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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:

Description of Acceptance Criteria and Proving Study

This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent points (2-9) are not applicable to this device submission, as it concerns a Class I medical device (patient examination gloves) that relies on nonclinical testing against established standards rather than clinical studies with human participants, expert ground truth, or AI algorithms.

However, I will address each point and explain why it's not applicable in this context.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The "test set" here refers to physical gloves undergoing nonclinical laboratory tests according to standards like ASTM. While a sample size would have been used for tests like pinhole detection or physical properties, the document does not specify these individual sample sizes. The data provenance is from laboratory testing performed to meet specified 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)

Not applicable. Ground truth, in the context of expert consensus, is not relevant for this device. The "ground truth" for glove performance is defined by the objective metrics and thresholds established within the referenced ASTM standards and FDA regulations (e.g., specific tensile strength values, acceptable pinhole rates, bio-reactivity tests).

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 used for resolving disagreements among multiple human readers in clinical studies. This is not pertinent to the nonclinical testing of gloves against predefined physical and chemical 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 device is a physical medical glove and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is a physical medical glove and does not involve any algorithm or AI performance.

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

The ground truth used for this device is based on established industry standards and regulatory requirements.

• For physical properties and dimensions: ASTM standard D 5250-06 e1 dictates the acceptable ranges and performance.
• For freedom from pinholes: 21 CFR 800.20 sets the standard.
• For powder residual: ASTM standard D 5250-06 e1 and D6124-06 set the acceptable limit.
• For biocompatibility: ISO 10993-10 outlines the testing methodology and acceptable outcomes (e.g., "Not a Primary Skin Irritation," "Not a Dermal Sensitization").

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply.

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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text is a 510(k) summary for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Based on the content provided, the device in question is a medical glove, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes of human reader improvement with AI assistance) are not applicable to this document. The provided text does not contain information about an AI/ML device or its performance study.

However, I can extract the acceptance criteria and reported device performance from the provided text for the medical glove.

Acceptance Criteria and Reported Device Performance (for Medical Glove):

Study Details (based on provided text for Medical Glove):

• Sample sizes used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of AI/ML, but the device was tested against the specified ASTM and CFR standards. No specific sample sizes for these tests are detailed in the summary. Data provenance is not specified beyond the device being manufactured by PPP Medical and Safety Products Company Limited in China. The study is implicitly a nonclinical study, as stated: "A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for medical glove testing typically relies on standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI/ML image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is adherence to established industry standards and regulations for physical properties, chemical composition (powder amount), freedom from defects (pinholes), and biocompatibility. This is determined through laboratory testing and measurements based on the specified ASTM and CFR standards, rather than clinical outcomes, pathology, or expert consensus on interpretations.
• The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a non-AI/ML medical device (patient examination gloves). The "acceptance criteria" relate to meeting established engineering and biocompatibility standards, and the "study" proving this involves nonclinical laboratory testing as per those standards. The concept of "ground truth" here refers to the measured physical and biological properties of the glove conforming to the standard specifications.

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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility).

The data provenance is for a device manufactured by "Hebei Shenzichen Plastic& Rubber Products Co.,Ltd." in "Ciyutuo Development Area,Luan County,Tangshan City,Hebei Province,063100,China". All data appears to be retrospective as it's presented as results of tests already conducted to demonstrate compliance with established standards.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The tests described are laboratory-based and standard-driven (e.g., ASTM, CFR, ISO). While technicians with specific qualifications would have performed these tests, the concept of "experts establishing ground truth" in the diagnostic or clinical sense, with defined numbers and qualifications (e.g., radiologists), does not apply directly to the evaluation of a medical device like examination gloves against mechanical and biological standards.

4. Adjudication Method for Test Set

Not applicable in the context presented. The tests performed are objective, standards-based evaluations (e.g., measuring dimensions, physical properties, pinhole presence, powder amount, and biological responses in animals). There is no indication of human interpretation or disagreement requiring an adjudication process for these types of tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or interpretive AI systems where human readers interpret medical images or data. The device in question is a physical medical glove and does not involve human interpretation of output.

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

Not applicable. This device is a passive medical device (an examination glove) and does not involve an algorithm or AI. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used (Test Set)

The ground truth used for the test set is based on:

• Established Industry Standards: ASTM standard D 5250-06 e1 and D6124-06 for physical properties, dimensions, and powder amount.
• Regulatory Standards: 21 CFR 800.20 for freedom from pinholes.
• International Biological Evaluation Standards: AAMI / ANSI / ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

These standards define the objective pass/fail criteria.

