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The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with <= 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography. The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).

The provided text is a 510(k) summary for the Bioptigen Spectral Domain Ophthalmic Imaging System. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical tests were "Not required" and therefore does not contain information about acceptance criteria or a study proving the device meets those criteria using expert review of clinical data.

The device gained clearance based on non-clinical tests demonstrating conformance to safety and performance standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2) and a technological comparison to predicate devices, showing that differences in resolution, acquisition rate, and internal fixation did not raise new questions of safety and effectiveness.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical performance evaluations which were not conducted or reported for this submission.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Since no clinical performance study was conducted or required for this 510(k) submission, there are no acceptance criteria related to a specific clinical performance metric (e.g., sensitivity, specificity, accuracy against a clinical ground truth). The "performance" described pertains to technical specifications compared against predicate devices.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined here as technical specifications substantially equivalent to or improved over predicate devices) is the non-clinical technical comparison and conformance to standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2). The submission argues that even with technological differences (e.g., improved axial resolution, higher scan rate), these do not present new questions of safety and effectiveness, thus demonstrating substantial equivalence.

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

Not applicable. No clinical test set was required or used for this 510(k) submission.

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)

Not applicable. No clinical test set or expert-established ground truth was required for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication was required for this 510(k) submission.

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 device is an imaging system, not an AI-powered diagnostic aid or reader assistance tool. No MRMC study was performed or required.

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

Not applicable. This device is an imaging system, not an algorithm/AI with standalone diagnostic performance.

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

Not applicable. No clinical ground truth was required for this 510(k) submission, as it relied on technical specifications and conformance to international safety/performance standards.

8. The sample size for the training set

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

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

Not applicable. This device is an imaging system, not an AI/ML algorithm requiring a training set.

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