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

The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.

The provided text describes Shandong Intco Medical Products Co, Ltd.'s Basic Synguard Nitrile Exam Gloves. This is a medical device submission, and the acceptance criteria and study described relate to the physical and biocompatibility performance of these gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Freedom from holes: 315 gloves were tested.
• Other physical properties (Dimensions, Physical Properties, Residual Powder): The document does not explicitly state the sample size for each test, but it references ASTM D6319-19, ASTM D6124-06, and ASTM D5151-19, which would define the sampling plans. For "Freedom from holes," the sample size of 315 and AQL 2.5 is typical for ASTM D5151.
• Biocompatibility: The sample sizes for the ISO 10993 tests are not explicitly stated in this document but are defined by the respective ISO standards.
• Data Provenance: The studies were conducted by Shandong Intco Medical Products Co., Ltd. (China) for their device. The nature of these tests (physical and biocompatibility testing on manufactured products) categorizes them as prospective performance evaluations of the device itself.

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

This section is not applicable as the device is a medical glove, and the "ground truth" is established through standardized laboratory testing against objective criteria (e.g., tensile strength, dimensions, presence of holes, chemical residues, biological reactions in test models) as defined by ASTM and ISO standards, not expert interpretation of cases.

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

This section is not applicable as the device is a medical glove, and the performance is measured directly by physical and chemical tests, not through human interpretation 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

This section is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a medical glove, not an algorithm.

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

The "ground truth" for the device's performance is established by:

• Pre-defined physical and chemical specifications from ASTM standards (e.g., minimum tensile strength, maximum residual powder, dimensional tolerances).
• Biological responses (e.g., no irritation, no sensitization, no systemic toxicity) in animal or in vitro test models, as defined by ISO 10993 standards.

8. The sample size for the training set

This section is not applicable. The device is a medical glove, and this is not a machine learning model requiring a training set.

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

This section is not applicable.

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The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.

The provided text describes the 510(k) summary for "Sterile Latex Examination Gloves Powder Free". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing, rather than an AI-driven medical device requiring extensive clinical validation of diagnostic accuracy. As such, many of the requested elements for AI/ML device studies (like sample sizes for test sets, expert ground truth adjudication, MRMC studies, training set details) are not applicable to the information provided.

However, I can extract the acceptance criteria and performance results for the non-clinical tests conducted for these gloves:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML-driven medical device, the following sections are either not applicable (N/A) or the information is not provided in the document:

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

• For the Freedom from holes test, the document states "314 of 315 passed," implying a test set size of 315 gloves for this specific attribute.
• For other physical and material property tests (Dimensions, Physical Properties, Residual Powder, Residual Protein, Sterility), specific sample sizes are not explicitly stated, but standard testing procedures for medical devices of this type would typically involve a statistically appropriate random sample from production lots.
• Data provenance (country of origin, retrospective/prospective) is not specified for the test data, but the manufacturer is based in China. This is a non-clinical/material performance study.

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):

• N/A. This is a physical product, and ground truth is established through standardized laboratory testing methods (e.g., ASTM and ISO standards), not human expert interpretation of images or clinical data.

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

• N/A. Ground truth is determined by objective laboratory measurements and tests according to cited standards, not by human adjudication of ambiguous cases.

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:

• N/A. This is not an AI/ML device; therefore, MRMC studies involving human readers are irrelevant.

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

• N/A. This is not an AI/ML device. The "standalone" performance refers to the device's inherent physical and material properties when tested according to standards.

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

• Ground truth for this device is based on objective measurements and results from standardized laboratory testing protocols as defined by ASTM International and ISO standards (e.g., ASTM D3578-19, ASTM D6124-06, ASTM D5151-19, ASTM D5712-15, ISO 10993-10, ISO 10993-11, ISO 11137-1, ISO 11137-2).

8. The sample size for the training set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. This device does not involve a "training set" or "ground truth establishment" for training purposes as understood in AI/ML.

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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.

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.

Here's a breakdown of the requested information:

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

The document provides two tables that fulfill this request:

• A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
• A "Non-clinical Testing Summary" table on page 6.

Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.

2. Sample sized 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 used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.

The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.

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 to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.

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

Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple experts.

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 device is a medical glove, not an AI-assisted diagnostic tool or system that involves human readers.

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

Not applicable. The device is a physical product (medical glove), not an algorithm.

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

The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
• ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
• ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.

The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.

8. The sample size for the training set

Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.

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

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

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