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The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and measurement of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and nonmydriatic conditions.

P200TE is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.

The P200TE includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics.

The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

The P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals.

The P200TE delivers images in the following image modes:

• . Scanning Laser Ophthalmoscopy
• . Reflectance imaging
• . Autofluorescence imaging
• . Optical Coherence Tomography

The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.

The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.

The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user.

The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eve by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the images are generated from the captured detector data.

P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation. A Reference Database enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population. Segmentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.

P200TE automatic seqmentation provides comprehensive retinal and optic nerve head information, including:

• . Full Retinal Thickness (FRT)
• . Ganglion Cell Complex Thickness (GCC)
• ONH Analysis
• ONH Nerve Fiber Layer Thickness

The P200TE refers to the scan head component of the system. together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems.

The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.

Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.

The provided text describes the P200TE device, a non-contact scanning laser ophthalmoscope and optical coherence tomographer. The primary purpose of the submission K233602 is to introduce a Reference Database (RDB) feature to the previously cleared P200TE, enabling the comparison of OCT segmentation analysis results to a known healthy population.

The acceptance criteria for the P200TE with the Reference Database are not explicitly stated in a quantitative table format with pass/fail metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Optovue iVue and previous P200TE) by showing that the updated P200TE has the same intended use, technological characteristics, principles of operation, and similar indications. The "acceptance criteria" are implied to be centered around the clinical performance testing of the Reference Database, specifically its ability to establish reliable cut-off values for various retinal and optic nerve head measurements based on a healthy cohort, and the effective color-coding of results for interpretation.

Here's an attempt to structure the information based on the provided text, inferring acceptance criteria from the study's design and reported results:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

• Central Foveal Thickness: Mean 247.04, 1st %ile: 195.74, 5th %ile: 212.32, 95th %ile: 283.34, 99th %ile: 302.84.
• Superior Parafoveal Thickness: Mean 315.00, 1st %ile: 278.64, 5th %ile: 290.54, 95th %ile: 339.33, 99th %ile: 351.57.
• And similar detailed statistics for Temporal, Inferior, Nasal Parafoveal, and Perifoveal thicknesses (see Table 4).
  Color-coding implemented: Values below 5% light blue, below 1% dark blue; values above 95% amber, above 99% red. |
  | Ganglion Cell Complex (GCC) Thickness Measurements:
  Ability to define statistically sound cut-off values for GCC measurements to differentiate "normal" from "borderline" or "outside normal." | GCC Thickness Measurements:
• Total Average: Mean 108.03, 1st %ile: 88.01, 5th %ile: 95.31, 95th %ile: 120.45, 99th %ile: 124.09.
• Superior Hemiretina: Mean 107.90, 1st %ile: 87.88, 5th %ile: 95.65, 95th %ile: 120.09, 99th %ile: 124.37.
• Inferior Hemiretina: Mean 108.16, 1st %ile: 87.22, 5th %ile: 94.20, 95th %ile: 121.44, 99th %ile: 125.07.
  Color-coding implemented: Values below 5% amber, below 1% red. |
  | Retinal Nerve Fiber Layer (RNFL) Measurements:
  Ability to define statistically sound cut-off values for RNFL measurements, considering optic disc size, to differentiate "normal" from "borderline" or "outside normal." | RNFL Measurements (stratified by optic disc size):
• Average RNFL, Temporal, Superior, Inferior, and Nasal Quadrant RNFL over TSNIT Circle (see Table 6 for detailed percentiles and means for Small, Medium, and Large optic disc groups).
  Color-coding implemented: Values below 5% amber, below 1% red. |
  | Optic Nerve Head (ONH) Analysis:
  Ability to define statistically sound cut-off values for ONH parameters (C/D Vertical, C/D Horizontal, C/D Area, Rim Area), considering optic disc size, to differentiate "normal" from "borderline" or "outside normal." | ONH Measurements (stratified by optic disc size):
• C/D Vertical, C/D Horizontal, C/D Area, Rim Area (see Table 7 for detailed percentiles and means for Small, Medium, and Large optic disc groups).
  Color-coding implemented: Values above 95% amber, above 99% red. |
  | Non-clinical Performance:
  Device meets defined functional and non-functional specifications.
  Compliance with relevant electrical, laser, and EMC standards.
  Software verification and validation. | Non-clinical system testing showed the system met defined specifications, with no concerns.
  Type tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and ANSI Z80.36-2021.
  Software V&V conducted according to QMS processes.
  All testing passed with no additional safety or performance concerns. |

