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.

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).

Acceptance Criteria and Device Performance Study for Non-Sterile, Powder-Free Latex Examination Gloves

This document outlines the acceptance criteria and the study conducted to demonstrate that the device, Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less), meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established industry standards and specific tests for biocompatibility. The table below summarizes these criteria and the reported performance.

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

The provided document does not explicitly state the sample sizes used for each specific test within the ASTM D 3578-05-e1 standard or for the biocompatibility studies. However, the standard itself dictates sampling plans for various tests (e.g., AQL for pinholes).

Data Provenance: The studies were conducted by Siam Sempermed Corp., Ltd., an organization based in Thailand. The nature of the tests (physical properties, chemical analysis, and animal biocompatibility studies) indicates that the data is retrospective relative to the date of the 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance. The country of origin for the data is Thailand, where the manufacturer is located.

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

For this type of device (medical gloves), the "ground truth" is not typically established by human experts in the same way as, for example, medical imaging diagnostics. Instead, the ground truth is defined by objective, measurable parameters outlined in the referenced standards (ASTM D 3578-05-e1) and established protocols for biocompatibility testing.

• ASTM D 3578-05-e1: Compliance with this standard is determined through prescribed laboratory testing methods, not by expert consensus. Therefore, no number of human experts with specific qualifications like "radiologist with 10 years of experience" would be involved in establishing this ground truth. The "experts" would be qualified laboratory technicians performing the tests according to the standard.
• Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These are standardized animal tests with defined pass/fail criteria. The interpretation of results would typically be done by qualified toxicologists or veterinarians specializing in animal studies, following established protocols. The number of such individual experts is not specified but is implicit in the execution of these regulatory-driven tests.

4. Adjudication Method (for the test set)

As described above, the "ground truth" for this device's performance is determined by adherence to established, quantitative standards and prescribed test protocols. Therefore, a human "adjudication method" like 2+1 or 3+1 (common in studies involving subjective interpretation, e.g., clinical diagnosis) is not applicable here. The results of the tests are objective and directly compared against the acceptance criteria outlined in the standards.

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

An MRMC comparative effectiveness study is not applicable and therefore was not done for this device. MRMC studies are used to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of AI in interpreting medical images or data. This device is a physical product (examination glove), not an AI diagnostic tool, so such a study would be irrelevant.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study is not applicable for this device. This device is a physical product, not an algorithm or AI model. Therefore, there is no "algorithm-only" performance to evaluate. The studies performed are to demonstrate the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The type of ground truth used is predominantly objective, quantitative measurements against established industry standards and regulatory biological safety protocols.

• ASTM D 3578-05-e1: Ground truth is defined by the specific values, ranges, and methodologies prescribed by this standard for dimensions, tensile strength, elongation, freedom from holes (AQL), and powder-free residue.
• Protein Level: The ground truth is the quantitative measurement of protein, with an acceptance criterion of "50 micrograms or less."
• Biocompatibility: Ground truth is established by the outcomes of validated animal tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization) against predefined "pass" criteria for these biological responses.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable for this device. Training sets are used in machine learning and AI development to teach an algorithm to recognize patterns. Since this device is a manufactured physical product, its characteristics are determined by the manufacturing process and material properties, not by an algorithm trained on data. There is no software or AI component that requires a training set.

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

As stated above, a "training set" is not applicable for this device. Therefore, the question of how its ground truth was established is moot.

Ask a specific question about this device

THIS DEVICE IS A DISPASABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WERN ON THE EXAMINER'S Official T AND HAND TO PREVENT CONTAMINATION SETWEEN EXAMINER

SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 200 ug or less of total water extractable protein per gram, 10 mg/dm- or less of residual powder

The provided text is a 510(k) summary for the SATARI® latex patient examination glove. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance evaluation.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness simply cannot be answered from the provided document. The document does not describe such a study.

However, I can extract the acceptance criteria that are implied through the device description and the "identical" or "similar" comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are inferred from the description of the device and the comparison to the predicate device. Since the device claims substantial equivalence, the "acceptance criteria" are essentially matching the characteristics of the predicate device and meeting regulatory standards for examination gloves.

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

• Sample size: Not specified. The document does not detail a specific performance study with a test set. It relies on a comparison to a predicate device and states "Technical comparison of specific elements is attached in the main submission."
• Data provenance: Not specified.

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

• Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is described as there is no specific test set study detailed.

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 a medical glove, not an AI diagnostic device.

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

• Not applicable. This is a medical glove, not an algorithm.

7. The type of ground truth used:

• Not applicable in the sense of a diagnostic or imaging study. The "ground truth" for this device's performance would be adherence to established material specifications, manufacturing standards, and regulatory requirements for patient examination gloves. The document implies compliance through comparison to its predicate device and adherence to listed protein and powder limits.

8. The sample size for the training set:

• Not applicable. This document does not describe a training set as it's not a machine learning or AI device.

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

• Not applicable. This document does not describe a training set.

Ask a specific question about this device