(113 days)
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.
This is a 510(k) premarket notification for a medical device cleared by the FDA. As such, it does not contain a study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed performance metrics, sample sizes, expert involvement, and statistical analyses typically associated with clinical trials or AI performance evaluations).
The document is a regulatory submission demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo clinical study proving novel performance criteria. Clinical studies as described in your request are not typically required for 510(k) clearances if substantial equivalence can be established through other means, such as performance testing detailed below.
Therefore, many of the requested fields cannot be directly extracted or are not applicable in their usual sense for this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device and states that "The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices." It also states "The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use."
Specific, quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The assessment for this type of device typically involves engineering specifications and functional performance tests (e.g., cutting rate, aspiration flow, material compatibility, sterilization efficacy, etc.) to demonstrate equivalence to the predicate device. These specific test results are usually found in the full 510(k) submission, which is more extensive than this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Physical Characteristics equivalent to predicate | Substantially equivalent to predicate devices (K950287) |
| Performance Characteristics equivalent to predicate | Substantially equivalent to predicate devices (K950287) |
| Manufactured to FDA (QSR) standards | In compliance with FDA (QSR) standards |
| Manufactured to ISO standards | In compliance with ISO standards |
| Safe for indicated use | Demonstrated to be safe for indicated use |
| Effective for indicated use | Demonstrated to be effective for indicated use |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. Performance testing for medical devices like this typically involves a defined number of units, but this information is not in the summary.
- Data Provenance: Not specified, but likely obtained from internal laboratory testing conducted by Advanced Medical Optics, Inc. in the USA. Given it's a 510(k) for an existing type of device, it's almost certainly retrospective in the sense that it relies on established engineering principles and performance testing benchmarks rather than prospective clinical trials to prove efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable (N/A): This type of medical device submission does not typically involve "ground truth" derived from expert consensus in a clinical diagnostic sense, as it is a surgical tool. Its performance is assessed through engineering and functional testing rather than diagnostic accuracy.
4. Adjudication method for the test set:
- Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic outcomes. For this device, performance is evaluated against engineering specifications and predicate device equivalence, not expert adjudication of clinical findings.
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:
- No: This is a surgical instrument, not a diagnostic imaging device or an AI-powered system that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No: This device is a manual surgical instrument and does not involve an algorithm or AI operating in a standalone capacity.
7. The type of ground truth used:
- Engineering Specifications / Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device (K950287 UnuVit and 4422CE) and adherence to recognized industry standards (FDA QSR, ISO). Performance is measured against these established benchmarks.
8. The sample size for the training set:
- Not Applicable (N/A): This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable (N/A): As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.