Search Results

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera, Green Color

This document is a 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera Green Color." It does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The letter is a regulatory approval for a medical device (gloves), not an AI/ML product.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Vinyl Exam Glove, Powdered

The provided document is a 510(k) clearance letter from the FDA for a Disposable Vinyl Exam Glove, Powdered. This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the request asks for information related to the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI-powered medical device. The document provided does not contain any information about AI, algorithms, or any studies involving performance metrics like sensitivity, specificity, or reader studies.

The 510(k) pathway for a medical glove typically focuses on aspects like material biocompatibility, physical properties (e.g., tensile strength, elongation), and barrier integrity (e.g., freedom from holes). These would be assessed through standard engineering and materials testing, not through clinical or AI-related performance studies.

Therefore, I cannot provide the requested information based on the given document. The document primarily concerns the regulatory clearance of a standard medical device (gloves) under the 510(k) process, which does not involve AI performance evaluation.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Synthetic Exam Glove, White Color

The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Synthetic Exam Glove, White Color. This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of a medical imaging or AI-powered diagnostic device, which is what your questions are geared towards.

The document is an approval letter for a medical glove, which falls under general controls and does not require complex performance studies like those for diagnostic devices. Therefore, I cannot extract the information you requested about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the content of this specific regulatory document for a medical glove.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED A FATIENT EXAMINATION ODD THE EXAMINER'S HAND OR SEARCH AND FOR MEDIOAL POR! OUD OF AND AND ATION BETWEEN PATIENT AND EXAMINER.

Disposable Vinyl Exam Glove, Powder Free

This document is a 510(k) premarket notification decision letter from the FDA for a Disposable Vinyl Exam Glove, Powder Free. It is not a study report for an AI/ML medical device. Therefore, most of the requested information about acceptance criteria and study details for an AI/ML device is not present in this document.

However, I can extract the safety and performance tests that would typically be required for such a device and what a "study" for this type of device would generally entail.

Here's an interpretation based on the standard requirements for patient examination gloves:

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

For examination gloves, the "acceptance criteria" and "device performance" are typically defined by recognized consensus standards. A 510(k) submission for a glove would include test reports demonstrating compliance with these standards. The document provided does not contain a table of acceptance criteria or reported device performance. However, typical acceptance criteria for examination gloves include:

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

• Sample Size: For physical and barrier integrity tests, sample sizes are typically specified by the relevant ASTM standards (e.g., ASTM D5250, ASTM D5151). For example, water leak tests often require a statistically significant number of gloves from multiple batches. This information is not in the provided document, but would be in the detailed test reports submitted with the 510(k).
• Data Provenance: The tests are conducted according to recognized international or national standards. The data provenance would be the test labs (internal or external to the manufacturer) that performed the tests. This information is not in the provided document. Such tests are usually performed on a prospective basis (i.e., on manufactured batches specifically for testing).

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 this type of device. "Experts" for establishing ground truth are relevant for AI/ML devices where human interpretation is the gold standard (e.g., radiologists for medical images). For examination gloves, performance is measured objectively through standardized physical, chemical, and biological tests, not subjective expert assessment.

4. Adjudication method for the test set

This question is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in AI/ML studies.

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 question is not applicable to this type of device. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. Examination gloves are a physical barrier device.

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

This question is not applicable to this type of device. "Standalone performance" refers to the algorithm's performance without human interaction, which is relevant for AI/ML software.

7. The type of ground truth used

For examination gloves, the "ground truth" is established through:

• Performance against defined standard specifications: e.g., a glove must achieve a certain tensile strength or elongation as per ASTM D5250.
• Absence of defects: e.g., a glove must not leak when tested according to ASTM D5151.
• Biocompatibility: e.g., the materials must not cause a toxic, irritating, or sensitizing reaction based on ISO 10993 tests.

This "ground truth" is objective and measured, not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.

8. The sample size for the training set

This question is not applicable to this type of device. "Training set" refers to data used to train an AI/ML algorithm.

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

This question is not applicable to this type of device.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Yellow Color

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a medical device meets specific acceptance criteria.

The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Yellow Color". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations that apply. It also includes an "Indications for Use Statement".

However, it does not contain any of the following information requested:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to the regulatory clearance of a basic medical glove, which typically does not involve the kind of performance studies or detailed acceptance criteria described in your request, often associated with software or more complex diagnostic/therapeutic devices.

Ask a specific question about this device

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Blue Color

The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Exam Glove, Blue Color. This document is for a Class I medical device and describes its intended use and regulatory classification.

The information requested in the prompt, such as acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are typically associated with performance validation of more complex devices, particularly those involving algorithms, diagnostics, or therapeutic effects.

This document does not contain the type of detailed performance study information requested.

Here's why and what can be extracted:

• Device Type: Exam gloves are Class I devices, meaning they pose the lowest risk to patients and users. Their substantial equivalence is typically demonstrated through compliance with recognized standards (e.g., for strength, leak resistance, biocompatibility) rather than complex comparative effectiveness studies or algorithm performance evaluations.
• Regulatory Focus: The FDA letter primarily confirms "substantial equivalence" to a legally marketed predicate device, allowing the introduction of the device to the market under general controls. It's about regulatory clearance, not detailed performance validation in the way one would see for an AI-powered diagnostic tool.

Therefore, I cannot populate the table or answer most of the questions using only the provided text.

However, I can extract the following limited information relevant to the prompt:

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

• Acceptance Criteria: The document implies that the acceptance criteria for this device are its substantial equivalence to a legally marketed predicate device, as well as compliance with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Specific performance metrics (e.g., tensile strength, barrier integrity) would be part of the underlying submission that led to this letter, but are not detailed here.
• Reported Device Performance: The letter states the FDA "determined the device is substantially equivalent," meaning it met the necessary criteria for regulatory clearance. Again, specific performance metrics are not listed in this public face page.

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

• Not explicitly stated in this document. For a Class I device like gloves, testing typically involves standardized material and physical property tests, not clinical "test sets" in the diagnostic sense.

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

• Not applicable/Not stated. This type of information is usually relevant for diagnostic devices that require expert interpretation or consensus for ground truth.

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

• Not applicable/Not stated.

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:

• No. This is not an AI/diagnostic device.

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

• No. This is not an algorithmic device.

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

• Not applicable for this type of device based on the document. Ground truth for gloves usually revolves around manufacturing standards and material properties (e.g., results of leak tests, tensile strength tests, biocompatibility tests).

8. The sample size for the training set:

• Not applicable/Not stated.

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

• Not applicable/Not stated.

Ask a specific question about this device