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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device is a patient examination glove made from nitrile latex compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided text is a 510(k) Summary for a medical device: "Powder Free Nitrile Examination Gloves (Black)". This document doesn't describe the kind of acceptance criteria or study that would have the information requested in your prompt (e.g., sample size for training sets, expert qualifications, MRMC studies, effect sizes). The submission is for a Class I general hospital and personal use device, which typically requires a demonstration of substantial equivalence to a predicate device rather than extensive clinical efficacy studies.

Instead, the document focuses on showing that the new device meets established ASTM and ISO standards for examination gloves and is substantially equivalent to another legally marketed glove.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not applicable or not provided in the document for this type of device and submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test. The tests refer to established standards (e.g., ASTM, ISO), which would define sample sizes within their methodologies. Data provenance is not mentioned.
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" here is defined by compliance with established physical and biocompatibility standards, not expert consensus on diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring human adjudication of results.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by existing, widely recognized industry standards and test methods (ASTM and ISO standards) for physical properties and biocompatibility of examination gloves.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided text describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, specifically focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. It does not describe an AI/ML-based medical device. Therefore, many of the requested details about AI/ML specific studies (MRMC, standalone algorithm, training/test set ground truth establishment, expert qualifications, etc.) are not applicable to this document.

However, I can extract information related to the acceptance criteria and "studies" (non-clinical performance tests) conducted for this glove device.

Here's the relevant information based on the provided text:

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

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

• The document refers to "Non-clinical tests" and lists various ASTM and ISO standards used. It does not specify the exact sample sizes used for each test beyond the requirements of these standards (e.g., AQL 2.5 for water leak test implies a specific sampling plan).
• Data Provenance: The document does not explicitly state the country of origin of the data for these non-clinical tests. It refers to Shanxi Hongjin Plastic Technology Co., Ltd. in China, which suggests the tests were likely performed in relation to their manufacturing and quality control processes. The tests are retrospective (i.e., performed on manufactured gloves to confirm compliance).

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

• This is not applicable as this is a physical device (gloves) and the "ground truth" is established by adherence to physical and chemical testing standards (e.g., measuring dimensions, tensile strength, breakthrough detection time for chemicals per ASTM/ISO standards). These are objective measurements, not subjective expert interpretations of images or other data.

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

• Not applicable for physical/chemical testing. The tests have defined methodologies and acceptance criteria.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., actual dimensions, measured tensile strength, breakthrough time as defined by ASTM D6978-05). It's based on scientific and engineering measurements, not expert consensus, pathology, or outcomes data in a medical context.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for physical product testing.

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

• Not applicable as this is not an AI/ML device.

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The Powder Free Nitrile Examination Gloves, Black 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.

The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.

The document discusses the substantial equivalence of "Powder Free Nitrile Examination Gloves, Black" (K161099) to a legally marketed predicate device. The study described focuses on non-clinical performance data to demonstrate that the device meets established acceptance criteria.

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 a specific "test set" sample size in terms of number of gloves tested for each characteristic. However, the data represents non-clinical performance evaluations against established standards like ASTM and ISO. The provenance of the data would be internal testing conducted by the manufacturer, PT. Maja Agung Latexindo, which is located in North Sumatera, Indonesia. The study is retrospective in the sense that the test results are presented as already completed data to demonstrate compliance.

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 ground truth for the performance of the gloves is established by adherence to recognized international standards (ASTM and ISO), which detail testing methodologies and acceptance criteria. The tests themselves are standardized procedures, so the "experts" would be the technicians or engineers conducting these tests in a laboratory setting, ensuring the methods are followed correctly.

4. Adjudication Method for the Test Set:

This is not applicable as the study involves standardized physical and chemical tests rather than expert review or adjudication of subjective interpretations. The outcomes are objective measurements against predefined limits.

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 relevant for diagnostic devices that involve human interpretation of medical images or data, which is not the case for examination gloves.

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

No, this question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for determining the device's performance is objective measurements derived from established international standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10:2010). These standards define the acceptable range for various physical, chemical, and biological properties of examination gloves.

8. The Sample Size for the Training Set:

This question is not applicable. The device is not an AI or machine learning model that requires a training set. The "training" here refers to the manufacturing process and quality control measures to ensure consistent product attributes.

