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The 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.

Sterile, powder free, examination gloves made of nitrile. The gloves are provided in sizes small, medium, and large. Sterile gloves are provided in dispenser boxes.

This looks像 a request for structured information extracted from the provided text about the K122727 device. Unfortunately, the provided text describes a Disposable Nitrile Examination Glove and not an AI/ML medical device.

Therefore, many of the requested fields, such as "Sample size used for the test set," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of device. These fields are specifically relevant to studies involving diagnostic or AI-powered devices that produce results requiring interpretation or comparison to a ground truth established by experts.

However, I can still extract the acceptance criteria and performance for the physical device characteristics from the provided text.

Here's the information that is applicable and can be extracted:

Acceptance Criteria and Device Performance (for a Nitrile Examination Glove)

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

Regarding the other requested points, they are not applicable to this medical device type:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove's performance testing described here. Performance is measured against physical standards, not, for example, diagnostic data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by the ASTM and ISO standards themselves, not by expert consensus on specific cases.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against objective standards.
• 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 glove, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical glove.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical properties, the "ground truth" is defined by the objective metrics and thresholds within the cited ASTM and ISO standards. For biocompatibility, it's the observed biological reactions in animal models as per ISO 10993-10:2010.
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical glove.
• 9. How the ground truth for the training set was established: Not applicable.

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The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein)

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for testing each characteristic. However, each standard (ASTM, ISO, 21 CFR) defines specific methodologies and sample sizes for their respective tests. For example, ASTM D5151 (Freedom from Pinholes) would specify a certain number of gloves to be tested.

The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is expected that the testing was conducted prospectively according to the listed standards. No information on country of origin for the data is provided, nor is it indicated if it's retrospective.

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

This information is not applicable (N/A) to this type of device (examination gloves). The "ground truth" for glove performance is established by objective measurements against harmonized standards (e.g., ASTM, ISO), not by expert consensus or interpretation of images/data. The tests are industrial and chemical, not interpretive.

4. Adjudication Method for the Test Set

This information is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective measurements of physical, chemical, and biological properties, results are either within spec or not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is N/A for this device. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The device in question is a physical glove, not an AI system.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A for this device. A "standalone study" typically refers to the performance of an AI algorithm independent of human interaction. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by objective measurements against recognized national and international standards. These standards define the acceptable range or threshold for each characteristic (e.g., minimum elongation, maximum protein level, freedom from pinholes). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these performance criteria.

8. The Sample Size for the Training Set

This information is N/A for this device. The concept of a "training set" (used to train machine learning models) is not relevant to the evaluation of physical medical devices like examination gloves. Development of such gloves involves manufacturing processes and quality control, not AI model training.

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

This information is N/A for this device, for the same reasons as point 8.

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

Powder free, examination gloves made of latex and colored blue. The gloves are provided in sizes small, medium, large and extra large.

The provided document describes the acceptance criteria and study results for the "Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50µg/dm2 Or Less of Water Soluble Protein)" in the context of an Abbreviated 510(k) Premarket Notification.

Here's the breakdown of the requested information:

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 the exact sample sizes for each test listed (e.g., number of gloves tested for dimensions, pinholes, etc.). It only states that the device "Meets" the respective ASTM and ISO standards. These standards would inherently define the required sample sizes for testing, but the document does not explicitly report them.

Data provenance is not explicitly mentioned (e.g., retrospective or prospective, country of origin). However, given these are non-clinical (laboratory/material) tests conducted against established international standards (ASTM, ISO), they are typically conducted in a controlled testing environment, likely in the manufacturer's facility or a certified testing laboratory.

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 and study. The "ground truth" for examination gloves is established by whether they meet objective, quantifiable physical and chemical standards (ASTM, ISO, and 21 CFR). There are no human "experts" or clinical interpretation involved in establishing the performance criteria for these tests. The tests are designed to objectively measure properties like dimensions, strength, and chemical content.

