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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.

Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.

However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.

Here's the information that is applicable based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).

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

• Pinhole Test: The sample size mentioned is "125 pieces gloves" for each test (subject and predicate).
• Residual Powder: Not explicitly stated, but implies a sampling based on ASTM D6124-06.
• Physical and Dimensions Testing: "Inspection level S-2, AQL 2.5."
• 1000 ml Water Fill Test: "samplings of AQL 2.5 inspection level G-1."
• Data Provenance: The testing was conducted by Anhui Intco Medical Products Co. Ltd. (China) or their contracted labs. The data is retrospective, as it's part of a 510(k) submission showing compliance with standards.

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 not a study involving human experts establishing ground truth for image interpretation or diagnosis. It involves standardized laboratory testing of physical and chemical properties of a medical device (gloves).

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations. The tests performed on the gloves are objective, standards-based measurements.

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-powered device.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" here is defined by the established ASTM (American Society for Testing and Materials) standards for patient examination gloves and the reported performance of the legally marketed predicate device. For example, for pinholes, the ground truth is "AQL 2.5 is met," meaning a certain acceptable quality level for defects based on statistical sampling. For biocompatibility, the ground truth is "not an irritant/sensitizer/cytotoxic" based on specific ISO or other standard test methods applied to animal models or cell cultures.

8. The sample size for the training set:

Not applicable. This is not an AI-powered device that requires a training set.

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

Not applicable. This is not an AI-powered device that requires a training set.

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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 finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

The acceptance criteria and device performance information from the provided text are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Pinhole Results (ASTM D5151-06): At least 125 pieces of gloves were tested.
  • For Water Fill Test: Specific sample size not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I."
  • For Physical and Dimensions Testing: "Inspection Level S-2, AQL 2.5" was used, which implies a sample size determined by these AQL standards, but the exact number isn't quantified.
• Data Provenance: The document does not specify the country of origin of the data for these tests. It implies these were internal tests conducted by the manufacturer, Shandong Yifan Plastic Products Co., Ltd., based in Zibo City, Shandong, China. The tests are presented as being conducted to demonstrate substantial equivalence, suggesting they were prospective tests performed on the device prior to submission.

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

This device (patient examination gloves) is a Class I medical device and typically does not involve human expert interpretation for establishing the "ground truth" in the same way an AI diagnostic device would. The "ground truth" is established by direct physical measurements and standardized chemical/biological tests. Therefore, this section is not applicable in the context of this device and report. The tests performed are objective, measurable physical properties and biocompatibility assessments.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., tensile strength, dimensions, pinhole count, chemical content) or standard biological assays (e.g., skin irritation, sensitization) that result in direct numerical or categorical outcomes, not requiring expert adjudication of subjective interpretations.

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 where human readers interpret medical images or data, and an AI would assist or replace them. For patient examination gloves, such a study is not applicable.

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 AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is established through:

• Objective Physical Measurements: Tensile strength, ultimate elongations, overall length, width, palm thickness, finger thickness, residual powder, and water leak test. These are directly measurable properties.
• Standardized Biological Tests: Primary skin irritation and dermal sensitization. These produce objective results (e.g., "not an irritant," "not a sensitizer") based on established protocols.
• Conformance to Standards: The "ground truth" is implicitly defined by the requirements outlined in the referenced ASTM standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151-06) and the FDA 1000 ml. Water Fill Test.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI development. It is a manufactured physical product.

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 patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands 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, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing, Pinhole Results: Inspection Level S-2, AQL 2.5 for physical/dimensions and Inspection Level I, AQL 2.5 for the FDA 1000 ml. Water Fill Test (pinhole). The specific number of gloves tested is implicitly defined by these AQL (Acceptable Quality Limit) levels and inspection levels, but the exact sample number isn't stated directly. For pinhole, it specifies "125 pieces gloves" were tested.
• Residual Powder: Not explicitly stated, but performed according to ASTM D6124-06.
• Biocompatibility (Primary Skin Irritation, Skin Sensitization): Not explicitly stated, but testing was conducted.
• Data Provenance: The testing was performed by Zibo Intco Medical Products, Co. Ltd. in China, as per the submitter's identification. The data is retrospective, as it's part of a 510(k) submission showing pre-market testing.

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

This type of information is not applicable to this device. The "ground truth" for glove performance characteristics like tensile strength, pinholes, or powder content is established by standardized testing methods (e.g., ASTM standards) and objective measurements, not by expert consensus or clinical interpretation. Biocompatibility testing results (irritation/sensitization) are also objective findings from laboratory tests, not expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is being assessed. This device is a medical glove, which does not involve human interpretation in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product (medical glove), not an algorithm or AI software. The performance testing focuses on the physical properties and biological compatibility of the glove itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized Measurement: Adherence to established performance standards defined by ASTM (American Society for Testing and Materials) such as D5250-06, D6124-06, and D5151-06.
• Laboratory Testing: Objective results from physical, chemical, and biological laboratory tests (e.g., tensile strength, elongation, residual powder measurement, water fill test for pinholes, primary skin irritation test, skin sensitization test).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical product, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The testing performed is to validate the manufacturing process and product characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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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 finger to prevent contamination between patient and examiner.

