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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.

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.

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)

The provided text describes the acceptance criteria and performance of the EVERGREEN MEDICAL PRODUCTS Vinyl Patient Examination Gloves - Powder Free. However, it does not contain information about a study proving the device meets the acceptance criteria in the manner of a multi-reader, multi-case (MRMC) comparative effectiveness study, or a standalone (algorithm only) performance study as typically seen for AI/ML medical devices. The document is a 510(k) summary for a medical device (examination gloves), which follows a different set of regulatory requirements focused on demonstrating substantial equivalence to a predicate device.

Instead, the "study" described in this document is essentially a series of quality characteristic tests performed against established ASTM and FDA standards for patient examination gloves.

Here's the breakdown of the information requested, 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 a distinct "test set" sample size in terms of number of gloves tested for each characteristic. It refers to established standards and tests (e.g., JIS-S-2045.509, JIS-S-2045.5.2, FDA Glove 1000ml Water Leak Test, Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization). These standards imply specific sampling plans.
• Data Provenance: The tests for biocompatibility were "Issued by Consumer Products Testing Co." The document states the manufacturer is located in Shijiazhuang City, Hebei, China. Thus, the provenance of the testing data is likely China. The study is retrospective in the sense that the data presented reflects the results of quality control and testing performed on manufactured batches 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:

• This concept is not applicable here as this is a physical medical device (gloves) and not an AI/ML diagnostic or image analysis device that requires expert consensus for "ground truth." The "ground truth" for the performance characteristics are the established ASTM and FDA standards themselves. The assessment is against these objective measurements.

4. Adjudication method for the test set:

• This concept is not applicable. Performance against physical and chemical specifications does not involve "adjudication" by experts in the context of diagnostic interpretation. The methods are standardized physical and chemical tests (e.g., measuring length, tensile strength, pinhole rate via water leak test, biological irritation 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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 type of study is relevant for AI/ML diagnostic systems, not for examination gloves.

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

• The "ground truth" for this device's performance is adherence to established, objective material and physical specifications and testing standards (e.g., ASTM Specification D 5250-99 for physical properties, FDA Glove 1000ml Water Leak Test for pinholes, and standard biocompatibility tests).

8. The sample size for the training set:

• This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process itself (described in Section 10.0) is continuously refined and controlled, but there isn't a "training set" in the sense of data used to train a model.

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

• This concept is not applicable, as there is no "training set." The standards for glove manufacturing and performance are established by regulatory bodies and industrial organizations (e.g., ASTM, FDA) based on extensive research and consensus within the medical and materials science communities to ensure safety and effectiveness for their intended use.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
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.

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)

The provided text describes the specifications and quality control scheme for vinyl patient examination gloves, rather than a medical device with an algorithm or AI component requiring a study to prove acceptance criteria in the typical sense of AI/ML devices. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract the acceptance criteria and the methods used to show the device meets those criteria based on the provided information, which primarily references ASTM and ISO standards for physical characteristics and manufacturing quality.

Here's a summary tailored to the provided document:

Acceptance Criteria and Device Performance for Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria based on two main sections:

• "SPECIFICATION OF VINYL GLOVES (Ambidextrous)" (Page 2) which lists specific physical dimensions and performance requirements. This section appears to be the target specification for the gloves.
• "PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS" AND "QUALITY CHARACTERISTICS" (Pages 5-6) which detail the quality control parameters and their associated Assurance Actions and AQLs (Acceptable Quality Levels). This section describes how the product is monitored and accepted during manufacturing.

Table 1: Acceptance Criteria and Reported Device Performance (Summary from Specifications and Quality Control)

The conclusion states: "The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims." This is the direct statement of performance against the acceptance criteria.

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

• Sample Size: The document refers to sampling procedures in accordance with ISO 2859 ("Sampling procedures and Tables for Inspection by Attributes"). It also mentions "median of not less than three measurements" for thickness (A.1), "median of at least 10 results" for residual powder (A.3), and "median of not less than 5 test results" for physical requirements (A.4). However, specific numerical sample sizes for the overall test set (e.g., number of gloves tested for full compliance) are not explicitly stated. The AQL (Acceptable Quality Level) values (e.g., 2.5, 1.0, 1.5, 4.0) and Inspection Levels (e.g., S-2, II, 1) refer to the statistical sampling plans within ISO 2859 and US FDA Test Methods, which would dictate the sample sizes based on lot size, but these specific numbers are not provided.
• Data Provenance: Not applicable in the context of an "AI device." The testing would be performed on manufactured batches of physical gloves at the manufacturing site (Evergreen Medical Products (Jingxing) Co., Ltd.) in China, as part of their quality control process. The biocompatibility testing was "Issued by Consumer Products Testing Co."

