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Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Green, Orange, Violet and White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

The provided document describes the performance testing and acceptance criteria for "Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile". This device is a Class I medical device and the submission focuses on its physical and chemical properties rather than an AI/ML algorithm. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies some sample sizes for specific tests:

• Residual Powder: N = 5
• Moisture Content: N = 8
• Visual Inspection: Not explicitly stated as a count, but AQL levels (0.65 for critical, 2.5 for major, 4.0 for minor defects) imply sampling plans.
• Water Leak Test: G-1, AQL 1.5
• Physical Properties (General): S-2, AQL 4.0 and S-2, AQL 2.5 (Single Sampling)

The data provenance is from Indonesia, where the manufacturer (PT MAHAKARYA INTI BUANA) is located. The study is prospective in the sense that these are laboratory tests conducted on the manufactured product to demonstrate compliance with standards.

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

Not applicable. This device is a patient examination glove, and its performance is assessed through physical and chemical laboratory tests, not by human expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. Performance is determined by objective laboratory measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This is not an AI/ML diagnostic or assistive device where human reader performance would be a factor.

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

No, a standalone algorithm performance study was not done. This device is a physical product (nitrile gloves), not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by international and national standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20, D6124 - 01, ISO standards for biocompatibility implicitly via "Consumer Product Safety Commission... and ASTM F720-86"). The performance measurements are directly compared against the numerical criteria specified in these standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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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High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.

HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE is a disposable device and made of natural rubber latex.

This document is about the FDA's 510(k) premarket notification for "High Risk Latex Examination Gloves, Powder Free, Non Sterile". It's a regulatory clearance document, not a study report for a novel medical device with AI components. Therefore, much of the information requested in the prompt (e.g., acceptance criteria for an algorithm, sample sizes for training/test sets, expert qualifications, MRMC studies) is not applicable or present in this type of document.

However, I can extract the relevant information about the "device" in question (gloves) and its regulatory classification.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This document does not detail specific testing protocols or sample sizes for performance evaluation in the context of an AI/algorithm-driven device. For gloves, testing typically involves standards related to physical properties (e.g., tensile strength, barrier integrity, dimensions) and biocompatibility, but the specifics are not in this FDA letter. The device manufacturer (Pt. Mahakarya Inti Buana) is from Sumut, Indonesia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. This information is for evaluating AI or diagnostic device performance, not for gloves.

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

• Not applicable / Not provided. This pertains to expert review in AI studies.

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 / Not provided. This is relevant for diagnostic devices that involve human interpretation assisted by AI.

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

• Not applicable / Not provided. There is no algorithm described for this device.

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

• Not applicable / Not provided. The "ground truth" for gloves would relate to their physical and biological properties meeting established standards (e.g., ASTM standards for medical gloves) and regulatory requirements, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not applicable / Not provided. There is no AI model or "training set" for this device.

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

• Not applicable / Not provided. There is no AI model or "training set" for this device.

In summary, the provided document is a regulatory clearance for medical gloves, which are a physical product, not a software or AI-driven diagnostic device. Therefore, the specific questions regarding AI device performance evaluation, expert reviews, and data sets for algorithms are not relevant to this document.

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Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber

This document is an FDA 510(k) clearance letter for a medical device: "Senstouch Latex Examination Glove, Powder Free Non Sterile."

Since this is a regulatory clearance for a medical device (a glove), the acceptance criteria and study information typically associated with complex AI/ML algorithms or software are not applicable here.

Medical gloves are cleared based on adherence to recognized standards for performance (like ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA determines substantial equivalence to a predicate device, meaning it performs as safely and effectively as a legally marketed device.

Here's why each point in your request is not applicable to this document:

1. A table of acceptance criteria and the reported device performance: This document doesn't contain a detailed table of acceptance criteria and performance data. The clearance is based on satisfying general controls and demonstrating substantial equivalence to a predicate, often through adherence to recognized consensus standards.
2. Sample size used for the test set and the data provenance: Not relevant for a glove clearance in this context. Testing would involve physical and chemical properties, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant. Ground truth in this context would refer to objective physical/chemical measurements against standards, not expert medical opinion on a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not relevant. Adjudication methods are used for interpreting complex medical imaging or clinical data, not for material properties of a glove.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size of how much human readers improve with AI vs without AI assistance: Not relevant. This is for AI-assisted diagnostic tools, not basic medical devices like gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. Again, this applies to AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant in the typical sense. "Ground truth" for a glove would be objective measures of its physical integrity, tensile strength, freedom from holes, biocompatibility, etc., as per established material science standards.
8. The sample size for the training set: Not relevant. There is no "training set" for a physical medical device like a glove.
9. How the ground truth for the training set was established: Not relevant.

In summary: This document is an FDA 510(k) clearance letter confirming that the "Senstouch Latex Examination Glove, Powder Free Non Sterile" is substantially equivalent to existing devices. The detailed analytical and clinical study information requested is applicable to AI/ML-driven medical devices, not to a standard medical glove undergoing a 510(k) clearance process described here. The "study" here refers to the testing performed to demonstrate that the glove meets relevant ASTM or ISO standards for medical gloves, and a comparison to a predicate device.

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Powdered Nitrile Examination Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.

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

Device: Powdered Nitrile Blue Examination Gloves, Blue, Non Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "performance test data" but does not specify the number of gloves tested for each characteristic.
• Data Provenance: The document states the submitter is PT MAHAKARYA INTI BUANA, located in SUMUT - INDONESIA. The tests were likely conducted by or for this manufacturer, but the specific location of the testing facility is not provided. The study appears to be a prospective series of tests conducted to demonstrate compliance with established standards (ASTM and FDA).

