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The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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A patient 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.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes

Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa

WARNING: Do not use with Carmustine

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 non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.

Below is a summary of the acceptance criteria and the study conducted for the Disposable Nitrile Examination Glove, as detailed in the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides sample sizes for specific tests:

• ASTM D5151 (Watertightness): 125 gloves per size (XS, S, M, L, XL) were tested.
• The specific sample sizes for other tests like physical dimensions (ASTM D6319, ASTM D412), powder content (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10) are not explicitly stated in numerical terms (e.g., "n=X"), but are implied to be sufficient to meet the requirements of the respective ASTM and ISO standards.
• Data Provenance: The studies were conducted by the device manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is located in China. The data would be considered prospective as it involves new testing on the subject device to demonstrate its performance against established standards.

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

This information is not applicable to this device. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., ASTM and ISO methods) rather than expert clinical judgment or consensus. These are physical and chemical properties measured according to specific protocols.

4. Adjudication Method for the Test Set:

This is not applicable to this device. As mentioned above, the evaluation relies on objective measurements from standardized test methods, not subjective assessments requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or other complex data, and their performance is compared with and without AI assistance. Examination gloves are a Class I device with performance assessed via bench testing, not human interpretation.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination glove), not an AI algorithm or software. Its performance is evaluated through material and physical property testing, not algorithmic output.

7. Type of Ground Truth Used:

The ground truth used in these studies is based on objective, quantitative measurements obtained through validated and standardized laboratory test methods as defined by:

• ASTM International (formerly American Society for Testing and Materials) standards: ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978.
• ISO (International Organization for Standardization) standards: ISO 10993-5 and ISO 10993-10.
  These standards define the methods for measuring physical properties, chemical resistance, and biocompatibility, and the "ground truth" is the result of these measurements compared against the specified acceptance criteria within the standard.

8. Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. The manufacturing process of examination gloves is based on established engineering principles and quality control, rather than machine learning models.

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

This information is not applicable as there is no "training set" for this device.

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The Disposable Nitrile 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 nitrile examination gloves. The subject device is blue. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study designs that are specific to AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable.

The document focuses on demonstrating substantial equivalence of the new glove to a legally marketed predicate device based on material, performance, and biocompatibility standards.

Here's a breakdown of the relevant information from the document related to performance and acceptance criteria for this non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Nitrile 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 subject device is powder free nitrile examination gloves. The subject device is in blue color. 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 Disposable Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Nitrile 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 nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold. 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 a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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A patient 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.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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 five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the regulatory filing (510(k) Premarket Notification) for a "Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)". This document is for a medical device (a glove), not an AI/Software as a Medical Device (SaMD) or an algorithm. Therefore, the questions related to AI/algorithm performance metrics (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set sample size, expert ground truth establishment for AI data) are not applicable to this submission.

The acceptance criteria and device performance for this physical medical device are related to its material properties, physical dimensions, and resistance to chemotherapy drugs, as outlined by various ASTM and ISO standards.

Here's the information extracted and formatted according to the request, with clarification where the questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The reported results for physical and chemical resistance tests seem to be based on representative samples from production, as per the respective ASTM and ISO standards. The specific sample sizes for each test are implicitly defined by these standard test methods (e.g., ASTM D5151 for watertightness mentions testing 125 gloves per batch/size for AQL).
• Data provenance: Not explicitly stated, however, the manufacturer is Inner Mongolia Cureguard Medical Technology Co.,Ltd. (China), suggesting the testing was likely conducted in China or by labs compliant with international standards, possibly in China or elsewhere. The tests are "non-clinical" bench tests, not involving human data or patient populations. The data is retrospective in the sense that it's generated from manufactured product batches for regulatory submission.

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

This question is not applicable as the device is a physical medical glove, and its performance and safety are assessed through objective laboratory tests governed by international standards (ASTM, ISO), not through expert interpretation of medical images or other data that would require a "ground truth" established by experts in a clinical context. The "ground truth" here is the result of standardized material science and chemical permeation testing.

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

Not applicable. This is not a study requiring human adjudication for data interpretation.

