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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.

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The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.

The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.

The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".

Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.

The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.

The provided document describes the Schoelly Nephroscope Set and Schoelly Ultra-Mini Nephroscope Set and claims substantial equivalence to predicate devices. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy in humans.

Instead, the performance data section focuses on engineering and biocompatibility testing to demonstrate the device's safety and functionality in a technical sense, aligning with established medical device standards.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and reported device performance:

   Performance Metric (Acceptance Criteria Implicitly Met)	Reported Device Performance (as per testing)
   Temperature (specified in IEC 60601-2-18)	Measured surface temperatures at various locations using different light sources reached steady state and met requirements specified in IEC 60601-2-18.
   Optical Parameters (specified in ISO 8600)	Tested for all relevant optical parameters (e.g., field of view and direction of view accuracy) and met requirements specified in ISO 8600.
   Biocompatibility (according to ISO 10993)	A series of biocompatibility tests (cytotoxicity, sensitization, acute systemic toxicity) demonstrated that patient-contacting components are biocompatible.
   Reprocessing - Cleaning (AAMI TIR12:2010, AAMI	Reprocessing validations completed, including manual and automated cleaning. These studies were performed in accordance with AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST15883-1:2009.
   Reprocessing - Sterilization (ISO 14937:2009,	Reprocessing validations completed, including steam sterilization. These studies were performed in accordance with ISO 14937:2009, ANSI/AAMI ST81:2004, ISO 17664:2004, and ANSI/AAMI/ISO 17665-1:2006.
   Electrical Safety (IEC 60601-2-18)	The device is stated to be IEC 60601-2-18 compliant, indicating it meets electrical safety standards.

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

   • Test Set Sample Size: Not applicable in the context of clinical studies. The document describes device testing (temperature, optical, biocompatibility, reprocessing) which involves physical samples of the device components, not a patient test set. No patient data is involved in these reported performance tests.
   • Data Provenance: The tests conducted are laboratory-based engineering and biological compatibility tests. They are not derived from patient data or clinical settings. The document implies these tests were conducted by the manufacturer (Schoelly Fiberoptic, GmbH) as part of their submission to the FDA.

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

   • Not applicable. These are engineering and safety tests against predefined standards (e.g., IEC, ISO, AAMI TIR), not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

   • Not applicable. This concept applies to clinical studies where expert consensus might be needed for diagnosis or outcome measurement. The reported tests are objective measurements against specified technical standards.

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 MRMC or AI-related study was done or is mentioned. The device is a traditional endoscope (nephroscope) and its accessories, not an AI-powered diagnostic tool.

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

   • Not applicable. The device is a surgical instrument, not an algorithm.

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

   • The "ground truth" for the reported performance evaluations is defined by international and national standards for medical device safety, performance, and reprocessing (e.g., IEC 60601-2-18, ISO 8600, ISO 10993, AAMI TIR, ISO 17664). The device's performance is compared against the technical specifications and requirements outlined in these standards.

8. The sample size for the training set:

   • Not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device submission.

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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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The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic control, through percutaneous or transurethal passages, in conjuction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors.

For diagnosis and therapy with endoscopic accessories in the upper and lower urogenital tract when performed by trained and qualified medical personnel.

The universal nephroscope has a reduced sheath diameter and an expanded working channel to accommodate auxiliary instruments and irrigation. The submitted nephroscope design has been modified to optimize user handling.

The submitted nehproscope can be held by the elongated right angled light connected which has been designed with a recessed grip and a thumb ring. An automatic valve for instrument insertion and an automatic locking mechanism between the endoscope and sheath is part of the submitted design. Accessory instruments have been adapted to the longer nephroscope.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K994223 Nephroscope Set:

Based on the provided K994223 510(k) summary, the device is a conventional medical instrument, not a software algorithm or AI-driven diagnostic device. Therefore, many of the typical performance study elements requested for AI/ML devices (like sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The 510(k) process for traditional devices primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: For traditional medical devices like this nephroscope, "acceptance criteria" and "device performance" are typically demonstrated through design verification and validation (often in-house testing) and adherence to recognized standards, rather than clinical performance metrics like sensitivity, specificity, or AUC as would be seen for AI/ML diagnostic tools. The document explicitly states "Clinical tests were not performed."

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

Not applicable. This device is a surgical instrument. There is no "test set" in the context of data for an AI/ML algorithm. Performance is demonstrated through in-house lab testing, design verification, and adherence to standards, not human data sets. The document explicitly states "Clinical tests were not performed" and "No known performance standards" in the context of human data.

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

Not applicable. There is no "ground truth" establishment in the context of human data for this type of device submission. The safety and effectiveness are established through engineering design, material selection, manufacturing controls, and bench testing to demonstrate functionality and meet design specifications.

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

Not applicable. There is no "test set" or human data requiring adjudication for this device type.

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. This device is not an AI/ML diagnostic tool and does not involve "human readers" or AI assistance.

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

Not applicable. This device is a manual surgical instrument, not an algorithm.

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

Not applicable. For this type of medical device, "ground truth" is defined by engineering specifications, material properties, and functional performance benchmarks demonstrated through non-clinical testing (e.g., mechanical strength, fluid flow rates, optical clarity, compatibility with accessories).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for this device.

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