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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) Summary for a medical device, "Disposable Vinyl Nitrile Synthetic Gloves Powder Free" (K211516). This document details the device's characteristics and its equivalence to a predicate device, as submitted to the FDA.

Based on the nature of the device (disposable patient examination gloves) and the content of the summary, the "device" in question is not an AI/ML-driven diagnostic or assistive technology. Instead, it is a physical medical device. Therefore, the questions related to AI/ML device performance metrics (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size, etc.) are not applicable to this document.

The acceptance criteria and performance are related to the physical properties, safety, and regulatory compliance of the gloves.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and how it meets them:

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

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Powder-Free Yellow Vinyl Patient Examination Gloves 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.

Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text is a 510(k) summary for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria simply do not apply to this document, as it concerns a medical glove and not an AI/ML device.

However, I can extract the relevant information from the document that is analogous to "acceptance criteria" and "reported device performance" for this specific product, a patient examination glove.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves are defined by their conformance to specific ASTM standards and FDA regulations. The "reported device performance" is the statement that the device meets these standards.

The study proving the device meets these criteria is an internal non-clinical testing program conducted by the manufacturer, Tangshan Hongyun Plastic Products Co.,ltd, to ensure compliance with the referenced ASTM standards and ISO standard for biocompatibility.

Regarding the requested information for AI/ML devices (which are not applicable to this document):

2. Sample size for the test set and data provenance: Not applicable. The "test set" here refers to samples of gloves tested according to ASTM standards. The document does not specify exact sample sizes for each test, but rather refers to conformance with standards which typically define sampling plans. The data provenance is internal testing by the manufacturer in China.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical product like a glove is established by standardized measurement methods defined in ASTM standards, not by expert consensus in the way an AI algorithm's output might be.
4. Adjudication method for the test set: Not applicable. Testing for physical properties follows specific protocols defined by the ASTM and ISO standards.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant for a medical glove.
6. Standalone (algorithm only) performance study: Not applicable. This device is not an algorithm.
7. Type of ground truth used: For physical properties, the "ground truth" is the quantitative measurement obtained through standardized tests (e.g., length in mm, thickness in mm, tensile strength in MPa, AQL for pinholes, residual powder in mg/glove, biological response for biocompatibility).
8. Sample size for the training set: Not applicable. This concept is for AI/ML models. For manufacturing, there are quality control processes, but not a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (gloves), not an AI/ML device. Therefore, most of the questions relating to AI/ML study design are not addressed. The "acceptance criteria" are the established ASTM and ISO standards, and the "study" is the non-clinical testing performed by the manufacturer to demonstrate compliance with these standards.

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Powder-Free 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.

Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The document provided is a 510(k) Premarket Notification Summary for Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored). This type of device is classified as a Class I medical device, which means it is subject to general controls and does not typically require extensive clinical data for market clearance. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

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

Device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)

Predicate Device: Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established industry standards, specifically ASTM standards for medical examination gloves. The device's performance is compared against these standards and to the predicate device.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it refers to compliance with ASTM standards (e.g., D5250, D5151, D6124), which inherently define the statistical sampling plans and methodologies for testing.

• Data Provenance: The tests for the subject device were likely conducted by or for Tangshan Hongyun Plastic Products Co., Ltd. in China, as indicated by the submitter's address. The data is retrospective in the sense that the testing was performed on the manufactured devices to demonstrate compliance with standards and equivalence to the predicate.

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

For this type of device (medical examination gloves), the "ground truth" is established by conformity to recognized international and national standards (e.g., ASTM, ISO, 21 CFR) rather than expert consensus on interpretive tasks. Therefore:

• Number of Experts: Not applicable in the sense of medical diagnosticians establishing interpretations. The "expertise" lies in the development and validation of the ASTM and ISO standards themselves, and the accreditation of testing laboratories that perform these physical and chemical evaluations.
• Qualifications of Experts: The experts involved would be those who develop and interpret the ASTM and ISO standards, and the qualified personnel in
  testing laboratories (e.g., chemists, material scientists, quality engineers) who perform the required tests according to those standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve disagreements among experts. This is not applicable here because the acceptance criteria are based on objective physical and chemical measurements against pre-defined, quantitative standards. The "adjudication" is inherent in the test method specified by the ASTM/ISO standard; if a test result falls outside the specified range, the sample (or batch) fails.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation of diagnostic images or data (e.g., CAD systems for mammography). This device (examination gloves) does not involve human readers or case interpretation in a diagnostic context. Its effectiveness is based on its physical barrier properties and biocompatibility.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device. A standalone study typically refers to the performance of an AI algorithm operating independently without human intervention. The device in question is a physical medical device (gloves) and does not involve any AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" for these gloves is defined by:

• Objective Measurement against Standards: The physical and performance characteristics (e.g., dimensions, tensile strength, elongation, freedom from pinholes, residual powder) are compared against the quantitative specifications outlined in ASTM D5250-06, ASTM D5151-06, and ASTM D6124-06.
• Biocompatibility Testing: The "ground truth" for biocompatibility (irritation and sensitization) is established through ISO 10993-10 compliant tests. The outcome of these tests determines if the material is deemed non-irritant and non-sensitizer according to established biological safety criteria.

8. The Sample Size for the Training Set

This question is not applicable. Since the device is a physical medical product and not an AI/ML algorithm or a diagnostic tool, there is no "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMP), and quality control tests (like those mentioned in ASTM standards) are performed on batches of products.

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

This question is not applicable because, as stated above, 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 5250-0084.

1. Acceptance Criteria and Reported Device Performance

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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 5250-00ed.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device