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, not an AI/SaMD.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

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

The ground truth for the device's performance is established by the specified international standard test methods (ASTM and ISO standards) for physical properties, chemical resistance, and biocompatibility. For example, for watertightness, the ground truth is the absence of leaks when tested according to ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time and the specific drug concentration in the testing apparatus according to ASTM D6978. For biocompatibility, it's the observed biological response to testing protocols defined in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" in the context of an algorithm.

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

Not applicable. See point 8.

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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/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Cytotoxicity: The table on page 11 explicitly states "Under conditions of the study, device extract is cytotoxic." for ISO 10993-5. This appears to contradict the general conclusion that the device is "as safe, as effective." However, the predicate comparison table on page 8 indicates that the predicate device also stated "ISO 10993-5 Under conditions of the study, device extract is cytotoxic," and the subject device has a "/" for this criterion without a definitive pass/fail statement in that specific comparison table. In the non-clinical testing summary, it lists ISO 10993-5 as one of the standards conducted. If the device genuinely exhibited cytotoxicity, it would typically be a concern. Given the overall clearance, there might be further explanation or context not fully detailed in this summary (e.g., the level of cytotoxicity was deemed acceptable, or the "is cytotoxic" statement might be an error in the summary table on page 11, or the nature of the cytotoxicity and its relevance to direct patient contact for a glove was evaluated and deemed non-critical).

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

• Physical Dimensions (ASTM D6319): Not explicitly stated, but the results show ranges across sizes (S, M, L, XL).
• Watertightness Test (ASTM D5151): The results specify "0/125/Pass," indicating a sample size of 125 items (gloves) were tested, all passing (0 failures).
• Powder Content (ASTM D6124): Not explicitly stated.
• Physical Properties (ASTM D412): Not explicitly stated.
• Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated.
• Chemotherapy Drug Permeation (ASTM D6978-05): Not explicitly stated, however, the standard ASTM D6978 mandates three specimens be tested for each drug exposure for each material tested (so, 3 specimens per drug per color of glove). There are 12 drugs tested for 3 colors, so at least 3 x 12 x 3 = 108 specimens would have been tested as a minimum requirement for this standard.

The data provenance is from non-clinical bench testing conducted to relevant ASTM and ISO standards, indicating laboratory testing. The country of origin of the test data is not explicitly stated, but given the manufacturer is Jiangsu Bytech Medical Supplies Co.,Ltd. in China, it is likely the testing was performed either in China or by a certified lab contracted by the manufacturer. The data is reported retrospectively as part of the 510(k) submission.

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

This device is a physical product (gloves) and the tests conducted are bench-top performance tests and biocompatibility tests. Therefore, human experts are typically not used to establish a "ground truth" in the way they would for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is established by the methods and specifications defined in the referenced industry standards (ASTM, ISO). Laboratory technicians and chemists, qualified to perform these specific tests, would have conducted the studies.

4. Adjudication method for the test set:

Not applicable, as this involves objective laboratory measurements against established standards, not human interpretation 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. This device is a medical glove, not an AI diagnostic or assistance tool. The evaluation focuses on its physical and chemical properties.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The ground truth is based on:

• Standardized Test Methods: Specifications and methodologies outlined in ASTM (e.g., D6319, D5151, D6124, D412, D6978) and ISO standards (e.g., 10993-5, 10993-10, 10993-11).
• Objective Measurements: These standards define how properties like dimensions, watertightness, powder content, tensile strength, elongation, and drug permeation breakthrough times are measured objectively.
• Pre-defined Acceptance Criteria: The pass/fail criteria for these measurements are often specified within the standards or derived from regulatory guidance for the device type.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning model, so there is no training set in this context.

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

Not applicable. There is no training set.

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The Disposable Nitrile 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 nitrile examination gloves. The subject device is Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.

The subject device is non-sterile.

This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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The Disposable Nitrile Examination Gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

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

This document describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Device Performance

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The Dermoaroma Disposable Nitrile Examination Gloveare 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 Dermoaroma Disposable Nitrile Examination Glove. 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 provided document is a 510(k) Premarket Notification summary for the Dermoaroma Disposable Nitrile Examination Glove. This device is a Class I, reserved product, and the information presented focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device's safety and effectiveness through a comprehensive clinical study.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for an AI/algorithm-based device and its validation study that your request is looking for. There is no AI or algorithm involved in this specific medical device (disposable examination gloves).

