all functions besides OCT Angiography.

The provided document details the 510(k) submission for the SPECTRALIS HRA+OCT and variants with OCT Angiography Module (K181594). The primary predicate device for the OCT Angiography module is the RTVue XR OCT Avanti with AngioVue™ Software (K153080).

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

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

The acceptance criteria are not explicitly stated in numerical thresholds in the provided document. Instead, the study aims to demonstrate comparable performance to the predicate device (RTVue XR) in terms of image quality and agreement in identifying vascular pathologies. The reported device performance is presented in various tables comparing the SPECTRALIS with the RTVue XR.

Below is a summary table aggregating some of the reported performance metrics that serve as de facto acceptance criteria based on the comparison to the predicate.

Note: Scan Pattern 1 refers to SPECTRALIS 10° x 10° and RTVue 3mm x 3mm; Scan Pattern 2 refers to SPECTRALIS 20° x 20° and RTVue 6mm x 6mm.

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

• Sample Size: A total of 95 participants were enrolled, with 37 in the "Normal" group and 58 in the "Pathology" group. Of these, 79 participants (32 "Normal" and 47 "Pathology") completed the study and were included in the primary analyses.
• Data Provenance: The study was conducted at a single clinical site in the United States. It was a prospective, case series study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The ground truth for the test set was established by three qualified, masked graders for OCTA image grading and another three qualified, masked graders for FA/ICGA grading. The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"), only that they were "qualified."

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

The document mentions "consensus OCTA image quality score" and "consensus overall anatomical structure score," implying an adjudication method where graders reached a consensus. For image quality scoring, one table shows "total inter-grader agreement on image quality scoring (where the same image quality score was determined by all three graders)." This suggests that when all three agreed, that was the score. For cases where agreement was not total (e.g., "same score from 2 graders"), the document does not explicitly state the adjudication rule (e.g., majority rule or a tie-breaker). For agreement in identification of vascular pathology, the percentages are also based on "consensus identification."

Therefore, it appears a consensus method (likely implicitly 3/3 or majority for 2/x scenarios) was used for grading both image quality and pathology identification, with some tables explicitly reporting instances where all three graders agreed.

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

Yes, a comparative effectiveness study was done, comparing the SPECTRALIS device (with its new OCTA module) to a legally marketed predicate device, the RTVue XR. However, this was not an MRMC study comparing human readers with AI assistance versus without AI assistance.

Instead, this study compares the performance of two different medical imaging devices (SPECTRALIS OCTA vs. RTVue XR OCTA) in visualizing vascular structures and pathologies. The AI component, if any, is embedded within the OCTA module's acquisition and processing, but the study design is not to assess the improvement of human readers with AI assistance. It evaluates the device's ability to produce images comparable to an existing device and align with a clinical reference standard (FA/ICGA).

Therefore, no effect size for human reader improvement with AI assistance is provided as that was not the objective of this comparative study.

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

The study does not describe a standalone algorithm-only performance evaluation. The data presented is based on the comparison of images generated by the SPECTRALIS OCTA module (which includes its proprietary algorithm for OCTA) with images from the predicate RTVue XR OCTA, and then these images were evaluated by human experts. The focus is on the device's output, not an autonomous diagnostic algorithm.

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

The primary ground truth for the test set was Fluorescein Angiography (FA) and Indocyanine Green Angiography (ICGA) images, which are considered a defined reference standard for visualizing retinal and choroidal vasculature. This was augmented by expert consensus (three qualified, masked graders) for evaluating image quality and ease of identifying vascular structures and pathologies on both OCTA devices, in comparison to the FA/ICGA reference.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. The study described is a clinical performance study for device clearance, focusing on demonstrating substantial equivalence to a predicate device, not on the development or training of algorithms.

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

Since no information on a training set is provided, how its ground truth was established is not detailed in this document. The study focuses on evaluating the performance of the already developed OCTA module in the SPECTRALIS device.

