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

Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

The provided document is a 510(k) summary for Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It is intended for regulatory approval of a medical device, not an AI/ML powered device. Therefore, much of the requested information (like AI-specific metrics, expert ground truth, training sets, etc.) is not applicable here.

However, I can extract the relevant "acceptance criteria" (which in this context are performance standards for gloves) and how the device meets them based on the provided text.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for a non-AI medical device):

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

   • Pinhole Testing (FDA 1000 ml Water Fill Test): AQL (Acceptable Quality Limit) 2.5, Inspection Level I. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards, which refer to statistical sampling plans.
   • Physical and Dimensions Testing: AQL 2.5, Inspection Level S-2. Similar to pinhole testing, the exact sample size is determined by the standard and specified AQL.
   • Primary Skin Irritation and Skin Sensitization Testing: The document states "conducted with results showing no primary skin irritant or sensitization reactions," but does not specify the sample size of subjects or the methodology of these biological tests beyond the positive outcome.
   • Data Provenance: Not specified, but generally, such tests are conducted in certified laboratories. The manufacturing origin is China.

2. 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 medical device (gloves), "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert interpretation of data.

3. Adjudication method for the test set:

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

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a study type for diagnostic algorithms or imaging, not for patient examination gloves.

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

   • No. This is not an AI/ML device.

6. The type of ground truth used:

   • Performance against established engineering and biological standards (e.g., ASTM D5250-06 for physical properties, FDA 1000ml water fill for barrier integrity, and standard biocompatibility tests for skin reactions).

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device. The "training" for such a product would be the manufacturing process control and quality system.

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

   • Not applicable. The manufacturing process and quality checks ensure the product meets the specifications, guided by the aforementioned standards.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

This document is a 510(k) summary for a medical device: "Zibo Yuqun New Material Science and Technology Co. Synthetic Vinyl Patient Examination Gloves - Powder Free".

Here's an analysis of the provided text in relation to the requested information:

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

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: Not explicitly stated for each test, but "samplings" were conducted for the Water Fill Test. For Physical and Dimensions Testing, an "Inspection Level S-2, AQL 2.5" is mentioned, and for the Water Fill Test, an "AQL 2.5, Inspection Level I" is mentioned. These are statistical sampling plans, but the exact number of gloves tested is not provided in this summary.
• Data Provenance: The manufacturing company is Zibo Yuqun New Material Science and Technology Co. in Zibo, Shandong, China. It is highly probable the testing was conducted in China or by labs affiliated with the manufacturer. The summary does not specify if the testing was retrospective or prospective, but product testing for premarket notification is typically prospective to demonstrate manufacturing controls and product quality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a patient examination glove, and the "ground truth" is established through standardized physical, chemical, and biological testing as outlined in ASTM standards and FDA guidelines, not by expert medical image interpretation. Therefore, this question is not applicable in the context of this device and study. The "experts" would be the industrial hygienists, chemists, and technicians performing the standard tests.

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

Not applicable. This device's performance is determined by objective, standardized tests (e.g., water fill for pinholes, tensile strength, powder content), not by human interpretation or adjudication in the medical context of image analysis.

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 physical product (gloves), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI-related performance metrics 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 software device.

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

The "ground truth" for this device is based on:

• Pre-defined Physical Standards: Established in ASTM D5250-06 (e.g., specific dimensions, tensile strength, elongation).
• Performance Standards: Such as the maximum allowable defect rate for pinholes (AQL 2.5) and maximum powder content (2 mg per glove).
• Biocompatibility Testing: Standards for primary skin irritation and skin sensitization reactions.

These "truths" are determined through objective laboratory testing against established specifications, not through expert consensus or medical outcomes data in the way it applies to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a physical product, not a machine learning model. There is no "training set."

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

Not applicable. As this is a physical product and not an AI/ML model, there is no "training set" or ground truth establishment relevant to an algorithm.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

The provided text describes the 510(k) summary for the "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color."

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions "samplings of AQL 2.5" and "Inspection Level S-2, AOL 2.5" for various tests. These are Acceptable Quality Limit (AQL) levels and Inspection Levels specified in quality control standards (like ASTM). While they define the statistical sampling plan (how many gloves are inspected from a lot and how many defects are allowed), they do not explicitly state the total number of gloves (sample size) actually tested for each criterion. The general practice for such tests involves taking samples from production lots.
• Data Provenance: The tests were conducted internally by Zibo Yingbo Medical Products Co., Ltd. or contracted labs on their behalf, adhering to established standards (ASTM, FDA). The provenance is specific to the manufacturer's testing of their product. No external country of origin or retrospective/prospective nature of data is mentioned beyond the manufacturing location (China) and the date the summary was prepared (Feb. 10, 2010), indicating the tests pre-date this submission.

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 type of device. Patient examination gloves are class I devices where performance is measured through objective physical, chemical, and biological tests based on recognized standards, not subjective expert interpretation of images or patient data. The "ground truth" is defined by passing the specified thresholds in ASTM and FDA test methods.

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

This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation by multiple human readers (e.g., radiologists) is involved in determining a "ground truth" for a diagnostic algorithm. For gloves, tests are objective and follow defined protocols, so no multi-reader adjudication is necessary.

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. The device is a physical product (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance 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 glove, not an algorithm.