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

• Test Set Sample Size: 860 eyes for full retina thickness and GCC measurements. For RNFL and ONH measurements, the sample was stratified by optic disc size:
  • Small optic disc ( 2.15 mm2): 254 eyes for RNFL, 255 eyes for ONH.
  • Overall, 879 eyes were enrolled in the study.
• Data Provenance: The document does not explicitly state the country of origin. It describes the age distribution as "skewed toward older eyes...to better match the age distribution typically found in eye clinics," implying a focus on a patient population that would likely use the device. It also mentions "good racial and ethnic diversity" (15% Hispanic, 16% Asian, 14% Black or African American, and 57% White), which suggests a US-based or diverse multinational cohort. The study was prospective in the sense that it established a reference database from healthy eyes for future comparison, effectively a one-time data collection for the database.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The ground truth for the reference database was established by collecting data from "healthy eyes." The criteria for defining an eye as "healthy" for inclusion in the reference database are not detailed (e.g., based on clinical examination by ophthalmologists, absence of specific diseases).

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method for the test set. The study describes the creation of a "reference database of healthy eyes" and the use of "non-parametric analysis to determine the 1%, 5%, 95%, and 99% cut off values." This suggests a statistical approach to defining "normalcy" from the collected data, rather than individual case adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance and the establishment of a reference database for interpretation by human users, not on the improvement of human readers with AI assistance beyond providing a data comparison tool. The device provides "automatic segmentation" but the core of the submission (K233602) is the RDB facilitating comparison guidance, not an AI-assisted diagnostic workflow assessment involving human readers.

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

• Yes, in essence, the study evaluated the standalone performance of the algorithm's segmentation and RDB comparison feature by establishing the statistical distribution and cut-offs from a healthy population. The "clinical performance testing" section primarily details the generation of these normative values and their statistical validity. The device performs "automatic segmentation," and the RDB then compares these segmented measurements to a normative dataset. The study does not describe a human-in-the-loop performance study for this specific submission's purpose (adding the RDB).

7. The Type of Ground Truth Used

• The ground truth for the Reference Database was derived from clinical data collected from a cohort of "healthy eyes." The specific criteria for "healthy" status and whether this involved expert consensus, clinical outcomes, or other methods are not detailed. It is explicitly stated that the "age distribution was intentionally skewed toward older eyes... Because of this, age-related corrections were not necessary for this database," suggesting the definition of "healthy" for each age group was considered stable across the cohort.

8. The Sample Size for the Training Set

• The document refers to the data collected as the basis for the "reference database." This dataset of 879 eyes (with 860 eyes analyzed for FRT and GCC, and stratified numbers for RNFL and ONH based on disc size) effectively serves as the "training set" or "normative dataset" from which the cut-off percentiles were derived.

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

• The ground truth for the "training set" (the healthy reference database) was established through a clinical study that enrolled "healthy eyes." The data from these eyes were then used in a non-parametric statistical analysis to determine the 1st, 5th, 95th, and 99th percentile cut-off values for various OCT measurements. The document states, "The cut-off values were determined using a non-parametric analysis to reduce potential bias introduced when using standard parametric techniques due to their underlying assumptions." For RNFL and ONH measurements, the database was further partitioned into three strata based on optic disc size to account for its influence. This statistical derivation from a healthy population defines the "ground truth" for the RDB's comparative function.

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The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions.

It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.

The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals.

The P200TE delivers images in the following image modes:

• Scanning Laser Ophthalmoscopy
• . Reflectance imaging
• Autofluorescence imaging
• . Optical Coherence Tomography

The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.

The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.

The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user.

The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eye by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the images are generated from the captured detector data.

P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.

P200TE automatic segmentation provides comprehensive retinal and optic nerve head information, including:

• . Full Retinal Thickness (FRT)
• . Ganglion Cell Complex Thickness (GCC)
• . ONH Cup and Disc Analysis
• . ONH Nerve Fiber Layer Thickness

The P200TE refers to the scan head component of the system, together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems.

The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.

Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.

Here's a summary of the acceptance criteria and study details for the P200TE device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The study for the P200TE focused on demonstrating agreement and precision compared to the predicate device, Optovue iVue, across various measurement parameters. The performance goals for acceptance were met for these parameters, with specific quantitative targets implied by the "Limit (Ratio)" in the precision tables, representing the upper limit of the coefficient of variation (CV%) or similar measure relative to an acceptable threshold.

