Search Results

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.

Ask a specific question about this device

The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.

Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.

The provided text is a 510(k) summary for the MID Labs Vit Enhancer, a vitrectomy device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to a different type of device clearance (a traditional medical device, not an AI/ML system).

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be directly extracted. The document does not define specific performance acceptance criteria for the Vit Enhancer in terms of quantitative metrics or clinical outcomes. The clearance is based on substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The device is a physical instrument, and the 510(k) summary does not describe a clinical study in the way an AI/ML device would require one for performance validation on a test set. There is no mention of a "test set" in the context of 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)

• Not applicable / Not provided. Ground truth establishment for a test set is not part of this 510(k) summary for a physical medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or adjudication method is mentioned.

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 relates to AI/ML performance improvement for human readers, which is not relevant to this traditional medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This refers to AI/ML algorithm performance, which is not applicable to a physical vitrectomy device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The concept of "ground truth" in the context of an AI/ML algorithm's output is not relevant to this device's 510(k) submission.

8. The sample size for the training set

• Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.

9. How the ground truth for the training set was established

• Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.

Summary of Device and Approval Process from the Document:

• Device: Vit Enhancer (Vitreous Aspiration & Cutting Instrument)
• Intended Use: Used in conjunction with standard vitrectomy machine for vitreous cutting, to remove vitreous and other intraocular tissue.
• Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System (K932669)
• Approval Basis: Substantial equivalence to the predicate device. The 510(k) submission compares the Vit Enhancer's design, intended use, and functional components (guillotine cutter, user interface, energy source, pressure control, output valve, frequency control) to those of the SupraVit, demonstrating that it operates similarly and has the same fundamental technological characteristics.
• The FDA's letter states that the device is "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified." This indicates that the clearance is based on demonstrating the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy through extensive trials.

Ask a specific question about this device