(186 days)
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with proposed device.
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
This document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs." It's a regulatory document for a medical device and not a study proving the device meets acceptance criteria for an AI/CADe product.
Therefore, the requested information about acceptance criteria for an AI/CADe study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the chemotherapy drug permeation testing for the gloves, as described in the document.
Here's the relevant information from the document as it pertains to the device (gloves), not an AI/CADe system:
1. A table of acceptance criteria and the reported device performance:
The document states that the device was "tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would define the acceptance criteria for breakthrough detection time. While the specific numerical acceptance criteria (e.g., "must be >X minutes") are not explicitly stated in this document, the reported performance is the "Breakthrough Detection Time in Minutes." Implicitly, a longer breakthrough time is better.
| Test Chemotherapy Drug | Concentration | Reported Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for testing each chemotherapy drug. This is a regulatory submission for a medical device (gloves), not an AI algorithm. The provenance would be from laboratory testing according to the ASTM D6978-05 standard.
3. 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. This is a physical product (gloves) tested for chemical permeation, not an AI algorithm requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to the resolution of disagreements among experts in AI/clinical studies, which is not relevant here.
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/CADe product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the gloves' performance is established by the laboratory measurement of chemotherapy drug permeation using the standardized method ASTM D6978-05. This involves quantitative detection of the drug passing through the glove material.
8. The sample size for the training set
Not applicable. This is not an AI/CADe product, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe product, so there is no "training set" or corresponding ground truth establishment.
§ 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.