(50 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner
This device is a powder free vinyl examination glove.
The provided text describes a 510(k) summary for the SensiTex Examination Glove, focusing on its substantial equivalence to a predicate device. This is primarily a regulatory submission rather than a study report proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/ML medical device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information (which are common in AI/ML performance studies) are not applicable or
available in this document.
However, I can extract the acceptance criteria and performance data as presented for the product compared to its predicate device.
1. Table of acceptance criteria and the reported device performance
The document compares the Oak Vinyl Exam Glove (SensiTex) to the Maxxim Vinyl Exam Glove based on several tests. The "acceptance criteria" here are essentially the performance of the predicate device, as the goal is to show substantial equivalence.
| TEST | Acceptance Criteria (Maxxim Vinyl Exam Glove) | Reported Device Performance (OAK Vinyl Exam Glove 96-X60 Series) |
|---|---|---|
| Water Leak Test ASTM D5151-92 | Pass | Pass |
| Tensile MPa Ultimate | 13.7 | 10.1 |
| Elongation, Ultimate (%) | 437 | 326 |
| Thickness - Palm (mm) | .130 | .178 |
| Thickness - Finger (mm) | .113 | .125 |
| Length (mm) | 241 | 241 |
| Width (mm) | L | |
| 105 | S, M, L, XL | |
| 95, 105, 118, 124 | ||
| Powdered | No | No |
| ASTM 5250-92 | Meets ASTM 5250-92 | Meets* ASTM 5250-92 |
| *Except for (width) dimensional requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. This document only provides aggregated results ("Pass", "10.1", etc.) and does not detail the number of gloves tested for each metric.
- Data provenance: Not specified.
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. This is a physical device performance test, not an AI/ML diagnostic or prognostic study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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. The performance data presented are for the standalone vinyl glove against the predicate glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of expert consensus or clinical outcomes. The "ground truth" or reference standards are the specified ASTM test methods (e.g., ASTM D5151-92 for water leak, ASTM 5250-92 for general glove standards) and the measured performance of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
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.