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The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:

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 exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, pinholes, or biocompatibility). The tests are based on established ASTM and ISO standards, which typically specify sampling plans.

• Data Provenance: The tests were conducted internally by the manufacturer, Guangdong Kingfa Sci.& Tech.Co., Ltd., in China. The documentation implies these were prospective 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 the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert interpretation of results. The "ground truth" for the performance of examination gloves is based on objective, quantifiable physical and chemical properties measured according to international standards (ASTM, ISO).

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

Not applicable. This is not an AI/ML device requiring human adjudication of qualitative data.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11). For example, tensile strength and elongation are measured directly, and biocompatibility is assessed through standardized in-vivo and in-vitro tests with specific endpoints.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device.

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.

However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Non-Applicable / Not Provided Information (for this type of device submission)

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

   • Sample Size: For specific tests, sample sizes are sometimes implicitly mentioned (e.g., "0/125" for watertightness), but a general "test set" sample size for overall performance evaluation as would be described for an AI model is not applicable or provided. The testing is per standard procedures for each physical/chemical property.
   • Data Provenance: Not applicable in the same sense as for clinical data. The tests are laboratory-based conformance tests. The manufacturer is Dezhou Hengchang Medical Technology Co., Ltd. from 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):

   • Not applicable. Ground truth for these physical and biocompatibility tests is established by objective measurements and standardized laboratory procedures/protocols, not expert consensus.

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

   • Not applicable. This concept is relevant for subjective evaluations or diagnostic tasks, not for objective material properties testing.

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 for AI-assisted diagnostic devices.

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

   • Not applicable. This is for AI algorithms.

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

   • The ground truth for this device's performance is based on objective measurements and chemical/biological assays conducted according to internationally recognized standards (ASTM, ISO). For example, a "hole" is objectively defined by the ASTM D5151 test, and tensile strength is measured quantitatively.

8. The sample size for the training set:

   • Not applicable (no AI/machine learning training involved).

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

   • Not applicable (no AI/machine learning training involved).

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international standards. These tests evaluate the physical properties (dimensions, watertightness, powder content, tensile strength, ultimate elongation) and biocompatibility (cytotoxicity, systemic toxicity, irritation, sensitization) of the Vinyl Examination Gloves. The results demonstrate that the device complies with all specified acceptance criteria derived from these standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). The conclusion is that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861" based on these non-clinical tests. Clinical testing was deemed "not needed for this device."

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Vinyl Examination Gloves, not an AI/ML medical device. Therefore, the information requested in the prompt regarding AI/ML device acceptance criteria and study details (such as sample sizes for test and training sets, expert ground truth, multi-reader multi-case studies, etc.) is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the Vinyl Examination Gloves to a predicate device through non-clinical performance testing.

Here's a breakdown of the non-clinical acceptance criteria and reported performance, as directly extractable from the provided text, adapted to the table format requested:

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

Regarding the other points, as this is a traditional medical device (gloves) and not an AI/ML algorithm, the following points are not applicable:

2. Sample sized used for the test set and the data provenance: Not an AI/ML device. Test "set" refers to the specific gloves tested according to standards, not a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by physical/chemical standards.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is for AI/ML devices assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is for AI/ML algorithms.
7. The type of ground truth used: Not applicable in the AI/ML sense. Ground truth is established by standardized physical and chemical testing methods (e.g., ASTM, ISO).
8. The sample size for the training set: Not applicable; there is no training set for gloves.
9. How the ground truth for the training set was established: Not applicable.

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The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided document is a 510(k) premarket notification for Vinyl Examination Gloves, a Class I medical device. This type of device does not involve AI or complex software, and thus the request asking about AI/algorithm performance metrics is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing, not through AI/algorithm performance.

Therefore, many of the requested points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI models, cannot be extracted from this document as they are not relevant to the device being described.

However, I can extract the acceptance criteria and performance data for the physical properties of the gloves, as well as the non-clinical testing information:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for Vinyl Examination Gloves)

This document describes the non-clinical testing performed to demonstrate that the Vinyl Examination Gloves (Yellow) are substantially equivalent to a legally marketed predicate device (K163168). The acceptance criteria are based on recognized standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, as well as biocompatibility standards ISO 10993-5 and ISO 10993-10.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates sample sizes for specific tests:

• Watertightness Test for Detection of Holes (ASTM D5151): Out of 125 units tested, 0 leaks were detected, meeting the AQL 2.5 requirement.
• Powder Content (ASTM D6124): A "Medium glove" was used as the representative sample.
• Physical properties (ASTM D412): A "Medium glove" was used as the representative sample.
• The exact sample sizes for other physical dimensions and biocompatibility tests are not explicitly stated in the summary, but they are implied to be sufficient to meet the respective standard requirements.

Data Provenance: The tests were conducted by the manufacturer, LIUPING TRADING CO.,LTD., in Shandong, China. The data is from non-clinical testing performed retrospectively for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This product is a physical medical device (gloves), not an AI/algorithm. Ground truth is established through standardized laboratory testing methods, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or AI model output, where there might be disagreements on classifications (e.g., in medical image analysis). For physical product testing, the results are objectively measured against established standards.

