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The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The F88 URE-SD Flexible Ureteroscope, Standard Deflection and the F88 URE-RD Flexible Ureteroscope, Reverse Deflection (both also collectively referred to as the "F88 URE-SD/RD Flexible Ureteroscope") is a handheld flexible ureteroscope with a flexible insertion portion length of 670 mm and a maximum outer diameter of 3.05 mm. The device includes a working channel of 1.2 mm diameter for the insertion of various compatible flexible instruments and irrigation systems. The distal tip is equipped with a CMOS imaging sensor and an LED light source for live videos. The control body has a deflection lever to deflect the distal tip up to at least 270° in the up or down directions for navigation and access to targeted areas. The push buttons can be programmed to perform functions such as white balance, brightness, picture, record, zoom and to provide access to the setup menu.

The standard deflection (SD) and reverse deflection (RD) models are functionally identical, with one primary difference: the direction of the distal tip deflection in response to the deflection lever's movement. When the deflection lever of the standard model moves upward, the distal tip deflects upward. In the reverse model, when the deflection lever moves upward, the distal tip deflects downward. The model is selected depending on the handling preference of the user.

The F88 URE-SD/RD Flexible Ureteroscope is a reusable device.

The F88 URE-SD/RD Flexible Ureteroscope is compatible for use with the F88 Flexible Camera Control Unit (FCCU) and several accessories, listed below:

• Single Luer Stopcock
• Vent Cap with Sterilization Card
• Manual Leak Tester
• Luer Port Cleaning Brush
• Cleaning Brush
• URE Working Channel Cleaning Brush

The F88 Flexible Camera Control Unit (FCCU) or F88 flexible camera console is a device that processes and produces live video images during endoscopic procedures. It is used together with the F88 URE-SD/RD Flexible Ureteroscope and compatible surgical display monitors to form the F88 Flexible Camera System.

The provided FDA 510(k) clearance letter for the F88 URE-SD/RD Flexible Ureteroscope does not contain information about specific acceptance criteria related to accuracy metrics (like sensitivity, specificity, or AUC) or the results of a study designed to demonstrate the device meets such criteria for diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Karl Storz Flexible Video-Uretero-Renoscope, K141250) based on:

1. Identical Indications for Use: Both devices are indicated for endoscopic examination in the urinary tract, including the kidney, for diagnostic and therapeutic procedures.
2. Similar Technological Characteristics: The differences between the devices are described as minor and not raising new questions of safety or effectiveness.
3. Performance Testing to Address Safety and Effectiveness: This testing primarily covers non-clinical aspects essential for medical devices, such as biocompatibility, reprocessing validation, electrical safety, EMC, and software validation.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this document. This is common for 510(k) submissions for devices like endoscopes, where the primary concern is the device's physical and functional equivalence and safety, rather than a quantifiable diagnostic accuracy claim that would necessitate extensive clinical performance studies.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Device Performance (as inferable from the document):

Since the device is a flexible ureteroscope, the "acceptance criteria" discussed are largely related to functional performance, safety, and equivalence to a predicate device rather than diagnostic accuracy metrics. The document states that the device "performs as intended" and "has the same or better performance than the predicate device."

Detailed Study Information (Based on provided text):

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

   • Not Applicable/Not Provided: The document does not describe a "test set" in the context of diagnostic accuracy data (e.g., medical images or patient cases). The performance testing conducted was primarily for engineering, safety, and functional validation (e.g., biocompatibility samples, reprocessed devices, electrical/EMC test units, software code).
   • Data Provenance: Not applicable for the types of tests described.

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

   • Not Applicable/Not Provided: No "ground truth" (e.g., disease presence/absence determined by an expert) for diagnostic performance was established or discussed. The device is an imaging tool, not an AI diagnostic algorithm making determinations. For human factors testing related to reprocessing, it's plausible experts were involved, but details are not provided.

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

   • Not Applicable/Not Provided: There was no diagnostic "test set" requiring adjudication of ground truth.

4. 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: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." MRMC studies are typically for evaluating the impact of AI on human diagnostic performance. Since this device is an endoscope and not an AI diagnostic tool, such a study would not apply in this context.

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

   • No: This is a physical medical device (an endoscope) with an accompanying camera control unit. It is not an algorithm that performs standalone diagnostic tasks. The closest equivalent would be the "Software Verification and Validation Testing" for the F88 Flexible Camera Control Unit (FCCU), but this only validates the software's functionality, not its diagnostic accuracy in a standalone capacity.

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

   • Not Applicable/Not Provided: For a ureteroscope seeking 510(k) clearance based on substantial equivalence, the "ground truth" is typically the established safety and effectiveness of the predicate device and the adherence of the new device to relevant performance standards and engineering specifications. No diagnostic "ground truth" data was used for a clinical performance evaluation.

7. The sample size for the training set:

   • Not Applicable/Not Provided: This device is not an AI algorithm that requires a "training set" of data.

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

   • Not Applicable/Not Provided: No training set was used.

Summary of what the document does describe:

The study proving the device meets its "acceptance criteria" (which are more focused on safety, functional performance, and technological equivalence) consists of a comprehensive suite of non-clinical tests:

• Biocompatibility Testing: According to ISO 10993-1 and FDA guidance, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity.
• Reprocessing Validation: Cleaning, sterilization, and human factors testing.
• Electrical Safety and EMC Testing: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: For the FCCU, following FDA guidance for basic software, including various stages of testing.
• Cybersecurity Testing: Vulnerability assessment and penetration testing following FDA guidance.
• Additional Performance Testing:
  • For Ureteroscopes: Design Verification, Simulated Transportation Validation, and Comparative testing with the predicate device.
  • For FCCU: Design Verification, EMC, Control Unit Feature Verification, System Reliability Testing, Video Performance and Timing, RF Interference, and Simulated Transportation Validation.

The overall approach relies on demonstrating that the new device is fundamentally similar to a previously cleared device, and that any minor differences do not adversely impact safety or effectiveness, as confirmed by robust non-clinical engineering and safety testing.

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