(192 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
This surgeon's glove is a device made of synthetic rubber.
The provided text is a 510(k) premarket notification for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs." This submission focuses on the performance of surgical gloves in resisting permeation by chemotherapy drugs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the "Breakthrough Detection Time" specifications for various chemotherapy drugs. The reported device performance is the actual breakthrough time measured for each drug.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Minutes) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | Implied: Minimum acceptable time | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | Implied: Minimum acceptable time | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | Implied: Minimum acceptable time | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
Note on Acceptance Criteria: The document directly presents the performance data rather than explicit numerical acceptance criteria for each drug from a regulatory body. However, for devices of this nature, the general "acceptance" is that the glove performs adequately for its intended use, typically implying that longer breakthrough times are better. The explicit mention of Carmustine and ThioTEPA's breakthrough times as a "Caution" implies that their performance, while reported, is at the lower end of the acceptable spectrum compared to the others that exceed 240 minutes.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of gloves or tests performed for each drug). For Carmustine and Thiotepa, three individual values are listed in parentheses (e.g., 47.8, 38.3, 37.5 for Carmustine), suggesting at least three tests were performed for these specific drugs, and an average was calculated. For other drugs, only ">240 min" is reported, so the exact number of tests is not discernible from the text.
- Data Provenance: Not specified in the document. It's likely from laboratory testing conducted by or for the manufacturer (Pt. Medisafe Technologies) to assess the glove's barrier properties against chemotherapy drugs. The country of origin of the data is not mentioned, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of testing (chemotherapy drug permeation) does not typically involve human experts to establish "ground truth." The ground truth is established through standardized laboratory testing methods that measure the chemical permeation. Therefore, information about experts and their qualifications in this context is not applicable. The "ground truth" for permeation resistance is determined by the output of the testing apparatus using recognized analytical techniques.
4. Adjudication Method for the Test Set
Not applicable. As this is chemical permeation testing, there is no expert adjudication process in the traditional sense. The results are derived directly from the laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic device that involves human readers interpreting cases. It's a medical device (surgical glove) whose performance is evaluated through material science and chemical permeation tests, not through human interpretation or comparative effectiveness studies with AI assistance.
6. Standalone Performance
Yes, the study describes the standalone (algorithm or device-only) performance. The reported breakthrough detection times are purely reflective of the glove's material properties and its resistance to chemical permeation, without any human-in-the-loop interaction during the performance measurement.
7. Type of Ground Truth Used
The ground truth used is laboratory measurement/chemical assay results. Specifically, it's the time until a chemotherapy drug is detected on the inner surface of the glove, as determined by appropriate analytical methods (e.g., spectroscopy, chromatography) following standardized test procedures (likely ASTM or similar international standards for chemical permeation of protective clothing).
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical glove) whose performance is determined by its material composition and manufacturing process. There is no "training set" in the context of machine learning or AI algorithms for this type of product. The manufacturing process is validated, and the product is tested to meet specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).