(46 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) summary for a medical device, specifically Safeskin Synthetic Powder-Free Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving novel performance. Therefore, many of the requested fields related to clinical studies and AI performance will not be applicable.
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Freedom from pinholes | Meets ASTM D 5250; Meets ASTM D 5151 | Meets ASTM D 5250; Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (2 mg/glove maximum) | Meets ASTM D 6124 (2 mg/glove maximum) |
| Primary Skin Irritation in Rabbits | Pass | Passes |
| Guinea Pig Sensitization | Pass | Passes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for testing to demonstrate compliance with ASTM standards. The data provenance is also not specified, only that "The performance test data that support a determination of substantial equivalence are described above." This typically implies testing conducted by the manufacturer. It is a retrospective summary of tests performed.
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. The ground truth for this type of device (examination gloves) is established through adherence to standardized physical and chemical testing methods (ASTM standards), not through expert consensus on images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations. Compliance with ASTM standards involves objective measurements and defined pass/fail criteria, not subjective 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 device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established by objective measurements against established industry standards (ASTM D 5250-99, ASTM D 5151, ASTM D 6124) as well as biocompatibility testing standards (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).
8. The sample size for the training set
Not applicable. This device is a physical product (medical glove), not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.