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

• Not applicable. This device is a Class I medical device (nitrile examination gloves) and the performance criteria are based on established engineering and safety standards (ASTM and FDA regulations), not on expert interpretations of complex data like medical images. The "ground truth" is defined by the objective pass/fail criteria of these standards.

4. Adjudication method for the test set:

• Not applicable. See point 3. The assessment involves physical and chemical tests against defined numerical or qualitative (e.g., "Passes") thresholds within established standards. There is no subjective interpretation requiring an adjudication process.

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. This is not a diagnostic imaging device or an AI-assisted device. Therefore, a MRMC study or AI assistance is not relevant to its evaluation.

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

• Not applicable. This device is a physical product (gloves), not an algorithm or software.

7. The type of ground truth used:

• The ground truth is based on established industry standards and regulatory requirements. Specifically:
  • ASTM D 6319-00aE3: Standard Specification for Nitrile Examination Gloves for Medical Applications.
  • FDA 21 CFR 800.20: Regulations for pinhole defects in medical gloves (referenced implicitly through the water leak test).
  • ASTM D6124 - 01: Standard Test Method for Residual Powder on Medical Gloves.
  • Biocompatibility Testing: Primary Skin Irritation in Rabbits and Dermal Sensitization tests (standard methods for assessing biological safety).
  • FDA 1000 ml Water Leak Test: A specific test for glove integrity.

8. The sample size for the training set:

• Not applicable. This study does not involve machine learning or AI, and therefore, there is no "training set." The device itself is the product being tested.

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

• Not applicable. See point 8.

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Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

Based on the provided document, the device in question is a medical glove, a Powder Free Nitrile Examination Glove, Blue, Non Sterile. The document describes a non-clinical performance study and explicitly states that clinical data is not needed for gloves or for most devices cleared by the 510(k) processes.

Therefore, most of the requested information for a typical medical AI device study (sections 2, 3, 4, 5, 6, 7, 8, 9) is not directly applicable or available in this context. Here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

• This is provided in the first table above, extracted directly from the document.

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

• Sample Size: Not explicitly stated for each test. The tests are for manufacturing quality control (e.g., pinholes, dimensions, physical properties, powder residue) and biocompatibility. For manufacturing tests, samples would be taken from production batches. For biocompatibility, animal testing (rabbits) was used.
• Data Provenance: The tests are likely conducted by the manufacturer, PT. MAHAKARYA INTI BUANA, based in SUMUT - INDONESIA. The exact country of origin of the data is Indonesia, as it's a submission from an Indonesian company.
• Retrospective or Prospective: These are likely prospective tests performed on the manufactured product to ensure compliance with standards.

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

• Not applicable in the context of device performance testing for medical gloves. The "ground truth" is established by the specified ASTM and FDA standards for physical and chemical properties and laboratory animal testing for biocompatibility. These standards define the objective criteria.

4. Adjudication method for the test set:

• Not applicable. Performance against defined objective standards (ASTM, FDA) for physical and chemical properties does not involve human adjudication in the same way clinical image interpretation might. Biocompatibility testing follows established laboratory protocols.

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-powered 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 AI-powered device. The "device performance" reported is the standalone performance of the glove itself against physical and chemical standards.

7. The type of ground truth used:

• Objective Standards: The ground truth for dimension, physical properties, freedom from pinholes, and powder residue is based on the objective criteria defined in the respective ASTM standards (D 6319-00aE3, D 6319-00aF3, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test).
• Biocompatibility Testing Protocols: For biocompatibility (Primary Skin Irritation and Dermal Sensitization), the ground truth is established by the results of standardized animal (rabbit) testing protocols, where "Passes" means "No primary skin irritation" and "No contact sensitizer."

8. The sample size for the training set:

• Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process is refined, but this is not a training set in the AI sense.

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

• Not applicable for the reasons stated above.

In summary, the provided document focuses on demonstrating substantial equivalence for a medical glove through non-clinical performance data against established industry standards and regulatory requirements. It explicitly states that clinical data is not required for this type of device within the 510(k) pathway.

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Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes the PT. MAHAKARYA INTI BUANA Polymer Examination Gloves, Powder Free, Non Sterile. The provided information focuses on non-clinical performance data and does not include details on clinical studies or AI-driven aspects.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for testing each characteristic. It also does not explicitly state the country of origin of the data for these tests, nor whether they were retrospective or prospective. Given the nature of a 510(k) submission for examination gloves, these would typically be conducted by the manufacturer in a controlled laboratory setting (prospective testing) following the specified ASTM and FDA 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. The measurements and assessments for these physical and chemical characteristics of gloves are determined by standardized test methods (e.g., ASTM standards) and laboratory procedures, not by expert interpretation or ground truth established by medical experts in the way that imaging or diagnostic AI would require.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically relevant for subjective assessments or when there's disagreement among human readers/experts, which is not the case for the objective physical, chemical, and biological tests 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This product is a physical device (examination gloves), not an AI-driven diagnostic or assistive tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant and were not conducted.

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 (examination gloves), not an algorithm or AI system.

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

The "ground truth" for these tests is defined by the objective criteria and methodologies outlined in the referenced ASTM and FDA standards (e.g., specific measurement techniques for dimensions, visual inspection criteria for pinholes, chemical assays for protein content, and animal testing protocols for biocompatibility). There is no "expert consensus" or "pathology" involved in establishing the ground truth for glove performance tests in the context of this submission.

8. The sample size for the training set

This is not applicable. The product is a physical device, and the testing described is not related to machine learning or AI, which would require a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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