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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 an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)":

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 size used for the test set for any of the performance characteristics. It refers to compliance with standards (ASTM D 5250-06, 21 CFR 800.20, D6124-06, and ISO10993-10), which would detail the required sample sizes for testing.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that the manufacturer is "Hebei Hongtai Plastic Products Co.,Ltd." in China, it is highly probable the testing was conducted in China. The testing appears to be prospective, as it's to demonstrate compliance of the manufactured device.

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

This information is not provided in the document. The standards mentioned define the test methodologies, but not the specific experts involved in evaluating the results or their qualifications. For device performance like glove characteristics, "ground truth" is typically established by the results of standardized physical and chemical tests, rather than expert consensus on subjective evaluations. For biocompatibility, the interpretation of the animal study results would be done by qualified toxicologists or pathologists, but the text doesn't specify who performed this interpretation or how many.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (mechanical, chemical, and animal biocompatibility), an adjudication method in the sense of multiple human readers or subjective evaluations is generally not applicable. The results are typically objectively measured against defined pass/fail criteria within the standards.

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 relevant for diagnostic imaging or subjective interpretation tasks involving human readers, which is not applicable to patient examination gloves.

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

N/A. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of a "standalone" algorithm performance does not apply.

7. Type of Ground Truth Used:

The ground truth used is primarily compliance with established industry standards and regulations. Specifically:

• Mechanical and Physical Properties: Defined specifications within ASTM standard D 5250-06 (e.g., tensile strength, elongation, dimensions).
• Freedom from Pinhole: Defined acceptance quality limits (AQL) in 21 CFR 800.20 (Waterleak test).
• Powder Residual: Defined limits and test methods in ASTM standard D 5250-06 and D6124-06.
• Biocompatibility: Results of animal studies (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) interpreted against established toxicological criteria, likely guided by ISO 10993-10. The "ground truth" here is the biological response observed and its classification as "Passes" or "Fails" based on established toxicological guidelines.

8. Sample Size for the Training Set:

N/A. This device is a physical product and not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The "training" for such devices involves setting up manufacturing processes to consistently meet specifications.

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

N/A. As mentioned above, there is no training set for this type of device. The ground truth for manufacturing and quality control would be the same as the acceptance criteria for the final product: adherence to ASTM standards, CFR regulations, and ISO guidelines.

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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.

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of an AI/ML powered device. The information requested (acceptance criteria, specific study details for AI/ML, sample sizes for training/test sets, expert adjudication methods, MRMC studies, etc.) is typically associated with AI/ML device submissions, which are significantly different in scope and requirements from a Class I glove submission.

Therefore, the requested information, which is primarily relevant to AI/ML powered devices, is not applicable and not available in this submission for the following reasons:

• Device Type: The device is a "Powder Free Vinyl Patient Examination Glove," a physical, low-risk medical device. It does not involve any imaging, diagnostic algorithms, or AI/Machine Learning components.
• Regulatory Pathway: This is a 510(k) submission for a Class I device, which relies heavily on demonstrating conformance to established standards (like ASTM) and substantial equivalence to a legally marketed predicate device. The detailed performance studies typical for AI/ML devices, especially those requiring complex ground truth establishment and human-in-the-loop assessments, are not required for this type of device.
• Nature of "Performance": For gloves, "performance" relates to physical properties, freedom from defects (like pinholes), and biocompatibility, as opposed to diagnostic accuracy or clinical decision support.

However, I can extract the acceptance criteria and the device performance as reported in the summary for the glove, which is the closest equivalent to your request within the provided text.

Here is the information based on the provided K102817 document, adapted to the context of a medical glove:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program where the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" were evaluated against the specific requirements of the listed ASTM standards, 21 CFR 800.20, and ISO10993-10 for biocompatibility. The summary states that the device "meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This indicates that tests were conducted according to these standards, and the device's measured properties (dimensions, physical properties, pinhole freedom, powder residual, skin irritation, dermal sensitization) fell within the acceptable limits defined by those standards.

The following questions are not applicable (N/A) to this device submission, as it is for a physical medical glove and not an AI/ML-powered diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: N/A (No test set in the context of AI/ML data; testing based on glove samples and standard methods).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is defined by physical/chemical measurements against standards, not expert consensus on data).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (No expert adjudication involved for physical glove 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: N/A (No AI, no readers involved).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" or reference is defined by established international and national standards (ASTM, FDA regulations for pinholes, ISO for biocompatibility). These standards specify acceptable ranges or outcomes for physical and chemical properties.
8. The sample size for the training set: N/A (No training set for an AI/ML model).
9. How the ground truth for the training set was established: N/A (No training set for an AI/ML model).

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