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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.

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