(39 days)
A 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.
Classified by FDA's General and Plastic Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging.
The provided text describes a 510(k) premarket notification for a "Blue Nitrile Examination Glove, Powder-free." This device is a patient examination glove, and the acceptance criteria and study described are related to its physical properties and hypoallergenic qualities, rather than a diagnostic AI device. Therefore, many of the requested categories (e.g., effect size of human readers with/without AI, sample size for training set, adjudication method for ground truth, expert qualifications) are not applicable to this type of medical device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties: | |
| Conformance to ASTM D5250 (Standard for poly(vinyl chloride) gloves for medical application) | Conforms fully to ASTM D5250. |
| Conformance to ASTM D3578 (Standard for rubber examination gloves) | Meets all requirements of ASTM D3578, except for ultimate elongation before aging. |
| Biocompatibility/Safety: | |
| Did not induce clinically significant irritation (human study) | Results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not induce clinically significant irritation. |
| No evidence of induced allergic contact dermatitis (human study) | Results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not have any evidence of induced allergic contact dermatitis in the human subjects. |
2. Sample size used for the test set and the data provenance:
- Physical Properties: The document does not specify a separate "test set" for the physical properties. Compliance with ASTM standards typically involves testing a defined number of samples from manufacturing lots. The provenance is implied to be from the manufacturer (Formosa Glove Industrial Co., Ltd. in Taiwan). This would be a retrospective evaluation of manufactured samples.
- Biocompatibility (Repeated Insult Patch Test): The document states "human subjects" but does not specify the sample size for this study. The provenance is from a "human study," which would be prospective data collection. The location where this study was conducted is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a patient examination glove, "ground truth" is established by adherence to recognized industrial standards (ASTM) for physical properties and by direct observation of human physiological responses in a clinical study for biocompatibility. There are no "experts" in the sense of radiologists or pathologists interpreting images for this device.
4. Adjudication method for the test set:
- Not Applicable. As there are no human interpretations of diagnostic images, no adjudication method would be used. The determination for physical properties is based on passing defined thresholds in ASTM tests. The biocompatibility study's results (e.g., absence of irritation) would be determined by clinical observation and possibly dermatological assessment, rather than an adjudication process.
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 patient examination glove, not an AI-powered diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a patient examination glove, not an AI algorithm.
7. The type of ground truth used:
- Physical Properties: The ground truth for physical properties is established by adherence to ASTM D5250 and ASTM D3578 standards, which define specific performance metrics and their corresponding acceptable ranges.
- Biocompatibility: The ground truth for biocompatibility is established by direct clinical observation of human subjects in a "repeated insult patch test (modified Draize test)," looking for absence of clinically significant irritation or allergic contact dermatitis. This is a form of outcomes data (clinical response).
8. The sample size for the training set:
- Not Applicable. This device is not an AI algorithm, so there is no training set in that context. The manufacturing process itself (where gloves are produced) could be seen as continuously "training" to meet specifications, but this isn't a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for an AI algorithm. For a manufactured product, the "ground truth" for manufacturing quality is established by the specifications and quality control procedures that ensure each batch meets the required standards (e.g., ASTM standards).
§ 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.