4. Adjudication method for the test set:

This information is not applicable. Since the tests are objective measurements against defined standards, there is no need for an adjudication method. The results either meet the standard or they do not.

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 information is not applicable. This device is a medical glove, not an AI-assisted diagnostic or imaging 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 information is not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used:

The ground truth used is based on established objective laboratory standards (ASTM and ISO standards) and regulatory requirements (21 CFR 800.20). These standards define specific thresholds and methodologies for evaluating the physical, chemical, and biocompatibility properties of examination gloves.

8. The sample size for the training set:

This information is not applicable as this is not a machine learning or AI-based device that would require a training set.

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

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

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The 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.

Nitrile Powdered patient examination glove

The provided text is a 510(k) Premarket Notification for Nitrile Powdered Examination Gloves. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on nonclinical data.

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

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

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

The document does not specify the exact sample sizes for each test set that led to the "Meets" determination. It references ASTM and ISO standards for testing, which would outline the appropriate sample sizes and methodologies for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility).

The data provenance is from nonclinical testing conducted by the manufacturer (Northstar Healthcare Holdings) or a designated testing facility on their behalf, designed to demonstrate compliance with established standards. No specific country of origin or retrospective/prospective nature of the data is mentioned beyond the standards themselves.

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 as the device is a patient examination glove. The "ground truth" for this type of device is established by compliance with standardized physical performance and biocompatibility tests, not by expert interpretation of images or clinical data. The standards (ASTM, ISO) themselves define the criteria for "ground truth" or acceptable performance.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, often with conflicting opinions, requiring a consensus mechanism. For the nonclinical testing of gloves, the results are quantitative measurements against predefined thresholds specified in the ASTM and ISO standards.

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. This device is a physical medical device (examination glove), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This is not applicable as the device is not an algorithm or an AI system. Its performance is evaluated through physical and biocompatibility testing.

7. The type of ground truth used

The ground truth for this device is based on established industry standards (ASTM and ISO), which define objective, measurable criteria for physical properties (dimensions, tensile strength, elongation, freedom from pinholes, powder residual) and biological safety (biocompatibility). The tests measure these characteristics directly against the specified thresholds.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML device that requires a training set. Its performance is assessed through direct testing against predetermined criteria.

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 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. 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 of Chemotherapy Drugs.

Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).

This document describes the acceptance criteria and performance of "Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein)".

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). However, it implicitly suggests that testing was conducted in accordance with the cited ASTM and ISO standards, which would define appropriate sample sizes for each evaluation.

The data provenance is not specified in terms of country of origin. The studies appear to be prospective laboratory tests conducted according to established international and US standards (ASTM, ISO, 21 CFR).

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

For the type of device and tests conducted (physical, chemical, and biocompatibility), the "ground truth" is established by adherence to specified, objective, and standardized testing methodologies. This typically involves trained laboratory technicians and/or engineers performing the tests, rather than a panel of "experts" as seen in clinical diagnostic studies. The qualifications would be expertise in conducting the specific ASTM and ISO standard tests. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective laboratory tests like those performed on gloves, the results are quantitative and directly compared against the pass/fail criteria of the standard.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a medical glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not human interpretation of medical cases.

6. If a Standalone Study Was Done

Yes, the studies described are standalone (algorithm/device only) in the sense that the performance of the glove itself was evaluated directly against the specified standards, without involving human users "in the loop" for the primary performance evaluations described. The performance metrics are objective measurements (e.g., tensile strength, pinhole count, breakthrough time, protein levels).

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established Standards and Regulatory Requirements: The performance is measured against the criteria defined by ASTM standards (D3578-05, D5151-06, D6124-06, D5712-10, D6978-05), ISO standards (10993-1:2009, 10993-10:2010), and U.S. FDA regulations (21 CFR 800.20).
• Objective Laboratory Measurements: Data is generated through physical, chemical, and biological testing protocols designed to yield quantitative and qualitative results that are then compared to the acceptance criteria specified in the standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (medical glove), not an AI algorithm requiring a training set. The performance is assessed through direct testing of the manufactured product.

