(40 days)
The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.
Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.
This document is a 510(k) Premarket Notification for the MID Labs Autonomous Vit Enhancer. It establishes substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or clinical trial data as would be found in a more comprehensive technical report or clinical study summary.
Therefore, many of the requested sections below cannot be populated from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document is a 510(k) Summary and does not contain specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity, throughput) that would typically be reported for a "study." It primarily focuses on comparing features to predicate devices to establish substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: The document does not describe a clinical performance study with a test set. This is a device modification submission, not a new device requiring extensive de novo clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No adjudication method is mentioned as no independent performance study 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
- No: This is not an AI device, and no MRMC study or comparative effectiveness study is mentioned. The device is a "Vitreous Aspiration & Cutting Instrument."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is not an algorithm-only device. The device is a "Autonomous Vit Enhancer," which is a stand-alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. Its function is mechanical, not algorithmic for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.
8. The sample size for the training set
- Cannot be provided: No training set is mentioned as this device is not a machine learning or AI-based system.
9. How the ground truth for the training set was established
- Cannot be provided: No ground truth for a training set is mentioned.
§ 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.