(85 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade
The provided text is a 510(k) summary for the Sempermed Derma Plus Powered Latex Surgeon's Gloves. The document states that the device is substantially equivalent to a predicate device, "Supreme" Sempermed® Latex Surgeon's gloves, powder-free (510k #K981096).
However, the 510(k) does not contain the specific detailed acceptance criteria and a study proving the device meets those criteria in a format that can be extracted into the requested table. Instead, it relies on a comparison of technological characteristics to establish substantial equivalence to the predicate device.
Here's an analysis based on the information provided regarding the requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with explicit acceptance criteria (e.g., minimum tensile strength, maximum protein content, AQL for pinholes) and numerical performance data for the Sempermed Derma Plus gloves to compare against those criteria.
Instead, it states:
- Performance: Identical (to the predicate device)
- Mechanical Safety: Identical (to the predicate device)
- Chemical Safety: Identical (to the predicate device)
- Biocompatibility: Identical (to the predicate device)
- Sterility: Identical (to the predicate device)
This implies that the device is expected to meet the same performance standards as the predicate device, but the specific numerical criteria and test results are not detailed in this 510(k) summary. The summary refers to "additional technical comparative table within 510K submission" for a more detailed comparison, which is not included in the provided text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text, beyond the submitter's location (Vienna, Austria). There is no mention of retrospective or prospective study data for a primary test set. The claim relies on the identity of the physical and chemical properties of the device relative to the predicate device to establish equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission is a 510(k) for substantial equivalence of a physical medical device (surgical gloves). It does not involve diagnostic image analysis or similar tasks that would require expert-established ground truth. The "ground truth" here would be objective physical and chemical testing results, which are not detailed.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.
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. This is a submission for a physical medical device (surgical gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used:
For a physical device like surgical gloves, the "ground truth" would typically refer to objective measurements of physical properties (e.g., tensile strength, elongation, barrier integrity assessed by leak tests, protein content) and chemical properties (e.g., types of materials used, powder content). The 510(k) summary indicates that the "Performance," "Mechanical safety," "Chemical safety," "Biocompatibility," and "Sterility" are "Identical" to the predicate device, implying that the ground truth for these aspects was established through appropriate testing methods for both the new device and the predicate. However, detailed results or the specific "type" (e.g., specific test standards or laboratory results) are not provided in this summary.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as 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).