(75 days)
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Duraprene Sterile Synthetic Powder-Free Surgical gloves are formulated using neoprene and are coated with a nitrile coating. These are offered powder-free and sterile.
The provided text describes the safety and effectiveness of "Duraprene Sterile Synthetic Powder-Free Surgical Gloves." This document is a 510(k) summary, which is typically for medical devices, but the information provided pertains to the physical and biological characteristics of surgical gloves rather than an AI/ML powered device. Hence, most of the requested information about AI model performance, ground truth establishment, training sets, and expert adjudication cannot be extracted.
However, I can provide the acceptance criteria and reported device performance for the glove's physical and biological properties.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (as implied by performance) | Reported Device Performance |
|---|---|---|
| Intracutaneous Reactivity | No reactivity (implied) | Gloves show no reactivity. |
| Guinea Pig Maximization | No potential for irritation (implied) | Gloves do not display any potential for irritation. |
| Barrier Defects | Exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5 | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5. |
| Powder Level | Meet powder level requirements for "Powder Free" designation (below 2 mg/glove) | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-00. Results generated values below 2 mg of residual powder per glove. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions meeting ASTM standards and CFR regulations, which would specify sample sizes for testing, but the numerical value is not provided in this summary.
- Data Provenance: Not explicitly stated. The manufacturer is Allegiance Healthcare Sdn. Bhd. located in Penang, West Malaysia, and Allegiance Healthcare Corporation in McGaw Park, IL, USA. The testing would likely have been conducted in facilities associated with these entities. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
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 document describes the testing of a physical medical device (surgical gloves) for its material properties and biological compatibility, not an AI/ML powered device that would require expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable for a physical device test. The tests are based on objective measurements and established standards (e.g., ASTM, CFR).
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 as this is a physical medical device, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device. The tests performed are standalone tests of the glove's properties.
7. The type of ground truth used:
- The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ASTM D3577-00 for barrier defects, ASTM D6124-00 for powder level, and biological safety standards for intracutaneous reactivity and sensitization). These are objective measurements against predefined criteria.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model being trained.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML model being trained.
§ 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).