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 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 thickness and optic nerve head neuroretinal rim paramements, 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 and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode. In K172649, an updated 55° objective lens (WFO2) with enhanced anti-reflective coating was added to allow for Widefield MultiColor imaging, as well as an updated and faster spectrometer, called OCT2 module, a replacement of the patient and data management system, named Heyex 2, restructured user documentation, and Windows 10 support.

The modification to the SPECTRALIS is:
Widefield OCT - In addition to OCT imaging with the standard objective (for posterior segment imaging; 30° field of view) and the Anterior Segment Objective (anterior segment imaging; 30° field of view), OCT imaging is enabled with the Wide Field Objective (WFO) and Wide Field Objective 2 (WFO2). Both objectives provide a 55° diameter circular field of view. The field of view can be reduced by software to 35° and 25°. The only difference between WFO and WFO2 is an enhanced antireflective coating to allow for MultiColor imaging on the WFO2 (cleared in K172649). Both coatings cover the OCT wavelength, so OCT imaging can be enabled for both objective lenses.

This document describes the 510(k) summary for the SPECTRALIS HRA+OCT and variants, a medical device for ophthalmic diagnostic imaging.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are primarily related to non-clinical performance (bench testing) and maintaining substantial equivalence to a predicate device. There are no explicit quantitative clinical acceptance criteria provided in the document in the format of a table with reported device performance against them.

However, based on the "NON-CLINICAL PERFORMANCE SUMMARY" and "OPTICAL RESOLUTION TESTING" sections, we can infer some criteria and reported performance:

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

The document does not describe a test set involving human subjects or clinical data in the traditional sense for evaluating device performance against a diagnostic endpoint. The performance evaluation is based on non-clinical bench testing.

• Sample Size for Test Set: Not applicable, as performance was assessed through bench testing on the device itself and a resolution test chart, not a separate clinical test set.
• Data Provenance: Not applicable, as it's not clinical data. The testing was performed by Heidelberg Engineering GmbH as part of their design control process.

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

Not explicitly applicable to this submission, as the evaluation is primarily for technical performance and substantial equivalence based on bench testing. There is no mention of "ground truth" derived from expert consensus for clinical disease states in this context. The "ground truth" for optical resolution, for example, is established by the known properties of the 1951 USAF resolution test chart.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This submission focuses on the technical modifications and substantial equivalence of the device, not an AI-assisted diagnostic workflow.

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

This device, the SPECTRALIS HRA+OCT, is a diagnostic imaging device that produces images for human interpretation and aids in detection and management. It is not an "algorithm only" device in the sense of AI-driven interpretation. Therefore, a standalone algorithm-only performance study is not directly relevant to this device's function as described. Its performance is related to its ability to acquire high-quality images and measurements, which are then used by clinicians.

7. The Type of Ground Truth Used

For the bench testing described, the "ground truth" effectively refers to physical standards and theoretical evaluations:

• Physical standards: Use of a 1951 USAF resolution test chart to objectively quantify optical lateral resolution.
• Theoretical evaluations: The measured optical resolution values were compared to theoretical expectations.
• Predicate device's established performance: The primary "ground truth" for this 510(k) is the performance and safety profile of the legally marketed predicate device (K172649), to which the modified device claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing imaging device, not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI algorithm mentioned for this device submission.

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 photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform 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, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode.

The modifications to the SPECTRALIS are:

1. OCT2 Module (OCT2) replacement of the Line Scan Camera and PC interface. OCT2 was developed due to the discontinuation of components.
2. Wide Field Objective 2 (WFO2) The WFO provides a 55° diameter circular field of view. The field of view can be reduced by the software to 35° and 25°. The AR-coating of the WFO was optimized in order to reduce the remaining reflections at the MultiColor wavelengths 486 nm. 518 nm and 815 nm. The AR-coating also allows for MultiColor imaging.
3. An upgrade to the data and patient management system (Heyex 2). Heyex 2 has the same basic functionality as the data and patient management system of the cleared SPECTRALIS, Heyex 1. The main improvements of Heyex 2 compared to Heyex 1 are an up-to-date and more scalable underlying image database, and a modern User Interface.
4. Windows 10 Operating System support.
5. Labeling The user manual has been updated to (1) improve clarity, (2) improve grammar and (3) include the modifications made to the SPECTRALIS HRA+OCT and variants. The Intended Use/Indications for Use of the modified device, as described in the labeling has not changed as a result of the modifications.