8. Sample Size for the Training Set

Not applicable. The device is a physical product (a glove), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is likely subject to quality control and statistical process control, but this is distinct from an AI training set.

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

Not applicable for the same reasons as #8. There is no training set for this type of device.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided information regarding the device's acceptance criteria and the study demonstrating its compliance:

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 the various characteristics. However, for the biocompatibility tests:

• Primary Skin Irritation: "rabbits" (plural, but exact number not specified).
• Dermal Sensitization: "guinea pig" (singular or plural, but exact number not specified).

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to the type of device and testing described. The "ground truth" for glove performance refers to meeting established engineering and biological standards, not expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set:

Not applicable. The testing involves objective measurements against established standards, not interpretation that would require adjudication.

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

No MRMC study was done, nor is it applicable to this type of medical device. This device is an examination glove, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth for the device's performance is based on established industry standards and regulatory requirements:

• ASTM standard D 5250-06 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, referred to generally in the nonclinical discussion)

8. Sample Size for the Training Set:

Not applicable. There is no mention or indication of a "training set" as this is not an AI/ML device. The testing described is for a manufactured product against specified performance standards.

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

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

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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

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 size used for the test set for each characteristic. It broadly states that the device "meets" the requirements, implying testing was performed to the standards. The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing, specifically Suzhou Shengyuda Plastic Products Co.,Ltd. The studies were nonclinical.

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 this device (patient examination gloves) does not involve human interpretation or subjective assessment by experts. The ground truth is established by objective physical and chemical testing against established industry standards and regulations.

4. Adjudication method for the test set

This information is not applicable as there is no subjective assessment or multiple interpretations requiring adjudication. Performance is determined by objective measurements against defined pass/fail criteria in the 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 information is not applicable. The device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI are irrelevant.

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

This information is not applicable. The device is a medical glove, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for this device's performance assessment is based on established industry standards and regulations. These include:

• ASTM standard D 5250-06 e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM D6124-06 (for powder amount)
• AAMI / ANSI / ISO 10993-10:2002 (for biocompatibility regarding primary skin irritation and dermal sensitization)

These standards define objective and measurable criteria for product performance.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical gloves), not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document is a 510(k) Premarket Notification summary for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed by your questions:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a medical device (patient examination gloves) that is subject to performance standards rather than requiring complex algorithmic analysis or human reader studies. Therefore, most of your requested points regarding AI/algorithm performance, ground truth establishment, and expert involvement are not applicable to this type of device and submission.

The "acceptance criteria" here refer to the performance requirements outlined in recognized standards (like ASTM and FDA regulations) for patient examination gloves. The "study" proving the device meets these criteria refers to non-clinical testing performed by the manufacturer.

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

Note: The powder amount in the "Device performance" column for "Biocompatibility" appears to be misplaced from "Powder Amount." I've corrected this in the table above based on the text. The Powder Amount test would yield a specific level, and the <10mg/dm² is under the biocompatibility section which is unusual. However, the document states "Powder Amount Meets" and then lists "<10mg/dm2" under the device performance for biocompatibility. I've attempted to align it to what seems most logical based on common glove testing.

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

The document explicitly states that "Clinical data is not needed for gloves or for most devices cleared by the 510(k) process."

Therefore, there is no "test set" in the context of clinical data or patient data. The tests performed are non-clinical, laboratory tests on the gloves themselves. The sample sizes for these specific non-clinical tests (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility testing on animals) are not provided in this summary.

Data provenance: Not applicable in the sense of country of origin for patient data or retrospective/prospective studies, as no human or patient data was used. The data comes from internal laboratory testing conducted by the manufacturer (Hebei Handform Plastic Products Co.,Ltd. in China) or a contracted lab.

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

Not applicable. There is no "test set" requiring ground truth established by experts in the context of this device and submission type. The ground truth is established by objective measurements against recognized industry standards (ASTM) and regulatory requirements (21 CFR).

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

Not applicable. No expert adjudication was required or performed for this type of non-clinical testing.

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) and does not involve AI or human readers.

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

Not applicable. This device is a physical product and does not involve an algorithm.

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

The "ground truth" for the performance claims relies on objective measurements against established, recognized industry standards (ASTM D 5250-06, ASTM D6124-01) and FDA regulations (21 CFR 800.20) for glove characteristics, as well as biocompatibility testing according to standards like ISO10993-10.

8. The sample size for the training set

Not applicable. There is no algorithm or model that requires a training set for this device.