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

This question is not applicable for the reasons stated above. The "ground truth" for the manufacturing process is established by internal quality control procedures and adherence to the specifications outlined in the referenced standards.

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Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.

The provided document pertains to a 510(k) premarket notification for "Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)". This is a medical device, and the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a novel AI/software-based device.

Therefore, many of the requested criteria (e.g., sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of medical glove submission. These criteria are typically relevant for AI/ML-based diagnostic or prognostic devices, clinical decision support systems, or other software as a medical device (SaMD).

However, I can extract the acceptance criteria and device performance as reported in the summary:

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

Additionally, the "Substantial Equivalence Comparison" table provides more detailed performance characteristics, with the acceptance criteria being conformance to ASTM D6319-10 or specific thresholds:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each test performed (e.g., for dimensions, physical properties, thickness, biocompatibility, watertightness, or tensile strength tests). The testing is generally understood to be performed on manufactured batches of gloves. The manufacturing facility is in Malaysia. The studies are non-clinical, likely prospective testing of manufactured samples.

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. This is for a physical medical device (examination gloves), not an AI/software device requiring expert interpretation of results for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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/software-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by standardized material and performance tests as defined by ASTM D6319-10 and 21 CFR 800.20. For biocompatibility, it refers to the results of standard irritation and sensitization tests.

8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established
Not applicable.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.

The provided document describes the acceptance criteria and performance of Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves. However, it does not describe an AI device or a study involving AI. Therefore, I cannot provide information related to AI-specific aspects like training sets, ground truth for training sets, MRMC studies, or standalone algorithm performance.

The document details the device's adherence to established standards for medical examination gloves to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the information based on the provided text, focusing on the device's performance against its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical performance evaluation comparing the subject device (Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves) to a predicate device (Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue) and against recognized industry standards. The purpose is to demonstrate "Substantial Equivalence" as required for FDA 510(k) clearance.

The study involved testing the physical properties, dimensions, freedom from pinholes, residual powder, and biocompatibility of the subject device.

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

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for tensile strength, pinholes, etc.). It only states that the device "Meets" the specified ASTM standards.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, beyond the manufacturing location of Hongye Plastic Products Co., Ltd. being in Hebei, China.

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)

This information is not applicable and not provided. The "ground truth" for examination gloves is adherence to measurable physical and biological standards (e.g., tensile strength, dimensions, biocompatibility), which are typically assessed through standardized laboratory testing, not expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when multiple human readers are involved in clinical studies. For physical property testing of gloves, objective measurements against a standard are performed.

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. This document describes a medical device (examination gloves), not an AI system or an imaging diagnostic tool where MRMC studies would be relevant.

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

This information is not applicable. The device is a physical product (gloves) and does not involve an algorithm or AI.

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

The "ground truth" for this device is based on objective, measurable criteria established by recognized industry standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization), and relevant CFR regulations (e.g., 16CFR 1500.41, 16CFR 1500.3 for flammability and irritation).

8. The sample size for the training set

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device, and therefore no training set or its associated ground truth was established.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The letter is a standard FDA communication confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must adhere to.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set size, or ground truth establishment for the training set) from the provided text. This information would typically be found in a separate study report or regulatory submission document describing the performance testing.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Black

The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Black." This document does not contain information about acceptance criteria or a study proving a device meets those criteria, as it pertains to AI/medical imaging devices.

Instead, this document is a regulatory letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. It outlines the regulatory classification, product code, and relevant FDA regulations for the device (patient examination gloves).

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is for over-the counter use.

Powder-Free Nitrile Examination Gloves, Black

The provided text is related to an FDA 510(k) clearance for "Powder-Free Nitrile Examination Gloves, Black." This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. For a Class I device like examination gloves, substantial equivalence is often demonstrated through adherence to recognized standards and manufacturing processes, rather than a clinical study with detailed performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment are all relevant to AI/ML device studies, which is not what this document describes.

In summary, the provided content is a regulatory clearance for a medical glove, not a technical study report for an AI/ML device. Therefore, the requested information elements related to AI/ML device performance and study design are not applicable or available in this document.

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