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A 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. Tested for use with Chemotherapy Drugs

The BioClean Chemo Shield is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.

The BioClean Chemo Shield is a patient examination glove. The acceptance criteria and performance data for this device are detailed in the provided document, primarily focusing on non-clinical tests.

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 non-clinical test (e.g., number of gloves tested for pinholes, dimensions, or permeation). The data provenance is derived from laboratory testing against established ASTM and ISO standards, indicating a controlled, prospective testing environment rather than retrospective data. The location of the submitter, Nitritex (M) Sdn. Bhd., is Malaysia, so the testing could have occurred there or at a certified lab elsewhere.

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

Not applicable. The ground truth for these non-clinical tests is established by standardized testing protocols (ASTM, ISO) and laboratory measurements rather than expert human interpretation.

4. Adjudication method for the test set:

Not applicable. The reported performance metrics are objective measurements from standardized tests, not subjective interpretations 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 patient examination glove, and its performance is evaluated through non-clinical laboratory testing, not through human reader interpretation or AI assistance.

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

Not applicable. This device is a physical product (a glove), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth used for the device's acceptance criteria is based on established industry standards and laboratory measurements. For physical properties, it's defined by the specifications outlined in ASTM D 6977-04. For freedom from pinholes, it's ASTM D 6977-04 and ASTM D 5151-06. For powder content, it's ASTM D 6124-06. For biocompatibility, it's ISO 10993-10: 2002. Notably, for resistance to chemotherapy agent permeation, the ground truth is the chemical breakthrough detection time as measured according to ASTM D 6978-05.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

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

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A 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. Tested for use with Chemotherapy Drugs

The BioClean Chemo Ultimate is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.

This document is a 510(k) summary for the BioClean Chemo Ultimate patient examination glove. It details the device's characteristics, intended use, and substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the physical and chemical performance of the glove, not a software-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study for a software-based device are not applicable.

However, I can extract information related to the performance testing of the glove.

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

Based on the provided text and extracted table (Image /page/1/Picture/0), here is the information:

Chemotherapy Drug Permeation Performance (from Image /page/1/Picture/0):

The remaining information requested is largely not applicable to this 510(k) submission for a non-software medical device like an examination glove. Here's why:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While samples were used for physical and chemical testing, the document does not specify exact sample sizes for each test in a clinical trials context. Data provenance refers to the origin of medical data (e.g., patient records), which is not relevant here.
• 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 pertains to expert review for diagnostic devices. For a glove, ground truth is established by standardized material testing following ASTM/ISO protocols, not expert consensus on medical images or diagnoses.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication is a process for resolving discrepancies in expert interpretations, again, not applicable to material testing of a glove.
• 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: This relates to comparative studies of diagnostic performance, specifically with AI assistance. Completely irrelevant for a patient examination glove.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, ground truth for a glove's performance is based on standardized physical and chemical tests, not clinical "ground truth" like pathology or outcomes.
• 8. The sample size for the training set: Training sets are used for machine learning models. This is not applicable to a physical glove.
• 9. How the ground truth for the training set was established: Ground truth for a training set is established for machine learning models. Not applicable for this device.

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A 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. Tested for use with the following Chemotherapy Drugs: Cisplatinum, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, 5-Flourouracil, Methotrexate & Paciitaxel.

BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)

This letter from the FDA pertains to the clearance of a medical device, specifically "BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)". It is a 510(k) premarket notification, which means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device.

The document does not provide details about acceptance criteria, a specific study proving the device meets these criteria, or any of the detailed information requested in points 1-9 regarding an AI/algorithm-driven device study.

This letter is a regulatory clearance for a physical medical glove and does not describe an AI/software device or its performance study.

Therefore, I cannot extract the requested information from the provided text.

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