Table of Acceptance Criteria and Reported Device Performance

Note on "Limit (Ratio)": The tables provide values like "6.2813 (1.1660)" for Fovea Thickness Repeatability. While the exact acceptance threshold isn't explicitly stated, the presented values (e.g., CV% and the Limit Ratio) are the reported performance that met the performance goals for the study.

Study Details

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

   • Sample Size: 106 subjects.
     • 35 subjects without ocular pathology (normal)
     • 35 subjects with glaucoma
     • 35 subjects with retinal pathology
     • (One subject was withdrawn, making the effective test set 105 or 106, depending on when the withdrawal occurred relative to analysis; the document states "106 subjects were enrolled" and then "one subject was withdrawn" without specifying if the analysis excludes this subject, but typically enrolled subjects would be analyzed or replaced.)
   • Data Provenance:
     • Country of Origin: Not explicitly stated. The applicant is based in the United Kingdom, but the study type ("single site study") does not specify location.
     • Retrospective or Prospective: Prospective.

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

   • The document does not explicitly state that experts were used to establish ground truth for the test set. The study focuses on agreement and precision between the P200TE and the predicate iVue device, rather than against an external expert-derived ground truth. The disease classifications (normal, glaucoma, retinal pathology) would have been determined by clinical diagnosis, presumably by qualified ophthalmologists, but the methods for this are not detailed as a separate "ground truth" establishment process for the measurements themselves.

3. Adjudication method for the test set:

   • None was explicitly described for establishing ground truth for the measurements. The study design involved three operators acquiring scans on three P200TE devices and three iVue predicate devices (a "3x3 crossed study"). Analysis focused on repeatability (within-device/operator consistency) and reproducibility (between-device/operator consistency) and agreement between the P200TE and iVue.

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:

   • No explicit MRMC comparative effectiveness study was done focusing on human readers improving with AI assistance. This study was a technical performance comparison between two devices (P200TE and iVue) and their measurement consistency, not an evaluation of human-in-the-loop performance. While the devices provide "analysis" and "aid in detection, diagnosis, documentation and management," the study did not measure clinical outcomes or the impact of the device on human reader performance.

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

   • Yes, a standalone performance assessment was conducted for the P200TE's segmentation and measurement capabilities. The study evaluated the "agreement and precision analysis...on all measurement parameters for Full Retina Thickness (FRT), Retinal Nerve Fiber Layer (RNFL) thickness, Ganglion Cell Complex (GCC) thickness, and Optic Nerve Head (ONH) measurements" directly from the device's output, comparing it to the predicate device's output. The automatic segmentation and analysis features of the P200TE are central to this.

6. The type of ground truth used:

   • For the quantitative measurements (FRT, RNFL, GCC, ONH), the "ground truth" in this comparative study was effectively the measurements obtained from the legally marketed predicate device (Optovue iVue), to which the P200TE's measurements were compared for agreement. The study also evaluated the device's own internal consistency (repeatability and reproducibility).
   • For subject classification (normal, glaucoma, retinal disease), this would be based on clinical diagnosis, which serves as the categorization of the patients.

7. The sample size for the training set:

   • The document does not provide information on the sample size for the training set for the P200TE's automatic segmentation or analysis algorithms. This section focuses solely on the clinical performance testing for device validation.

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

   • The document does not provide information on how the ground truth for the training set was established, as details about the training set itself are not included.

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The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroido-scleral interface. It is indicated for producing high-resolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures.

The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.

P200TxE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography. The device is intended to be used by ophthalmic and optometry health care professionals, most commonly in a hospital environment.

The P200TxE delivers images in the following image modes:

• Scanning Laser Ophthalmoscopy
  • Red and green reflectance
  • Green-pumped autofluorescence
  • Fluorescein Angiography
  • Indo-Cyanine Green Angiography
• Optical Coherence Tomography

The P200TxE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.

The P200TxE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the human fundus.

The P200TxE instrument uses infrared laser illumination for reflectance imaging simultaneously with OCT imaging. Infra-red reflectance images are used to track eye position during OCT imaging and are not available to the user. The P200TxE instrument uses infrared swept-source laser illumination for optical coherence tomography allowing a depth profile of the reflectance of the human fundus to be recorded.

The P200TxE instrument uses blue laser illumination to excite emission from Sodium Fluorescein dye which is injected into the patient's bloodstream in a separate medical procedure as part of a Fluorescein angiography (FA) examination.

