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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.

POWDER-FREE BLUE VINYL EXAM GLOVES

The provided document is for a 510(k) premarket notification for "POWDER-FREE BLUE VINYL EXAM GLOVES". This is a medical device submission for physical examination gloves, and the evaluation criteria and studies are related to the performance characteristics of these gloves, not to an AI/Software as a Medical Device (SaMD).

Therefore, many of the requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Number of experts used to establish ground truth," and "Effect size of how much human readers improve with AI vs. without AI assistance," are not applicable to this type of device.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The standards (e.g., ASTM, ISO, MIL Std) typically outline specific sampling plans, but the document only states that the device "met or exceeded" them.
• Data Provenance: Not explicitly stated. For physical device testing, the "country of origin of the data" is generally less relevant than the standards followed. The testing would have been conducted by the manufacturer or a contracted lab to demonstrate compliance with the listed standards. It is implied to be prospective testing for the specific device being submitted.

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

• Not Applicable. For physical device testing like examination gloves, "ground truth" is established through standardized physical, chemical, and biological tests, not by expert consensus in the diagnostic sense. The "experts" would be the scientists and technicians performing the tests according to the specified ASTM, ISO, and other standards.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for interpreting diagnostic images or clinical scenarios where human judgment is involved. For physical tests of gloves, results are typically objective measurements against predefined thresholds in the standards.

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 is an AI/SaMD related study type and does not apply to examination gloves.

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

• Not Applicable. This is an AI/SaMD related evaluation and does not apply to examination gloves.

7. The type of ground truth used:

• For examination gloves, the "ground truth" is defined by the performance specifications and acceptance criteria outlined in the referenced industry standards (ASTM D 5250-00E4, ASTM D 5151-99, ASTM D 6124-01, ISO 2859, MIL Std 105E) and biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Bio-Burden). These standards define the acceptable levels for properties such as strength, barrier integrity (pinholes), biocompatibility, and perhaps dimensions.

8. The sample size for the training set:

• Not Applicable. Physical devices like gloves do not have "training sets" in the context of machine learning. The manufacturing process is controlled and validated, and batches are tested to ensure ongoing quality.

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

• Not Applicable. As there is no training set for this type of device, this question is irrelevant.

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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.

POWDERED VINYL EXAM GLOVES, WHITE

This document describes the acceptance criteria and study proving a device meets these criteria. The device is 'Powdered Vinyl Exam Gloves, White' (K031104) from Glormed International, Inc.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, the tests referenced are recognized industry standards for gloves.

• Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected as part of the regulatory submission process. The study appears to be prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The "ground truth" for this type of device is established by meeting the specified performance standards rather than expert consensus on individual observations.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective measurements against established technical standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not relevant for this type of medical device (examination gloves). Such studies are typically conducted for diagnostic imaging devices where human interpretation plays a role.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study is not applicable as this is a physical medical device (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and adherence to established industry-specific performance standards (e.g., ASTM, ISO, MIL Std for physical properties, and specific bio-compatibility tests). There is no "expert consensus," "pathology," or "outcomes data" in the conventional sense for proving the functional performance of examination gloves.

8. Sample Size for the Training Set

There is no training set for this type of device. The device's performance is evaluated against predefined standards, not by training an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set 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.

POWDER-FREE POLY-VINYL EXAMINATION GLOVES, COLOR: WHITE

The document describes the summary of a 510(k) premarket notification for "Powder-Free Poly-Vinyl Examination Gloves, Color: White" by GLORMED INTERNATIONAL, INC. This device is classified as a Class I medical device (80LYZ) and is intended for medical purposes to prevent contamination between patient and examiner.

The submission focuses on demonstrating substantial equivalence to previously marketed devices (K002340 and K992979) rather than presenting a detailed de novo device study. Therefore, the information regarding acceptance criteria, study details, and specific performance metrics for this particular device is limited to compliance with established standards.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to have been conducted to demonstrate compliance with the listed ASTM and IEST-RP standards, which would typically involve testing a sample of the manufactured gloves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and not provided in the document. The device is a patient examination glove, and its performance is evaluated against material and biocompatibility standards, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance is measured against predefined technical and biological standards, not through adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging software) where human readers' performance is influenced by the device. For examination gloves, the focus is on material properties and safety.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and not provided. The device is a physical product (gloves), not an algorithm or software. Its performance is inherent in its physical and chemical properties.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and tests for physical properties (e.g., tear resistance, tensile strength – implied by ASTM standards mentioned) and biological safety (biocompatibility tests).

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided as there is no training set for this type of device.

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This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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.

The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GLORMED INTERNATIONAL, INC. VINYL EXAMINATION GLOVE, POWDER-FREE:

It's important to note that this document is a 510(k) Summary for a medical glove, which is a relatively low-risk device. The regulatory requirements and the nature of the "study" for such devices are much simpler than for complex AI-powered diagnostic tools. Therefore, many of the requested categories (like MRMC studies, ground truth establishment for training data, number of experts for ground truth, etc.) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of the device (a vinyl examination glove), the "study" is a series of laboratory tests to demonstrate compliance with relevant standards and safety requirements.

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

• Sample Size: Not explicitly stated for each test. For physical property tests like water leak, ASTM standards typically specify a sampling plan (e.g., AQL levels). For biocompatibility tests (skin irritation, sensitization), testing is typically done on a representative biological model or a small group of human volunteers.
• Data Provenance: Not specified, but the tests were performed "in a certified testing laboratory." The country of origin of the data is not mentioned, but it's presumed to be from a laboratory that can provide data acceptable to the FDA for a US market submission. The tests are prospective in the sense that they were conducted specifically for this device submission to demonstrate compliance.

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

• Not Applicable. For physical and chemical tests of a medical glove, "ground truth" is established by the objective physical and chemical properties of the glove itself, as measured by standard laboratory procedures. Biocompatibility studies are typically evaluated by toxicologists or dermatologists, but the number of "experts" for ground truth adjudication in the AI sense is not relevant here.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, adjudication in the context of expert consensus for AI is not relevant for these types of lab tests. The tests have pass/fail criteria based on standards.

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 physical product (medical glove), not an AI-powered diagnostic or assistive tool.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used:

• Objective Test Results against Standards. The "ground truth" for the performance claims of the glove is the objective data obtained from the specified laboratory tests (e.g., water leak test, tensile strength implicit in ASTM D5250, results of irritation and sensitization studies) compared against the acceptance criteria defined by the relevant ASTM standards and FDA requirements.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As above, no training set for a physical device.

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

Vinyl Patient Examination Glove, Powdered

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Vinyl Patient Examination Glove, Powdered." It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study for the device based on the given input.

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