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The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.

The Repris Bladder Injection System consists of an introducer that is positioned onto the shaft of a cystoscope lens, a needle that is contained within a lumen in the wall of the introducer, and a metered syringe. The fully assembled Repris device has an overall length of 32.4 cm (12.75 inches); the introducer's working length is 20.4 cm (8.06 inches). External to the introducer is a metered syringe that is attached to the luer connection at the proximal end of the needle. The metered syringe delivers a pre-determined dose for each of the multiple injection sites as the plunger is advanced. The syringe provides the user with a tactile and auditory feedback when the exact dose is delivered.

The provided text describes a 510(k) premarket notification for the "Repris Bladder Injection System." For this type of submission, the focus is on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative performance acceptance criteria through the kind of studies you've described for an AI/algorithm-based device.

Therefore, many of the questions you've asked (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document because it pertains to a physical medical device (an injection system) and its assessment for substantial equivalence.

Here's why, based on the provided text:

• Type of Device: The Repris Bladder Injection System is a physical medical device (an injection system for drugs), not an AI/algorithm-based diagnostic or assistive system.
• Regulatory Pathway: It's a 510(k) premarket notification, which seeks to establish substantial equivalence to a predicate device. This pathway generally relies on comparison of design, materials, and intended use, along with bench testing and biocompatibility. It does not typically require the type of clinical performance studies with "acceptance criteria" for accuracy, sensitivity, specificity, etc., that are common for AI/ML devices.
• Performance Data (Section VI): The document explicitly states: "All necessary performance testing was conducted with bench testing and included: Design verification and validation studies; Packaging and shelf-life studies; and Biocompatibility testing. ... No animal or clinical testing was necessary to support this submission." This directly indicates that the types of studies you're asking about (involving human subjects, expert ground truth, MRMC, etc.) were not performed.

However, I can extract the information relevant to the substantial equivalence argument, which serves as the "proof" the device is acceptable for market:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):

For a 510(k) submission, the "acceptance criteria" effectively boil down to demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The "performance" is shown through direct comparison and bench testing.

1. Table of Acceptance Criteria (as interpreted for Substantial Equivalence) and Reported Device Performance:

Conclusion from document: "Any differences between the Repris Bladder Injection System and the predicate device do not alter the intended use of the Repris Bladder Injection System." And "The minor differences between the Repris Bladder Injection System and the predicate device do not raise any new issues of safety or effectiveness."

Regarding the specific questions about clinical study design for AI/ML devices:

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from human subjects was used. The "test set" for this device comprised bench testing of the physical device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of clinical cases was performed.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
• 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 physical injection device, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm to evaluate.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to engineering specifications, design requirements, and biocompatibility standards (e.g., ISO 10993).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device, not an AI/ML device. Therefore, the detailed questions about AI/ML study design and performance criteria are not addressed or relevant in this context. The "proof" of acceptability lies in the demonstration of substantial equivalence to a predicate device through comparative analysis and bench testing.

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