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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

This 510(k) summary for the Veloxion System (K190099) does not include a detailed study with acceptance criteria and reported device performance in the format of a table, nor does it provide a multi-reader multi-case comparative effectiveness study or details on standalone algorithm performance.

However, based on the provided text, here's an attempt to outline the acceptance criteria and study information where available, focusing on what can be inferred or directly stated.

Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance. Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device. The general acceptance criterion implied across all these tests is that the subject device performs as safely and effectively as the predicate device, or meets relevant industry standards.

Here's a summary of the performance claims based on the non-clinical testing data:

Here's the additional information requested, based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for any of the non-clinical tests.
• The data provenance (country of origin, retrospective/prospective) is not provided. All tests listed are non-clinical, implying laboratory or simulated environments, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided. No clinical studies are described, therefore "ground truth" in the clinical sense (e.g., from expert diagnoses) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and medical standards and functional specifications that the device is tested against.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is not applicable to the non-clinical testing described. Adjudication methods are typically associated with clinical studies involving human observers or diagnoses.

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 multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an active medical device (resectoscope system) for prostate adenoma resection, not an AI-powered diagnostic or assistive tool for image interpretation by human radiologists/clinicians in the sense that MRMC studies typically evaluate. The "visualization testing in a simulated model" is the closest mentioned, but it's not an MRMC study.

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

• This device is not an algorithm or AI system in the typical standalone sense. It's a surgical system with integrated software and controls. While software verification and validation were performed (per IEC 62304), this refers to the performance of the integrated software controlling the device's functions, not a standalone AI algorithm producing diagnostic or predictive outputs.

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

• For the non-clinical tests, the "ground truth" would be objective measurements against established technical specifications, engineering principles, and relevant international and national standards (e.g., ISO, IEC, ASTM standards mentioned in the text). For fluid flow, pressure control, temperature, electrical safety, durability, and biocompatibility, the ground truth is the scientific and engineering benchmarks and standards themselves. For "simulated use" and "comparative visualization," the "ground truth" would involve demonstrating the device's ability to achieve its intended function effectively within the simulated environment, comparable to the predicate.

8. The sample size for the training set

• This information is not applicable. The Veloxion System is a physical medical device with integrated software for control, not a machine learning or AI model that requires a "training set" to learn from data.

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

• This information is not applicable for the reasons stated in point 8.

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