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The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.

The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries. The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components: Cap, Needle, Needle house, Hub, Barrel, Gasket, Plunger.

This looks like a 510K submission for a medical device. I will break down the information section by section as requested.

Acceptance Criteria and Device Performance Study for Auto-Disable Sterile Safety Syringe For Single Use, 5mL (K121637)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format for a specific "device performance" study that would typically involve sensitivity, specificity, accuracy, etc., for an AI/diagnostic device. Instead, the performance testing focuses on compliance with various ISO and ASTM standards relevant to the physical and biological aspects of a sterile safety syringe.

However, the "Simulated Clinical Use Study" directly addresses the safety and usability of the device's main feature. We will infer the acceptance criteria from the study design and the conclusion of substantial equivalence.

Inferred Acceptance Criteria and Reported Device Performance for Simulated Clinical Use:

Other Performance Testing (Compliance with Standards):

The device underwent and passed a series of standard tests for biological evaluation, sterilization, packaging, and general syringe functionality to demonstrate substantial equivalence to the predicate device. These are not performance metrics in the sense of sensitivity/specificity but rather compliance with established safety and quality standards.

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

• Sample Size for Simulated Clinical Use:
  • Test Device (Auto-Disable Syringe): 500 samples
  • Predicate Device (Invirosnap Safety Syringe): 100 samples
• Data Provenance: The study was a "simulated clinical use study" conducted by Sunwell Biotech Co., Ltd. The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, "simulated clinical use" implies a prospective collection of data in a controlled environment, likely in the country of the submitting company (China) or a contracted facility.

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

• Number of Experts: 10 nurses.
• Qualifications of Experts: They are identified as "nurses," implying healthcare professionals with practical experience in using syringes for injections and withdrawals. Specific years of experience or specialization are not provided.

4. Adjudication Method for the Test Set

The document states that the 10 nurses "reported their experience with each sample." This suggests a direct user feedback or observation method rather than a formal adjudication process where multiple experts collectively establish a single ground truth for each case. Given the nature of a safety syringe (does it retract or not, is it easy to use), direct user experience reports serve as the primary data. There is no mention of a 2+1, 3+1, or similar adjudication method.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the context of an AI/diagnostic device improving human reader performance. This device is a physical medical instrument (syringe), not a diagnostic algorithm. The "simulated clinical use study" involved human users (nurses) testing the device, but it was not designed to measure an effect size of how much human readers improve with AI assistance.

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

• No, this question is not applicable. The device is a physical auto-disable safety syringe, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the simulated clinical use study, the "ground truth" was based on user experience and observation of functional performance by the participating nurses, guided by the objective to assess the "reliability and usability of the safety feature." The success or failure of the needle retraction, ease of use, and overall experience reported by the nurses effectively constitute the ground truth for this type of device performance evaluation.

8. The Sample Size for the Training Set

• This device is a physical safety syringe, not an AI/ML algorithm that requires a "training set" of data. Therefore, the concept of a training set sample size is not applicable to this submission.

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

• As the concept of a training set is not applicable to this physical device, there is no information on how ground truth for a training set was established.

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