Here's why the document doesn't fit your request and what information it does provide:

1. AI/Algorithm Focus: The request explicitly asks about an "AI device" or an "algorithm-based performance study" and its acceptance criteria. The device in this document is a physical product (nitrile gloves), not an AI or algorithm.

2. Clinical Study vs. Substantial Equivalence: The document explicitly states: "No clinical study is included in this submission." Instead, it relies on non-clinical performance testing and comparison to a legally marketed predicate device to demonstrate substantial equivalence.

3. Type of Performance Data: The performance data presented refers to physical and chemical properties of the gloves (e.g., length, width, thickness, tensile strength, elongation, freedom from holes, powder content, biocompatibility). These are not the types of metrics (e.g., sensitivity, specificity, AUC) or study designs (MRMC, standalone algorithm performance) relevant to an AI/algorithm.

To address your specific questions based on the provided document (and explain why most cannot be answered):

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

   • Context: This table relates to the physical and biological characteristics of the gloves, not AI performance metrics.
   • Table 5: Summary of Non-Clinical Performance Testing provides this information.
     • Acceptance Criteria Examples:
       • Skin Sensitization Test: Grades less than 1.
       • Skin Irritation Test: Primary irritation index 0-0.4 (Negligible).
       • In Vitro Cytotoxicity: Viability reduced to 70%).
       • Systemic Toxicity: Toxicosis response of testing group not greater than control.
       • Residual Powder: Powder residue limit of 2.0 mg.
       • Freedom from Holes: AQL 2.5, Criterion ≤7 gloves for water leakage (for 125 samples).
       • Dimensions (e.g., for Size S glove): width 80±10mm, Length ≥220 mm.
       • Physical Properties (Before Aging): Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 500%.
       • Physical Properties (After Accelerated Aging): Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 400%.
     • Reported Device Performance Examples:
       • Skin Sensitization Test: All grades are 0.
       • Skin Irritation Test: Primary irritation index is 0 (Negligible).
       • In Vitro Cytotoxicity: Viab.% of 100% test article extract is 20.8% (Indicates potential toxicity, but the submission argues this difference does not affect safety/efficacy when compared to predicate, likely due to the nature and contact of the device).
       • Systemic Toxicity: No toxicosis response in testing group.
       • Residual Powder: 0.13mg - 0.16 mg / glove.
       • Freedom from Holes: No glove water leakage found.
       • Dimensions (e.g., for Size S glove): width: 80-87 mm, Length 240-246 mm.
       • Physical Properties (Before Aging): Tensile strength 15.3-19.8 MPa, Ultimate Elongation 508.480% - 669.787%.
       • Physical Properties (After Accelerated Aging): Tensile strength 14.3-15.2MPa, Ultimate Elongation 435.176% - 542.968%.

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

   • Sample Sizes (for physical/biocompatibility tests):
     • For "Freedom from Holes" test (ASTM D5151), the sample size was 125 gloves.
     • Other tests (e.g., dimensions, physical properties, biocompatibility) would have specific sample sizes per the referenced ASTM/ISO standards, but these are not explicitly listed in the summary beyond "125 gloves"for the holes test. Often, these standards specify minimum sample sizes for material testing.
   • Data Provenance: The tests were conducted by the manufacturer, ChuZhou Harmony Gloves Medical Technology Co.,Ltd, based in AnHui Province, China. The document does not specify if these were retrospective or prospective studies in the general sense, but rather standard performance evaluations of manufacturing batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not involve expert-established ground truth like an AI diagnostic algorithm. Ground truth here is based on measurements against established engineering and biological standards (e.g., "0.13mg - 0.16 mg / glove" for powder content as measured by ASTM D6124).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no diagnostic component requiring human interpretation and consensus.

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 a non-AI device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance relies on established international standards and their specified methodologies for measuring physical, chemical, and biological properties (e.g., ASTM D6319 for dimensions and physical properties, ASTM D5151 for freedom from holes, ISO 10993 for biocompatibility).

8. The sample size for the training set: Not applicable. This device does not use an AI model that would require a training set.

9. How the ground truth for the training set was established: Not applicable. This device does not use an AI model or a training set.

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