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Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and related study information for the device described in the provided 510(k) summary:

This device is a Powder free Vinyl Patient Examination Glove. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which primarily involves meeting recognized standards for physical properties, safety, and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized ASTM standards and FDA regulations for patient examination gloves. The reported device performance states that the device "Meets" these standards.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for testing each characteristic (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It simply states that the device "Meets" the standards.
• Data Provenance: The tests are implied to be conducted by the manufacturer, TANGSHAN KANGJIA GLOVE CO., LTD., which is based in China. The data could be considered internal manufacturer data from China. Whether it's retrospective or prospective is not explicitly stated, but typically these types of tests are conducted prospectively as part of product development and quality control.

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

This type of device (patient examination glove) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" here is defined by objective, measurable criteria specified in ASTM standards and FDA regulations (e.g., a pinhole is present or not, tensile strength is within a range). Therefore, no "experts" in the clinical sense are used to establish ground truth for this device's performance. The "experts" might be the technicians and engineers who perform the standardized tests.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are not applicable to the testing of patient examination gloves. The tests involve objective measurements and pass/fail criteria based on established standards, rather than subjective interpretations that would require multiple reviewers and adjudication.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. For a patient examination glove, there is no "reading" involved, and therefore, such a study is not applicable.

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

Yes, in a conceptual sense, a "standalone" assessment was done. The device's performance characteristics (dimension, physical properties, freedom from pinholes, powder residual, biocompatibility) were evaluated directly against the established standards without human intervention in the interpretation of the results beyond performing the standardized test. There is no algorithm, but its physical qualities were tested independently.

7. The Type of Ground Truth Used

The ground truth used is primarily objective, measurable criteria defined by recognized standards (ASTM) and regulatory requirements (21 CFR). For example:

• Dimensions: Measured against specified ranges in ASTM D 5250-06.
• Physical Properties: Measured against specified tensile strength, elongation, and other properties in ASTM D 5250-06.
• Freedom from Pinhole: Assessed via water leak test against AQL (Acceptable Quality Level) in 21 CFR 800.20.
• Powder Residual: Measured gravimetrically against the threshold of <2mg/glove.
• Biocompatibility: Assessed through standardized animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) to determine if irritation or sensitization occurs, according to ISO10993-10 guidelines.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product, and its manufacturing and quality control do not typically involve data-driven model training.

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

As there is no training set for this device in the AI/ML sense, the question of how its ground truth was established is not applicable.

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Powder free 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.

Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow).

It's important to note that this document is for a Class I medical device (patient examination gloves). For devices of this classification, the regulatory requirements are generally less stringent compared to higher-risk devices, and often the "studies" primarily involve adherence to recognized standards rather than complex clinical trials or AI performance evaluations.

Here is the requested information:

1. 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 explicitly state specific sample sizes for each test in the acceptance criteria table. However, it references ASTM standard D 5250-06, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10. These standards typically specify the appropriate sampling plans and methodologies for testing.

• Data Provenance: The document does not specify the country of origin of the data. It's likely that the testing was conducted by the manufacturer (Tangshan Kangyuan Glove Co., Ltd. in China) or a contracted lab. The testing for a device of this nature is generally retrospective in the sense that batches of manufactured gloves are sampled and tested according to the standards.

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

The concept of "ground truth established by experts" is not directly applicable in the context of testing these types of medical gloves. The performance of these gloves is assessed against objective physical and chemical standards rather than subjective expert interpretation.

• Experts: N/A for establishing "ground truth" as it's typically understood in AI/clinical studies. The "experts" in this context would be the technicians and scientists performing the standard-based tests and interpreting the results according to the specified criteria. Their qualifications would be in laboratory testing, materials science, or related fields, with expertise in executing the cited ASTM, CFR, and ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where subjective interpretations (e.g., image readings) need consensus. For objective physical and chemical tests on gloves, the results are typically quantitative or directly pass/fail according to the standard, not requiring adjudication.

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, particularly those involving human interpretation (e.g., radiology AI), to evaluate how AI assistance impacts reader performance. It is not applicable to patient examination gloves.

• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical product (gloves), not an AI algorithm. Therefore, the concept of algorithm-only performance does not apply.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements and assessments against established industry standards and regulations. This includes:

• ASTM D 5250-06: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves. This standard dictates physical properties, dimensions, and other performance characteristics.
• 21 CFR 800.20: FDA regulation concerning the water leak test (freedom from pinholes) for medical gloves.
• ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• 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

Not applicable. "Training set" refers to data used to train an AI model. This device is not an AI algorithm or software and therefore does not have a training set.

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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Powder free 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.

powder free 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 based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance

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

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

• Sample Size: Not explicitly stated for each test, but the device was tested against the requirements of ASTM standard D 5250-06, ASTM standard D6124-01, 21 CFR 800.20, and ISO10993-10. These standards would specify their own sampling plans.
• Data Provenance: Not explicitly stated, but given the manufacturer's location (Tangshan, China), the testing was likely conducted in China or by a certified laboratory supporting the Chinese manufacturer. The data is retrospective as it was conducted to demonstrate substantial equivalence for premarket notification.

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

• Number of Experts: Not applicable. The ground truth for this device (patient examination gloves) is established through standardized physical, chemical, and biological testing as per the listed ASTM and FDA regulations, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable as per the above.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. The "ground truth" for this device is based on quantifiable measurements against pre-defined thresholds in industry standards and regulations, rather than subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a disposable medical glove, and its performance is evaluated through physical, chemical, and biological testing, not through human reader interpretation or AI assistance.

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

• Standalone Performance: Not applicable. This device is a physical medical product (gloves), not an algorithm or an AI-powered system. Its performance is inherent to its material properties and manufacturing.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this device is based on standardized measurements and testing results against established criteria outlined in:
  • ASTM standard D 5250-06 (for dimensions and physical properties)
  • ASTM standard D6124-01 (for powder residual)
  • 21 CFR 800.20 (for freedom from pinholes/waterleak test AQL)
  • ISO10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization).

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable for this type of device. There isn't a "training set" in the context of data-driven machine learning for a physical product like a glove. The testing performed is to ensure the product meets specifications.

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

• Ground Truth (Training Set): Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish in that context. The "ground truth" for the device's characteristics is defined by the technical specifications and performance limits set forth in the referenced ASTM standards and FDA regulations.

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