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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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Powder Free 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.

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

This document describes the acceptance criteria and study for "Powder Free 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 the data provenance:

The document does not explicitly state the exact sample sizes used for each test. However, it indicates compliance with ASTM and ISO standards, which typically specify sample sizes for such tests.
The data provenance is from the manufacturer, PPP Medical and Safety Products Company Limited, located in Wuxi, Jiangsu, China. The studies appear to be retrospective, as they are part of a 510(k) submission for a device already manufactured and tested.

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

This information is not provided in the document. The standards themselves (ASTM, ISO, CFR) establish the methodologies and criteria for testing, and compliance is determined by laboratory results, not expert consensus on ground truth in a clinical sense.

4. Adjudication method for the test set:

Not applicable. The tests are based on objective measurements against predefined standards and regulations (e.g., ASTM standards for physical properties, 21 CFR for freedom from pinholes, AAMI/ANSI/ISO for biocompatibility). There is no mention of a human adjudication process beyond standard laboratory testing and reporting.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical glove, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving AI assistance for human readers are irrelevant to this product.

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

Not applicable. This is a physical medical device (gloves), not an algorithm or software. Its performance is evaluated through material and biological testing, not algorithmic performance.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by the specified industry and regulatory standards. For example:

• Dimension and Physical Properties: The ground truth is defined by the measurable specifications outlined in ASTM standard D 5250-06 e1.
• Freedom from pinholes: The ground truth is the pass/fail criteria defined in 21 CFR 800.20 for water leak tests.
• Powder Residual: The ground truth is the quantitative limit specified in ASTM standard D 5250-06 e1 and D6124-06 (<2mg/glove).
• Biocompatibility: The ground truth is the absence of primary skin irritation or dermal sensitization as determined by the methodologies in AAMI / ANSI / ISO 10993-10 in animal models.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models. Its manufacturing process is subject to quality control, but not a data-driven training process.

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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Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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 Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Light Yellow Color." This is a Class I medical device, and the study described is a non-clinical assessment against established standards, not a study of an AI-powered device. Therefore, many of the requested fields related to AI, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "adjudication method," are not applicable.

Here's the information extracted from the document:

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 a distinct "test set" sample size in the context of a typical AI/software study. Instead, it refers to compliance with established standards (ASTM, CFR, ISO) which define their own sampling methods for quality control testing of physical products. The data provenance is implied to be from the manufacturer's own testing procedures to demonstrate compliance with these standards. There is no mention of country of origin of data (beyond the manufacturer's location in China) or whether it was retrospective or prospective in the sense of a medical study.

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

Not applicable. The "ground truth" for this device is compliance with established physical and biological standards, determined through laboratory testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of results requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The ground truth used is defined by established regulatory and industry standards for patient examination gloves, including:

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

8. The Sample Size for the Training Set

Not applicable. This is a physical product and not an AI/machine learning device that requires a training set.

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

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

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