A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Vinyl Patient Examination Gloves based on the provided 510(k) summary:

This device is a Class I medical device (21 CFR 880.6250) and a patient examination glove, which is generally subject to general controls and performance standards, rather than an AI/software device that would require the typical studies you've asked about (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, training set details). The "studies" for this device relate to physical and biological testing to ensure safety and conformance to recognized standards.

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 sample size for each specific test in the format typically requested for AI/software model testing.

• Pinhole Test: For the FDA 1000 ml Water Fill Test (ASTM D5151-06), the sampling plan used was "AQL 2.5 inspection level G-1." This implies a specific sample size based on the lot size, but the exact number of gloves tested is not provided.
• Other Physical Tests: For physical and dimensions testing (ASTM-D-6319 and ASTM D-5250), the inspection level was S-2, AQL 2.5. Again, the exact sample size for specific tests is not explicitly stated but is determined by the AQL standard applied to the manufacturing lot.
• Biocompatibility Tests: No specific sample size (e.g., number of test subjects or animals) is mentioned for the Primary Skin Irritation and Dermal Sensitization tests.
• Data Provenance: The manufacturing company is Shandong Haoyu Medical Products Co., Ltd. in Qingzhou, Shandong, China. The testing was conducted by the manufacturer or authorized labs, though the specific location of the testing labs is not provided. The data is from retrospective testing of manufactured glove samples.

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

Not applicable. For patient examination gloves, "ground truth" is established by adherence to recognized performance standards (ASTM standards, FDA testing protocols) for physical properties and biocompatibility. There are no "experts" establishing clinical ground truth for a diagnostic outcome like in AI/imaging studies. The "experts" in this context would be the technicians and scientists performing the standardized tests according to documented procedures.

4. Adjudication Method for the Test Set

Not applicable. This device relies on standardized physical and biocompatibility testing, not on human interpretation or adjudication processes like 2+1 or 3+1 consensus commonly used for expert review of medical images or data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for diagnostic or AI-assisted devices where human readers interpret data with or without AI assistance. This device is a physical barrier (glove), so such a study is not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical product, not a software algorithm.

7. Type of Ground Truth Used

For examination gloves, the "ground truth" is defined by:

• Performance Standards: Adherence to established ASTM standards (D5250-06, D5151-06, D6124-06) for physical properties, dimensions, pinhole integrity, and residual powder.
• Biocompatibility Testing: Results from primary skin irritation and dermal sensitization tests demonstrating non-irritant and non-sensitizing properties. These tests are standardized methods.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning. The manufacturing process is controlled and optimized, but there's no data-driven model training involved.

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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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of finger to prevent contamination between patient and examiner (21CFR 880.6250)

A Powder-Free Vinyl Patient Examination Gloves'is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250). Our Powder-Free Vinvl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ, and meets all requirement of ASTM Standard D5250-06.

The provided text is a 510(k) summary for the Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile. This document aims to demonstrate substantial equivalence to predicate devices, not primarily to prove a device's performance in terms of AI/algorithm-based criteria. Therefore, most of the requested fields related to AI/algorithm studies (sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, etc.) are not applicable to this type of medical device submission.

However, I can extract the acceptance criteria and the studies performed to demonstrate equivalence for the physical and biocompatibility properties of the gloves.

Here's the 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 does not specify exact sample sizes for each test in the way an AI study would. Instead, it refers to industry standards for sampling:

• Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5
• FDA 1000 ml Water Fill Test (Pinhole): AQL 2.5, Inspection Level 1

The data provenance is not explicitly stated in terms of country of origin of the raw data, but the manufacturer is Shandong Binxiang Medical Products Co., Ltd. in China, implying testing was likely conducted in China or by labs adhering to these international standards. The studies were part of a "non-clinical tests performed for Determination of Substantial Equivalence," which implies they were conducted specifically for this submission (prospective in that sense, but testing a manufactured product).

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

Not Applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for glove performance is determined by the results of standardized physical and biocompatibility tests.

4. Adjudication method for the test set

Not Applicable. This is not a study requiring medical expert adjudication. Test results are based on objective measurement according to specified standards.

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 physical medical device (gloves), not an AI/algorithm-based diagnostic or assistive system.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth is established by objective measurements against recognized industry standards (ASTM, ISO, FDA requirements). For example:

• Pinhole presence is determined by the 1000 ml Water Fill Test and ASTM D5151-06.
• Residual powder is measured and compared to the ASTM D6124-06 standard (≤ 2mg/pc).
• Biocompatibility is assessed based on animal testing (rabbits for irritation, pigs for sensitization) according to ISO 10993-10.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI study.

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

Not Applicable. This is not a machine learning or AI study.

