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510(k) Data Aggregation
(70 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED A FATIENT EXAMINATION ODD THE EXAMINER'S HAND OR SEARCH AND FOR MEDIOAL POR! OUD OF AND AND ATION BETWEEN PATIENT AND EXAMINER.
Disposable Vinyl Exam Glove, Powder Free
This document is a 510(k) premarket notification decision letter from the FDA for a Disposable Vinyl Exam Glove, Powder Free. It is not a study report for an AI/ML medical device. Therefore, most of the requested information about acceptance criteria and study details for an AI/ML device is not present in this document.
However, I can extract the safety and performance tests that would typically be required for such a device and what a "study" for this type of device would generally entail.
Here's an interpretation based on the standard requirements for patient examination gloves:
1. A table of acceptance criteria and the reported device performance
For examination gloves, the "acceptance criteria" and "device performance" are typically defined by recognized consensus standards. A 510(k) submission for a glove would include test reports demonstrating compliance with these standards. The document provided does not contain a table of acceptance criteria or reported device performance. However, typical acceptance criteria for examination gloves include:
| Test/Characteristic | Acceptance Criteria (Example) | Reported Device Performance (Not within this document) |
|---|---|---|
| Physical (ASTM D5250) | ||
| Tensile Strength (before aging) | ≥ 9 MPa (median) | (Would be provided in a test report) |
| Tensile Strength (after aging) | ≥ 9 MPa (median) | (Would be provided in a test report) |
| Elongation (before aging) | ≥ 300% (median) | (Would be provided in a test report) |
| Elongation (after aging) | ≥ 300% (median) | (Would be provided in a test report) |
| Barrier Integrity (ASTM D5151) | ||
| Water Leak Test (AQL) | 1.5% for critical defects (Pinholes) | (Would be provided in a test report) |
| Biocompatibility (ISO 10993) | ||
| Cytotoxicity | Non-cytotoxic | (Would be provided in a test report) |
| Sensitization | Non-sensitizing | (Would be provided in a test report) |
| Irritation | Non-irritating | (Would be provided in a test report) |
| Labeling | Compliant with 21 CFR Part 801 (e.g., sterilization status) | (Reviewed by FDA for compliance) |
2. Sample size used for the test set and the data provenance
- Sample Size: For physical and barrier integrity tests, sample sizes are typically specified by the relevant ASTM standards (e.g., ASTM D5250, ASTM D5151). For example, water leak tests often require a statistically significant number of gloves from multiple batches. This information is not in the provided document, but would be in the detailed test reports submitted with the 510(k).
- Data Provenance: The tests are conducted according to recognized international or national standards. The data provenance would be the test labs (internal or external to the manufacturer) that performed the tests. This information is not in the provided document. Such tests are usually performed on a prospective basis (i.e., on manufactured batches specifically for testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device. "Experts" for establishing ground truth are relevant for AI/ML devices where human interpretation is the gold standard (e.g., radiologists for medical images). For examination gloves, performance is measured objectively through standardized physical, chemical, and biological tests, not subjective expert assessment.
4. Adjudication method for the test set
This question is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in AI/ML studies.
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
This question is not applicable to this type of device. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. Examination gloves are a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this type of device. "Standalone performance" refers to the algorithm's performance without human interaction, which is relevant for AI/ML software.
7. The type of ground truth used
For examination gloves, the "ground truth" is established through:
- Performance against defined standard specifications: e.g., a glove must achieve a certain tensile strength or elongation as per ASTM D5250.
- Absence of defects: e.g., a glove must not leak when tested according to ASTM D5151.
- Biocompatibility: e.g., the materials must not cause a toxic, irritating, or sensitizing reaction based on ISO 10993 tests.
This "ground truth" is objective and measured, not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.
8. The sample size for the training set
This question is not applicable to this type of device. "Training set" refers to data used to train an AI/ML algorithm.
9. How the ground truth for the training set was established
This question is not applicable to this type of device.
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