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

• Not applicable as this is a physical product (gloves) and not an AI/ML device relying on expert-labeled data. Ground truth here refers to adherence to objective physical and chemical standards.

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

• Not applicable for the reasons stated above. Testing involves measuring characteristics against predefined physical/chemical limits. Visual inspection for defects ("Visual, Sensual" in Section 22.0) would follow established quality control protocols, but not multi-expert adjudication in the AI sense.

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 device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for the device's performance is adherence to established international and national standards for medical gloves:
  • ASTM Specification D 5250-99 (Standard Specification for Vinyl Examination Gloves for Medical Application) for general glove properties.
  • JIS-S-2045.509/5.9/5.2 for specific dimensions and mechanical tests.
  • ISO 2859 for sampling procedures.
  • US FDA Test Method for Leakage Defects as published in the Federal Registration of Nov. 31, 1989 (21 CFR Part 800.20) for pinholes.
  • ASTM D 3578 (Standard Specification for Rubber Examination Gloves) for physical requirements (aging).
  • BS 4005 (Single Use Sterile Surgical Rubber Gloves, Appendix C) for air inflation and cuff test (partial adherence).
  • Biocompatibility testing results (Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization) for safety.
  • Chemical composition (Polyvinyl Chloride, Plasticizers, etc.) against specified percentages.
  • Manufacturing Practice: Compliance with current Good Manufacturing Practice (GMP) requirements.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI 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 Patient Examination Gloves- Pre-powdered

I am sorry, but the provided text is a letter from the FDA regarding the clearance of Vinyl Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance for the product. Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study as the necessary information is not present in the given document.

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A glove is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. 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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Acceptance Criteria & Study Analysis for K974151: Vinyl Patient Examination Gloves

This device, the Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered, is a Class I medical device (21 CFR 880.6250) and is substantially equivalent to predicate devices. The safety and effectiveness are established through compliance with existing industry standards and specific tests, not through clinical trials in the traditional sense, as there are no specific claims requiring such studies (e.g., hypoallergenic).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions: The document states "Inspection Level S-2, AQL 4.0". This refers to attributes sampling plans defined in standards like ISO 2859 (or MIL-STD-105E from which it is derived).
  • AQL (Acceptable Quality Level) 4.0: This means that the statistical sampling plan is designed to accept lots where the percentage of defective items is 4.0% or less.
  • Inspection Level S-2: This is a special inspection level for circumstances where smaller sample sizes are desired, usually for testing that is destructive or expensive, while still providing some protection. The exact sample size would depend on the batch size, but for S-2, it would be significantly smaller than general inspection levels.
• Barrier Integrity (Pinhole Defects): The document states "samplings of AQL 2.5, Inspection Level S-4".
  • AQL 2.5: This means the sampling plan is designed to accept lots where the percentage of defective items is 2.5% or less.
  • Inspection Level S-4: Similar to S-2, this is a special inspection level for reduced sample sizes.
• Biocompatibility: No specific sample sizes for these tests are provided in the summary. Standardized tests (e.g., ISO 10993 series which often includes these tests) would typically specify the number of animals or human subjects (for patch tests) required, but the summary only provides the results.
• Data Provenance: The device is manufactured by Shanghai Super Gloves Co., Ltd. in Shanghai, China. The testing was conducted by the manufacturer, or by a testing laboratory on behalf of the manufacturer, to demonstrate compliance with the stated standards. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed for this submission.

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

• Not Applicable in the traditional sense for this device.
• For these types of devices (examination gloves), "ground truth" is established by adherence to recognized industry standards (ASTM-D-5250-92 for physical properties, FDA 1000 ml water fill test for pinholes, and general biocompatibility testing standards). The "experts" involved are the certified testing laboratories and their personnel who conduct these standardized tests according to established protocols and interpret the results against the defined acceptance criteria.
• There would not be a panel of human experts establishing a subjective "ground truth" for each glove.

4. Adjudication Method for the Test Set

• Not Applicable. As "ground truth" is based on objective, standardized tests against specified criteria, there is no need for expert adjudication. The tests yield definitive results (e.g., pass/fail for pinholes, quantitative measurements for physical properties, presence/absence of irritation for biocompatibility) which are then compared directly to the acceptance criteria.

