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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: extra-small, small, medium, large, and extra-large.

The provided document describes the FDA 510(k) premarket notification for "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)". This document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or a sample size for training data are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and chemical performance standards for the gloves, particularly their resistance to chemotherapy drugs and biocompatibility.

Here's the information extracted from the provided text, tailored to the context of a physical medical device:

Acceptance Criteria and Device Performance for Disposable Nitrile Powder-Free Examination Gloves

The acceptance criteria for the Disposable Nitrile Powder-Free Examination Gloves are based on compliance with established international and national standards for medical gloves, particularly regarding their physical properties, freedom from holes, residual powder content, and resistance to permeation by chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes material and performance testing, not a "test set" in the sense of an AI model's dataset. The "samples" refer to physical gloves selected for testing.

The provenance of the data is from laboratory testing conducted on the manufactured gloves. The specific country of origin for the testing itself is not explicitly stated, but the manufacturer is Shandong Maida Medical Technology Co.,Ltd. in China. The testing is prospective in the sense that newly manufactured gloves are tested to ensure they meet the standards.

• ASTM D5151 (Detection of Holes): Sample size for water leakage test: 125 gloves.
• ASTM D6319 (Dimensions & Physical Properties): Results are shown for multiple lots (e.g., Lot no.: 210515, 210518, 210520), indicating multiple samples were tested across different manufacturing batches. The exact number of gloves per lot for each physical test (e.g., tensile strength, elongation) is not specified but would be defined by the ASTM standard.
• ASTM D6978 (Chemotherapy Permeation): The results provide triplet values for Carmustine and Thio Tepa (e.g., 22.8(23.7, 22.8, 23.1)), suggesting three independent measurements were taken for these drugs. The standard itself specifies the number of replicates.
• Biocompatibility Testing: The number of animal subjects used for the animal irritation, sensitization, and systemic toxicity tests is not specified in the summary but would conform to the respective ISO standards.

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

This section is not applicable as the evaluation involves standardized laboratory testing against defined physical and chemical properties, not human expert interpretation of subjective data or images. The "ground truth" is defined by the objective measurement results according to the specified ASTM and ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert assessments (e.g., in medical image interpretation). Here, numerical test results from standardized methods are directly compared against established quantitative or qualitative acceptance criteria.

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

This is not applicable. MRMC studies are used to evaluate diagnostic imaging systems or AI tools where human readers are involved. This submission is for a physical medical glove.

6. Standalone (Algorithm Only) Performance

This is not applicable. This concept applies to AI/software performance. The device is a physical glove, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is based on objective, quantitative measurements derived from standardized laboratory tests (bench testing) and biological responses observed in validated biocompatibility assays according to international standards (ASTM and ISO). This includes:

• Quantitative Thresholds: e.g., minimum tensile strength, maximum residual powder, minimum breakthrough time for chemotherapy drugs.
• Qualitative Observations (Biological): e.g., absence of irritation or sensitization, absence of systemic toxicity.
• Conformity to Standards: The device's performance is compared directly to the specified requirements within each standard (e.g., ASTM D6319-19 dimensions, physical properties).

One point of note is the cytotoxicity result (17.1% viability) which is below the 70% threshold, indicating cytotoxicity. The document addresses this by stating: "Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test." And the systemic toxicity test showed "no evidence of systemic toxicity." This implies that despite the in vitro cytotoxicity, the manufacturer argues that in vivo systemic toxicity (which is generally considered a more critical endpoint for patient safety) was not observed, suggesting the findings are acceptable for the device's intended use according to the biocompatibility evaluation framework.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical device. The manufacturing process is controlled to produce gloves consistently, and batch testing ensures quality.

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

This is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant. The manufacturing process is designed and verified to produce products meeting the specified design and performance criteria.

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The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The document provided is a 510(k) summary for Disposable Nitrile Powder-Free Examination Gloves. It details the safety and effectiveness information, comparing the proposed device to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance testing rather than studies involving human readers or AI.

Based on the provided text, here's a breakdown of 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:

• Sample Size for Test Set:
  • For the hole detection test (ASTM D5151-06), the sample size specified in the acceptance criteria is 125 gloves. The actual results state that "no glove water leakage found," implying 125 gloves were tested.
  • For biocompatibility tests (ISO 10993 series), the specific number of animals or samples is not explicitly stated in the summary, but standard protocols for these tests involve specific sample sizes (e.g., animal groups for irritation/sensitization, cell cultures for cytotoxicity).
  • For material properties (tensile strength, elongation, dimensions), the results are provided for specific "Lot no." (e.g., 210515, 210518, 210520), suggesting samples were taken from these production lots. The exact sample size per lot for these physical tests is not detailed in the summary.
• Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being Shandong Maida Medical Technology Co.,Ltd. in China. The studies are non-clinical performance tests, meaning they are not conducted on human subjects and therefore the concepts of "retrospective or prospective" as typically applied to clinical studies are not directly applicable. These are laboratory/bench tests to confirm product specifications.

