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THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl
Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl

The provided document is a 510(k) clearance letter from the FDA for medical gloves, specifically "Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl" and "Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl".

This document does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves it meets those criteria. It is entirely focused on the regulatory clearance of examination gloves, outlining their indications for use, the chemotherapy drugs they were tested against, and fentanyl permeation times. There is no mention of algorithms, machine learning, human readers, or any other aspects related to AI/ML device evaluation.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this document.

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

Non sterile, Powder free Nitrile Examination Glove, Blue.

Here's a breakdown of the acceptance criteria and the study information 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:

• Sample Size: Not specified in the provided text. The document states "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above," referring to the table of characteristics, but does not detail the sample sizes used for each test.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the data collection itself. However, the tests cited are ASTM standards, which are internationally recognized. The manufacturer is Siam Sempermed Corp., Ltd from Thailand.

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

• Not Applicable. This device is a nitrile examination glove. The "ground truth" for its performance is established through standardized physical and biocompatibility testing (e.g., tensile strength, freedom from holes, skin irritation), not through expert interpretation of medical images or clinical outcomes that would require adjudicators.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the evaluation of this device relies on standardized physical and chemical tests against ASTM standards, not on subjective assessment or consensus among experts.

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 does not involve AI or human "readers" in its intended use or evaluation.

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

• Not Applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" is based on objective measurements and observations according to established industry standards (ASTM D 6319-10) for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and standardized biological assays for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set:

• Not Applicable. This device concerns a physical product tested against standards, not a machine learning model requiring 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.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.

The provided document is a 510(k) premarket notification decision letter for Sterile, Powder Free Nitrile Examination Gloves, Blue, tested for use with chemotherapy drugs. It does not describe an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies for such devices cannot be extracted.

The document discusses the substantial equivalence determination for nitrile examination gloves to legally marketed predicate devices. The "Indications for Use" section lists specific chemotherapy drugs and their respective permeation (breakthrough detection) times when tested with the gloves.

Information that CAN be extracted, reorganized from the "Indications for Use" section:

1. A table of specific performance data (permeation times) for the device:

Note: The document does not explicitly state the "acceptance criteria" as a single defined threshold for all drugs, but rather presents the measured performance against a listed set of chemotherapy drugs. The determination of "substantial equivalence" implies that the observed permeation times are considered acceptable compared to predicate devices for the indicated use. The warnings for Thiotepa and Carmustine indicate that the performance for these drugs was deemed insufficient for safe use, despite having measured breakthrough times.

The following information cannot be extracted from the provided text as it pertains to AI/ML device studies, which is not the subject of this document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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