Search Results

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.

Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 microgram per Gram of Glove or Less)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 microgram per Gram of Glove or Less)".

This document simply states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not contain any information about acceptance criteria for a study, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This type of information would typically be found in a separate performance study report or design validation documentation, not in an FDA clearance letter.

Ask a specific question about this device

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.

Sterile Powder-Free Nitrile Patient Examination Glove, Blue Colored,
Non-sterile Powder-free Nitrile Patient Examination Glove, Blue Colored,

This document is a 510(k) premarket notification letter from the FDA for a medical device: "Sterile Powder-Free Nitrile Patient Examination Glove, Blue" and "Non-Sterile Powder-Free Nitrile Patient Examination Glove, Blue." This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria in the way described in the request.

A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent for its intended use. It does not provide performance study details.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms market clearance based on substantial equivalence, but it does not detail:

1. A table of acceptance criteria or 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 for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This information would typically be found in the actual 510(k) submission, specifically sections related to performance data, or in a separate clinical study report, not in the FDA's clearance letter.

Ask a specific question about this device

A patient Examination Powder 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.

Not Found

This is an FDA 510(k) clearance letter for Patient Exam Nitrile Powdered Gloves. It is not a study of an AI/ML device, and therefore does not contain information about acceptance criteria or a study proving device performance as requested.

The document is a regulatory approval for a medical glove, confirming its substantial equivalence to previously marketed devices. It does not involve any AI components or performance metrics suitable for the detailed questions about AI device studies.

Ask a specific question about this device

A patient Examination Powder-Free Polymerisation 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.

Patient Latex Examination "Powder-Free" Trade Name: Polymer Coated Gloves

The provided document is a 510(k) premarket notification letter from the FDA regarding "Patient Latex Examination 'Powder-Free' Polymer Coated Gloves" by Wear Safe Malaysia Sdn. Bhd.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of medical device validation for performance or effectiveness.

Instead, the letter:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Allows Wear Safe Malaysia Sdn. Bhd. to market the device subject to general controls provisions of the Act.
• Provides information on regulatory compliance (GMP regulations, labeling, promotion, and advertising).

Therefore, I cannot extract the requested information from this document. The sections you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sized 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
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

are not present in this regulatory correspondence. Such details would typically be found in the 510(k) submission itself (which includes test reports, studies, and data) but are not generally summarized in the FDA's decision letter.

Ask a specific question about this device

A patient Examination Powder glove sterile 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.
A patient Examination Powder-Free Chlorinated glove sterile 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.

Patient Latex Examination Glove Powdered & Powder-Free, Sterile

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving device performance in the way typically expected for an AI/ML medical device.

The information provided in the document pertains to the regulatory clearance of a physical medical device (latex examination gloves) based on substantial equivalence to a predicate device, not on algorithmic performance or clinical study outcomes involving AI.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document. The concepts are not applicable to the content of the provided text.

Ask a specific question about this device

A patient Examination Powder-Free Chlorinated 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.

Not Found

I am sorry, but the provided text does not contain the required information to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a Nitrile Patient Examination Glove, Powder-Free, and outlines the regulatory classification and compliance, but does not detail the specific performance acceptance criteria or the studies conducted. Therefore, I cannot generate the requested table and accompanying details.

Ask a specific question about this device

A Surgeon's glove is a device made of natural or synthetic rubber * intended to be worn by operating room personnel to protect a surgical wound from contamination.

SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES

The given text is a 510(k) clearance letter from the FDA for "Latex Surgical Gloves Powder-Free". This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria analysis typical for more complex medical devices or AI algorithms.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document. The letter confirms regulatory approval for marketing, not a scientific study report with performance metrics.

However, based on the provided text, I can infer the following:

1. Acceptance Criteria and Reported Device Performance: Not explicitly stated. The acceptance for regulatory clearance is based on "substantial equivalence" to a predicate device. This implies the device meets the basic performance and safety standards of similar legally marketed devices. For surgical gloves, this would typically involve standards related to sterility, barrier integrity (e.g., freedom from pinholes), strength, and biocompatibility, but no specific numerical criteria or reported results are in this document.

2. Sample Size Used for Test Set and Data Provenance: Not applicable. This document does not describe a clinical study with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. This document does not describe a process of establishing ground truth by experts.

4. Adjudication Method for the Test Set: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study of human readers or AI assistance.

6. Standalone Performance Study: Not applicable in the context of an algorithm. For a physical device like a glove, performance standards would have been met but are not detailed here.

7. Type of Ground Truth Used: Not applicable.

8. Sample Size for the Training Set: Not applicable.

9. How Ground Truth for the Training Set Was Established: Not applicable.

Summary based on the document:

This document is a 510(k) clearance, a regulatory process to demonstrate that a device is as safe and effective as a legally marketed predicate device. It is not a report on a clinical or performance study with detailed acceptance criteria and results as typically understood for AI/ML devices or complex medical devices. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, which would have been supported by underlying testing data not included in this letter.

Ask a specific question about this device

A patient Examination Powder-Free Chlorinated 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.

Not Found

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" (K973020). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, or in supporting documentation, not in the clearance letter.

Therefore, I cannot fulfill your request for the specific information you asked for based on the provided text. The document confirms the regulatory approval of the device but offers no technical specifications or study details.

Ask a specific question about this device