(48 days)
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Poly-Isoprene Non-Latex Sterile Powder-Free Surgeon's Glove, organized according to your requested points:
The provided text is a 510(k) clearance letter from the FDA for a surgeon's glove and its Indications for Use statement. It does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria.
A 510(k) clearance relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing device characteristics (including performance) to the predicate device and showing that differences don't raise new questions of safety or effectiveness. While performance tests are conducted, the detailed acceptance criteria and study results are usually part of the 510(k) submission materials and not fully presented in the FDA's clearance letter itself.
Therefore, for almost all your requested points, the answer based solely on the provided text will be that the information is not available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The FDA clearance letter confirms "substantial equivalence" to a predicate device, implying that performance met the standards of the predicate, but the specific numerical criteria or performance results are not detailed here. | Not specified in this document. The FDA clearance letter only states that the device is "substantially equivalent" for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified in this document.
- Data provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable to this type of device and document. For a surgeon's glove, "ground truth" as typically understood in medical device studies (e.g., for AI algorithms or diagnostic tools) involving expert review wouldn't be relevant. Performance is generally assessed via standardized physical and chemical tests (e.g., tensile strength, puncture resistance, sterility, barrier integrity). The FDA reviewer (Chiu Lin, Ph.D., Director of Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to this type of device and document. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth from expert opinions in diagnostic or interpretive tasks, which is not relevant for a surgeon's glove performance evaluation.
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
- No, this is not applicable. MRMC studies and the concept of "human readers" improving with AI assistance are relevant for AI-powered diagnostic or assistive devices, not for a surgeon's glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This applies to AI algorithms, not a surgeon's glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a surgeon's glove, the "ground truth" for performance would be based on objective measurements from standardized tests (e.g., ASTM standards for glove performance such as tensile strength, elongation, puncture resistance, barrier integrity (water leak test), and sterility testing) compared against predetermined specifications. It is not established by expert consensus or pathology in the same way a diagnostic device would be.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm. If "training set" refers to manufacturing process validation or quality control, that information is not provided in this regulatory letter.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm.
§ 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).