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510(k) Data Aggregation
(57 days)
OPC
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 14.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 22.9 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes. Warning: Do not use with Carmustine Warning: Do not use with Thiotepa
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The provided document describes the FDA 510(k) clearance for a "Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)". This is not an AI/ML device but a physical medical device (examination gloves).
Therefore, the requested information (acceptance criteria and study details related to AI/ML device performance, ground truth, expert adjudication, MRMC studies, etc.) is not applicable to this document.
The document focuses on the glove's performance against chemotherapy drugs, as detailed in the "Indications for Use" section. It reports breakthrough times for various chemotherapy drugs based on ASTM D6978-05 (Reapproved 2019) standards.
Here's the relevant information that can be extracted from the provided text, modified to fit the closest possible interpretation of your request, even though it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | (Implicitly, would ideally be high) | 14.9 |
| Cisplatin (1.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Cyclophosphamide (20.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Dacarbazine (10.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Etoposide (20.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Fluorouracil (50.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Methotrexate (25.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Mitomycin C (0.5 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Paclitaxel (6.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
| Thiotepa (10.0 mg/ml) | (Implicitly, would ideally be high) | 22.9 |
| Vincristine Sulfate (1.0 mg/ml) | (Implicitly, would ideally be high) | >240 |
Note: The "acceptance criteria" here are implied by the standard ASTM D6978-05 for assessing permeation. The higher the breakthrough time, the better the performance. The document explicitly issues warnings for Carmustine and Thiotepa due to their low breakthrough times, suggesting these values did not meet an implicit desired criterion for safe use.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the document. The ASTM D6978-05 standard would define the sample size requirements for testing gloves against chemotherapy drugs.
- Data Provenance: The document does not specify the country of origin of the data. The testing was conducted according to ASTM D6978-05 (Reapproved 2019), which is an American Society for Testing and Materials standard. The study is prospective in the sense that the gloves were specifically tested for this clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device where expert consensus for ground truth is typically required. The "ground truth" here is the physical measurement of chemical permeation according to a standardized test method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in AI/ML performance evaluation. The ASTM D6978-05 standard is a physical chemical test with objective 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 is not an AI/ML device; therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI system. The testing describes the standalone performance of the physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by objective chemical permeation measurements obtained through standardized laboratory testing as per ASTM D6978-05.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
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