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Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT).

The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.

The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye.

Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment.

The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (< 3.5 lbs), compact handheld scanner makes it possible to image pediatric patients, supine patients, or any patient that finds it difficult to sit upright or where it is clinically preferable to image without the constraint of a chin rest. Tabletop, chin-rest mediated imaging is enabled though a mounting accessory.

The Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) (K120057) did not involve a clinical study to prove its acceptance criteria. Instead, the submission leveraged non-clinical performance and safety data, as well as a review of existing clinical literature, to establish substantial equivalence to a predicate device (K063343).

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this was a 510(k) submission based on substantial equivalence to a predicate device, the "acceptance criteria" were primarily defined by the performance characteristics of the predicate device. The "reported device performance" refers to the Envisu™ SDOIS meeting or exceeding these characteristics, with specific design modifications noted.

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

No specific test set or data provenance (country, retrospective/prospective) explicitly described for a clinical study. The submission relies on:

• Non-clinical performance and safety data: This involves testing under established protocols (e.g., IEC standards, image resolution, image comparison, software validation).
• Clinical Literature Review: This review analyzed existing peer-reviewed publications on handheld SDOIS for pediatric populations, suggesting safety, non-invasiveness, and effectiveness.

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

Not applicable. No ground truth establishment by experts for a test set is described, as a clinical study was not performed by Bioptigen.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

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-assisted diagnostic tool, and no MRMC study was conducted or described.

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, and no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, in the context of this 510(k), was largely established by:

• Engineering specifications and measurements: Demonstrating that the device's technical specifications met or exceeded those of the predicate device.
• Compliance with recognized standards: Such as IEC-60601-1, IEC 60601-1-2, IEC 60825-1, and ISO 15004-2 for electrical, electromagnetic, optical emission, and safety.
• Referencing existing clinical literature: To support the safety and effectiveness of the technology (SDOIS) for its intended use, particularly for handheld operation in different patient populations.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

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

Not applicable. No training set was used.

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