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

This is a new medical device submission for examination gloves, which is a Class I device. The "ground truth" for this type of device is established through adherence to recognized international and national standards (ISO, ASTM) for material properties, biocompatibility, and physical characteristics. There is no mention of "experts" in the context of human data interpretation or labeling for AI models. The "ground truth" here is the pass/fail criteria defined by these standards.

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

Not applicable. This is not a study involving human interpretation or AI where adjudication of conflicting opinions would be necessary. The tests are based on objective measurements and established standard protocols.

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 submission is for medical examination gloves, which are physical devices, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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 concensus, pathology, outcomes data, etc.):

The ground truth for this device's performance is based on accepted international and national standards (e.g., ISO 10993 series for biocompatibility, ASTM D6124 for residual powder, ASTM D5151 for holes, ASTM D6319 for physical properties). The device's performance is compared against the specific numerical and qualitative criteria defined within these standards.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These are non-clinical performance tests to ensure the product meets manufacturing and safety specifications.

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

Not applicable, as there is no training set.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This document describes the acceptance criteria and the study proving that the "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The device was tested against several standards, as detailed in the "Summary of Non-Clinical Testing" section (pages 8-13). Here's a summary:

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

The document provides the following details:

• ASTM D5151 (Freedom from Holes): Sample size of 125 gloves. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but is implied to be from laboratory testing conducted as part of the regulatory submission process.
• For other tests (Biocompatibility, Physical Properties, Chemotherapy Drug Permeation), specific sample sizes are not detailed in the provided text. However, testing was stated to be "in accordance with the following standards" (ISO and ASTM), which would implicitly define minimum sample sizes for each test method. Data provenance is implied to be from laboratory testing.

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

This information is not provided in the document. The tests conducted are laboratory-based and follow established international and national standards (ISO, ASTM). The "ground truth" for these tests is defined by the methodologies and performance requirements within these standards, not by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are laboratory performance tests following well-defined standards, not clinical studies requiring independent adjudication of outcomes.

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

This information is not applicable as the device is a medical glove, and the studies are pre-market non-clinical performance and biocompatibility evaluations. It is not an AI-assisted diagnostic device or a device where human reader performance would be a relevant metric.

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

This information is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is the physical and chemical resistance of the glove itself.

7. Type of Ground Truth Used:

The ground truth for the evaluations is based on:

• Standardized Laboratory Test Results: Defined by the methodologies and acceptance criteria specified in the referenced ASTM and ISO international standards (e.g., specific tensile strength values, breakthrough times, chemical concentrations).
• Biocompatibility Endpoints: As defined by ISO 10993 standards (e.g., absence of irritation, sensitization, systemic toxicity).

8. Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.

Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.

Here's the relevant information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.

Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:

Study Details (Non-Clinical Performance Testing):

This document describes non-clinical performance testing of a physical device (examination gloves), not a study of an AI algorithm or human reader performance. Therefore, most of the requested fields are not applicable.

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

   • Freedom from Holes: 125 gloves. No specific country of origin is mentioned for the test samples; it's implied they are samples of the manufactured gloves. The testing is prospective as it's part of the product characterization for market submission.
   • Other tests (Biocompatibility, Physical properties): Sample sizes are not explicitly stated for individual tests but are implied to be sufficient for compliance with the respective standards (e.g., ISO, ASTM). The data provenance is testing conducted by the manufacturer (Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.) or its contracted labs.

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

   • Not applicable. Ground truth for device performance is established by standardized test methodologies and their objective measurements, not by expert consensus or interpretations.

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

   • Not applicable. This is not a human interpretation study.

4. 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 not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • The "ground truth" for the device's performance is defined by adherence to established international and national standards (ASTM, ISO) for material properties, dimensions, and biological safety. This is based on objective measurements and laboratory testing results.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning model. The manufacturing process is implicitly "trained" over time to produce consistent results that meet standards.

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

   • Not applicable. As above, no training set for an AI model.

In summary, this FDA 510(k) submission for examination gloves demonstrates substantial equivalence to a predicate device, primarily through non-clinical laboratory testing that shows compliance with relevant performance and safety standards. The regulatory pathway is not driven by AI model validation or human reader performance studies.

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