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

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

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

Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements. Non-sterile, powder free, examination gloves made of nitrile and colored blue. The textured gloves are provided in sizes extra small, small, medium, large and extra large. Non-sterile gloves are provided in dispenser boxes.

The provided text describes a 510(k) summary for the "ETS Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. The summary focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the specific tests (e.g., number of gloves tested for dimensions, pinholes, etc.). It only indicates that the device "Meets" the specified ASTM and ISO standards, which inherently include sampling plans within those standards.

• Sample Size: Not explicitly stated for each test. The standards referenced (ASTM D6319, D5151, D6124, ISO 10993-10) would define the required sample sizes for demonstrating compliance.
• Data Provenance: Not explicitly stated. This information is typically generated by the manufacturer or a contracted testing lab during product development and quality assurance. It's retrospective testing of the manufactured product.

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

This information is not applicable to this type of device. The "ground truth" for patient examination gloves is established by objective, verifiable physical and chemical properties measured against recognized industry standards (ASTM, ISO). There are no human "experts" establishing a subjective ground truth for these performance criteria in the way there would be for, for example, image interpretation in a diagnostic AI study.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the "ground truth" is determined by objective physical and chemical testing against standards, not by expert consensus or adjudication of subjective interpretations.

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

No. This is a Class I medical device (patient examination glove). MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of complex data (like medical images), where the AI might assist a human reader. This device does not involve that type of interaction or assessment.

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

No. This is a physical product (glove), not an algorithm or software device. Standalone performance refers to the accuracy of an AI algorithm on its own.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements against established national and international standards. Specifically:

• Physical properties (dimensions, tensile strength, ultimate elongation) are measured against ASTM D6319-10.
• Freedom from pinholes is measured against ASTM D5151-06 and D6319-10.
• Residual powder is measured against ASTM D6124-06.
• Biocompatibility (skin irritation and sensitization) is assessed against ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This product is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this device. The manufacturing process is validated (which might involve statistical process control and testing of batches), but this is distinct from an AI training set.

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

Not applicable. (See point 8).

In summary: The provided 510(k) summary for the ETS Blue Powder Free Nitrile Patient Exam Glove demonstrates its safety and effectiveness by showing that it meets recognized consensus standards (ASTM and ISO) for physical characteristics and biocompatibility, thereby establishing substantial equivalence to a legally marketed predicate device. The nature of this device means that many of the AI/algorithm-specific questions are not relevant.

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

Powder free black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

Powder free blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Powder free blue nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

The provided text describes the regulatory filing for a medical device: "UTB Blue Powder Free Nitrile Patient Examination Gloves." The information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI performance, clinical effectiveness, or diagnostic accuracy. Therefore, many of the requested categories related to AI studies, reader performance, and ground truth establishment are not applicable.

Here's the breakdown of the available information:

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 exact sample sizes for each test mentioned (e.g., number of gloves tested for pinholes, number of animals for biocompatibility). The data provenance is described by the standards used, which are international (ASTM, ISO). There is no explicit mention of the country of origin of the data or whether the tests were conducted retrospectively or prospectively, except that they generally refer to evaluations of the product itself for regulatory compliance.

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

Not applicable. The "ground truth" here is compliance with established international standards for patient examination gloves, rather than interpretation of medical images or data by human experts. The tests are laboratory-based.

4. Adjudication method for the test set

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments. Here, the tests involve objective measurements against predefined standards.

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. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The tests performed are on the physical and biological properties of the glove.

7. The type of ground truth used

The ground truth used is the standards themselves (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10:2010). The device performance is compared against the requirements stipulated in these recognized industry and international standards for each characteristic.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set for this type of medical device.

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

Powder Free Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)

Acceptance Criteria and Device Performance for Powder Free Latex Patient Exam Glove

1. Table of Acceptance Criteria and Reported Device Performance

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