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The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.

The document provided is a 510(k) premarket notification for a "Safety Auto-Disable Syringe with Needle (Auto-Lock)". It describes the device, its intended use, and a comparison to predicate devices, along with summaries of performance testing.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" for each individual test in the format usually expected for a medical device. Instead, it lists various bench tests and indicates that the device conforms to relevant ISO standards. For the simulated clinical study, a specific performance metric related to the failure rate is given.

Here's a table based on the information provided, focusing on the simulated clinical study's outcome as the most direct "performance" metric stated:

For other tests, the document generally states "Conforms to [ISO Standard]" or "Comply to [ISO Standard]" as the performance, implying that the standards themselves define the acceptance criteria. Examples include:

2. Sample size used for the test set and the data provenance

• Sample Size for Simulated Clinical Study: 512 devices.
• Data Provenance: The simulated clinical study and a "clinical investigation" were "performed in China per the requirements of China FDA." This indicates the data is prospective, acquired from China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of "experts" to establish ground truth in the context of the simulated clinical study or other performance tests. The tests performed are primarily bench tests and a simulated clinical study, which would rely on objective measurements and established protocols rather than expert consensus on a "ground truth" (e.g., as in image interpretation).

4. Adjudication method for the test set

Not applicable. The tests described are objective performance and safety evaluations, not subjective assessments requiring adjudication by multiple readers or experts.

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 medical device (syringe), not an AI-powered diagnostic or assistive tool where MRMC studies would be relevant to evaluate AI assistance for human readers.

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

Not applicable. This device is a physical syringe, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not directly applicable to the performance testing of this physical medical device. The "ground truth" for the tests mentioned (e.g., sterility, fluid delivery accuracy, needle integrity) would be defined by the specifications and measurable parameters within the referenced ISO standards. For example, for "Sterile test," the ground truth is "sterile" as determined by microbiology methods conforming to standards. For "hub/needle bond strength," the ground truth is a specific force threshold defined in ISO 7864.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

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