Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and evan miner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 Ed

The provided document is a 510(k) summary for the "Powder free Vinyl Examination" glove, detailing its substantial equivalence to a predicate device. It does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be described for a diagnostic AI device.

However, based on the information provided, I can extract what is considered the "acceptance criteria" for regulatory clearance (substantial equivalence) and the "study" that supports it, even if it's not a quantitative clinical study with metrics like sensitivity, specificity, or AUC.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technological characteristics, intended use, and safety/effectiveness.

2. Sample size used for the test set and the data provenance

The document describes a regulatory submission for a medical device (examination glove) claiming substantial equivalence to a previously cleared predicate device. This is not a study in the sense of collecting new performance data on a "test set" from patients or a specific dataset. Instead, the "test" is the comparison of the device's characteristics and performance against established standards and the predicate device.

• Sample size for the test set: Not applicable in the context of clinical data. The assessment is based on the device's design, materials, manufacturing processes, and compliance with standards. If physical testing (e.g., for tensile strength, barrier integrity) was performed, the sample sizes for those specific tests are not detailed in this summary.
• Data provenance: Not applicable. The "data" here refers to the device's specifications and comparison to the predicate, as well as adherence to standards like ASTM D5250-00 Ed. This is not clinical data from patients or a specific country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic outcome. The "ground truth" for a medical glove's safety and effectiveness is established through compliance with recognized standards and demonstration of equivalent performance to predicate devices which have already been deemed safe and effective.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of human interpretation or diagnostic outcomes 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 is a medical glove, not an AI-powered diagnostic device. No MRMC study or AI assistance is relevant.

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

Not applicable. This is a medical glove, not an algorithm.

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

The "ground truth" for the device's safety and effectiveness relies on:

• Compliance with recognized standards: Specifically, ASTM Standard D5250-00 Ed for Vinyl Patient Examination Gloves.
• Demonstrated equivalence to a predicate device: The predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415), which was previously cleared by the FDA, serves as the benchmark for safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device