The P200TxE instrument uses Infra-red (IR) laser illumination to excite emission from Indocyanine Green dye which is injected into the patient's bloodstream in a separate medical procedure as part of an Indocyanine Green anqiography (ICG) examination.

Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other DICOM compliant PACS viewers.

The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures. It is indicated for producing high-resolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit, quantitative acceptance criteria for image quality or diagnostic performance as typically seen for AI/CADe devices. However, the qualitative findings of the comparative study serve as the "reported device performance" against an implicit acceptance criterion of non-inferiority to the predicate device.

• ISO 15004-2:2007 Ophthalmic Instruments Fundamental requirements and test methods - Part 2: Light hazard protection
• IEC 60825-1 Safety of Laser Products
• IEC 62366: Application of usability engineering to medical devices | Results of bench testing demonstrated that the Optos P200TxE complies with the relevant recognized consensus standards. |

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

• Sample Size: Not explicitly stated. The document mentions "images of retina patients" but doesn't quantify the number of patients or images included in the comparative qualitative OCT image grading study.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: "three graders" were used.
• Qualifications of Experts: Not explicitly stated. The document refers to them as "graders" but does not provide details of their specific qualifications (e.g., ophthalmologist, optometrist, years of experience, subspecialty).

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly described as a formal adjudication method (e.g., 2+1, 3+1). The document states that "The average grading result across all three graders found the P200TxE images were graded higher..." and "A Kappa analysis shows the graders had reasonably good agreement in their results, and all three graders had similar trends in their scoring." This suggests that individual expert scores were aggregated or analyzed for concordance, but a specific rule for establishing a single ground truth from dissenting opinions (e.g., majority vote or third expert tie-breaker) is not detailed.

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. This study was a comparison of two different medical imaging devices (P200TxE vs. P200TE/P200DTx) and not a study assessing the improvement of human readers with AI assistance. The P200TxE itself is an imaging device, not an AI/CADe system.

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

• Not Applicable. This device is an imaging system designed for human operation and interpretation. The "clinical data" section pertains to the quality and utility of the images produced by the device, which are then interpreted by human practitioners.

7. The Type of Ground Truth Used:

• Expert Consensus/Grading: The "ground truth" for the comparison of OCT image quality and visualization of pathology was established through the qualitative grading by "three graders." This can be considered a form of expert consensus on image utility and quality, rather than a definitive "ground truth" derived from a separate, more objective standard like pathology (biopsy) or long-term clinical outcomes.

8. The Sample Size for the Training Set:

• Not Applicable. The P200TxE is an imaging device, not an AI/CADe algorithm that requires a "training set" in the context of machine learning. The device's functionality is based on its optical and hardware design.

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

• Not Applicable. As explained above, the device is not an AI/CADe algorithm, so the concept of a training set and its ground truth is not relevant here.

Ask a specific question about this device

The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retinal nerve fiber layer and optic disc. It is indicated for producing high-resolution, widefield, en face reflectance images, autofluorescence images, and axial, cross-sectional images of the posterior ocular structures.

The P200TE is based on Scanning Laser Ophthalmoscope (SLO) technology which scans in two dimensions over the retina. Light reflected from the retina is detected and transformed into a digital image. Images may be stored and subsequently reviewed. The P200TE allows images to be captured in the following imaging modes: Reflectance imaging, Autofluorescence imaging, Optical coherence tomography imaging. The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths. The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the human fundus. The P200TE instrument uses infrared laser illumination for reflectance imaging simultaneously with OCT imaging. Infra-red reflectance images are used to track eye position during OCT imaging and are not available to the user. The P200TE instrument uses infrared superluminescent diode (SLD) illumination for optical coherence tomography allowing a depth profile of the reflectance of the human fundus to be recorded. The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eye by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores returns through the same path to the detectors; the images are generated from the captured detector data. This is operationally installed to be networked with computer peripherals and proprietary software that facilitate the storage, management and viewing of the retinal images. The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PC's are connected via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.

The provided text focuses on establishing substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance metrics. However, it does describe a clinical study conducted to demonstrate the device's similarity to its predicate for qualitative clinical use.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for device performance. Instead, the "acceptance criteria" for the study were implicitly tied to demonstrating non-inferiority and similarity in image quality for qualitative clinical use compared to the predicate device.

