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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, Light Yellow Color 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes a 510(k) summary for "Powdered Vinyl Patient Examination Gloves, Light Yellow Color." This is a medical device that falls under the category of general hospital devices, specifically patient examination gloves.

The text does not describe an AI/ML powered device, nor does it involve any studies related to human readers, AI assistance, or complex diagnostic tasks. The "acceptance criteria" and "study" described in the document are for basic physical, chemical, and biological properties of the gloves, not for an AI algorithm.

Therefore, I cannot extract the information required for the requested table and parameters related to an AI/ML device. The document pertains to a much simpler Class I medical device.

Here's a breakdown of why this document doesn't fit the request and what information can be extracted:

• No AI/ML Component: The device is a physical product (gloves), not a software or AI-driven system.
• No "Ground Truth" for AI: Concepts like expert consensus, pathology, or outcomes data as "ground truth" are irrelevant for examination gloves.
• No "Readers" or "Adjudication": There are no human readers or AI algorithms being evaluated in a diagnostic context.
• No "Sample Size for Test/Training Set" in AI Sense: The phrase "sample size" in this document refers to the quantity of gloves tested for physical properties (e.g., freedom from pinholes), not data points for an AI model.
• No "Effect Size of Human Readers Improve with AI": This is completely unrelated to the device described.

What can be extracted related to "acceptance criteria" from the provided text for this specific device:

The "acceptance criteria" are essentially the relevant ASTM standards and FDA regulations that the gloves must meet. The "device performance" is stated as "Meets" for all these criteria.

Table of Acceptance Criteria and Reported Device Performance (as per the document):

Regarding the other requested information (which is not applicable to this device type):

• Sample sized used for the test set and the data provenance: The document indicates that the product "meets" various ASTM standards and CFR regulations. These standards define the sampling plans for testing. For example, ASTM D5250 specifies various testing methods and sampling requirements (e.g., for physical properties, freedom from holes). However, the specific sample sizes used in this particular submission's tests are not detailed in the summary, only that the product met the standards. The data provenance is implied to be from the manufacturer's internal testing as part of their quality control and submission process, likely conducted in China (based on the manufacturer's location).
• Number of experts used to establish the ground truth...: Not applicable. Ground truth for a glove is its physical properties, not expert interpretation.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For gloves, the "ground truth" is defined by the objective measurements and tests prescribed by the relevant ASTM standards and FDA regulations (e.g., tensile strength, elongation, barrier integrity, protein content, powder amount).
• The sample size for the training set: Not applicable as there is no "training set" for an AI model.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a traditional medical device (patient examination gloves) and its regulatory compliance, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device evaluation criteria cannot be answered from this document.

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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 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 describes the acceptance criteria and the study results for the Hebei Tengda Plastic Co., Ltd. Powdered Vinyl Patient Examination Gloves, Clear (Non-colored).

1. Table of Acceptance Criteria & 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 of the tests (Dimension, Physical Properties, Freedom from pinholes, Powder Amount, Biocompatibility). However, it indicates compliance with recognized standards (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which inherently define the testing methodologies and sample sizes required for compliance.

The data provenance is from nonclinical studies conducted to demonstrate substantial equivalence. The document does not specify the country of origin where these tests were performed, but it is submitted by a Chinese manufacturer (Hebei Tengda Plastic Co., Ltd.) to the US FDA. The studies would be considered retrospective in the context of this 510(k) submission, as they were conducted prior to the submission to demonstrate compliance.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in the way medical imaging or diagnostic AI devices do. The "ground truth" for the performance criteria is established by the well-defined and objective metrics within the ASTM and FDA standards. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable in this context.

4. Adjudication Method for Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical image reading) to resolve disagreements among experts. Since the tests for glove performance are objective and based on measurable physical and chemical properties, an adjudication method is not applicable. The results are directly compared against the quantitative thresholds defined by the standards.

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

No MRMC study was conducted or is applicable for this device. This device is a physical medical device (gloves), not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only)

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

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM standard D 5250-06 (for Dimension, Physical Properties, Powder Amount)
• 21 CFR 800.20 (for Freedom from pinholes)
• ISO10993-10 (for Biocompatibility testing, although not explicitly listed in the performance table, it's mentioned as a standard met)

These standards define objective and measurable criteria that the device must meet.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical 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 a breakdown of the acceptance criteria and study information for K101664, based on the provided text:

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

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 (e.g., number of gloves tested for pinholes or dimensions). It only states that the device "Meets" the specified standards.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for a Class I device like examination gloves, where performance standards are well-established.