This FDA 510(k) summary does not contain information about a study that assesses a device's performance against specific acceptance criteria. Instead, it details modifications made to an existing device (SPECTRALIS HRA+OCT and variants) and argues for its substantial equivalence to a previously cleared predicate device (K152205).

The document's primary argument is that the modifications (OCT2 Module replacement, Wide Field Objective 2, Heyex 2 software upgrade, Windows 10 support, and labeling updates) do not change the intended use, indications for use, or fundamental scientific technology of the device. Therefore, no new clinical studies demonstrating performance against acceptance criteria are presented.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Reported Performance: No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are defined or reported. The document focuses on demonstrating that the modified device functions similarly to its predicate.
• Sample Sizes (Test/Training) & Data Provenance: No test or training sets are mentioned, as this is not a study assessing new clinical performance.
• Expert Ground Truth & Adjudication: These concepts are relevant to clinical performance studies, which are not detailed here.
• MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study, with or without AI assistance, as AI is not a component of this device as described.
• Standalone Performance: The document doesn't describe a 'standalone' performance study in the context of an algorithm's diagnostic accuracy. It's about ensuring the modified hardware and software components maintain the proven functionality of the predicate.
• Type of Ground Truth: Not applicable, as no performance study is being presented.
• Training Set Sample Size & Ground Truth: Not applicable, as no machine learning algorithm is being trained for diagnostic purposes in this context.

In essence, this 510(k) submission relies on the concept of substantial equivalence, where the modified device is deemed safe and effective because its changes are minor and do not alter its fundamental nature or intended use compared to a device already cleared by the FDA. The "study" here is more accurately described as a technical and risk assessment to confirm that the modifications do not negatively impact the device's established safety and effectiveness.

The "Non-Clinical Performance Summary" section mentions evaluations against recognized consensus standards (ISO 14971, AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993 series, IEC 60825-1, and AAMI/ANSI/IEC 62304). These standards cover aspects like:

• Risk management (ISO 14971)
• Medical electrical equipment safety (AAMI / ANSI ES60601-1)
• Electromagnetic compatibility (IEC 60601-1-2)
• Biocompatibility (ISO 10993 series)
• Laser product safety (IEC 60825-1)
• Medical device software lifecycle processes (AAMI / ANSI / IEC 62304)

Meeting these standards serves as the "acceptance criteria" for the non-clinical aspects of the device's modifications, ensuring that the new components and software continue to meet established safety and quality requirements. However, these are not tied to specific diagnostic performance metrics (e.g., sensitivity/specificity for disease detection) because the device's core diagnostic capabilities are considered unchanged from the predicate.

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 (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including agerelated macular degeneration, macular edema, diabetic retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include normative databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal paraments, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

The SPECTRALIS HRA+OCT is a real-time imaging system of anterior and posterior segments of the human eye and for aiding in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma.

The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). OCT imaging includes high-resolution cross-sectional imaging of ocular structures (e.g., retina, macula, optic nerve head); cSLO imaging includes high-resolution and dynamic infrared reflectance, blue reflectance, fluorescein angiography, indocyanine green angiography, and autofluorescence imaging. OCT images and cSLO images are acquired simultaneously and are viewed side-by-side on the computer screen. Images are acquired and stored using SPECTRALIS operation software, which runs on a standard personal computer. SPECTRALIS components include a laser scanning camera mount with headrest, operation panel, power supply box, operation software, and host computer. A MultiColor option is included to provide additional green reflectance imaging and a "composite color" image, which provides a different view of the features of the eye. This composite color image is not the same as fundus color photo. This submission includes Enhanced Depth Imaging (EDI) as an optional viewing mode that allows for better visualization of deep eye structures below the retina.

