(293 days)
This Surgeons Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. These gloves are tested for use with Chemotherapy Drugs.
Polychloroprene Synthetic Tan Surgical gloves Powder Free
This document is a 510(k) clearance letter for a medical device, specifically the Nuzone X2T surgical gloves. The provided text primarily focuses on the regulatory approval and a table of chemotherapy drug permeation data. It does not describe an AI/ML device or its performance criteria in the typical sense of a diagnostic or predictive model.
Therefore, many of the requested categories are not applicable to this type of medical device clearance.
Here's the breakdown based on the provided information, addressing what is relevant and noting what is not:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for surgical gloves, as indicated by the reference to ASTM D6978-05 for chemotherapy drug testing, usually involve minimum breakthrough times for specific drug concentrations. The study demonstrates the device's performance against these criteria.
| Acceptance Criteria (Minimum Breakthrough Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|
| Greater than 5.18 minutes (for Carmustine) | Avg. 5.18 (6.55, 5.95, 3.04) Minutes (Carmustine) |
| Greater than 3.03 minutes (for Thiotepa) | Avg. 3.03 (6.41, 1.63, 1.06) Minutes (Thiotepa) |
| Up to 240 Minutes (for other listed drugs) | Up to 240 Minutes (for the remaining 8 drugs) |
Note: The exact "acceptance criteria" for Carmustine and Thiotepa are not explicitly stated as a minimum threshold in the document, but rather the reported average breakthrough times are given. For the other drugs, "Up to 240 Minutes" is both the reported performance and implies that permeation did not occur within that timeframe, which is a common acceptance criterion for chemotherapy gloves. The phrasing "Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes" serves as a warning, indicating these are critical values that users should be aware of.
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: The document does not specify the sample size (e.g., number of gloves) used for testing each chemotherapy drug.
- Data Provenance: Not specified in the provided text, but testing based on ASTM standards is typically conducted in a laboratory setting. This would be prospective testing of new glove samples.
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. This is a physical product (surgical glove) test, not an AI/ML diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of drug permeation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a laboratory test, not an expert-based adjudication process.
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. No AI component or human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No algorithm or AI component is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is established by physical laboratory measurements of chemotherapy drug permeation through the glove material, following the methodology described in ASTM D6978-05.
8. The sample size for the training set
- Not Applicable. No AI/ML model or training set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML model or training set is mentioned.
§ 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).