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

VitalCare Exam Gloves (Latex), Paude

I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for VitalCare Latex Exam Gloves, Powdered, and it primarily focuses on the regulatory clearance process and the device's substantial equivalence to legally marketed predicate devices.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document confirms the device's classification and allows its marketing, but it does not provide the detailed study results or acceptance criteria you are asking for.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
A MEDICAL GLOVE IS WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

Latex Patient Examination glove Powderfree (blue color) Polymer coated

Based on the provided text, the acceptance criteria and device performance for the Siam Sempermed D Corporation's Latex Patient Examination Glove Powderfree are as follows:

1. Acceptance Criteria and Reported Device Performance

The document states: "Siam Sempermed Latex Patient Examination Glove Powderfree (blue color) polymer coated meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims". This indicates that the reported device performance meets or exceeds all the specified acceptance criteria.

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

The document specifies "S-2 AQL 4.0" for dimensions and physical properties, "S-4 AQL 4.0" for freedom from hole, and "II AQL 1.5" for freedom from hole. AQL (Acceptable Quality Limit) refers to an inspection level and a sampling plan, but the exact sample size (n) for the test set is not explicitly stated in the provided text. The data provenance is from Siam Sempermed D Corporation, Ltd in Thailand, and the study appears to be prospective manufacturing quality testing to ensure the product meets specified standards.

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

This information is not provided in the text. The evaluation criteria are based on objective physical and chemical properties and ASTM standards, which typically do not involve expert consensus in the same way medical imaging or diagnostic devices might.

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

This information is not applicable and not provided in the context of this device. The assessment is based on measured physical and chemical properties against established standards, not on subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was performed or is relevant for this device. This is a medical glove, a Class I device, and its performance is evaluated based on physical characteristics and material properties, not on diagnostic performance aided by AI.

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

No standalone algorithm-only performance testing was done or is relevant for this device. This device is a physical product (a glove), not an algorithm or AI system.

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

The ground truth used is based on objective measurements against established engineering and material standards, specifically ASTM D3578-95 and internal specifications for dimensions, physical properties, water extractable protein, powder level, and freedom from holes. For "Freedom from Hole," it also refers to "pinhole FDA requirements."

8. The sample size for the training set

There is no "training set" in the context of this device. It is not an AI/ML or diagnostic device that requires training. The described process is a quality control and conformity assessment against manufacturing standards.

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

Not applicable, as there is no training set for this device.

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A glove is worn on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment

Latex Patient Examination glove ( . color)

This document is a 510(k) summary for a latex patient examination glove. It outlines the specifications and quality characteristics of the glove, demonstrating its compliance with relevant standards.

Here's an analysis of the provided information in the requested format:

1. Table of acceptance criteria and the reported device performance

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

The document specifies the "S-2 AQL 4.0" and "S-4 AQL 4.0" for various tests (e.g., Dimension, Physical Properties, Freedom From Hole). AQL (Acceptable Quality Level) is a sampling standard, but it does not directly state the sample size used for the specific testing presented. It implies an inspection plan based on AQL, but the actual number of units tested is not explicitly provided.

The data provenance is from Thailand, as the applicant is Siam Sempermed Corporation.,Ltd, located in Thailand, and the Guinea pig Sensitization study was conducted at Prince of Songkla University, Department of Pharmacology, Faculty of Science, also in Thailand. The studies appear to be prospective as they are testing the product for its specifications directly stated in the document.

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

For the technical performance of the glove (dimensions, physical properties, powder level, freedom from hole), the "ground truth" is established by adherence to the ASTM standard D3578-95 and the internal specifications shown. There is no mention of "experts" in the context of interpreting results for these objective measurements; rather, it's about meeting predefined numerical thresholds.

For the Guinea pig Sensitization (Buehler) test, the study was conducted by the "Prince of Songkla University, Department of Pharmacology Faculty of Science." While the specific number and qualifications of experts (e.g., toxicologists, veterinarians) involved in this study are not detailed, it can be inferred that appropriate scientific personnel from the pharmacology department conducted the experiment.

4. Adjudication method for the test set

There is no mention of an "adjudication method" in the context of interpretation by multiple experts for the performance criteria of the medical device (latex glove). The evaluation is based on objective measurements against pre-defined specifications and AQLs. For the Guinea pig sensitization test, the interpretation of results would have been by the scientific team conducting the study, but no specific adjudication method (like 2+1, 3+1 consensus) among multiple readers is described.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a latex patient examination glove, which does not involve human readers interpreting medical images or data, nor does it involve AI assistance in its primary function.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (glove), not an algorithm or AI system.

7. The type of ground truth used

For the physical and dimensional properties of the glove, the ground truth is based on objective measurements against established engineering specifications and the ASTM standard D3578-95.

