(46 days)
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure. Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3577, Physical Properties Meets ASTM D 3577, Freedom from pinholes Meets ASTM D 3577 Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
The provided document is a 510(k) Premarket Notification for a medical device, specifically a surgical glove. It does not describe an AI/ML powered device, nor does it detail a clinical study with an AI component. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.
However, I can extract information related to the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria as presented in the document for the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from pinholes | Meets ASTM D 3577 & Meets ASTM D 5151 | Meets ASTM D 3577 & Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (2 mg/glove maximum) | Meets ASTM D 6124 (2 mg/glove maximum) |
| Primary Skin Irritation | Passes in Rabbits (Biocompatibility) | Passes |
| Guinea Pig Sensitization | Passes (Biocompatibility) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the individual tests (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used). It implicitly refers to compliance with ASTM standards, which would dictate appropriate sampling methods.
The data provenance is not explicitly stated as "country of origin" for testing, but the company is based in San Diego, CA, USA, and the submission is to the US FDA. The testing described is intrinsic to the product's physical and biocompatibility characteristics, not clinical data provenance in the sense of patient records.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a physical device (surgical glove) meeting manufacturing standards, not a diagnostic or AI device requiring expert-established ground truth from medical images or data. The "ground truth" here is the pass/fail criteria defined by ASTM and biocompatibility standards.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against engineering and biological standards, not subjective expert assessment 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
Not applicable. This is a physical device submission and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device submission and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- ASTM (American Society for Testing and Materials) Standards: These are consensus standards for material properties and testing methods (e.g., D 3577 for rubber surgical gloves, D 5151 for detecting pinholes, D 6124 for powder residue).
- Biocompatibility Standards: These standards (implied by "Passes" for skin irritation and sensitization) ensure the material is safe for contact with human tissue.
8. The sample size for the training set
Not applicable. This is a physical device and the concept of a "training set" for an AI model does not apply. The manufacturing process is analogous to "training" in the sense of quality control and process optimization, but not in the AI context.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no AI training set. The "ground truth" for the device's acceptable quality is defined by adherence to established, external manufacturing and material standards (ASTM, biocompatibility).
§ 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).