(87 days)
For removal of vitreous and vitral membranes during opthalmic surgery.
The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically.
This document is a 510(k) Premarket Notification for a medical device called the "Peregrine OptiPort Vitrectomy Probe." It does not contain information about acceptance criteria or a study proving the device meets them in the way described in your request.
Here's why and what information is available:
- 510(k) Premarket Notifications: These submissions aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its safety and effectiveness through clinical trials with specific acceptance criteria. The focus is on comparison and similarity, not on novel performance testing against predefined metrics.
- "Substantial Equivalence Comparison" Section: This section directly addresses the core of a 510(k). It compares the Peregrine OptiPort Vitrectomy Probe to the H.S. International Shapiro Cutter Vitrectomy Probe (the predicate device) based on features like intended use, driver type, cutting action, shaft size, port size, insertion method, and reusability. The implicit "acceptance" in a 510(k) is that the new device shares enough characteristics with the predicate that it can be considered equally safe and effective without requiring new clinical performance studies.
Therefore, I cannot populate the table or answer most of your detailed questions about acceptance criteria, efficacy studies, sample sizes, ground truth, or expert involvement because this type of information is generally not part of a 510(k) summary focused on substantial equivalence.
However, I can provide the following based on the document's content:
Summary of Device Information from the 510(k) Notification:
1. Table of Acceptance Criteria and Reported Device Performance:
- Formal acceptance criteria and a study demonstrating performance against these criteria are NOT present in this 510(k) submission. The submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study against specific acceptance criteria. The implicit "acceptance" is that the device is substantially equivalent to the predicate.
| Characteristic/Feature | Peregrine OptiPort Vitrectomy Probe | H.S. International Shapiro Cutter Vitrectomy Probe (Predicate) | Fulfilled/Met (Based on Substantial Equivalence Claim) |
|---|---|---|---|
| Intended Use | Vitreous Removal | Vitreous Removal | Met (Identical) |
| Driver Type | pneumatic driver | pneumatic driver | Met (Identical) |
| Cutting Action | guillotine cutting action | guillotine cutting action | Met (Identical) |
| Shaft Size | 20 GA stainless steel shaft | 20 GA stainless steel shaft | Met (Identical) |
| Port Size | .035mm port at distal tip | .034mm port at distal tip | Met (Very similar, considered equivalent) |
| Insertion | through 1mm incision | through 1mm incision | Met (Identical) |
| Usage | single use | single use | Met (Identical) |
| Handle | ergonomic handle | ergonomic handle | Met (Similar design principle) |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document does not describe a performance test set or clinical study with a sample size. The "test" is a comparison to a predicate device, not an independent assessment of performance on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" and no ground truth established by experts for performance in this 510(k) submission. FDA reviewers evaluate the substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or expert adjudication process 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 a surgical instrument (vitrectomy probe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth data of this type is presented or required for a 510(k) focused on substantial equivalence of a surgical tool. The "ground truth" for the submission is the legally marketed predicate device and its known characteristics.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Relevant Information from the Document:
- Sterility: The device will be ETO Sterilized, and the method used to validate the sterilization cycle is the AAMI Overkill Method. This is a crucial "acceptance criteria" for sterility, and the method for validation is stated.
- Predicate Device: H.S. International Shapiro Cutter Vitrectomy Probe (Product# HS32-803).
- Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This decision is the "acceptance" for the 510(k) process.
§ 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.