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BioproTM, Nitrilon™, Correct Touch® (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to present contamination between patient and examiner.

Biopro™, Nitrilon™, Correct Touch® or any other private labeling Nitrile Powdered Examination Gloves (Green, Purple)

This looks like a 510(k) clearance letter for examination gloves. The provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document is a regulatory clearance for a medical device (nitrile examination gloves) and confirms its substantial equivalence to legally marketed predicate devices. It discusses general controls, manufacturing practices, and labeling, but not the kind of performance evaluation typically associated with AI/ML systems.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove device performance for an AI/ML device from this text. The questions you've posed are pertinent to evaluating AI/ML medical devices, but the provided text describes a much simpler, non-AI medical device.

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Biopro™, Nitrilon™, Correct Touch (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Biopro™, Nitrilon™, Correct Touch or any other private labeling Nitrile Powder Free Examination Gloves (Green, Purple)

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a medical device. The document is an FDA 510(k) clearance letter for examination gloves, which primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "general controls" and "good manufacturing practice" but does not detail specific performance criteria or a study proving those criteria are met.

Therefore, I cannot provide the requested information based on the given input.

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Biopro™, Correct Touch® (Powdered) is a medical glove which is worn on the hand of health care and similar personnel to prevent contamination between patient and the examiner.

Latex Powdered Examination Glove

This document is a marketing clearance letter for Latex Powdered Examination Gloves. As such, it does not contain the detailed technical study information like performance data, ground truth establishment, or sample sizes for AI/algorithm-based devices. The request is for information on a device and its acceptance criteria and the study that proves the device meets the acceptance criteria. This document is a regulatory approval for a physical medical device not a software medical device. The information requested (acceptance criteria, details of a study with sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are specific to the validation of software algorithms or AI-based medical devices. This document pertains to traditional physical medical devices.

Therefore, most of the requested information cannot be extracted from this document, as it outlines marketing approval based on substantial equivalence for a physical glove, not a software device's performance study.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable/Not available. This document does not detail specific performance criteria for the latex glove beyond its intended use for preventing contamination. The primary "acceptance criteria" here is substantial equivalence to a legally marketed predicate device, not performance metrics based on a clinical or technical study.

2. Sample size used for the test set and the data provenance: Not applicable/Not available. No test set or data provenance details are provided as this is not a software device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not available. No ground truth establishment by experts is described for a latex glove.

4. Adjudication method: Not applicable/Not available. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not available. This type of study is for diagnostic software devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not available. This is not a software algorithm.

7. The type of ground truth used: Not applicable/Not available. Ground truth, in the context of AI/software, is not relevant for a physical medical glove. Its approval is based on material properties, manufacturing standards, and substantial equivalence.

8. The sample size for the training set: Not applicable/Not available. There is no training set for a physical glove.

9. How the ground truth for the training set was established: Not applicable/Not available. There is no training set or ground truth for a physical glove.

What the document does indicate regarding "acceptance":

The device (Latex Powdered Examination Glove) was accepted by the FDA based on substantial equivalence to devices marketed prior to May 28, 1976. This is the primary regulatory "acceptance criteria" for this type of device and submission (510(k)).

The "study that proves the device meets the acceptance criteria" in this context refers to the 510(k) submission itself, which demonstrates substantial equivalence, typically through comparison of physical and chemical properties, intended use, and performance claims (e.g., barrier integrity, biocompatibility) to a predicate device, rather than a clinical performance study with human readers or AI algorithms. The document does not provide the specifics of how that substantial equivalence was demonstrated (e.g., specific test results on barrier integrity, tensile strength, etc.), as it is merely the clearance letter.

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The Powder Free 911 Latex Examination gloves is disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves (colored) BLUE

This document is a 510(k) clearance letter from the FDA for examination gloves. It is not a study report for an AI/ML device, so much of the requested information regarding AI device performance metrics, study design, and ground truth establishment is not applicable or available in this document.

However, I can extract the relevant information regarding the device and its intended use, and discuss how regulatory acceptance might be framed for a simple medical device like an examination glove, aligning with the spirit of the request as much as possible for a non-AI product.

Device: Powder Free 911 Latex Examination Gloves (Blue)

Regulatory Class: Class I

Product Code: LYY

Indications For Use: The Powder Free 911 Latex Examination gloves is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Given that this is a 510(k) submission for examination gloves, the "acceptance criteria" and "device performance" are typically related to physical properties and biocompatibility, demonstrating substantial equivalence to a predicate device. The "study" would refer to the testing performed to demonstrate these properties.

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

For examination gloves, the acceptance criteria are generally based on industry standards (e.g., ASTM, ISO) and FDA guidance for physical properties and barrier integrity. Since the provided document is a 510(k) summary, specific numerical performance results are not detailed, but the general categories would be:

Note: The actual 510(k) submission document would contain the detailed test reports demonstrating equivalence. The FDA clearance letter implies that these criteria were met to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For examination gloves, the "test set" samples would be batches of gloves produced by the manufacturer.

• Sample Size: Typically, sample sizes for physical property and barrier integrity testing are determined by statistical sampling plans (e.g., ISO 2859-1 for AQL, or specific ASTM standards for destructive testing). These can range from a few gloves per batch for certain destructive tests to hundreds for AQL-based integrity tests.
• Data Provenance: The manufacturing location is Malaysia (BioPro (M) Sdn. Bhd.). The testing would typically be performed at the manufacturer's facility or at an accredited contract laboratory, likely in Malaysia or a country adhering to international standards. This data would be prospective in the sense that the manufacturer tested batches of their new device to demonstrate compliance.

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

This concept is not directly applicable to examination gloves. Ground truth, in the context of AI/ML, refers to a definitive correct answer for a diagnostic or classification task. For physical devices like gloves, "ground truth" is established by direct measurement and standardized testing protocols.

• "Experts": The "experts" would be qualified laboratory technicians and engineers who perform the tests according to established ASTM, ISO, and FDA recognized standards. Their qualifications would include training in laboratory procedures, instrumentation, and quality control. There isn't a "number of experts" in the sense of clinical consensus, but rather adherence to validated methods by qualified personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for AI/ML validation, where there might be disagreements in human expert interpretations that need resolution. For physical characteristic testing of gloves, the results are objective measurements or pass/fail criteria based on defined thresholds. Any discrepancies would be resolved by re-testing or investigation into methodology, not expert consensus.

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. MRMC studies are designed for evaluating diagnostic tools where human interpretation is involved, often comparing human performance with and without AI assistance. Examination gloves are a barrier device, not a diagnostic tool, and do not involve "human readers" in this context.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For examination gloves, the "ground truth" is based on:

• Standardized Measurement & Testing: Objective measurements of physical properties (e.g., tensile strength, elongation, dimensions), and direct tests for barrier integrity (e.g., water leak test) and biocompatibility (e.g., in vitro or in vivo biocompatibility assays).
• Predicate Device Performance: Comparison to the performance characteristics of an existing, legally marketed predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system, 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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A medical glove is worn on the hand of A medical grow similar personnel to prevent contamination between health care personnel and the patient.

Nitrilon™ Correct-Touch® Nitrile Powder-Trade Name: Free Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for a Nitrile Powder-Free Examination Glove. It is not a study report or a technical document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use: "A medical glove is worn on the hand of medical or similar personnel to prevent contamination between health care personnel and the patient."

The document does not contain any of the specific information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

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