The provided document describes the SPECTRALIS HRA+OCT device and its updated version, focusing on software version 6.0. The acceptance criteria and the study proving the device meets them are primarily related to the precision and agreement of measurements of retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) neuroretinal rim width (BMO-MRW). The document establishes "within specified range" and "small and within expected ranges and below predefined thresholds" as acceptance criteria for precision and agreement, respectively.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative ("within the specified range," "small and within expected ranges and below predefined thresholds") rather than specific numerical thresholds presented in a table format. However, the study results, presented as coefficients of variation (CV) for precision and limits of agreement (LOA) for agreement, demonstrate that the device achieved these general criteria.

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

• Precision Study (Test Set):

  • Sample Size: 34 subjects enrolled, data from 32 subjects included in analysis (16 healthy eyes, 16 glaucomatous eyes), 16 left and 16 right eyes.
  • Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.

• Agreement Study (Test Set):

  • Sample Size: 48 subjects enrolled, data from 40 subjects included in analysis (20 healthy eyes, 20 glaucomatous eyes), 20 left and 20 right eyes.
  • Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.

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

• Precision Study: "Three qualified individuals, each operating one of three Spectralis devices equipped with the study software, performed the study device measurements." These could be the "experts" performing the measurements that form the basis of the precision analysis. Also, "All acquired images were inspected by three experienced physicians for image quality... and layer segmentation."

  • Number of Experts: 3 (for both operators and image inspection)
  • Qualifications: "Qualified individuals" for device operation; "experienced physicians" for image quality inspection. Specific years of experience or specialization (e.g., radiologist) are not provided.

• Agreement Study: "All acquired images were inspected by the investigator for image quality... and layer segmentation."

  • Number of Experts: 1 (the investigator).
  • Qualifications: "Investigator" who inspected for image quality. Specific qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth diagnoses for the test sets in either the precision or agreement studies. The "ground truth" for these studies is the measurement values themselves and their statistical consistency, rather than a diagnostic label. For image quality and layer segmentation, images were inspected by experts, but no multi-reader adjudication process is detailed beyond inspection.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The studies focus on the precision and agreement of the device's measurements compared to a predicate device and within itself.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system (OCT/cSLO) that performs measurements. The precision and agreement studies evaluate the measurement capabilities of the device (software version 6.0 with APS) in performing these measurements. These studies are essentially standalone evaluations of the device's measurement accuracy and consistency, as the "algorithm" here refers to the device's ability to acquire and process images to produce measurements. While operators ("qualified individuals") are involved in acquiring the images, the evaluation is of the device's output (measurements and their consistency), which is driven by its internal algorithms for processing. Therefore, the precision and agreement studies can be considered standalone performance assessments of the device's measurement functions.

7. The Type of Ground Truth Used

• Precision and Agreement Studies: The "ground truth" here is the measurement values themselves. These studies assess the device's ability to consistently reproduce measurements (precision) and agree with measurements obtained by a previous method/device (agreement). The reference ranges for "normal" are derived from large normative databases (see point 9).

8. The Sample Size for the Training Set

The document refers to "reference databases" which serve a similar purpose to a training set for normative comparisons.

• RNFL Thickness Reference Database: 330 eyes of 330 normal subjects.
• BMO-MRW Reference Database: 368 eyes of 368 normal subjects.

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

The "ground truth" for the reference databases (training sets) was established by rigorously selecting "normal subjects" based on strict inclusion/exclusion criteria in prospective, multi-center, observational studies.

• Inclusion Criteria for Normal Subjects (RNFLT and BMO-MRW Databases):
  • Healthy eyes without prior intraocular surgery (except cataract surgery or Lasik).
  • No clinically significant vitreal, retinal, or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
  • No history of glaucoma.
  • Intraocular pressure ≤21 mmHg.
  • Best corrected visual acuity ≥0.5.
  • Refraction between +6 and -6 diopters, astigmatism ≤2 diopters.
  • Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
  • Clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape.

These criteria, applied by clinical investigators, define what constitutes a "normal" ground truth for the purpose of creating the normative databases.

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