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

Not Applicable. MRMC studies are relevant for evaluating the performance of AI-assisted systems in clinical decision-making contexts (e.g., radiology). This is a physical product.

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

Not Applicable. This is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the specifications and test methods defined by recognized industry standards, specifically:

• ASTM D5250 for physical dimensions and properties.
• ASTM D5151 for watertightness (freedom from holes).
• ASTM D6124 for residual powder content.
• ISO 10993-5 for in vitro cytotoxicity.
• ISO 10993-10 for irritation and skin sensitization.

These standards define the objective measurements and pass/fail criteria.

8. The Sample Size for the Training Set

Not Applicable. This is a physical product, not an AI/algorithm that requires a training set.

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

Not Applicable. As stated above, this is a physical product and does not have a "training set" in the context of AI.

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The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document is a 510(k) summary for Vinyl Examination Gloves (Yellow). It does not describe an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set information is not applicable.

The document assesses the substantial equivalence of the Vinyl Examination Gloves (Yellow) to a predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves (White, Blue, Yellow), K163168).

The comparison focuses on physical dimensions, performance properties, material, and biocompatibility, demonstrating that the new device meets relevant ASTM and ISO standards for vinyl examination gloves.

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The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This FDA 510(k) summary is for a Vinyl Examination Glove and does not describe an AI/ML powered medical device. Therefore, it does not include the detailed information typically associated with such device evaluations, such as studies on acceptance criteria, reader performance, or ground truth establishment.

However, I can extract the acceptance criteria and performance data for this traditional medical device based on the provided document.

Acceptance Criteria and Device Performance (Vinyl Examination Gloves):

The acceptance criteria are primarily defined by adherence to recognized international and national standards for medical gloves, and comparability to the predicate device. The performance data is presented in the context of these standards and comparisons.

Since this document is for a traditional medical device (Vinyl Examination Gloves) and not an AI/ML powered device, the following points are not applicable or the information is not provided in the document:

2. Sample size used for the test set and the data provenance: The document mentions "test results" for physical and biological properties, but it does not specify the sample size for these tests. The provenance of the data is implied to be from the manufacturer (XINYING TRADING CO.,LTD.) in China, for the device manufactured there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. Ground truth is established by standardized testing protocols (e.g., ASTM, ISO) and laboratory results, not expert consensus in the clinical sense.

4. Adjudication method: Not applicable. Performance is based on objective measurements against established 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 as this is not an AI/ML-powered 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-powered device.

7. The type of ground truth used: The "ground truth" for this device's performance is derived from compliance with recognized performance standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5) through laboratory testing.

8. The sample size for the training set: Not applicable as this is not an AI/ML-powered device requiring a training set.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML-powered device requiring a training set.

Summary of the Study that Proves Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Test Conclusion" (Section 8.0). The device was tested for compliance with the following standards:

• ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: This standard was used to demonstrate that the glove is not an irritant or sensitizer.
• ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity: This standard was used to show that the glove did not exhibit potential toxicity to L-929 cells.
• ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: This standard confirms the powder content within acceptable limits for a powder-free glove.
• ASTM D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard ensures the integrity of the gloves (freedom from holes).
• ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application: This is a comprehensive standard covering general physical requirements such as tensile strength, ultimate elongation, and dimensions.

The document states that the "test results demonstrated that the proposed device complies with the following standards," suggesting that the performance metrics listed in Table 3 and Table 4 were obtained through testing against these specified standards. The comparison to the predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves K163168) further supports the substantial equivalence claim by showing similar technological characteristics and performance within the established standards, even with some numerical differences in physical properties like tensile strength and elongation, which were deemed to still meet ASTM D5250 and thus not raise new safety or performance questions. Clinical testing was not deemed necessary for this device (Section 9.0).

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The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.

The provided document is a 510(k) Pre-market Notification for Vinyl Examination Gloves. This type of device is a Class I medical device, which falls under general controls and does not typically require extensive clinical data or complex performance studies like those seen for higher-risk devices (e.g., AI/ML-driven diagnostic tools).

Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/ML device, as requested in the prompt, are not applicable to this document.

For Vinyl Examination Gloves, "acceptance criteria" primarily relate to material properties, performance standards for physical integrity, and biocompatibility, rather than diagnostic accuracy or human performance improvement. The "study" proving these criteria are met consists of non-clinical, laboratory-based tests.

Here's how to interpret the document in the context of the prompt, while acknowledging the fundamental difference in device type:

Device: Vinyl Examination Gloves (White, Blue, Yellow)
Submission Number: K163168
Predicate Device: K150224 Blue Vinyl Examination Gloves Powder Free

Basis for "Acceptance Criteria" and "Proof":

For this Class I device, "acceptance criteria" are defined by recognized consensus standards to ensure the gloves are safe and effective for their intended use. "Proof" is provided through non-clinical bench testing demonstrating compliance with these standards and comparability to a legally marketed predicate device.

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

Since this is not an AI/ML device, specific "performance" metrics for diagnostic accuracy are not relevant. Instead, the performance metrics relate to the physical and biological characteristics of the gloves. The "acceptance criteria" are the minimum requirements set by the ASTM and ISO standards, and the "reported device performance" indicates that the proposed device met or exceeded these.

