(145 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
The provided document is a 510(k) premarket notification decision letter from the FDA regarding Nitrile Blue Powder Free Examination Gloves. This document describes the regulatory classification and general controls applicable to the device, and importantly, includes the "Indications for Use" statement and a table of chemotherapy drug permeation test results.
Therefore, the acceptance criteria and study proving the device meets the acceptance criteria are related to the performance of the gloves against permeation by chemotherapy drugs, not an AI/ML algorithm or a diagnostic device, which is what the prompt's questions are geared towards.
Given the nature of the device (examination gloves) and the content of the document, most of the questions in the prompt are not applicable. The information provided is for a physical medical device, not a software or AI-based diagnostic tool.
However, I can extract information relevant to the performance claims and their supporting study as presented in the document, reinterpreting the prompt's questions for this context.
Here's an attempt to answer the questions based only on the provided document, acknowledging that most questions are designed for AI/ML or diagnostic devices and do not fit:
Device Under Evaluation: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
1. A table of acceptance criteria and the reported device performance
For the specific claim "Tested for Use with Chemotherapy Drugs," the acceptance criterion is implied by the standard referenced (ASTM D6978-05) and the reported "Breakthrough Detection Time." While an explicit "acceptance criterion" value (e.g., must be > X minutes) is not stated in this document, the demonstration of high breakthrough times for most drugs indicates meeting a performance expectation set by the standard for protective gloves.
| Chemotherapy Drugs | Concentration | Reported Breakthrough Detection Time in Minutes | Implicit Acceptance Criterion (as demonstrated performance) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | 11.1 | Permeation Resistance Demonstrated |
| Cisplatin | 1.0mg/ml | > 240 | High Permeation Resistance |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | High Permeation Resistance |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | High Permeation Resistance |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | High Permeation Resistance |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | High Permeation Resistance |
| Fluorouracil | 50.0mg/ml | > 240 | High Permeation Resistance |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | High Permeation Resistance |
| Thiotepa | 10.0mg/ml | 40.1 | Permeation Resistance Demonstrated |
| Amethopterin Hydrate | 25.0mg/ml | > 240 | High Permeation Resistance |
| Methotrexate | 25.0mg/ml | > 240 | High Permeation Resistance |
| Mitomycin C | 0.5mg/ml | > 240 | High Permeation Resistance |
| Vincristine Sulfate | 1.0mg/ml | > 240 | High Permeation Resistance |
2. Sample size used for the test set and the data provenance
The document references "ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would specify the sample size requirements (e.g., number of gloves tested per drug). This specific document does not state the sample size used for the permeation tests.
- Data Provenance: The tests were conducted according to a recognized ASTM standard, implying a controlled laboratory setting. The country of origin of the data is not specified, but the applicant (GMP MEDICARE SDN.BHD.) is based in Malaysia ("MY"). The testing would typically be done in a lab, which could be internal or external.
- Retrospective or Prospective: Not applicable in the context of physical product testing. These are laboratory characterization tests on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for chemical permeation is established by the standardized test method (ASTM D6978-05) itself, which involves specialized laboratory equipment and procedures, not human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements in expert interpretations (e.g., in medical image reading). This study involves objective chemical permeation measurements.
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. This document is about a physical product (gloves) and their chemical resistance, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the standalone performance of an algorithm. The "device" here is a pair of gloves. The performance (breakthrough time) is inherently "standalone" in the sense that it's a direct measurement of the glove material properties, not an assisted human process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims would be the objective measurements obtained according to ASTM D6978-05. This standard defines how permeation is measured and what constitutes a "breakthrough detection time." It's a direct physical measurement/test outcome, not an interpretation from experts, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of physical medical device performance testing like chemical permeation. This concept applies to machine learning models.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.