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The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.

The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.

The provided document, a 510(k) Premarket Notification summary for Disposable Automatically Retractable Safety Syringes, does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the manner typically found for AI/ML-based medical devices. This document specifically pertains to a physical medical device (syringes) and not an AI/ML diagnostic or therapeutic system.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of a new syringe design to a predicate device based on non-clinical testing of physical and chemical properties and a simulated clinical study for sharps injury prevention.

Here's an interpretation of the closest relevant sections to your request formats, acknowledging the fundamental difference in device type:

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

The document lists "Non-Clinical Tests performed on the subject device" and references various ISO standards for syringe and needle properties. These standards implicitly define the acceptance criteria, and the statement "The proposed devices were tested per the following standards, to evaluate its performance" implies that the device met these standards. However, the document does not report specific quantitative performance data or explicit acceptance thresholds met by the device for each test. It only lists the tests performed.

2. Sample size(s) used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated, but the "Simulated Clinical Study Summary" mentions a study "conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features." While the exact number of devices tested is not provided, the claim of "99% reliability of device activation is achievable" implies a statistically significant sample was used to arrive at this figure.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is "Shantou Wealy Medical Instrument CO.,Ltd." located in Guangdong, China. The testing was conducted to international ISO standards.

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 device; "ground truth" as it applies to AI/ML diagnostic or annotation data is not relevant here. Performance is measured against physical standards and functional requirements.

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

• Not Applicable. This is a physical device. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, usually involving multiple human readers. Here, performance is based on objective lab measurements and functional tests.

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 a physical device and involves no human "readers" or AI assistance. The "Simulated Clinical Study" refers to evaluating the sharps injury prevention feature, not an AI-assisted diagnostic task.

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

• Not Applicable. This is a physical device. There is no algorithm to run in a standalone fashion.

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

• Not Applicable. For this physical device, "ground truth" is established by the specifications of the relevant ISO standards (e.g., a certain force must be applied, there should be no leakage, specific dimensions are met, activation must occur). The "99% reliability of device activation" from the simulated clinical study would be considered a performance outcome, not a "ground truth" in the AI/ML sense.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no AI/ML training set.

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

• Not Applicable. This is a physical device; there is no AI/ML training set or associated ground truth.

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