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

This information is not applicable to this submission. For examination gloves, the "ground truth" is typically defined by adherence to published ASTM and FDA standards, which involve objective measurements and tests rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is subjective interpretation of data (e.g., medical imaging) which necessitates a consensus among experts. For objective measurements of glove properties, such a method is not relevant.

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 physical product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study is irrelevant.

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

This information is not applicable. As mentioned, this is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established objective standards and test methods. Specifically:

• ASTM D 5250-06': Standard specification for vinyl examination gloves for medical application, covering dimensions, physical properties, and powder amount.
• 21 CFR 800.20: FDA regulation for freedom from pinholes (water leak test).
• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm. The manufacturing process for gloves involves quality control checks, but this is distinct from an AI training set.

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

This information is not applicable. As this is not an AI device, there is no "training set" in the AI context, and thus no ground truth to be established for it. The product's compliance is directly assessed against the outlined standards.

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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 text, outlining the acceptance criteria and study details for the Shijiazhuang Star Plastic Powdered Vinyl Patient Examination Gloves:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (Dimension, Physical Properties, Freedom from pinholes, Powder Amount). For Biocompatibility, it mentions "rabbits" and "guinea pig" as test subjects, implying a small animal study; specific numbers are not given. The studies are non-clinical, meaning they were conducted in a lab setting, not with human subjects. Data provenance is not specified beyond being part of the manufacturer's evaluation.

2. 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 these device performance tests (e.g., dimensions, physical properties, pinholes) is established by adherence to recognized ASTM standards and FDA regulations, not by expert consensus on individual cases. For biocompatibility, the ground truth is determined by standard toxicological testing protocols, not expert consensus in the human sense.

3. Adjudication method for the test set: Not applicable for these types of objective device performance tests that rely on adherence to established standards and measurement protocols.

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 a patient examination glove, not an AI-powered diagnostic or assistive medical imaging device.

5. 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 algorithm.

6. The type of ground truth used:

   • For Dimension, Physical Properties, and Powder Amount: Adherence to ASTM standard D 5250-06.
   • For Freedom from pinholes: Adherence to 21 CFR 800.20.
   • For Biocompatibility: Results from standard animal primary skin irritation and dermal sensitization tests (likely following ISO10993-10 guidelines, as referenced).

7. The sample size for the training set: Not applicable. This device is a physical product, not a machine learning model that requires a training set. The performance is based on manufacturing processes and material science, validated against established standards.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for a physical device. The "ground truth" for manufacturing is the adherence to design specifications and quality control procedures that ensure the product meets the cited standards.

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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 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.

The provided text describes the acceptance criteria and performance of "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It does not pertain to an AI/ML device or software. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted relevant to the prompt, acknowledging the nature of the device:

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

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

The document does not specify exact sample sizes for each test. It refers to adherence to standards like "ASTM standard D 5250-06" and "21 CFR 800.20," which define testing methodologies and sample sizes. The biocompatibility tests were likely prospective studies in animals (rabbits and guinea pigs), as is standard for these tests. The country of origin for the data is not explicitly stated beyond the manufacturing location in China.

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

Not applicable. This device is a physical medical glove and does not involve AI/ML interpretation of data requiring expert ground truth for classification. Performance is determined by objective physical and chemical testing against established standards.

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

Not applicable. Adjudication methods are relevant for subjective assessments, particularly in medical image analysis or similar fields. This device's performance is measured objectively against 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.

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 (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by objective measurements against predefined scientific and regulatory standards. For example:

• Dimensional accuracy: Measured directly against specifications in ASTM D 5250-06.
• Freedom from pinholes: Determined by water leak tests as specified in 21 CFR 800.20.
• Powder amount: Measured gravimetrically against limits in ASTM D 5250-06.
• Biocompatibility: Determined by observing physiological responses in animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to ISO10993-10.
  These are all objective measurements, not subjective expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of how the device meets acceptance criteria:

The device, "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)," demonstrates it meets acceptance criteria by successfully conforming to established industry and regulatory standards. The study summary indicates that the gloves were tested according to:

• ASTM standard D 5250-06 for characteristics such as Dimension, Physical Properties, and Powder Amount.
• 21 CFR 800.20 for Freedom from pinholes (water leak test).
• ISO10993-10 for Biocompatibility, including Primary Skin Irritation (tested in rabbits) and Dermal Sensitization (tested in guinea pigs).

For all listed characteristics, the "Device performance" is explicitly stated as "Meets" or "Passes," indicating compliance with the respective standards and criteria. The conclusion is drawn that the gloves "meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims," thus demonstrating safety and effectiveness comparable to legally marketed predicate devices.

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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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