• Linearly weighted Cohen's kappa analyses showed adequate inter-grader agreement in scoring.
• Results "showed that the image quality for purposes of qualitative clinical use are similar between the P200TE and the Spectral OCT/SLO." |
  | Compliance with recognized consensus standards (Non-Clinical) | - P200TE complied with ISO 15004-2:2007 (Light hazard protection), IEC60825-1 (Safety of Laser Products), and IEC 62366 (Usability engineering).
• Results of bench testing demonstrated compliance with relevant recognized consensus standards. |

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

• Sample Size: 35 participants (32 study eyes).
• Data Provenance: Prospective, observational study at a single U.S. clinical site.

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

• Number of Experts: Three independent, masked graders.
• Qualifications of Experts: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). However, they were referred to as "graders" at a "third-party reading center" and "qualitatively evaluated the images based on pre-specified grading criteria... for qualitative clinical use," suggesting they were likely ophthalmologists, optometrists, or trained image graders with expertise in ocular imaging.

4. Adjudication Method for the Test Set

• The document states that "three independent, masked graders qualitatively evaluated the images." It then notes that "The grading results from the two devices were then compared using one-tailed Wilcoxon signed-rank test analyses... and linearly weighted Cohen's kappa analyses."
• The use of "independent" graders and the subsequent statistical comparison (including inter-grader agreement with kappa) suggests a consensus or comparison approach, rather than a strict 2+1 or 3+1 adjudication rule where disagreements are explicitly resolved by a third party. The primary goal was to assess agreement and similarity across graders and between devices.

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

• Yes, a form of MRMC study was conducted. Three independent graders evaluated images from both the P200TE and the predicate device (Spectral OCT/SLO) across multiple cases (32 study eyes from 35 participants).
• Effect Size of Human Readers' Improvement with AI vs. without AI Assistance: This information is not applicable/not provided. The study described is a comparison of two imaging devices (P200TE vs. Spectral OCT/SLO) in terms of image quality for qualitative clinical use, not an AI-assisted interpretation study. The P200TE is an imaging device, not an AI algorithm designed to improve human reading.

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

• Not applicable/not provided. The P200TE is an ophthalmoscope and optical coherence tomographer, a diagnostic imaging device. Its performance is assessed in terms of image quality for human interpretation, not as a standalone algorithm performing automated detection or diagnosis.

7. Type of Ground Truth Used

• The ground truth for the qualitative evaluation of image quality was established by expert assessment/consensus based on "pre-specified grading criteria... based on the presence or absence of clinically relevant structures and anatomic boundaries and on the overall image clarity necessary for qualitative clinical use."
• The "truth" for the study was not about disease presence (e.g., pathology, outcomes data) but rather the quality of the images produced by the device as judged by experts.

8. Sample Size for the Training Set

• Not provided/not applicable. The P200TE is an imaging device (hardware and embedded software) for image acquisition, not an AI model that requires a training set of images for learning. The document describes clinical validation of the device's output, not the development of a trained algorithm.

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

• Not provided/not applicable. As mentioned above, this device is not an AI model that underwent a training phase on a labeled dataset. The study focused on validating the image quality of the P200TE compared to its predicate for human interpretation.

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OptosAdvance 4.0 is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports, videos, and measurement of DICOM-compliant images.

The OA4 software application provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The OptosAdvance user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

The key features of OptosAdvance 4.0 include the ability to:

• Acquire, store, retrieve and display DICOM image data;
• Access patient data securely:
• Search patient studies and select images for closer examination:
• Interactively manipulate an image to visualize anatomy and pathology;
• Select multiple images for comparison;
• Annotate, tag and record selected views;
• Measure distance (linear) and area of DICOM images;
• Manage, backup and archive data;
• Import and export data to network storage devices;
• Securely access and transfer data: and
• Output selected views to printers.

The software relies on images being provided to a specified network path on the OptosAdvance Server by the connected ophthalmic device (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.) in a DICOM-compliant format. The software will then place the image and associated data on the network storage unit in a format which will allow the image to be available via a securely connected web browser. Locally archived studies will be securely pushed to the remote archive server for storage. The archive in the remote secure server serves as disaster recovery storage as well as access to the patient history.

The provided text describes OptosAdvance 4.0 software, a Picture Archiving and Communication System (PACS), and its substantial equivalence to predicate devices. The approval is based on non-clinical performance testing.