Table 1: Acceptance Criteria (Referenced Standards) and Reported Device Compliance

Footnote: The acceptance criteria are largely based on the predicate device's performance and/or compliance with the specified ASTM/ISO standards. Performance shows general compliance and sometimes superior values (e.g., tensile strength for proposed device).

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

• Sample Size: The document does not specify the exact numerical sample sizes for each non-clinical test (e.g., how many gloves were tested for holes or tensile strength). However, it refers to standards like ISO 2859-1 (Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection) for sampling, which implies that appropriate statistically relevant sample sizes were used according to these standards. For biocompatibility, typical animal testing or in-vitro tests are used, but specific numbers are not given.
• Data Provenance: The tests were conducted by the manufacturer, Hebei Hongtai Plastic Products Company Limited, in China ("Hebei Province 055250, China"). The data is retrospective as it was collected prior to the 510(k) submission.

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

• Not Applicable. For a Class I device like examination gloves, "ground truth" as it pertains to medical diagnosis by experts (e.g., radiologists) is not relevant. The "ground truth" for the performance of the gloves is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards (e.g., a hole is a hole as defined by the test method, tensile strength is measured quantitatively). These standards are developed and agreed upon by expert committees in their respective fields (materials science, biocompatibility, etc.).

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

• Not Applicable. As no human experts are performing diagnoses or interpretations to establish ground truth for this device, an adjudication method is irrelevant. The tests are objective, quantitative measurements against predefined 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

• No. An MRMC study is not applicable to a Class I physical device like examination gloves. These studies are typically performed for diagnostic devices (especially AI/ML-driven ones) where human performance (e.g., agreement with ground truth, detection rates) is a key outcome.

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

• Yes, in spirit, but not in the context of an algorithm. The "standalone performance" of the gloves refers to their physical and biocompatibility characteristics when tested independently according to the specified standards. This is what the non-clinical tests (e.g., for holes, tensile strength, irritation) prove. It's the device's inherent properties, without human interpretation or intervention in its diagnostic capability because it has none.

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

• The "ground truth" for these gloves is objective, measurable criteria defined by consensus standards:
  • Physical Parameters: Measurements of length, width, thickness, tensile strength, elongation, and powder content are quantitative and directly measured by standard methods (e.g., ASTM D5250).
  • Integrity: "Freedom from holes" is determined by a standardized test method (ASTM D5151) that objectively detects leaks.
  • Biocompatibility: "Non-irritant" and "non-sensitizer" status is determined by standardized biological evaluation tests (ISO 10993-10), typically involving in-vitro and/or animal testing, not human expert consensus on a subjective finding.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against standards.

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

• Not Applicable. There is no "training set" or corresponding "ground truth" establishment process for this type of device.

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

Vinyl Examination Gloves, Powder Free, Green Color

This document, a 510(k) premarket notification approval letter, does not contain the detailed information necessary to fully answer all aspects of your request. The letter confirms that Vinyl Examination Gloves, Powder Free, Green Color, manufactured by Arista Latindo Industrial Limited PT, are substantially equivalent to legally marketed predicate devices. However, it does not include a study describing acceptance criteria and device performance in the way you've outlined for an AI/CAD product.

Here's a breakdown of what can and cannot be extracted from the provided text:

Information Available:

• Device Name: Vinyl Examination Gloves, Powder Free, Green Color
• Intended Use/Indications for Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
• Regulatory Class: I
• Product Code: LYZ

Information NOT available in this document:

This document is a marketing clearance for a simple medical device (gloves) and therefore does not include the kind of detailed performance study information typically associated with AI/CAD devices. Specifically, it does not contain:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., as would be expected for an AI/CAD system).
2. Sample size used for a test set or data provenance (country, retrospective/prospective).
3. Number of experts, their qualifications, or methods to establish ground truth for a test set.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (pathology, expert consensus, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

To answer your request, if this were an AI/CAD device, the 510(k) submission itself (which this letter refers to) would contain the study details you are looking for, not the approval letter. For devices like these gloves, the "performance" is generally assessed against established manufacturing standards (e.g., tensile strength, barrier integrity, dimensions, biocompatibility) rather than diagnostic accuracy metrics.

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

Vinyl Examination Gloves, Powdered

I apologize, but this document is a 510(k) clearance letter from the FDA for "Vinyl Examination Gloves, Powdered." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them.

The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with detailed acceptance criteria and performance metrics like those described in your prompt for AI/software devices.

Therefore, I cannot provide the requested information based on the provided text.

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

Vinyl Examination Gloves, Powder Free, Pink Color

This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Powder Free, Pink Color." It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided in the document does not contain details about acceptance criteria, device performance, study types, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device in a clinical or diagnostic context.

Instead, the document primarily focuses on the regulatory approval process for a patient examination glove, confirming its substantial equivalence to predicate devices for its intended use (preventing contamination between patient and examiner). The "Indicators For Use" section defines the product, but does not specify performance metrics.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory approval letter, not a performance study report.

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