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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.

The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the typical sense of AI/software device evaluation.

Therefore, many of the requested points related to AI/software device studies (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of medical device submission. The device is a physical product (gloves), not a software or AI tool.

However, I can extract the relevant acceptance criteria and reported performance based on the information provided, which refers to conformance with ASTM standards.

Here's the breakdown of the information as it applies to this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is not described as a single, centralized study in the document. Instead, it refers to the device's conformance with recognized consensus standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151, and ISO 10993-10) and FDA requirements (specifically 21 CFR 800.20 for water leak test on pinhole AQL).

The manufacturer asserts that their "Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This implies that the device successfully passed testing according to the methodologies outlined in these standards.

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

• Sample Size: Not explicitly stated in the summary. For physical products tested against ASTM standards, the sample sizes are typically defined within the specific standard's test methods (e.g., for AQL testing for holes, specific sample plans are used).
• Data Provenance: Not explicitly stated beyond "nonclinical submitted". Given the submitter's address in China, it's presumed the testing was conducted in China. It is a retrospective evaluation against established standards.

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

• Not Applicable. This is a physical device submission. Ground truth in the context of expert consensus for AI models is not relevant here. Conformance is determined by physical and chemical testing against objective standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, this is a physical device tested against standards; an adjudication method in the context of expert review is not relevant.

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

• No, Not Applicable. MRMC studies are for evaluating diagnostic performance of imaging systems or AI software. This is a physical glove.

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

• No, Not Applicable. This is a physical device.

7. The Type of Ground Truth Used:

• For this device, "ground truth" equates to the objective measurements and results obtained from testing the gloves against the criteria and methodologies defined in the referenced ASTM standards (D5250, D5151, D6124) and ISO standard (10993-10), as well as FDA regulations for AQL. These are direct physical properties and performance characteristics.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device; there is no "training set" in the context of an AI/software algorithm.

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

• Not Applicable. As per 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.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This device, a patient examination glove, is a Class I medical device, which typically requires less rigorous testing than higher-class devices. The primary focus of the testing is to demonstrate substantial equivalence to a predicate device and adherence 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 the specific sample sizes used for each test (e.g., for dimension, physical properties, pinholes, powder residual, or biocompatibility). It references adherence to standards like ASTM D5250-06, 21 CFR 800.20, and ISO10993-10, which would typically specify minimum sample sizes for individual tests.

The data provenance implies that the testing was conducted by the manufacturer, SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD, located in China. The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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

This type of device (patient examination glove) does not typically involve human expert interpretation of results in the way, for example, a diagnostic imaging AI algorithm would.

• For physical and chemical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the "ground truth" is established by the specifications of the referenced ASTM standards and 21 CFR regulations. The results are quantitative measurements compared against predefined thresholds.
• For biocompatibility tests (Primary Skin Irritation, Dermal Sensitization), the "ground truth" is established by observing animal responses (rabbits for irritation, guinea pigs for sensitization) against established protocols (ISO 10993-10) and interpretation by trained toxicologists or scientists. The number and specific qualifications of these experts are not stated in this summary, but would be implicit in the conduct of these standardized tests.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "adjudication" is essentially the direct comparison of measured device characteristics against the objective, pre-defined criteria in the referenced standards. There isn't a scenario described where multiple interpretations of data would require an adjudication process by human experts.

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

No. This type of study is typically conducted for diagnostic devices where human readers (e.g., radiologists) interpret medical images or data, and the study compares their performance with and without AI assistance. A patient examination glove is a simple barrier device, not a diagnostic tool, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is also not relevant. The device is a physical product (a glove), not an algorithm. The performance is assessed through laboratory testing of its physical and biological properties.

7. The Type of Ground Truth Used

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

• Standard Specifications: For mechanical properties (dimension, physical properties, pinholes, powder residual), the ground truth is the quantitative limits defined by ASTM standards (D 5250-06, D6124-06) and 21 CFR 800.20.
• Biological Response Protocols: For biocompatibility, the ground truth is determined by the observed biological reactions in animal models following the established protocols of ISO 10993-10 (often interpreted as "Pass" or "Fail" based on whether reactions exceed certain thresholds).

Essentially, it's a combination of objective measurement against predefined criteria and standardized biological testing outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

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

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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.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided document:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a premarket notification for a Class I medical device (patient examination gloves). For such devices, extensive clinical studies are generally not required. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908) by meeting established industry standards and regulatory requirements.

Here's an analysis of the requested information based on the document:

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 Test Set: 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). It references adherence to the standards (ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10), which would define the required sample sizes for each test.
• Data Provenance: The manufacturing company is TANGSHAN CHANGRONG GLOVE CO., LTD. in China. The testing was conducted to ASTM and ISO standards, which are internationally recognized. The document doesn't explicitly state the country of origin of the data itself beyond the manufacturer's location. The studies are retrospective in the sense that they are conducted on finished product batches to ensure compliance with standards, rather than a prospective clinical trial.

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)

• Number of Experts & Qualifications: Not applicable in the context of this device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ASTM, ISO, and FDA standards themselves (e.g., a hole is present or not, weight is above/below a threshold, a biological response is observed or not). These are physical and chemical tests, not interpretations by medical experts.

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

• Adjudication Method: Not applicable. The tests are objective and based on established measurement methods and criteria within the referenced standards. There is no subjective interpretation or need for expert consensus adjudication for these types of physical, chemical, and biological safety tests.

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

• MRMC Study: No. This type of study is completely irrelevant for patient examination gloves. MRMC studies are typically used for evaluating diagnostic imaging algorithms where human readers interpret medical images.

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

• Standalone Performance: Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

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

• Type of Ground Truth: The ground truth is based on objective measurements against established scientific and regulatory standards. For example:
  • Dimension: Measured physical dimensions compared to ASTM D5250-06 specified ranges.
  • Physical Properties: Tensile strength, elongation at break, etc., measured according to ASTM D5250-06.
  • Freedom from pinholes: Water leak test (21 CFR 800.20), where the presence or absence of a water leak constitutes the ground truth.
  • Powder Residual: Gravimetric analysis to determine powder weight, compared to the <2mg/glove threshold.
  • Biocompatibility: Observation of specific biological reactions (irritation, sensitization) in animal models as defined by ISO10993-10 protocols.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical product, not an AI/ML algorithm that requires a "training set." The manufacturing process itself (Good Manufacturing Practices) and quality control over successive production batches ensure consistency, rather than a data training process.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or relevant for this device.

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This 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

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

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to patient examination gloves, which undergo non-clinical testing rather than classification with a "test set" in the context of AI/ML or medical imaging devices. The tests are performed on samples of the manufactured gloves. The document does not specify exact sample sizes for each test but refers to standard testing methods. The data provenance is derived from direct testing of the manufactured gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical device manufacturing like gloves, "ground truth" is established by adherence to specified physical, chemical, and biological standards (e.g., ASTM, CFR). No human experts are used to subjectively determine a "ground truth" for the test set in the way they would for diagnostic imaging.

4. Adjudication method for the test set: Not applicable. Since the evaluation relies on objective measurements against predefined standards, no subjective adjudication method (like 2+1 or 3+1 consensus) is required.

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 patient examination glove, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used: The ground truth is defined by objective, quantitative, and qualitative criteria established in international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, limits for pinholes, maximum powder residual, and biological response criteria for biocompatibility tests.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of manufacturing and testing patient examination gloves.

9. How the ground truth for the training set was established: Not applicable. There is no "training set" for this type of device. The established standards are the "ground truth" against which all manufactured gloves are evaluated.

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