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Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.

Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them, structured as requested:

Device: Safelock Disposable Insulin Syringe

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary details various non-clinical tests performed according to recognized ISO and ASTM standards. The reported performance is generally stated as "met all design specifications" or "met the pre-established criteria." Specific quantitative acceptance criteria or performance metrics are largely absent from this summary but are implied by adherence to the referenced standards.

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

The provided text does not specify the sample size for any of the non-clinical tests (e.g., number of syringes tested for each ISO standard criterion, number of packages for ASTM, number of devices for safety feature testing).

The provenance of the data is that it was generated through non-clinical bench testing performed by the manufacturer, Jiangyin Caina Technology Co., Ltd. (located in China). The summary reports on tests performed on the "proposed device." It does not indicate retrospective or prospective in the typical sense of clinical studies, as these are lab-based evaluations.

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

This section is not applicable as the evaluation relies on direct measurement and adherence to objective standards (ISO, ASTM, USP) rather than expert interpretation of a ground truth in a clinical or image-based context. The "ground truth" is defined by the parameters and limits set forth in the referenced standards.

4. Adjudication Method for the Test Set

This section is not applicable. The tests are objective measurements against established standard criteria, not subjective assessments requiring adjudication among multiple reviewers.

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

This is not applicable as the device is a medical syringe with a safety feature, not an AI-powered diagnostic or assistive technology for human readers. There is no mention of AI in this submission.

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

This is not applicable for the same reason as point 5. The device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most tests is based on objective, internationally recognized performance standards (ISO, ASTM, USP) which define acceptable limits for physical, mechanical, chemical, and sterility properties. For the simulated clinical study and safety feature testing, the "ground truth" was derived from "pre-established criteria" and FDA guidance for sharps injury prevention devices, which likely includes defined force thresholds or functional performance checks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This is not applicable for the same reason as point 8.

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