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

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The provided submission (K050529) is for a medical device that does not involve artificial intelligence (AI). It is a 510(k) premarket notification for "Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim." As such, the concept of a "device" in this context refers to the examination gloves themselves, and the acceptance criteria and supporting study are related to the physical and performance characteristics of these gloves, not an AI algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of medical device submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document refers to "Performance data of gloves based on ASTM D3578-01 a22 FDA 1000 ml watertight test." and "The average result obtained from Attachment C." However, the exact sample size used for the performance tests (e.g., watertightness, physical properties, thickness) is not explicitly stated in the provided text. ASTM D3578-01aE2 specifies an AQL (Acceptable Quality Level) of 2.5%, implying a statistical sampling plan (e.g., ISO 2859-1 or similar), but the specific number of units tested is not provided.
• Data Provenance: The manufacturing entity is "SPI GLOVES SDN. BHD." located in Malaysia. The tests conducted would presumably be performed on gloves produced in Malaysia.

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

• Not applicable. The ground truth for glove performance is established through standardized laboratory testing against objective criteria (e.g., measurements for length and thickness, tensile testing for physical properties, chemical analysis for powder and protein content, and standardized water leak tests). There is no "expert" (like a radiologist) establishing a subjective truth.

4. Adjudication method for the test set:

• Not applicable. Performance data is derived from objective measurements and standardized tests, not 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:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• Objective measurement and standardized test results against established engineering and chemical specifications (ASTM D3578-01aE2 for physical properties, FDA requirements for watertightness, powder content, and protein content).
• Biocompatibility testing (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) against established biological safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set in the AI sense. The manufacturing process of the gloves could be considered "trained" through quality control and process optimization over time, but not in the context of a "training set" for an algorithm.

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

• Not applicable. This is not an AI 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

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)

I am sorry, but the provided text is a Food and Drug Administration (FDA) clearance letter for a medical device, specifically "Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling."

This document does not contain the information required to answer your request about acceptance criteria and a study proving device performance.

The letter focuses on:

• Confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
• Outlining regulatory requirements and general controls provisions.
• Providing contact information for further guidance.
• Stating the intended use of the gloves.

There is no mention of:

• Specific acceptance criteria for performance.
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot generate the requested table or answer the specific questions based on the provided input.

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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 & examiner.

Not Found

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but this refers to regulatory equivalence based on intended use and technological characteristics, not performance against specific criteria.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document.

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

Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA Water Leak Test.

The provided document describes the acceptance criteria and performance data for Cashmere Powder Free Latex Examination Gloves.

1. Acceptance Criteria and Reported Device Performance

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

The document specifies "GI AQL=4.0%" for the watertight test, which refers to General Inspection Level 1 with an Acceptance Quality Limit of 4.0% according to ASTM D3578-00a. This standard typically involves sampling plans where the sample size is determined by the lot size, but the exact number of units tested is not explicitly stated in the provided text.

The data provenance is from Malaysia, specifically from SEAL POLYMER INDUSTRIES SDN. BHD. The study appears to be prospective as it involves the testing of a manufactured product against established 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 applicable as the document describes performance testing of a physical product (gloves) against established engineering and material standards (ASTM D3578-00a and FDA requirements), not the establishment of ground truth by human experts for a diagnostic algorithm.

4. Adjudication method for the test set

This information is not applicable as the document describes performance testing of a physical product against established objective standards, not a process requiring 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 information is not applicable as the document describes the performance of a physical medical device (examination gloves) and does not involve AI, human readers, or case studies.

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

This information is not applicable as the document pertains to the performance of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used consists of established industry standards and regulatory requirements:

• ASTM D3578-00a Standard for Latex Examination Gloves
• FDA Water Leak Test requirements (1000 ml watertight test)
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)

8. The sample size for the training set

This information is not applicable. The document describes the performance of a physical product, not a statistical model or algorithm 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 mentioned or implied for this physical product performance testing.

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The glove is disposable and intended for Medical purpose that is worn on the hand of healthcare and similar personnel to prevent contamination between the patient and the examiner.

Polymer Coated Powderfree Latex Examination Gloves

This document is a 510(k) Premarket Notification for a medical device. It's an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance details, study design, or ground truth establishment.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This document states the device (Polymer Coated Powder-Free Latex Examination Gloves) is "substantially equivalent" to legally marketed predicate devices. It does not present specific acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity) or reported device performance data against those criteria. Such data would typically be found in test reports submitted as part of the 510(k) application, but not in the FDA's clearance letter itself.

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): A 510(k) submission for examination gloves primarily relies on bench testing to demonstrate performance characteristics (like those related to barrier integrity and physical properties) and comparison to a predicate device for substantial equivalence. It is highly unlikely that the types of studies described in the prompt (e.g., MRMC comparative effectiveness studies, studies involving experts for ground truth, large-scale clinical trials with human readers) would be conducted or required for this type of Class I device.

  • For example, proving substantial equivalence for gloves typically involves testing attributes like:
    • Dimensional specifications
    • Tensile strength and elongation
    • Puncture resistance
    • Water leak test (for barrier integrity)
    • Protein content (for latex gloves)
    • Powder residue (for powder-free gloves)

  These tests are performed on a statistical sample of the manufactured gloves according to recognized standards (e.g., ASTM, ISO). The "ground truth" for these measurements is the physical measurement itself, not an expert consensus or pathology report.

In summary, the provided document is a regulatory clearance and not a study report. It confirms the device's substantial equivalence but does not detail the specific performance criteria or the studies used to demonstrate compliance.

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