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The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.

The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification.

This document is a 510(k) summary for a Disposable Sterile Needle, detailing its equivalence to a predicate device. It primarily focuses on regulatory compliance and performance testing against established standards for medical devices, rather than a clinical study comparing an AI system's performance to human readers. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test/training sets, number of experts, MRMC studies, AI effect size, standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and performance data related to the device's adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes non-clinical performance testing against international standards for medical devices. It does not refer to a "test set" in the context of clinical data or AI model evaluation. The tests are conducted on samples of the manufactured device. The document does not specify the exact sample sizes used for each individual test (e.g., how many needles were tested for seal integrity or biocompatibility).

The data provenance is from the manufacturer's (Jiangsu Caina Medical Co., Ltd., China) internal testing/verification processes, conducted to demonstrate compliance with the referenced standards.

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

Not applicable. This document does not describe a clinical study requiring human experts to establish ground truth for a test set. The "ground truth" for this device's performance is compliance with the defined parameters and limits specified in the referenced international standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of clinical data or AI systems with human-in-the-loop for this type of device submission. Performance is assessed against quantitative and qualitative criteria defined by the standards.

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 document describes a medical device (hypodermic needle), not an AI system or software that interacts with human readers.

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

Not applicable. This document is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to the specifications and performance criteria outlined in the cited international and national standards (e.g., ISO 7864, ISO 9626, ISO 6009, ISO 594, ASTM F1929, ASTM F88, USP <85>, ISO 11135, ISO 10993, ISO 14971). These standards define the acceptable physical properties, sterility, biocompatibility, and safety parameters for hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. This document does not describe an AI system requiring a training set.

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

Not applicable. This document does not describe an AI system requiring a training set.

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Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient.

Disposable sterile needle retractable safety syringe is a piston syringe. The device is intended for medical purposes and consists of a protective cover, Needle base, circle ring, Pull & back part, Piston, Plunger and barrel. The needle is fixed on the syringe. The device is used to inject fluids into the body. The subject device of Disposable sterile needle retractable safety syringe is available in 0.5ml, 1ml, 3ml, 5ml and 10 ml volumes. The subject device is provided sterilized. Disposable sterile needle retractable safety syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. After the injection is completed, the groove of the upper end of the plunger locks the needle. The plunger is retracted completely after the injection. The needle is retracted completing into the barrel of the syringe.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Disposable sterile needle retractable safety syringe" are primarily based on conformity to a set of international ISO and ASTM standards. The study demonstrates compliance with these standards.

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

The document states that "Bench tests were conducted to verify that the subject device met all design specifications." However, it does not specify the sample size used for these bench tests.

The data provenance is from tests conducted by the manufacturer, Guangdong Haiou Medical Apparatus Stock Co., Ltd., based in China. The study appears to be retrospective in the sense that the results are being presented as part of a 510(k) submission, confirming the device meets the standards.

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

This document does not provide information on the number of experts used or their qualifications to establish ground truth for the bench tests. The tests are based on established international standards, implying compliance with methods defined by accredited testing bodies rather than expert consensus on individual test outcomes.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method. The performance is assessed against the requirements of the standards, which typically have defined pass/fail criteria.

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 more common for imaging or diagnostic devices where human interpretation plays a significant role. This document concerns a physical medical device (syringe) that is evaluated through bench testing and material compatibility.

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

Yes, the study is essentially a standalone (algorithm only) performance evaluation, where "algorithm" refers to the device itself and its functional characteristics tested against pre-defined performance standards. There is no human-in-the-loop component in the evaluation of the syringe's mechanical, material, or biological properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on the objective, empirically defined pass/fail criteria and specifications within the referenced international ISO and ASTM standards. For example, cytotoxicity is measured against a standard threshold for cellular viability, and sterility is confirmed against a Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

This product is a physical medical device (syringe), not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set is not applicable and not provided.

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

As explained above, a "training set" is not relevant for this type of device.

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