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

The "ground truth" for these gloves is established by:

• Standard Specifications: Meeting predefined physical properties (e.g., tensile strength, elongation), dimensional tolerances, and leakage resistance as outlined in ASTM D5250-06.
• Biocompatibility Standards: Demonstrating the absence of significant irritation or sensitization through specific biological tests, where "ground truth" is defined by the absence of a reaction according to test protocols.
• Chemical Analysis: Confirming the "powder-free" claim through quantitative measurement of powder content (e.g., less than 2 mg per glove).

These are all objective, measurable criteria defined by established industry and regulatory standards.

8. The sample size for the training set:

This is not applicable. This is a product that undergoes manufacturing and quality control testing, not an AI model that requires a "training set."

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

This is not applicable. There is no "training set" for this type of device.

Ask a specific question about this device

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.

The provided text is a 510(k) summary for Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document pertains to the regulatory submission for a medical device (examination gloves), and thus, the concepts of "acceptance criteria," "study," "training set," "test set," "ground truth," and "experts" as they relate to advanced AI/ML algorithms or diagnostic devices are not directly applicable in the same way.

The document primarily focuses on demonstrating substantial equivalence of the gloves to a predicate device, as required for Class I medical devices. This involves showing that the device meets established industry standards and biocompatibility requirements.

Here's an interpretation of your request based on the provided document:

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

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 Testing: The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are Acceptable Quality Level (AQL) standards used in statistical quality control for batch inspection, not a fixed sample size in the traditional sense of a clinical study. The AQL specifies the maximum percentage of defective units considered acceptable in a batch. To determine the exact sample size for a given batch size, one would need to refer to military standard tables (e.g., MIL-STD-105E or ISO 2859-1) for single-sampling plans based on the specified inspection levels and AQLs. The document does not explicitly state the number of gloves sampled.
• Data Provenance: The testing was conducted by Zibo Goldenline Plastic Products Co., Ltd. in Zibo, Shandong, China. The testing would have been prospective, as it was performed on the manufactured gloves to assess their quality against the 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)

This concept is not applicable. For an examination glove, "ground truth" is established by adherence to predefined physical and chemical specifications and performance standards (like ASTM-D-5250-00 and FDA water fill test). The "experts" are the testing personnel and the certifying bodies who verify compliance with these standards, not medical experts establishing a diagnostic ground truth.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to resolve discrepancies. For physical product testing, results are objective measurements against a standard, 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

Not applicable. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices. This document describes a physical medical device (gloves) and does not involve human interpretation or AI.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the examination gloves is defined by:

• Industry Standards: Adherence to ASTM-D-5250-00 for physical properties and dimensions.
• Regulatory Requirements: Meeting FDA's 1000 ml Water Fill Test for barrier integrity and specific biocompatibility requirements (primary skin irritation, skin sensitization).
• Manufacturer Specifications: Meeting internal "powder-free" claims (≤ 2 mg powder per glove).

These are objective, measurable criteria, not subjective expert consensus or diagnostic outcomes.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of examination glove manufacturing and regulatory submission. Training sets are relevant for machine learning algorithms.

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

Not applicable. As there's no training set, there's no ground truth for it.

Ask a specific question about this device

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

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 D5250-00.

The provided text is a 510(k) summary for Zibo Wanci Plastic & Rubber Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves - Powder Free. This document establishes the substantial equivalence of the device to a predicate device, rather than proving its effectiveness through a typical clinical study with acceptance criteria, human readers, or specific outcomes data regarding disease.

The "acceptance criteria" discussed in this document refer to adherence to established industry standards and regulatory requirements for medical gloves, and the "study" is a series of non-clinical tests performed to demonstrate compliance with these standards.

Here's an analysis of the provided information in the requested format:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Physical and Dimensions Testing: The document mentions "Inspection Level S-2, AOL 2.5". This refers to an Acceptance Quality Limit (AQL) sampling plan described in ASTM standards. However, the specific number of gloves sampled for these tests is not explicitly stated.
• Sample Size for FDA 1000 ml. Water Fill Test: The document mentions "samplings of AOL 2.5, Inspection Level I". The specific number of gloves sampled for this test is not explicitly stated.
• Sample Size for Biocompatibility Testing: The specific number of subjects or samples used for primary skin irritation and skin sensitization testing is not explicitly stated.
• Data Provenance: The tests were conducted by the manufacturer, Zibo Wanci Plastic & Rubber Co., Ltd., presumably in China. The data is retrospective for the purpose of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance.

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

• Not Applicable. For medical gloves, "ground truth" is not established by expert consensus on diagnoses or interpretations. Instead, compliance with objective, measurable performance standards (e.g., tensile strength, dimensions, freedom from holes, biocompatibility) is the "ground truth." These standards are developed by organizations like ASTM and regulatory bodies like the FDA. The testing itself is typically performed by trained technicians in a laboratory setting according to the standard's methodology.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, especially in image-based diagnostic studies. For objective physical and chemical properties of medical gloves, the results are determined by adherence to pre-defined numerical thresholds and test methodologies, not by expert consensus or adjudication. The "adjudication" is met when the test results fall within the specified AQLs (Acceptance Quality Limits) or pass/fail 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

• Not Applicable. This device is a medical glove, a physical product, not an AI-powered diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to its evaluation.

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

• Not Applicable. As mentioned, this is a physical medical device (glove), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized consensus standards (e.g., ASTM-D-5250-00) and regulatory requirements (e.g., FDA Water Fill Test, biocompatibility guidelines). These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation), maximum permissible defect rates (pinholes), and biological reactions (irritation, sensitization).

8. The sample size for the training set

• Not Applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not the development of an AI model.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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