For the sensitization study, the "ground truth" for the non-sensitizing potential was established through an animal model experiment (Guinea pig Sensitization (Buehler) test), which is a recognized scientific method for assessing contact sensitization. The outcome is a direct observation of the animals' reaction (or lack thereof).

8. The sample size for the training set

Not applicable. This document describes a physical medical device (latex glove) and its testing, not an AI/ML algorithm that requires a "training set."

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

Not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm.

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A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment

Latex Patient Examination glove ( color)

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

The provided document describes a Class I Latex Patient Examination Glove. The "study" referenced in this context is the testing and adherence to established ASTM (American Society for Testing and Materials) standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Latex patient examination glove (color) - 80LYY meets all of the requirements of ASTM standard D3578-95, and the table above reinforces this by showing the device's measured performance aligns with or exceeds the specified ASTM criteria.

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

The document specifies "AQL" (Acceptable Quality Level) values for various criteria (e.g., S-2 AQL 4.0, S-4 AQL 4.0, II AQL 1.5). These AQLs are part of a sampling plan that dictates how many units from a lot are inspected and how many defects are allowed before the lot is rejected. The exact sample size for each specific test is not explicitly stated as a numerical value (e.g., "n=100 gloves"). Instead, it refers to the AQL standard, which implies a statistically determined sample size based on lot size and the chosen AQL.

• Sample Size: Not explicitly stated as a number; instead, refers to AQL levels (e.g., S-2 AQL 4.0, S-4 AQL 4.0, II AQL 1.5) which determine sample sizes based on lot size according to ASTM D3578-95.
• Data Provenance: The testing appears to be internal verification against established ASTM standards. The Guinea Pig Sensitization test was performed at "Prince of Songkla University, Department of Pharmacology Faculty of Science" in Thailand, indicating some external testing. The overall nature of the tests (material properties) suggests a retrospective assessment based on manufacturing outputs rather than prospective clinical trials.

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

This is not applicable in the context of this device. The "ground truth" for a patient examination glove is defined by predefined physical and chemical standards (ASTM standard D3578-95), not by expert consensus or interpretation of complex medical data. The tests are objective measurements.

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

This is not applicable. Adjudication methods like 2+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution. For objective measurements against specified physical standards, there is no need for expert adjudication.

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 is not applicable. This is a physical medical device (a glove), not an AI diagnostic or assistive technology. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

This is not applicable. This is a physical medical device. There is no algorithm.

7. The type of ground truth used

The ground truth used is objective, quantifiable physical and chemical standards as defined by ASTM standard D3578-95 for Latex Patient Examination Gloves. Additionally, for biocompatibility, the ground truth for sensitization was based on the results of a Guinea Pig Sensitization (Buehler) test, which is a standard animal model for assessing skin sensitization potential.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of validating a physical product against established performance standards. The product is manufactured and then tested to ensure it meets the specified criteria.

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

This is not applicable as there is no training set for this type of device validation.

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A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment

Latex Patient Examination glove (Hypoallergenic) 50 micrograms or less of total water extractable protein per gram of glove

This is a 510(k) summary for a latex patient examination glove, not a software device employing AI. Therefore, most of the requested information (like sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not applicable.

However, I can extract the acceptance criteria and the "device performance" (as described in the document as "SPECIFICATION") for the glove, along with the studies mentioned for safety and basic quality.

Acceptance Criteria and Device Performance for Siam Sempermed Latex Patient Examination Glove (Hypoallergenic)

1. Table of Acceptance Criteria and Reported Device Performance

Study Demonstrating Device Meets Acceptance Criteria

The document refers to a general statement that the device "meet or exceed the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims". This implies that internal quality control and testing validated these specifications against the stated ASTM standards.

Specific studies mentioned not directly for the performance table above, but for safety and claims, include:

• Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc. Study Number. SAT-001
  • Finding: "From the complete lack of reactions noted during the Elicitation Phases (Challenge) of this test, it is evident that the irritation and allergenic potential of the test article is extremely low, If existent at all It is the opinion of the undersigned that this product can be safely distributed for its intended use". This supports the "Hypoallergenic" claim and safety for intended use.
• Primary Dermal Irritation in Rabbits / Guinea Pig Sensitization (Buehler): Consumer Product Testing Co. Experiment reference number T95-0189-1.
  • Finding: "According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this test article is not a primary dermal irritant". This supports the safety of the device.

Non-Applicable Information for this Device (Medical Glove)

The following information requested in the prompt is not applicable to this type of device (a latex patient examination glove, not an AI software device):

2. Sample size 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 for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

These questions are relevant for AI/software devices that analyze data (like medical images), not for a physical product like a glove where performance is typically assessed through physical and chemical testing against established standards.

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