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The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® Smith™ Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

The Gyrus ACMI® IPN-2505. Invisio® Smith™ Percutaneous Nephroscope (referred to hereafter as the IPN-2505) is a rigid endoscope that incorporates CMOS (complimentary metal oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the IDC-1500 Camera Control Unit (CCU).

The IPN-2505 can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The IPN-2505 uses an IDC-1500 CCU that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

Here's an analysis of the provided text regarding the Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System:

Based on the provided 510(k) summary, there is no acceptance criteria or study information related to device performance in the traditional sense of metrics like sensitivity, specificity, accuracy, or any comparative effectiveness studies with human readers or standalone AI performance.

This document is a submission for a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on showing similar technological characteristics and intended uses, rather than extensive clinical performance studies that establish quantitative acceptance criteria or human-in-the-loop performance.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-related metrics cannot be filled from the given text.

Here's a breakdown of what can be extracted or inferred from the provided text:

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

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

• Not applicable / Not provided. No specific test set or clinical study data is detailed in this 510(k) summary for performance evaluation. The submission relies on a comparison of technological characteristics and intended use to predicate devices.

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 / Not provided. No test set requiring expert ground truth is described.

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

• Not applicable / Not provided. No test set requiring adjudication is described.

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, an MRMC comparative effectiveness study was not done. This device is a percutaneous nephroscope system, which is a physical instrument for direct visualization, not an AI-assisted diagnostic or imaging interpretation tool.

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

• No, a standalone performance study was not done. This device is an endoscope, not an AI algorithm.

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

• Not applicable / Not provided. The substantial equivalence claim is based on technological characteristics and intended use alignment with predicate devices, not on a ground truth derived from clinical data in a performance study.

8. The sample size for the training set

• Not applicable / Not provided. This device is a physical medical instrument, not an AI system that requires a training set.

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

• Not applicable / Not provided. As above, this device does not utilize a training set or ground truth in the context of AI.

Summary of Approach in the 510(k) Filing:

The approach taken in this 510(k) filing is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing:

• Similar Intended Use: The IPN-2505 system's intended use for "close visualization of the urinary bladder, renal pelvis and major calyces" and its introduction methods (percutaneous tract, urethra) are compared to the predicates.
• Similar Technological Characteristics: The filing highlights that the IPN-2505 incorporates:
  • The same basic CMOS video imaging technology as the ACMI® DUR-Digital Ureteroscope and Choledochoscope System (K060269).
  • Dimensional similarity (working channel diameter, similar lengths and diameters) to the ACMI® MRO-20 Rigid Percutaneous Nephroscope (K791182).
  • Similar construction materials as the MRO-20 (K791182) and the MR-6A/MR-6LA Autoclavable Ureteroscope (K052044).
• No New Questions of Safety or Efficacy: The conclusion states that because of these similarities, the device "presents no new questions of safety or efficacy."

This type of submission does not typically include detailed performance data or clinical study results as would be expected for novel devices or those utilizing AI/ML.

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