(28 days)
HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.
HyperVit™ Vitrectomy Probe (27 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:
- Vitreous aspiration & cutting
- Membrane cutting & aspiration
- Lens removal
- Dissect tissue in the eye
The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.
The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.
This document describes the HyperVit™ Vitrectomy Probe, a device designed for vitreous aspiration and cutting, membrane cutting and aspiration, lens removal, and tissue dissection in the eye during vitreoretinal or cataract surgery.
Here's the breakdown of the acceptance criteria and the study proving the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cut Quality | The forward and return cutting surfaces must meet the same acceptance criteria for cut quality and cut reliability as the predicate device (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951). | "Results show that the probe met the acceptance criteria and, therefore, have the same cut quality as the predicate device." |
| Aspiration Flow | Aspiration flow characteristics at default vacuum settings should be similar to those of the predicate device, given identical fluid path dimensions. | "The aspiration flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum settings were characterized and compared with the predicate device. The flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum setting were similar to those of the predicate device as a result of the identical dimensions of the fluid path (e.g., cutter and aspiration tubing). Therefore, the aspiration flow is equivalent to the predicate device." |
| Heat Generation | Maximum temperature increase at the vitreous cutter tip should be no more than 10°C during operation, based on literature review (Ref: Wu et al., Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481, 2006). | "Testing showed that the maximum temperature increase was 0.8℃ throughout 30 minutes of operation; this is less than the maximum allowed temperature increase at the probe tip of no more than 10°C..." |
| Metal Particulates | No metal particulates should be generated by the device during operation. | "After running the test continuously for 20 minutes, the filter in the container was microscopy-examined for metal particulate and no particulates were detected, thus meeting the acceptance criteria." |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set for each mechanical test. For the metal particulates test, the experiment describes "The probe was actuated at the maximum 10,000 cycles per minute in a water container" and "After running the test continuously for 20 minutes." This implies a single probe was tested for this specific criterion during the specified duration.
The data provenance is from mechanical testing conducted by Alcon Research, Ltd. This is an internal developmental and validation study, not data collected from patient populations. Therefore, country of origin of data or retrospective/prospective nature is not applicable in the patient-data sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests conducted are mechanical and objective (e.g., measuring flow, temperature, presence of particulates, and comparing cut quality to a defined standard), not relying on expert interpretation of ambiguous data to establish ground truth.
4. Adjudication method for the test set:
Not applicable. The tests are objective mechanical performance evaluations, not diagnostic/interpretive tasks requiring adjudication.
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 or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.
7. The type of ground truth used:
The ground truth used for these tests is based on:
- Predicate device performance: The HyperVit™ Probe's performance (cut quality, aspiration flow) was compared to the performance of the legally marketed predicate devices (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951).
- Established engineering specifications and safety limits: For heat generation, a maximum allowed temperature increase of 10°C was derived from literature (Wu et al., 2006). For metal particulates, the absence of particulates on microscopy served as the ground truth for meeting the acceptance criteria.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical medical device.
§ 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.