(95 days)
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs is a non-sterile 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 list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml) 10.1 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 30.4 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 10.1 minutes.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
This document is a marketing authorization from the FDA for a medical device, specifically a "Nitrile Powder Free Examination Glove With Colloidal Oatmeal Tested For Use With Chemotherapy Drugs". As such, it does not describe a study involving an AI or algorithm, human readers, or a typical "acceptance criteria" and "device performance" in the context of diagnostic or interpretive devices.
The document primarily focuses on the glove's resistance to chemotherapy drugs and its intended use. Here's how I can interpret the request in the context of this document:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" here refers to the minimum breakthrough time deemed acceptable for chemotherapy drugs. The "reported device performance" is the actual breakthrough time observed for this specific glove.
| Chemotherapy Drug | Acceptance Criteria (e.g., minimum breakthrough time accepted for labeling drug as appropriate for glove type) | Reported Device Performance (Breakthrough Time) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Not explicitly stated, but implies a minimum acceptable time for labeling/use | 10.1 minutes |
| Cisplatin (1.0 mg/ml) | Not explicitly stated | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | Not explicitly stated | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Not explicitly stated | > 240 minutes |
| Etoposide (20.0 mg/ml) | Not explicitly stated | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated | > 240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | Not explicitly stated | > 240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated | > 240 minutes |
Note: The document itself does not explicitly state the acceptance criteria/thresholds for these breakthrough times. It only provides the measured times and notes that Carmustine and Thiotepa have "extremely low permeation times." Typically, such criteria would be derived from recognized standards for medical gloves, such as ASTM D6978, which specifies a minimum breakthrough time for labeling purposes.
2. Sample size used for the test set and the data provenance:
This document does not specify the sample size of gloves tested for each chemotherapy drug. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is a regulatory submission for a medical device manufactured by Hartalega Sdn. Bhd. in Malaysia, suggesting the testing data likely originates from testing conducted by or for this company.
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):
This information is not applicable to
this type of device and study. The "ground truth" for glove permeability is established through laboratory testing protocols, not expert clinical interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation where consensus or arbitration is needed to determine a final "answer" (e.g., diagnosis from medical images).
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 or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here is based on objective laboratory measurements of breakthrough time for various chemotherapy drugs, typically conducted according to recognized industry standards (e.g., ASTM D6978 "Standard Test Method for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs").
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
In summary, the provided document describes a medical glove and its resistance to chemotherapy drugs. The concepts of AI, algorithms, human readers, and associated study methodologies (like MRMC, training/test sets, expert adjudication) are not relevant to this specific premarket notification (510(k)) documentation.
§ 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.