Here's a breakdown of the requested information:

1. A 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 explicitly state the sample size for the test set or the data provenance for the performance testing. It mentions "previously acquired medical images" for verification, validation, and evaluation, and "DICOM objects that contain features with known dimensions" for equivalence tests. This suggests the use of retrospective or simulated data, but specifics are not provided. Given the nature of a PACS system, the "data" would consist of DICOM images.

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 document does not specify the number of experts or their qualifications used to establish ground truth. For the measurement equivalence tests, "known dimensions" implies a pre-established ground truth, likely from the creation of the DICOM objects themselves or from other validated measurement tools, rather than expert annotation.

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

The document does not describe any adjudication method. The performance testing appears to be based on objective comparisons (e.g., measured values vs. known dimensions, checking if features operate as required) rather than subjective expert review requiring 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 MRMC comparative effectiveness study was done. OptosAdvance 4.0 is a PACS system designed for managing, displaying, and measuring ophthalmic data, not for providing AI assistance to human readers for diagnostic interpretation. Therefore, there is no mention of human reader improvement with or without AI assistance. The submission specifically states: "Thus, clinical studies are not required to support the subject device's safety and effectiveness; the non-clinical objective test methods used for evaluation demonstrate that the software's performance is equivalent to that of the legally marketed predicates."

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

Yes, the performance testing described is effectively standalone testing of the software's functionalities. The "equivalence tests" for measurements involve the software's ability to provide measurements accurately compared to known dimensions. The overall software verification and validation are for the algorithm's performance in managing and displaying data, not for human-in-the-loop diagnostic accuracy. The device itself is described as a "standalone, browser-based software application."

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

For the measurement tests, the ground truth was "known dimensions" embedded within DICOM objects. For general software functionality, the ground truth would be the defined requirements and specifications of the software.

8. The sample size for the training set

The document does not describe a training set. This is not an AI/machine learning device that requires a training set. It is a PACS system.

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

Not applicable, as there is no training set for this type of device.

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The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

The Optos P200DTx is a scanning laser ophthalmoscope that uses lasers as a light source to illuminate the eye. The device consists of the following components and accessories:

• . A scanhead which houses the lasers, the scanning elements of the light input path and the light return path including the detectors which convert light into electronic signal. The scanhead with its integral head and chin rest forms the key patient interface in conjunction with a facepad and associated aperture where the eye is placed. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
• . A touchscreen is attached by a cable to the scanhead to assist the operator in optimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken. Patient positioning and image capture can also be conducted via a hand control.
• o A personal computer with a monitor to allow image review and storage in a Windows environment.

The provided text is a 510(k) summary for the P200DTx scanning laser ophthalmoscope. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria and a study proving a device meets these criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on compliance with engineering specifications, safety standards, and biocompatibility. There is no information about diagnostic performance metrics (like sensitivity, specificity, accuracy) or clinical studies involving human patients to assess the device's ability to aid in diagnosis or monitoring of diseases.

Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical performance studies, which are not detailed here.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily engineering and safety specifications, not clinical performance metrics related to diagnostic accuracy.

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

• Test set: The document refers to "in-house developed test targets" for device specifications and "off the shelf commercial ray tracing software" for patient eye variation. These are technical tests, not clinical evaluations on a human patient test set. Therefore, there is no sample size of human patients or data provenance (country, retrospective/prospective) for a clinical test set mentioned.
• Data provenance for safety/engineering: The testing was done internally by Optos Plc. ("in-house developed test targets," "internal design validation"). The data provenance is from the manufacturer's testing, not from a clinical patient population.

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

Not applicable. The tests described are engineering and safety tests, not diagnostic performance evaluations requiring expert clinical ground truth.

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

Not applicable, as there is no clinical test set or diagnostic accuracy evaluation mentioned.

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. This document is for a medical imaging device (ophthalmoscope), not an AI-powered diagnostic system. There is no mention of AI or MRMC studies.

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

Not applicable. The P200DTx is a medical imaging device that requires a human operator and interpretation. It is not an algorithm performing a standalone diagnostic task.

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

For the engineering and safety tests, the "ground truth" was established by the specifications and standards themselves (e.g., a specific optical resolution, a safety threshold, a biocompatibility limit). No clinical ground truth (like pathology or expert consensus on disease presence) is mentioned.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:

• A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
• A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.
• · A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
• A personal computer with a monitor to allow image review and storage in a Windows . environment.

The provided text describes the Optos Daytona ICG (P200TICG) Ophthalmoscope and its substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria and specific reported device performance in the way typically found for a diagnostic algorithm or a clinical trial.