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

Not applicable. There is no algorithm or model that requires a training set for this device.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not specify the exact sample size used for each test. Instead, it states that the device "meets" the requirements of the specified ASTM standards and FDA regulations. These standards typically define the sampling plans and acceptable quality levels (AQLs) for testing.

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but the submitting company is based in China. The study appears to be retrospective in the sense that the results are reported as meeting established standards rather than detailing a specific prospective clinical trial.

3. Number of Experts and their Qualifications for Establishing Ground Truth for the Test Set

This type of device (patient examination gloves) does not typically involve human experts to establish ground truth in the way a diagnostic imaging AI would. The ground truth for these tests is defined by the objective physical and chemical standards themselves (e.g., tensile strength, tear resistance, water leak rates, irritation levels). The "experts" in this context would be the technicians and scientists performing the standardized tests according to the protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations of data, particularly in medical imaging or clinical diagnoses where multiple experts might disagree. For objective physical and chemical tests, the results are typically directly measurable and compared against predefined thresholds in the standards.

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

No. This is a medical device for patient examination, not a diagnostic AI system that assists human readers in interpreting medical data. Therefore, an MRMC comparative effectiveness study is not applicable.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission focuses on the standalone performance of the gloves against established standards (ASTM D5250-004, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10). These are objective tests of the device itself, without human interpretation in the loop beyond ensuring the tests are conducted correctly.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily objective physical and chemical standards, including:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (water leak test on pinhole AQL).
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization tests).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, not algorithmic training data.

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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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI/ML medical device. Therefore, many of the requested categories (such as AI-specific study details, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document.

The document outlines the acceptance criteria and the "device performance" in terms of meeting established standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/ML algorithm. The performance evaluation is based on meeting industry standards and regulations for medical gloves. The tests for these characteristics are typically performed on representative samples from manufacturing batches. The document does not provide details on the sample sizes for these tests or their provenance (country of origin, retrospective/prospective).

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

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements. For a medical glove, "ground truth" is established by adherence to physical, chemical, and biological performance standards defined by regulatory bodies and consensus organizations (e.g., ASTM, FDA). There is no mention of experts establishing a "ground truth" for a test set in the way it would be done for an AI/ML diagnostic device.

4. Adjudication method for the test set

Not applicable. There is no "test set" requiring adjudication in the context of an AI/ML algorithm. The evaluations are direct 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. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM standard D 5250-00e4 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

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

Not applicable. This is not an AI/ML device.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004

Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. The document refers to meeting standards without detailing the number of units tested for each characteristic.
• Data Provenance: Not explicitly stated. The studies are described as "nonclinical" and likely conducted in a laboratory setting, but the country of origin of the data is not specified. It's implicitly from the manufacturer, JIANGSU CUREGUARD GLOVE CO., LTD.

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 for this device is based on objective measurements against established industry standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among experts. Here, the tests involve objective measurements against predefined limits.

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 medical 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 device is not an algorithm or AI system.

7. The type of ground truth used:

• The ground truth used is based on objective measurements conforming to recognized standards (e.g., ASTM standard D 5250-00d for dimensions, physical properties, and powder amount; 21 CFR 800.20 for freedom from pinholes; ISO10993-10 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The assessment is based on physical and biological testing against established specifications.

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

• Not applicable, as there is no training set involved for this type of device. The "ground truth" for ensuring compliance is established by the referenced standards themselves and the methods described within those standards for testing.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00"4.

The provided text describes the acceptance criteria and performance of a medical device, specifically Powdered Vinyl Patient Examination Gloves, Clear (Non-colored). It relies on non-clinical testing rather than clinical studies involving human patients or complex algorithms.

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 specify sample sizes for the tests performed (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility).

The data provenance is from non-clinical tests performed by the manufacturer (Tangshan Luxiong Plastic Products Co.,Ltd) to ensure compliance with established standards (ASTM, CFR, ISO). It is retrospective in the sense that the tests were performed on the manufactured product to demonstrate its characteristics.

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

This question is not applicable in the context of this device. The "ground truth" for these performance criteria is established by objective engineering and biocompatibility standards (ASTM, CFR, ISO), not by expert human interpretation. The outcomes are binary (pass/fail) or quantitative measurements compared against predefined thresholds.

4. Adjudication Method for the Test Set

Not applicable. As described above, the assessments are based on objective measurement against established standards, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that human readers interpret. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established objective laboratory test methods and standardized metrics as defined by:

• ASTM standard D 5250-00e4 (for dimensions, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO10993-10 (for biocompatibility testing - primary skin irritation and dermal sensitization)

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms.

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

Not applicable. As there is no training set, this question is not relevant.

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