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WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope.

WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a deflection control and a two-way deflectable insertion tube.

WiScope®Single-Use Digital Flexible Cystoscope has the following 4 models:

OTU-C300S: Standard Deflection Model for OTU-C300 series

OTU-C300R: Reverse Deflection Model for OTU-C300 series

OTU-C310S: Standard Deflection Model for OTU-C310 series

OTU-C310R: Reverse Deflection Model for OTU-C310 series

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

Based on the provided text, the submission is a 510(k) for the WiScope® Digital Cystoscope System. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (K212202) rather than proving novel performance against specific clinical acceptance criteria. Therefore, the information typically found in a clinical study seeking to establish performance against acceptance criteria for a new device is largely absent.

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

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

The document does not explicitly present a table of acceptance criteria for clinical performance with reported results in the same way a de novo device might. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (K212202). The "acceptance criteria" are implicitly met by showing that the differences between the proposed device and the predicate do not raise new questions of safety or effectiveness, which is supported by non-clinical testing.

The non-clinical testing performed includes evaluations of:

Note: For the Optical and Color Performance, the document lists the parameters tested but does not provide specific numerical acceptance criteria or reported performance values (e.g., "Resolution > X lp/mm" or "Distortion < Y%"). The implicit acceptance is that these performances are comparable to or meet the requirements for the intended use and are at least as good as the predicate device.

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study. The testing revolves around non-clinical engineering and biological safety tests. For these non-clinical tests, the "sample size" would refer to the number of device units tested according to the respective standards. This specific number is not provided in the text; only the type of test and the standard followed are mentioned.
• Data Provenance: Not applicable for clinical data, as "No clinical study is included in this submission." The non-clinical data provenance is internal to the manufacturer (OTU Medical Inc.) and conducted according to international standards (ISO, ASTM, IEC).

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)

• Not applicable. Since no clinical study or expert-adjudicated ground truth for a test set was performed, there's no mention of experts for this purpose. The non-clinical tests rely on established scientific methods and adherence to standards.

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

• Not applicable, as no clinical study with a test set requiring 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. No MRMC study or AI assistance is mentioned in the context of this device. The device is a digital cystoscope system, not an AI-powered diagnostic tool.

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

• Not applicable as the device is a medical instrument (digital cystoscope), not a standalone algorithm.

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

• Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests is defined by the objective pass/fail criteria of the referenced international standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety, ASTM for shelf life).

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device submission.

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

• Not applicable. There is no mention of a training set.

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