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This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes Thiotepa: 13.6 minutes Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.

The provided text is a 510(k) summary for a Nitrile Examination Glove. It details the device's characteristics, indications for use, and non-clinical testing conducted to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes used for each specific test in the test set. However, it indicates tests were conducted according to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not mentioned, so we cannot determine the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is typically not applicable to studies for medical gloves, as the "ground truth" is established by direct physical, chemical, and biological testing against predefined scientific standards, not by expert consensus or review of diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable, as the tests involve objective measurements against established standards, not interpretation by experts requiring adjudication.

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 a medical glove, not an AI-powered diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical glove, not an algorithm. The device performance is assessed through laboratory testing.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and chemical/physical assessments against established industry standards (ASTM and ISO). For example:

• Dimensional measurements: Direct physical measurement.
• Physical properties (Tensile strength, Elongation): Mechanical testing.
• Freedom from holes: Water leak test as per ASTM D5151.
• Powder-free residue: Gravimetric analysis as per ASTM D6124.
• Biocompatibility (Irritation and Sensitization): Biological testing on animal models (typically as per ISO 10993-10).
• Permeation by Fentanyl and Chemotherapy Drugs: Chemical permeation testing as per ASTM D6978, measuring breakthrough time.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below

Do not use with Carmustine and Thiotepa.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.

The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.

The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder-free Nitrile Patient Examination Glove." This document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

It's important to note that this document does not describe an AI/ML medical device. The "device" in question is a physical glove, and the "tests" are for its physical properties and chemical resistance, not for an algorithm's performance on a dataset. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and how the glove's performance was proven based on the provided text.

Acceptance Criteria and Device Performance (for a physical medical glove)

The document primarily focuses on demonstrating that the subject device (the green nitrile glove) is substantially equivalent to a predicate device (blue or white nitrile gloves) by meeting established standards for patient examination gloves and resistance to chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Specifics (from "Indications for Use" and "Technological Characteristics" tables):

Important Note: The document explicitly states "Do not use with Carmustine and Thiotepa" due to their extremely low permeation times, even though the subject device still improved upon Carmustine's breakthrough time compared to the predicate.

Regarding the AI/ML-specific questions (which are not applicable to this physical glove device):

2. Sample sizes used for the test set and the data provenance: Not applicable. Testing was on physical glove samples from various production lots, not on a dataset in the AI/ML context. Data provenance is implied to be from the manufacturer's testing of their product.
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 physical properties (e.g., hole in glove, chemical permeation) is established through standardized laboratory tests, not human expert consensus. "Experts" would be laboratory technicians or chemists.
4. Adjudication method for the test set: Not applicable. Laboratory tests follow predefined protocols; no human adjudication is mentioned or implied for test results.
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 a physical device, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For physical and chemical tests, the ground truth is objective measurement against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. For biocompatibility, it's the biological response in standardized in-vitro or in-vivo (human repeat insult patch testing) models.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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