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The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during endoscopic procedures.

The Carbon Medical Injection Needle consists of a stainless steel needle attached to two or more luer lock hubs. A standard syringe can be attached to the hubs for injection of materials through the lumen of the needle into tissue. Multiple needle lengths and gauges are available.

The provided text describes a 510(k) summary for the Carbon Medical Technologies Injection Needle. This submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics, biocompatibility, and bench testing. It does not contain information about a study that assesses performance against specific acceptance criteria for diagnostic or AI-driven devices. Therefore, I cannot provide the detailed information requested in your prompt.

The document states:
"Technological Characteristics and Performance
The technological characteristics are substantially equivalent to the predicate devices. Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

This indicates that the submission relied on demonstrating that the new device's design and materials are similar to previously cleared devices, and that standard engineering tests (bench testing) confirmed its basic function and safety (biocompatibility). There is no mention of a clinical study, performance metrics like sensitivity or specificity, or any evaluation involving human readers or AI.

To answer your specific questions in the context of this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity) for comparison. The performance claim is general substantial equivalence to predicate devices based on technological characteristics and bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set involving patient data is described. The evaluation was based on bench testing and characterization of technological similarity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth based on expert review is mentioned, as there was no study involving patient data or diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method is mentioned.

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 device is an injection needle, not an AI or diagnostic imaging device. No MRMC study was performed.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic performance is not relevant to this device's submission. The "ground truth" for this submission would be the established performance and safety of the predicate devices, which the new device is claimed to be substantially equivalent to, based on bench testing.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.

In summary, the provided 510(k) summary for the Carbon Medical Technologies Injection Needle is for a hardware medical device (an injection needle) and relies on demonstrating substantial equivalence to pre-existing predicate devices through technological characteristics, biocompatibility, and bench testing, rather than performance studies requiring the criteria you've outlined, which are typical for diagnostic or AI-powered devices.

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