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

• No. This type of study is not relevant or applicable for an examination glove. MRMC studies are typically used to evaluate diagnostic imaging devices or algorithms where human readers interpret medical images.

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

• Not Applicable. This is not an algorithmic or AI-enabled device. Its performance is intrinsic to its physical and chemical properties.

7. Type of Ground Truth Used

• Objective Test Results against Established Standards: The ground truth for this device is based on objective measurements and observations derived from standardized tests. Examples include:
  • Physical Properties: Measurements of dimensions, tensile strength, elongation, etc., compared against the specifications in ASTM-D-5250-92.
  • Pinhole Detection: Direct observation using the FDA 1000 ml Water Fill Test.
  • Biocompatibility: Clinical observation of skin reactions in standardized animal or human patch tests, interpreted against established criteria for irritation and sensitization.
• The "ground truth" here is the direct, measurable compliance with these recognized benchmarks.

8. Sample Size for the Training Set

• Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The manufacturing process is designed to consistently produce gloves that meet the specifications, and quality control sampling is an ongoing process, not a "training set."

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

• Not Applicable. No training set exists for this device.

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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.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.

This is a 510(k) summary for Vinyl Patient Examination Gloves, Powdered. It describes the device, its intended use, and compares its performance to the ASTM D5250-92 standard and the FDA 1000ml water leak test.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The document states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." It also mentions a "Modified Draize Test" for clinical performance.

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

• Non-Clinical Performance Data (Physical Properties and Water Leak Test): The document does not specify the exact sample sizes used for each of the physical property tests (length, width, thickness, tensile strength, elongation). For the FDA Water Leak Test, it mentions an "Inspection Level of S-4," which is a sampling plan specification, but not the absolute number of gloves tested.
• Clinical Performance Data (Modified Draize Test): The document refers to "human subjects" but does not specify the number of subjects used in the Modified Draize Test.
• Data Provenance: The document is from Everrise Glove Products Co., Ltd. in Tainan Hsien, Taiwan, R.O.C. The data appears 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 the qualifications of those experts

This information is not provided in the document. The tests performed are objective measurements against defined standards (ASTM D5250-92 and FDA 1000ml water leak test) and a standardized skin irritation test (Modified Draize Test). These do not typically involve human expert "ground truth" establishment in the way medical imaging or diagnostic algorithms do.

4. Adjudication method for the test set

This is not applicable as the tests performed are objective measurements against established standards, not subjective interpretations 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 is not applicable as the device is a vinyl patient examination glove, not an AI-assisted diagnostic or imaging system.

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

This is not applicable as the device is a physical product (gloves), not an algorithm.

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

The "ground truth" for the non-clinical performance data is defined by the ASTM Standard D5250-92 specifications and the FDA 1000ml water leak test criteria. For the clinical performance, the "ground truth" is the lack of clinically significant irritation or allergic contact dermatitis as determined by the Modified Draize Test. This is based on direct observation of human physiological reactions rather than expert consensus on subjective data or pathology.

8. The sample size for the training set

This is not applicable. The context is a medical device (gloves) undergoing testing against established standards, not a machine learning model that requires a training set.

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

This 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 on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
Viryl Patient Examination Glove, Power Free, 80LYZ
conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

This document describes the performance of the Vinyl Patient Examination Gloves, Powder Free, manufactured by Everrise Glove Products Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against ASTM Standard D5250-92 and FDA water leak test requirements.

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

The document does not explicitly state the sample sizes used for the physical property tests (length, width, thickness, tensile strength, ultimate elongation) or the FDA water leak test. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The studies are non-clinical performance studies conducted on the applicant's device. No information on whether they were retrospective or prospective is provided, but standard test methods like ASTM D5250-92 are typically conducted prospectively on a sample set.

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

Not applicable. This device is a physical product (gloves), and performance is assessed against established engineering and safety standards (ASTM D5250-92 and FDA water leak test), which do not involve expert interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication method for the test set:

Not applicable. Performance is measured against quantitative standards, not through adjudication of expert opinions.

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 (examination gloves), not an AI-powered diagnostic tool engaging human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the objective, measurable criteria specified in ASTM Standard D5250-92 and the FDA 1000ml water leak test. These are engineering and quality control standards.

8. The sample size for the training set:

Not applicable. There is no training set as this is a physical product evaluated against standards, not a machine learning algorithm.

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

Not applicable.

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