(265 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
The document describes a medical device called "Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" and its clearance for marketing. The acceptance criteria and the study proving the device meets these criteria are specifically related to the gloves' permeation resistance to various chemotherapy drugs.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The implicit acceptance criterion for gloves tested with chemotherapy drugs is to demonstrate a reasonable "Breakthrough Detection Time," meaning the time it takes for the chemotherapy drug to permeate through the glove material. While not explicitly stated as a pass/fail threshold in the provided text, the standard practice in evaluating such gloves is typically referenced against established guidelines (e.g., ASTM standards for barrier protection). The performance reported is the actual breakthrough detection time for each drug.
| Chemotherapy Drugs: | Acceptance Criteria (Implied) | White Glove Reported Performance (Breakthrough Detection Time) | Blue Glove Reported Performance (Breakthrough Detection Time) |
|---|---|---|---|
| 1. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | High breakthrough time | 79.0 min | 48.5 min |
| 2. Cisplatin 1.0 mg/ml (1,000 ppm) | High breakthrough time | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | High breakthrough time | >240 min | >240 min |
| 4. Dacarbazine (DTIC) 10.0 mg/ml (10,000ppm) | High breakthrough time | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | High breakthrough time | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | High breakthrough time | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | High breakthrough time | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | High breakthrough time | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | High breakthrough time | >240 min | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | High breakthrough time | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | High breakthrough time | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | High breakthrough time | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | High breakthrough time | 79.2 min | 169.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | High breakthrough time | >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 while higher numbers are generally better, specific breakthrough times are reported and acknowledged. The "acceptance criteria" here is simply the demonstration and reporting of these values to show the glove's performance against specific drugs, allowing users to make informed decisions.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample size used for testing each glove type with each chemotherapy drug. The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, it implies that the testing was conducted in a controlled, prospective manner to meet regulatory requirements, likely in a laboratory setting adhering to recognized standards (e.g., ASTM D6978).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable (N/A) to the clearance of surgical gloves for chemotherapy drug permeation. The "ground truth" here is objective scientific measurement (breakthrough detection time) determined through laboratory testing, not subjective expert assessment as would be the case for image interpretation or diagnostic accuracy.
4. Adjudication Method for the Test Set:
This is N/A. Since the "ground truth" is established by objective laboratory measurements, there is no need for expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
This is N/A. Surgical gloves are not diagnostic devices that involve "readers" or "cases" in the context of comparative effectiveness studies against AI. The document focuses on the material's barrier properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is N/A. The device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used is objective laboratory measurement of Breakthrough Detection Time obtained through standardized chemical permeation testing (e.g., following a standard like ASTM D6978), which measures the time it takes for a chemotherapy drug to permeate through the glove material.
8. The Sample Size for the Training Set:
This is N/A. The device is a physical product, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This is N/A for the same reason as point 8.
§ 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).