(146 days)
The Zimmer Cut Resistant Glove Liners are intended to provide moderate cut resistance when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.
The Zimmer Cut Resistant Glove Liner is designed to provide the surgeon, assistant, scrub nurse or any surgical arena personnel extra protection in the event of an accidental cut when used as a liner to a surgical glove. The Zimmer Cut Resistant Glove Liner is produced from high strength polyethylene.
Here's an analysis of the provided text regarding the Zimmer Cut Resistant Glove Liners, focusing on the acceptance criteria and the supporting study, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM 1790-04 for cut resistance | Demonstrated to meet ASTM 1790-04 requirements for cut resistance |
| Biocompatibility | Tested in accordance with ANSI/AAMI/ISO 10993-1:1997 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests. The testing appears to have been non-clinical/laboratory-based. Therefore, there's no mention of country of origin or whether the data was retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for the performance of the device was established through laboratory testing against a recognized standard (ASTM 1790-04), not through expert consensus on a test set in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. There was no "adjudication method" in the sense of reconciling multiple expert opinions, as the evaluation was based on objective laboratory measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data and conclusions were not needed for this device." This confirms that no clinical studies, including MRMC studies, were conducted or required for this 510(k) submission. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical glove liner, not an algorithm or AI system. The performance evaluated was the inherent material property of cut resistance.
7. Type of Ground Truth Used
The ground truth used was objective performance standards and laboratory measurements. Specifically:
- Compliance with ASTM 1790-04 for cut resistance.
- Compliance with ANSI/AAMI/ISO 10993-1:1997 for biological evaluation (biocompatibility).
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).