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The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French or larger. This product is 35 cm (ref: NBI035) or 70 cm (ref: NBI070) length and is made of thermoplastic tubing polyamide (PA) marked by ink, a stainless steel cystoscopic needle, a polyamide Luer Lock connector and a Tuohy Borst adapter to allow connection with the cystoscope. The assembly of the different components is being insured by gluing (UV process). A blue protective cap in Neoplex® is also supplied to prevent cystoscope channel degradation during needle insertion. Shelf life of the full range of the needle for bladder injections is 2 years. The needle for bladder injections is provided sterile and is intended for single use.

The provided text describes a 510(k) premarket notification for a medical device called the "Bonee Needle for Bladder Injections." A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies in the way you might find for novel device approvals (PMA) or algorithm-based AI/ML devices.

Therefore, many of the requested points cannot be answered from the provided document as it focuses on demonstrating equivalence through bench testing and material comparisons, not extensive clinical or performance studies with ground truth, expert adjudication, or large sample sizes for AI/ML.

Here's an analysis based on the available information:

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

The document does not specify formal "acceptance criteria" for the Bonee Needle in the sense of performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond general safety and effectiveness). Instead, the device's performance is demonstrated through comparison to a predicate device.

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

• Sample Size: Not explicitly stated. The studies mentioned are "bench testing" and "biocompatibility testing." These generally involve a limited number of devices or material samples for specific tests (e.g., tensile strength, flow rate).
• Data Provenance: Not specified. "Bench testing" typically refers to in-vitro laboratory testing, not human or animal studies with provenance like country of origin.

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

This information is not applicable to the provided document. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image annotations, pathology reports) is not relevant for bench testing of a mechanical device.

4. Adjudication method for the test set:

Not applicable. There's no mention of a test set requiring adjudication in the context of human expert review.

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:

No. This is not an AI/ML device, and no MRMC study with human readers is mentioned.

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

No. This is not an AI/ML device.

7. The type of ground truth used:

The concept of "ground truth" as it applies to clinical outcomes or expert labels for diagnostic AI is not used here. Instead, the "ground truth" for this device's performance validation would be established by:

• Engineering specifications and validated test methods (for bench testing).
• Recognized standards for biocompatibility (e.g., ISO standards).
• The performance characteristics of the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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