(91 days)
The Visante™ OCT is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness.
The Visante OCT is computerized instrument that acquires and analyzes cross-sectional tomograms of the anterior eye segment (cornea, anterior chamber, iris and the central portion of the lens). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Visante OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.
The provided text is a 510(k) summary for the Visante OCT, a device intended for imaging and measuring anterior segment ocular structures. However, it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving the device meets those criteria.
The document states:
- "Clinical evaluation performed on the Visante OCT supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to anterior segment analysis devices and ophthalmoscopes."
- "Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the indications for use statement for the Visante OCT."
- "As described in this 510(k) Summary, all testing deemed necessary was conducted on the Visante OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."
This indicates that clinical data was used to establish substantial equivalence, but it does not provide details on:
- Specific acceptance criteria (numerical thresholds for performance metrics).
- Reported device performance against those criteria.
- The sample size of the test set, its provenance, or how ground truth was established for it.
- Any information regarding training sets, expert involvement, or adjudication methods.
- Whether MRMC or standalone performance studies were conducted.
Therefore, the requested tables and answers cannot be fully generated from the provided text.
Unable to fill the table and answer the questions with the provided information.
The document discusses a clinical evaluation that supported the device's indications for use and demonstrated substantial equivalence to predicate devices. However, it does not specify any quantifiable "acceptance criteria" or present "reported device performance" against such criteria. It also lacks details on the methodology of the clinical evaluation beyond stating that data was collected on a "statistically significant number of normal human patients."
Detailed Information Missing from the provided text:
- Table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance: The document states "Clinical data was collected on a statistically significant number of normal human patients" but does not specify the exact sample size, country of origin, nor if it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
- 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 explicitly stated, and this device (Visante OCT) is an imaging device, not an AI interpretation tool intended to assist human readers in the way an MRMC study typically assesses. The primary goal stated is imaging and measurement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device as a "computerized instrument that acquires and analyzes cross-sectional tomograms," implying standalone functionality for image acquisition and initial analysis, but no specific "standalone performance study" details are given regarding algorithm accuracy for specific measurements or diagnostic tasks without human oversight.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not provided.
- The sample size for the training set: This information is not provided. The term "training set" is not mentioned, as the focus is on clinical evaluation for substantial equivalence, not algorithm development and validation in the AI sense.
- How the ground truth for the training set was established: This information is not provided.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.