Search Results

Percutaneous System for adults
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.

Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.

The Percutaneous Nephroscope System consists of the following:

• Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes
• HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)
• Operating Sheaths
• One-Step Dilators
• Telescope Bougie Set
• Hollow Obturator and Fascial Dilator Applicators
• Biopsy and Grasping forceps
• Scissors
• Knives
• Insertion Aid
• Laser Hand Instrument
• Suction tube
• Adaptors
• Luer-Lock tube connectors

The provided text is a 510(k) summary for the KARL STORZ Percutaneous Nephroscope System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and a literature review for pediatric use.

Based on the provided text, the sections relating to acceptance criteria and the study that proves the device meets them are primarily about non-clinical bench testing and literature review, as opposed to a complex clinical study for AI or image analysis devices.

Here's a breakdown of the information requested, based only on the provided document:

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

The document states: "Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments (forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific illumination levels) and the precise reported performance values are not explicitly detailed in this 510(k) summary. The summary only generally states that the device "meets all its design specification."

Therefore, a table of specific acceptance criteria and reported performance cannot be fully constructed from the provided text. The document refers to compliance with ISO and IEC standards, which would imply that the device met the performance requirements outlined in those standards.

2. Sample size used for the test set and the data provenance

• Sample size: The document does not specify a "sample size" in the context of clinical testing of humans or images. The "test set" refers to the specific devices and instruments undergoing bench testing. The document implies that sufficient units were tested to demonstrate compliance with design specifications and substantial equivalence, but the exact number of devices tested is not stated.
• Data provenance: The document indicates non-clinical bench testing (likely performed internally by the manufacturer or contracted labs) and a literature review. The provenance of the literature is not specified beyond "Published literature." There is no mention of country of origin for any human data (as no new human clinical studies were performed). The testing is implicitly prospective in the sense that the manufacturer conducted the tests for this submission.

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

This information is not applicable to the data provided. The "ground truth" for this type of device submission (Percutaneous Nephroscope System) is established through engineering and performance specifications validated by bench testing and adherence to recognized standards. There isn't a "test set" of patient images or clinical cases requiring expert interpretation to establish ground truth in the way it would be for an AI diagnostic device. The "ground truth" for the pediatric indication was established through existing published literature, not by new expert consensus specifically for this submission.

4. Adjudication method for the test set

This information is not applicable as there are no human-read test sets requiring adjudication of interpretations. The tests are bench tests proving physical and functional characteristics.

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, and this type of study is not relevant to a Percutaneous Nephroscope System. This device is a surgical instrument, not an AI-assisted diagnostic or image analysis tool.

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

No, this is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the bench testing, the "ground truth" is based on engineering design specifications, established performance standards (ISO, IEC, AAMI), and the performance of the predicate device. For the pediatric indication, the "ground truth" for safety and effectiveness was established from published literature, which likely includes clinical outcomes data, expert opinions, and various study types from prior research involving similar devices/procedures in pediatrics.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.

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

This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.

Ask a specific question about this device

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.

Ask a specific question about this device