(129 days)
This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
NUZONE SYNGARD, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTMID 3577 - 01a-2.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NUZONE SYNGARD Surgical Glove:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Device Performance |
|---|---|
| Physical Properties | |
| ASTM D 3577 - 01a-2 | The device "meets the requirements for surgical gloves described by the American Standard for Testing ASTM D 3577 - 01a-2." Specifically, it "meets the requirements" of ASTM D 3577 - 01a-2 and ASTM D512 (though D512 is not explicitly detailed as an acceptance criteria, it's mentioned in conjunction with D3577 requirements). The conclusion states it "will perform according to the performance standards referenced and therefore meets ASTM standards." |
| Biocompatibility | |
| ASTM F 719-81 (Primary Skin Irritation) | The device was subjected to "Testing to conform to the Primary Skin Irritation test ASTM F 719-81." The result is that "Polyisoprene is not a primary skin irritant." |
| ASTM F 720-81 (Dermal Sensitization) | The device was subjected to "Testing to conform to the...Dermal Sensitization Test ASTM F 720-81." The result is implicitly that it does not cause dermal sensitization, as the overall conclusion states it meets FDA requirements which include biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the described tests (ASTM D 3577-01a-2, ASTM F 719-81, ASTM F 720-81).
The data provenance is not explicitly stated in terms of country of origin for the testing itself, but the submission is from Malaysia. The tests are based on American Society for Testing and Materials (ASTM) standards. The nature of the tests (physical properties and biocompatibility) suggests they were conducted on samples of the manufactured device.
The study is retrospective in the sense that the tests were performed on finished products before submission, rather than as part of an ongoing clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the data presented. The tests described are laboratory-based physical and biocompatibility assessments against established industry standards (ASTM). They do not involve expert interpretation or ground truth establishment in the way clinical studies with human participants or imaging data would. The "ground truth" for these tests is defined by the parameters and methodologies outlined in the respective ASTM standards themselves.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective, laboratory-based measurements against pre-defined ASTM standards. There is no mention of subjective interpretation requiring 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
This information is not applicable. The device is a surgical glove, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a surgical glove, not an algorithm or software. Standalone performance for an algorithm is not relevant.
7. The Type of Ground Truth Used
The ground truth used for the device's performance assessment is based on regulatory and industry standards (ASTM) for physical properties and biocompatibility (skin irritation and sensitization). These standards define acceptable ranges and methodologies for determining whether a surgical glove performs as intended and is safe for use.
8. The Sample Size for the Training Set
This information is not applicable. As a physical medical device (surgical glove), there is no "training set" in the context of machine learning or AI. The product is manufactured and then tested to ensure it meets pre-defined quality and safety standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).