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Powder free vinyl 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 Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text describes the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Geenli Plastic Co., Ltd. It outlines the device's characteristics and its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against ASTM standards and FDA requirements. The text explicitly states that the Subject Device (Geenli's gloves) meets these standards.

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

• Sample Size: The document does not specify the precise sample size used for the non-clinical tests (e.g., how many gloves were tested for holes, powder residue, or biocompatibility). It simply states that the device "meets requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO10993-10: 2006 third edition 2010-08-01." These standards themselves would typically define the sampling plans and acceptable quality levels (AQLs) for testing.
• Data Provenance: The document does not explicitly state the country of origin for the test data, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.

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

This section is not applicable as the device is a medical glove, and the acceptance criteria are based on objective physical, chemical, and biological performance standards (e.g., hole detection, tensile strength, biocompatibility), not on expert subjective interpretation or ground truth derived from expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers on a specific finding. The tests for these gloves are objective physical and chemical tests against defined standards.

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 readers interpreting results (e.g., radiologists reading images). This device is a medical glove, whose performance is assessed through objective criteria.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. A standalone performance evaluation (without human-in-the-loop) is relevant for AI algorithms or diagnostic systems. This device is a physical medical glove.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective, standardized test results against established national and international standards. Specifically:

• Physical properties (e.g., integrity, dimensions) are evaluated against ASTM D5250 and D5151.
• Chemical properties (e.g., powder residue) are evaluated against ASTM D6124.
• Biocompatibility is evaluated against ISO 10993-10.
• Manufacturing quality and AQL for pinholes are evaluated against 21 CFR 800.20.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic device. The ground truth is the measured compliance with the specified performance standards.

8. The Sample Size for the Training Set

This section is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical medical glove and does not involve an algorithm or AI that requires training data.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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Powder free vinyl 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 Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by SHANDONG JUNFENG INDUSTRIES CO., LTD.

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 the sample sizes used for each specific test within the ASTM standards or the biocompatibility tests. However, the tests performed (e.g., freedom from pinholes, powder residual, primary skin irritation, dermal sensitization) imply that samples of the gloves were rigorously tested according to the specified international and national standards.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective," but the testing was conducted to meet established standards like ASTM and ISO, which are internationally recognized. The testing would have been prospective in nature, as the device was manufactured and then tested against these criteria to demonstrate compliance.

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

This section is not applicable in the context of device performance testing against established standards for patient examination gloves. The "ground truth" here is defined by the objective metrics and thresholds set out in the ASTM and ISO standards themselves, not by expert consensus on qualitative observations. The product simply had to "meet" the quantitative or qualitative pass/fail criteria of these standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple experts. This is not relevant for the objective performance testing described for these gloves. The device performance was evaluated directly against the quantitative and qualitative requirements of the listed standards.

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 where human readers interpret results, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. This is not applicable to patient examination gloves, which are physical barrier devices.

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 concept is applicable to AI/ML software devices. The device in question is a physical medical device (gloves) and its performance is evaluated through material and physical property tests, not algorithmic performance.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises:

• Objective Standards: Defined by international and national consensus standards such as ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10. These standards specify precise methodologies for testing and define quantifiable pass/fail criteria (e.g., maximum allowable pinholes, maximum powder residual, specific methods for biocompatibility testing).
• Laboratory Testing Results: The "Meets" or "Passes" reported for each characteristic directly reflects the results of laboratory tests conducted in accordance with these objective standards.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI. The device is a physical product (gloves), not an AI algorithm. Therefore, the concept of a training set is not applicable. The manufacturer produces the gloves, and then tested samples from production lots against the outlined standards.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a "training set" is not applicable to this device. Therefore, no ground truth was established for a training set. The "ground truth" for the device's acceptable performance is derived from the established and publicly available standards it must meet.

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Powder free vinyl 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 Vinyl Patient Examination Gloves, Clear (non-colored)

The provided text describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is described as meeting established standards (ASTM, FDA regulations, ISO).
The data provenance is not explicitly mentioned as retrospective or prospective, nor are specific countries of origin for the data provided beyond the manufacturer's location in China. The testing is non-clinical, primarily relying on performance against established industry 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 to this device and its testing. The "ground truth" for these types of medical gloves is established by their adherence to defined physical, chemical, and biological performance standards, not by expert consensus in diagnostic interpretation. The standards themselves are developed by expert bodies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For physical product testing against objective standards, the results are either pass or fail based on the standard's 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:

This is not applicable. This device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI are irrelevant.

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

This is not applicable. This device is a physical product (a glove), not a software algorithm.

7. The type of ground truth used:

The ground truth is established by industrial and regulatory standards.

• Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): The ground truth is defined by the objective pass/fail criteria outlined in ASTM D 5250-06, ASTM D6124-06, and 21 CFR 800.20. These are quantifiable measurements and thresholds.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The ground truth is established by the results of biological tests on animal models, as per ISO10993-10, demonstrating the absence of harmful irritant or sensitizing reactions.

8. The sample size for the training set:

This is not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development or evaluation.

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

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

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