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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.

Important Note: The provided document is a 510(k) summary for a medical device (patient examination gloves). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove a new therapeutic effect. Therefore, the information typically requested in your prompt regarding clinical studies, human reader comparisons, and detailed ground truth establishment methods for complex algorithms is not applicable to this device. The "study" here refers to non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The device is a non-sterile, powder-free nitrile patient examination glove. Its acceptance criteria are based on compliance with established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For Physical and Dimensions Testing and the FDA 1000 ml. Water Fill Test, an Inspection Level S-2 and Inspection Level I, respectively, with an AQL (Acceptable Quality Limit) of 2.5 was used. The exact numerical sample size for each batch tested is not explicitly stated but is determined by the AQL and inspection level standards (e.g., ISO 2859-1 or ANSI/ASQ Z1.4 for attributes sampling plans). For biocompatibility, the sample size is also not explicitly stated, but it would typically involve animal or in vitro testing.
• Data Provenance: The tests were performed by Zibo Yingbo Medical Products Co., Ltd. on their own products. The country of origin of the data is China, where the manufacturer is located. The testing is prospective in the sense that it's performed on manufactured glove batches to ensure ongoing quality and compliance.

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

This concept is not applicable to the type of device and testing described. Ground truth for glove performance is established through objective, reproducible physical and chemical tests (e.g., tensile strength, elongation, water leak, powder residue, biocompatibility studies), not human expert consensus on interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication typically refers to resolving disagreements among human experts in interpreting data. The tests performed are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. For patient examination gloves, the "effectiveness" is primarily determined by barrier protection, strength, and biocompatibility, which are measured objectively.

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

This concept is not applicable. This device is not an algorithm or AI system. It is a physical medical device (gloves). The performance tested is the standalone performance of the gloves themselves.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Industry Standards: Adherence to ASTM D6319-05 (Standard Specification for Nitrile Examination Gloves for Medical Application).
• Regulatory Requirements: Compliance with the FDA 1000 ml. Water Fill Test for pinholes, indicating barrier integrity.
• Biocompatibility Standards: Results from primary skin irritation and skin sensitization tests demonstrating safety for skin contact.
• Manufacturing Specifications: Ensuring powder residue meets the "powder-free" claim (less than 2 mg/glove).

These are objective, measurable criteria.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" in the context of a physical medical device like gloves. Training sets are used in machine learning for AI systems.

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

This concept is not applicable as there is no training set.

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A patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.

This is not a medical device that utilizes AI/ML. The provided text describes a 510(k) submission for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.

The acceptance criteria and study detailed in the document pertain to the physical properties, biocompatibility, and regulatory compliance of these medical gloves, not to the performance of an AI/ML powered device.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for training/test sets, expert qualifications, or MRMC studies, as these concepts are not applicable to the device described.

However, I can extract the relevant information for the glove device based on the provided text:

Acceptance Criteria and Reported Device Performance for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves

Regarding the other requested points, they are not applicable to this medical glove device:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "samplings of AOL 2.5, Inspection Level I" and "Inspection Level S-2, AOL 2.5" for physical testing and water fill tests, which refers to Acceptable Quality Levels (AQL) for manufacturing quality control, not a sample size for an AI/ML test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove involves standardized physical and chemical tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device is based on standardized testing protocols and ASTM standard specifications (ASTM-D-6319-05) for physical properties, barrier integrity (water leak test), and biocompatibility.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device