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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The tested chemotherapy drugs are as follows:

Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time
Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes
Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes
Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes
Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes
Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes
Methotrexate 25 mg/mL, No breakthrough up to 240 minutes
Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes
Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time
Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes

CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.

Non-sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for a Non-Sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs.

The request asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specific details about MRMC studies, ground truth establishment, sample sizes, and expert qualifications.

However, the provided document does not contain information related to an AI/ML medical device or a diagnostic study involving human readers or algorithms. It is a regulatory clearance letter for a physical medical device (examination gloves). Therefore, I cannot extract the requested information about acceptance criteria, study details, human-in-the-loop performance, or AI model training from this document.

The document focuses on:

• Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs
• Regulation Number: 21 CFR 880.6250 (Non-Powdered Patient Examination Glove)
• Regulatory Class: Class I
• Indications for Use: Disposable device for medical purposes worn on examiner's hand to prevent contamination between patient and examiner. Specifically tested for use with Chemotherapy Drugs as per ASTM D6978-05.
• Chemotherapy Drugs Tested: Lists 11 specific chemotherapy drugs and their breakthrough detection times.
• Caution: Highlights low breakthrough times for Carmustine and Thiotepa.

Therefore, I cannot fulfill the request as it pertains to AI/ML device studies using this specific document.

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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The tested chemotherapy drugs are as follows:

• Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
  Note that Carmustine(BCNU) and Thiotepa have low permeation times.

Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.

This document describes a 510(k) premarket notification for a non-sterile, powder-free nitrile examination glove. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is primarily related to the physical and chemical properties of the gloves, and their performance against established ASTM and ISO standards for medical gloves, rather than a diagnostic AI device requiring a clinical study with ground truth.

Given the nature of the device (medical gloves), the request for acceptance criteria and a study proving device meets acceptance criteria in the context of an AI device with ground truth, multi-reader studies, and training sets is not directly applicable. However, I can extract and present the relevant information from the document as it pertains to the performance criteria and testing used for these gloves.

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table between the predicate device (K083755) and the subject device (K182241) against various technical characteristics and standards. It implicitly uses the standards as acceptance criteria.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for dimensions, tensile strength, or holes). It refers to standards like ASTM D6319 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the sample sizes and sampling methods used for such material tests.

The data provenance is from non-clinical tests performed to demonstrate that the proposed device met all design specifications. The country of origin of the data is not explicitly stated, but the manufacturer is Sri Trang Gloves (Thailand) Co., LTD. Given the nature of manufacturing quality control and standard testing, this data would be considered prospective for the purpose of validating the product before its market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the device described. The device is a medical glove, and its performance is evaluated against engineering and biological compatibility standards, not by experts establishing a "ground truth" for a diagnostic task. The tests are objective measurements and standardized biological assays.

4. Adjudication method for the test set

Not applicable. Performance is measured against objective standards, not subjective assessments 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 device is a medical glove, not an AI-powered diagnostic tool.

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

Not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used

For the physical and chemical properties, the "ground truth" is defined by the specific parameters and limits set forth in the referenced ASTM and ISO standards (e.g., minimum length, minimum tensile strength, maximum number of holes at a given AQL). For biocompatibility, the "ground truth" is the qualitative assessment of biological response (e.g., non-irritant, non-sensitizer, no systemic toxicity) in accordance with ISO 10993 series, using defined animal models and in vitro tests.

8. The sample size for the training set

Not applicable. This device is a medical glove, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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