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510(k) Data Aggregation
(97 days)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
This document is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, tested for use with chemotherapy drugs, in blue, orange, and white colors. The primary purpose of this document is to establish substantial equivalence to legally marketed predicate devices and list the indications for use, specifically detailing their resistance to various chemotherapy drugs. This is not a study report demonstrating the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document.
The document provides information on the performance of the gloves against chemotherapy drugs, which involves breakthrough times. This is the closest analog to "acceptance criteria" and "device performance" in this context but is related to the physical properties of the gloves, not an AI/ML system.
I will attempt to structure the information based on the glove performance, but please be aware that it does not align with the requested information for an AI/ML study.
Acceptance Criteria and Performance (for the gloves' resistance to chemotherapy drugs):
The acceptance criterion, though not explicitly stated as "acceptance criteria," is the breakthrough time of the glove when exposed to chemotherapy drugs. The device "meets" this by demonstrating the reported breakthrough times, which are then used to inform users about the glove's suitability for different chemotherapy drugs. A longer breakthrough time indicates better protection. The FDA's acceptance of these values implies they are deemed sufficient for the stated indication.
1. Table of Acceptance Criteria and Reported Device Performance:
| Chemotherapy Drugs | Concentration (mg/ml) | Acceptance Criteria (Implicit: Higher is better, FDA approved these values) | Device Performance (Blue Glove) Breakthrough Time (minutes) | Device Performance (Orange Glove) Breakthrough Time (minutes) | Device Performance (White Glove) Breakthrough Time (minutes) |
|---|---|---|---|---|---|
| Carmustine | 3.3 | N/A (See note below table) | 0.1 | 20.3 | 20.4 |
| Cisplatin | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Dacarbazine | 10.0 | N/A (See note below table) | >240 | >240 | >240 |
| Doxorubixin Hydrochloride | 2.0 | N/A (See note below table) | >240 | >240 | >240 |
| Etoposide | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Fluoroucil | 50.0 | N/A (See note below table) | >240 | >240 | >240 |
| Methotrexate | 25.0 | N/A (See note below table) | >240 | >240 | >240 |
| Mitomycin | 0.5 | N/A (See note below table) | >240 | >240 | >240 |
| Paclitaxel | 6.0 | N/A (See note below table) | >240 | >240 | >240 |
| Thiotepa | 10.0 | N/A (See note below table) | 20.4 | 50.6 | 71.0 |
| Vincristine Sulfate | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
Note on Acceptance Criteria: For these types of medical devices (gloves), the "acceptance criteria" for chemical resistance testing are typically defined by regulatory standards (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). While the document does not explicitly state the specific acceptance thresholds, the FDA's clearance of the device indicates that the provided breakthrough times are considered acceptable for the intended use and for informing users about the limitations/capabilities of the gloves. The document "notes the following drugs Carmustine and Thiotepa have extremely low permeation times," which serves as an important user warning based on the test results.
The following numbered points (2-9) are irrelevant to this document as it concerns medical gloves, not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to chemical permeation testing, not a dataset for an AI/ML model. The "test set" in this context would be the gloves themselves subjected to chemical testing. No sample size information for these physical tests is provided in the document. Data provenance is not applicable for an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established through laboratory testing protocols, not expert consensus in the way an AI/ML study would use it.
4. Adjudication method for the test set: Not applicable. This pertains to expert review for AI/ML performance, not physical product testing.
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 for AI/ML performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI/ML performance evaluation.
7. The type of ground truth used: For the glove performance, the "ground truth" is the empirically measured breakthrough time determined by standardized laboratory methods (e.g., ASTM F739). This is an objective measurement, not expert consensus, pathology, or outcomes data in the context of an AI/ML device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned or implied in this document.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned or implied in this document.
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