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The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may help to prevent needlestick injuries as well as help to prohibit syringe reuse.

The HookSafe™ series is the Safety Syringe with the following functional advantage:

• The syringe and components can be completely self-destroyed and safely discarded.
• Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, the syringe plunger should be fully depressed to ensure complete injection into the bloodstream. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the syringe. Because the needle, when retracted, is in a safely tilted pose against the inner shoulder of the syringe, the syringe becomes completely harmless and fully meets its anti-reuse functionality.

The provided text describes a 510(k) summary for the BIOTOP HookSafe™ Safety Syringe, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for testing, ground truth establishment, or human reader studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (BIOTOP DJT-A) for regulatory clearance. It describes the device's function and intended use, and states that non-clinical tests were performed. However, it does not provide the results of those non-clinical tests or the specific acceptance criteria used.

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth methodology, or human reader studies.

The document concludes that the "non-clinical tests performed" demonstrated the device could maintain the same safety and effectiveness as the cleared predicate device. This implies that testing was done to ensure the safety features worked as intended (anti-needlestick and anti-reuse), but the specific metrics and targets for these tests are not included.

Summary of what can be gleaned and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in the document. The general acceptance criterion is likely "maintaining the same safety and effectiveness as the predicate device" in terms of its anti-needlestick and anti-reuse functionality.
   • Reported Device Performance: Not numerically reported. The document states that "non-clinical tests performed demonstrated [the device] could maintain the same safety and effectiveness as that of [the] cleared device." This implies the tests passed, but no specific results (e.g., success rate of retraction, force required to re-engage needle) are provided.

2. Sample sized used for the test set and the data provenance: Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device does not involve expert interpretation or diagnosis for most of its functional tests (e.g., anti-needlestick, anti-reuse). If "ground truth" refers to the verification of the safety mechanism, it would typically be factory or lab testing, not expert consensus.

4. Adjudication method for the test set: Not applicable based on the information provided.

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 mechanical safety syringe, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used: For a device like this, "ground truth" for its safety features (anti-needlestick, anti-reuse) would typically be established through engineering specifications, validated mechanical testing protocols, and perhaps simulated use testing. The document does not elaborate on these.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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