(84 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text is a 510(k) summary for a medical device: "Better Care Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical tests that were performed to demonstrate substantial equivalence to the predicate device.
Here's the information based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Name | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | ASTM D-5250-06e1 (Inspection Level S-2, AQL 4.0) | All testing meets requirements for physical and dimensions testing. |
| Pinhole / Water Fill Test | FDA 1000 ml. Water Fill Test based on ASTM DS151-06 (Inspection Level G-1, AQL 2.5) | Meets these requirements. |
| Primary Skin Irritation | Standard Biocompatibility Testing | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Standard Biocompatibility Testing | No sensitization reactions. |
| Residual Powder Test | ASTM D-6124-06 (for "powder-free" claims) | Contains no more than 2 mg powder per glove. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- For physical and dimensions testing: Inspection Level S-2, AQL 4.0. (Specific number not provided, but these are statistical sampling plans.)
- For FDA 1000 ml. Water Fill Test: Inspection Level G-1, AQL 2.5. (Specific number not provided, but these are statistical sampling plans.)
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified (but for powder at finished inspection to ensure "powder-free" claims).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are laboratory tests conducted on samples of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the non-clinical testing of examination gloves. The "ground truth" or acceptance criteria are based on established ASTM standards and FDA requirements, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against physical and chemical standards, not expert 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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for the tests mentioned are the established ASTM standards and FDA requirements for glove performance (e.g., tensile strength, elongation, dimensions, freedom from pinholes, biocompatibility, residual powder limits).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.