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Powder Free Vinyl Patient Examination Gloves, Colored (White) 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 (White) 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 (White)".

This product is a medical device (patient examination gloves), which falls under a different regulatory and testing paradigm than AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test/training sets, adjudication methods, MRMC studies, and ground truth for AI) are not applicable.

However, I will provide the information based on the provided text, indicating "Not Applicable" where appropriate for an AI/SaMD context.

Acceptance Criteria and Study for "Powder Free Vinyl Patient Examination Gloves, Colored (White)"

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

• Sample Size: Not explicitly stated as this is a physical product test. The standards (ASTM, CFR) define sampling plans for lot release and quality control, but specific sample sizes for this submission are not provided.
• Data Provenance: The device meets ASTM standards and CFR regulations, implying internal testing by the manufacturer (TANGSHAN ZHONGPU PLASTIC PRODUCTS CO.,LTD. in China) and verified through accredited testing processes. The studies are non-clinical (laboratory/physical testing, biocompatibility studies).

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

• Not Applicable. This is a physical product (gloves) for which "ground truth" in the AI/SaMD sense is not relevant. Performance is determined by objective measurements against established engineering and biocompatibility standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication is not relevant for objective physical and chemical properties testing. Results are typically pass/fail or quantitative measurements against specified limits.

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/SaMD device.

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

• Not Applicable. This is not an AI/SaMD device.

7. The type of ground truth used

• Established Standards and Objective Measurements: The "ground truth" for this device's performance is defined by the requirements of recognized standards such as:
  • ASTM standard D 5250-06 (for dimensions, physical properties, powder residual)
  • 21 CFR 800.20 (for freedom from pinholes)
  • ASTM D 6124-06 (for powder residual)
  • ISO 10993-10 (for biocompatibility testing methodology, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

• Not Applicable. This is not an AI/SaMD device, so there is no "training set."

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

• Not Applicable. This is not an AI/SaMD 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, 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):

Acceptance Criteria and Device Performance Study

The information provided describes the non-clinical testing performed to establish substantial equivalence 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 exact sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility studies).

• Test Set Sample Size: Not explicitly stated. The standards (ASTM D5250-06, 21 CFR 800.20, D6124-06, ISO 10993-10) define statistical sampling plans, but the specific number of units tested in this submission is not provided in the summary.
• Data Provenance: The studies are non-clinical, likely performed by the manufacturer or a contract research organization (CRO) in China, given the submitter's address. The data is retrospective in the sense that the testing was performed, and the results are being submitted for regulatory review.

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

This type of information is generally not applicable to the non-clinical testing of patient examination gloves. The "ground truth" is established by adherence to standardized testing protocols and measurement methodologies defined by the cited ASTM and CFR standards, not by expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly when interpreting subjective outputs like medical images. For the non-clinical tests described for these gloves, the results are objective measurements (e.g., pass/fail for pinholes, numerical values for powder residual, observed biological reactions) and do not involve an adjudication process. The determination of "meets" or "passes" is based on comparing the measured outcome to the predefined threshold in the standard.

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 relevant for devices involving interpretation by multiple human readers (e.g., radiologists, pathologists) and assessing the impact of a device (like AI) on their performance. This device is a disposable medical glove, and its performance is evaluated through standardized physical and biological testing, not by human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical medical product (a glove), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by the objective performance criteria specified in the referenced industry standards and regulations:

• Physical Properties: Defined by ASTM standard D 5250-06 (e.g., minimum tensile strength, elongation, dimensions).
• Freedom from Pinholes: Defined by 21 CFR 800.20 (Water Leak Test) with specific Acceptable Quality Limits (AQLs).
• Powder Residual: Defined by ASTM standard D 5250-06 and D6124-06 (maximum powder weight per glove).
• Biocompatibility: Defined by ISO 10993-10 (tests for primary skin irritation and dermal sensitization) with specific criteria for "passes" (e.g., minimal or no observed reaction).

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve machine learning or AI algorithms requiring a training set.

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

This question is 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 an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This document is a 510(k) Premarket Notification Summary for a Class I medical device, specifically patient examination gloves. As such, the "study" described is a demonstration of substantial equivalence to a predicate device, primarily through meeting established performance standards rather than a typical clinical trial.

Acceptance Criteria and Reported Device Performance

Study Information

This document does not describe a "study" in the traditional sense of a clinical trial or a deep learning model evaluation. Instead, it details the non-clinical testing performed to demonstrate that the device meets established consensus standards and regulatory requirements for substantial equivalence.

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

   • Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility testing). It simply states that the device "meets" the standards.
   • Data Provenance: The testing was conducted by TANGSHAN ZHONGPU PLASTIC PRODUCTS CO.,LTD., which is located in Tangshan City, Hebei Province, China. The data would be considered prospective internal testing.

2. 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)

   • This question is not applicable. For a Class I device like examination gloves demonstrating compliance with ASTM standards and regulatory requirements, "ground truth" is not established by expert consensus on clinical findings. Instead, it's determined by the results of standardized physical, chemical, and biological tests following established protocols. The experts involved would be laboratory technicians and engineers qualified to perform these specific tests.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or subjective clinical endpoints. For the objective performance criteria of gloves, test results are directly compared to the specified standard thresholds.

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

   • This is not applicable. This device is a physical medical product (examination gloves), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.

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

   • This is not applicable, as this is not an AI/SaMD product.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for the performance characteristics of these gloves is defined by:
     • Standardized Test Methods and Thresholds: For dimensions, physical properties, powder residual, and freedom from pinholes, the "ground truth" is adherence to the specified quantitative and qualitative criteria within ASTM D5250-06 and 21 CFR 800.20.
     • Biocompatibility Standard Interpretations: For primary skin irritation and dermal sensitization, the "ground truth" is the interpretation of animal study results according to ISO10993-10, demonstrating a "Pass" (i.e., not a primary skin irritant or dermal sensitizer).

7. The sample size for the training set

   • This is not applicable, as this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for product validation against established standards.

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

   • This is not applicable, as there is no training set for this type of device.

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