Instead, the performance data presented focuses on engineering and safety compliance rather than a clinical effectiveness study against specific diagnostic metrics.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition) are explicitly stated for the Daytona ICG (P200TICG) device in the provided text. The performance data focuses on compliance with various safety and operational standards.

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

• Sample Size for Test Set: No specific "test set" in a clinical sense (i.e., human subjects or patient data for diagnostic accuracy) is mentioned. The performance data relies on laboratory ex vivo testing and compliance with engineering standards.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective):
  • Ex Vivo Testing: Equine blood and a phantom eye were used. This is a laboratory setting, not clinical patient data.
  • Electrical, Light Hazard, Biocompatibility, Software Testing: Conducted to international standards (e.g., IEC, ISO). The location of these tests is not specified in the summary, but the submitter is based in the UK. This is engineering verification, not clinical data provenance.

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

• This information is not provided as there was no clinical "test set" for diagnostic performance in the traditional sense, and thus no expert ground truth establishment for a clinical diagnosis. The "ground truth" for the ex-vivo testing was based on known concentrations of ICG in equine blood.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• This information is not applicable as there was no clinical "test set" requiring expert adjudication for diagnostic ground truth.

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 MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This device is a standalone imaging device, not an AI diagnostic algorithm.

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

• This device is an imaging instrument (ophthalmoscope), not an algorithm. Its performance is evaluated based on its ability to capture images and meet safety/engineering standards, not as a diagnostic algorithm. Therefore, "standalone" algorithm performance in the context of an AI device is not applicable. The device itself operates "stand-alone" in terms of capturing images for physicians to interpret.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the ex-vivo testing, the "ground truth" was the known, controlled concentrations of indocyanine green (ICG) in equine blood passing through a phantom eye.
• For safety and electrical testing, the ground truth was compliance with international standards and regulations (e.g., IEC, ISO).

8. The Sample Size for the Training Set

• This information is not applicable. The document describes an imaging device, not an AI model that would require a training set.

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

• This information is not applicable as there was no training set for an AI model.

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The Optos spectral OCT/SLO with Microperimetry is indicated for use for in vivo viewing, axial cross section, and three dimensional imaging and measurement of posterior ocular structures including retina, macula, retinal nerve fiber layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior of the eye. In addition, cornea sclera and conjunctiva can be imaged with the system by changing the focal position.

The additional microperimetry functionality is indicated for use as a fixation examiner locating the patient's fixation site and by using the patient's subjective answer to light stimuli, generating a sensitivity map of the inspected retinal region.

The Optos OCT/SLO Microperimeter is a non-contact, non-invasive, high-resolution device that is an add-on module to the FDA-cleared Optos Optical Coherence Tomography/Scanning Laser Ophthalmoscope (OCT/SLO). The OCT/SLO is a computerized instrument that employs non-invasive, low-coherence interferometry to acquire simultaneous high-resolution cross-sectional OCT and confocal images of ocular structure, including retinal nerve fiber layer, macula and optic disc of the eye. The light source used for this is a super luminescent diode (SLD).

The microperimetry test runs simultaneously with the confocal ophthalmoscope (SLO) and provides real-time tracking of retinal motion and patient fixation during the exam. Additionally, the patient's subjective response by depressing a button to light stimuli generates a sensitivity map for the inspected retinal region. The variable light stimuli are generated by an organic light emitting diode (OLED).

The provided document describes two clinical evaluations for the Optos Spectral OCT/SLO Microperimeter device: a Precision Study and an Agreement Study.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the provided "Repeatability SD Limit*" which is derived from ISO 5725-1 and ISO 5725-6. The "Agreement study" also describes an acceptable range of agreement with the predicate device.

2. Sample Sizes and Data Provenance:

• Precision Study:

  • Sample Size (Test Set): 12 subjects total (4 normal, 4 with early/intermediate AMD, Geographic Atrophy, Diabetic Retinopathy, Macular Edema, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane, or Macular Hole - total 8 diseased subjects, likely 1 eye per subject), with 3 replicates each.
  • Data Provenance: Not explicitly stated, but given the "in-house" nature of the agreement study and the UK submitter, it's likely originating from the UK or a similar region. It appears to be a prospective study based on the "replicates with repositioning at the start of each test" methodology.

• Agreement Study:

  • Sample Size (Test Set): 40 eyes (20 normal, 20 diseased).
  • Data Provenance: "An in-house study was conducted," implying a prospective study conducted by the manufacturer. Country of origin not explicitly stated, but likely the UK given the submitter.

