(195 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML device testing is not present in the provided text.
The document discusses the substantial equivalence of the "Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" to legally marketed predicate devices. The primary performance data provided relates to the glove's resistance to permeation by chemotherapy drugs.
Here’s an attempt to structure the available information, keeping in mind the original request, but highlighting what is not applicable to this document:
1. Table of Acceptance Criteria and Reported Device Performance
For chemotherapy drug permeation, the implicit acceptance criterion is that the glove demonstrates a reasonable breakthrough detection time, particularly given the explicit note about Carmustine and Thio-Tepa having lower permeation times. The actual "acceptance criteria" for a 510(k) for this type of device would likely involve compliance with recognized standards (e.g., ASTM standards for medical gloves) which are not explicitly detailed in this letter but are implied by the regulatory review process.
| Chemotherapy Drug | Acceptance Criterion (Implicitly desirable high value) | Reported Device Performance (White Glove) | Reported Device Performance (Green Glove) |
|---|---|---|---|
| 1. Carmustine (BCNU) 3.3 mg/ml | N/A (Standard dependent) | 108.3 min | 88.2 min |
| 2. Cisplatin 1.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 4. Dacarbazine (DTIC) 10.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 10. Mitomycin C 0.5 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml | N/A (Standard dependent) | 118.7 min | 99.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This indicates that even with these lower times, the device was considered acceptable for its intended use, likely with appropriate labeling.
The following points are not applicable to this document as it pertains to the regulatory clearance of surgical gloves, not an AI/ML powered device. Therefore, there is no information in the provided text to answer these questions.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not pertain to AI/ML software; it is for surgical gloves. The "test set" would refer to physical glove samples and the chemicals used for permeation testing, not data for an algorithm.
-
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. Ground truth, in the context of AI/ML, refers to labels or diagnoses established by experts. For surgical glove testing, "ground truth" would relate to precise chemical permeation measurements, which are typically performed by laboratory technicians using standardized instruments, not by medical experts establishing a diagnosis.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth. This is not applicable to a physical device performance test.
-
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. MRMC studies are for evaluating diagnostic performance of readers, usually in conjunction with AI. This is entirely outside the scope of surgical glove clearance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question relates to AI algorithm performance. No algorithm is being reviewed here.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As mentioned previously, "ground truth" for AI/ML does not apply here. For surgical gloves, the "truth" is based on physical measurement protocols for chemical permeation.
-
The sample size for the training set
- Not Applicable. This refers to AI/ML model training data. No AI/ML model is involved.
-
How the ground truth for the training set was established
- Not Applicable. This refers to AI/ML training data labeling. No AI/ML model is involved.
§ 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).