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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 EXAM GLOVES, COLOR: WHITE

The document describes the acceptance criteria and the study for "POWDER-FREE POLY VINYL EXAM GLOVES, COLOR: WHITE."

Here's the breakdown of the requested information:

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 sizes used for the specific tests (ASTM D 5250-00, D 5151-00, D 6124-00, ISO 2859, Bio Burden, Dermal Sensitization, Primary Skin Irritation). The data provenance is implied to be from tests performed on the device by Heyuan Hongli Industries, Inc., which is based in China. The submission date is July 11, 2002, suggesting these were retrospective tests conducted on the manufactured gloves.

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

This information is not provided in the document. The tests performed are standardized and do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI device would. Instead, these are material and biological safety tests with predefined methodologies and pass/fail criteria.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are standardized and have objective pass/fail criteria. There isn't an adjudication process involving multiple human reviewers to determine a "ground truth" for these types of tests.

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

An MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.

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

This is not applicable. The device is a physical product (medical glove), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements and assessments based on the specified ASTM and ISO standards, as well as bio-compatibility tests. These standards define the acceptable physical properties (e.g., strength, dimensions), absence of holes, and biological safety (e.g., absence of skin irritation, allowable bioburden). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device's testing.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve a training set as a machine learning model would. Production quality control would involve sampling from manufacturing batches, but this is distinct from "training data."

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

This information is not applicable as there is no "training set" for a medical glove in the context of AI/algorithm development.

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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 EXAM GLOVES, COLOR: WHITE

This submission is for "POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE". The device is a Class I medical device (80LZA).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies refer to meeting or exceeding ASTM standards and biocompatibility tests, which imply a defined methodology within those standards for sample selection and testing.

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

This information is not applicable. The device is an examination glove, and its performance is assessed against technical standards (ASTM) and biological safety tests (biocompatibility, bio-burden), rather than requiring expert interpretation of diagnostic output to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device and study. The testing involves laboratory measurements against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The device in question is an examination glove.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through physical and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specifications and pass/fail criteria outlined in the referenced ASTM standards (D 5250-00, D 5151-00, D 6124-00) and the acceptable levels for Bio-Burden, Dermal Sensitization, and Primary Skin Irritation. These standards represent scientifically established benchmarks for glove quality and safety.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

Ask a specific question about this device