3. Number and Qualifications of Experts for Ground Truth:

• The document does not specify the number of experts or their qualifications for establishing ground truth in either study. Instead, the studies focus on quantitative measurements and their consistency/agreement, rather than a subjective assessment of clinical findings by experts. The "diseased" and "normal" classifications infer a pre-existing diagnosis, but the process of confirming these diagnoses for the study subjects is not detailed.

4. Adjudication Method:

• The document does not mention any adjudication method for establishing ground truth in either study. The precision study focuses on repeatability of measurements, and the agreement study compares device measurements to a predicate device.

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

• No MRMC comparative effectiveness study is reported in the provided text. The studies focus on device performance (precision, agreement) and not on human reader improvement with or without AI assistance.

6. Standalone Performance (Algorithm Only):

• Yes, the studies describe standalone performance. Both the Precision Study and the Agreement Study evaluate the device's ability to produce consistent and comparable measurements without explicit human interpretation being part of the primary outcome assessment. The "patient's subjective answer to light stimuli" is input for the microperimetry functionality, but the reported performance metrics are related to the device's measurement and tracking capabilities.

7. Type of Ground Truth Used:

• The ground truth for the Precision Study is implicitly defined by the physical state of the eye (normal vs. specific pathologies). The study measures the device's consistency in reporting attenuation values for these known states.
• The ground truth for the Agreement Study is the measurement obtained from the predicate device (Nidek MP-1 Microperimeter). The study assesses how closely the Optos device's measurements align with those of an already marketed device.

8. Sample Size for the Training Set:

• The document does not mention a training set or its sample size. The studies described are clinical evaluations for a 510(k) submission, typically focused on verification and validation of the finished device and its algorithms, rather than the development and training of new machine learning models.

9. How the Ground Truth for the Training Set was Established:

• As no training set is mentioned, this information is not applicable.

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The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.

The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems. The Optos Advance Software is an image review application that allows the user to view DICOM compatible images. The Optos Advance Software organizes the digitized images into studies and sessions. The digitized studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between old and new images). The software also allows physicians or technicians to create on-line notes with the ability to zoom in or out (i.e., enlarge or decrease magnification of images) and annotate such images with arrows or text boxes to highlight areas the user determines by training and experience to be of interest. The Optos Advance Software does not automatically highlight, annotate, or otherwise alter the images. In addition, the digitized studies and sessions and on-line notes may be viewed, archived on a central file server, or electronically shared in a secure manner with other health care professionals. The Optos Advance Software allows the user to interface a Scanning Laser Ophthalmoscope, Fundus Camera, OCT or other DICOM compliant diagnostic camera with the Optos Advanced Software via a secure network connection to the Optos Advance Server. The server has a watchdog service which processes the DICOM information sent via the network. The information is then processed and placed in local storage on the Optos Advance Server. The data is obfuscated at the server side to protect any patient information transferred. The Optos Advance Software does not require any customized software installed on the client PC. The images, annotations and DICOM data are all stored on the Optos Advance Server, which handles the archiving, reporting, and retrieval of the data. This server can be set up remotely over an HTTPS connection which allows secure remote transfer of the stored data for archive purposes.

The provided text describes a 510(k) summary for the Optos Advance Software. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general software verification and validation.

The document explicitly states:

• "A full software and system verification and validation was performed as per the Software Development Lifecycle Process in Optos PLC." This is a general statement about standard software development practices, not a detailed performance study with acceptance criteria and results.
• The comparison to the predicate device (Carl Zeiss Surgical GmbH FORUM Software) is based on "substantially similar indications for use" and "minor differences in technological characteristics...raise no new questions of safety and effectiveness." This is an argument for substantial equivalence, not a direct performance study comparing the device against specific metrics.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, or details about MRMC or standalone studies. The document does not contain this type of information.

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The Panoramic 200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

The Optos P200T is a scanning laser ophthalmoscope that uses lasers as a light source that is scanned by a deflection system in two axes across the retina to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary for the Optos P200T Ophthalmoscope, outlining its intended use, principles of operation, modifications from a predicate device (P200CAF), and a determination of substantial equivalence by the FDA.

Specifically, the document focuses on justifying that the P200T is substantially equivalent to its predicate device, the Panoramic 200CAF (K100644), based on similar intended use, indications for use, principles of operation, technological characteristics, and that its minor technological differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information.

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