(32 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.
POWDER-FREE BLUE VINYL EXAM GLOVES
The provided document is for a 510(k) premarket notification for "POWDER-FREE BLUE VINYL EXAM GLOVES". This is a medical device submission for physical examination gloves, and the evaluation criteria and studies are related to the performance characteristics of these gloves, not to an AI/Software as a Medical Device (SaMD).
Therefore, many of the requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Number of experts used to establish ground truth," and "Effect size of how much human readers improve with AI vs. without AI assistance," are not applicable to this type of device.
Here's a breakdown of the available information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or exceeded |
| ASTM D 5151-99 | Met or exceeded |
| ASTM D 6124-01 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| MIL Std 105E | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
| Bio-Burden (Procedure Method 8315) | Met or exceeded |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in the provided text. The standards (e.g., ASTM, ISO, MIL Std) typically outline specific sampling plans, but the document only states that the device "met or exceeded" them.
- Data Provenance: Not explicitly stated. For physical device testing, the "country of origin of the data" is generally less relevant than the standards followed. The testing would have been conducted by the manufacturer or a contracted lab to demonstrate compliance with the listed standards. It is implied to be prospective testing for the specific device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For physical device testing like examination gloves, "ground truth" is established through standardized physical, chemical, and biological tests, not by expert consensus in the diagnostic sense. The "experts" would be the scientists and technicians performing the tests according to the specified ASTM, ISO, and other standards.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for interpreting diagnostic images or clinical scenarios where human judgment is involved. For physical tests of gloves, results are typically objective measurements against predefined thresholds in the standards.
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 an AI/SaMD related study type and does not apply to examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an AI/SaMD related evaluation and does not apply to examination gloves.
7. The type of ground truth used:
- For examination gloves, the "ground truth" is defined by the performance specifications and acceptance criteria outlined in the referenced industry standards (ASTM D 5250-00E4, ASTM D 5151-99, ASTM D 6124-01, ISO 2859, MIL Std 105E) and biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Bio-Burden). These standards define the acceptable levels for properties such as strength, barrier integrity (pinholes), biocompatibility, and perhaps dimensions.
8. The sample size for the training set:
- Not Applicable. Physical devices like gloves do not have "training sets" in the context of machine learning. The manufacturing process is controlled and validated, and batches are tested to ensure ongoing quality.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this type of device, this question is irrelevant.
§ 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.