(15 days)
The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.
The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.
The provided document is a 510(k) summary for the Synergetics VersaVit, a vitreous aspiration and cutting instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for clinical trials. Instead, it states that the device "has undergone testing and is in compliance with the applicable requirements of safety standards." and was "found to perform equivalently to the predicate device in a series of bench tests."
| Element | Synergetics VersaVit (Subject Device Performance) | Predicate Device (Alcon Accurus, K911808) | Acceptance Criteria (Implied Equivalence) |
|---|---|---|---|
| Intended Use | Posterior Segment Vitrectomies | Anterior and Posterior Segment Ophthalmic Surgery | Substantially Equivalent (for posterior segment) |
| Microprocessor based | Yes | Yes | Equivalent |
| Aspiration Pump Type | Diaphragm | Venturi | Sufficient for intended use, functionally equivalent |
| Operating Pressure | 72.5 - 120 PSI | 70 - 120 PSI | Within acceptable/equivalent range |
| Pneumatic Source | Compressed Air, CO2 cartridges | Compressed Air | Functionally equivalent methods |
| Unit Height x Weight x Depth | 10" x 13" x 11" | 20" x 19" x 20.5" | Differences allowed if not impacting safety/effectiveness |
| Unit weight | 25 pounds | 90 pounds | Differences allowed if not impacting safety/effectiveness |
| Electrical power specifications | 100-120V, 220-240V, 50/60 Hz | 100-120V, 220-240V, 50/60 Hz | Equivalent |
| Consumable Packs provided sterile | Yes | Yes | Equivalent |
| Consumable Packs method of sterilization | ETO | ETO | Equivalent |
| Consumable Packs Sterility Assurance Level | 10-6 | 10-6 | Equivalent |
The "acceptance criteria" here are largely implied to be "substantially equivalent" or "functionally equivalent" to the predicate device for parameters where direct identical values are not present, or "compliant with applicable safety standards" for overall performance.
2. Sample size used for the test set and the data provenance:
The document mentions "a series of bench tests" and "internal comparative bench testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests. This is typical for a 510(k) application relying on bench testing for equivalence, rather than clinical studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided because the submission primarily relies on bench testing and comparison to an existing predicate device rather than human-read image interpretation or diagnostic performance that would require expert-established ground truth.
4. Adjudication method for the test set:
Not applicable, as the document describes bench testing and not a study requiring adjudication of human interpretations or diagnoses.
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. The document describes a medical device (vitreous aspiration and cutting instrument) and not an AI/CAD system for image interpretation or diagnosis. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device is a surgical instrument.
7. The type of ground truth used:
For bench testing, the "ground truth" would typically refer to established engineering specifications, performance standards, or known performance characteristics of the predicate device against which the subject device's performance is measured. The document states compliance with "applicable requirements of safety standards" and equivalence to the predicate device's performance.
8. The sample size for the training set:
Not applicable, as this is a medical device and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a medical device and not an AI/machine learning model.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.