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The KARL STORZ Flexible Video-Uretero-Renoscope is 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 KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.

The provided FDA 510(k) clearance letter and summary describe a medical device (FLEX XC ureteroscope), not an AI or software-based medical device. Therefore, the information requested about acceptance criteria and studies that apply to AI/Software as a Medical Device (SaMD) are not present in this document.

The clearance is based on the substantial equivalence of the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) to a previously cleared predicate device (K141250 KARL STORZ Flexible Video-Uretero-Renoscope).

Here's an analysis of the provided information concerning the device's performance, but it does not include any of the AI/SaMD specific criteria you requested as the device is a physical endoscope.

Device: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Product Code: FGB
Regulatory Class: Class II

Acceptance Criteria and Reported Device Performance (Non-AI/SaMD)

Since this is a physical medical device (endoscope), the "acceptance criteria" primarily relate to its physical and functional specifications, and its compliance with relevant performance and safety standards.

Note on Differences: The subject device (FLEX XC) shows an improved deflection range (285° up/down vs. 270°) and a potentially wider field of view range (80-110° vs. 80-95°) compared to the predicate. The submission argues these differences do not raise new questions of safety and effectiveness, supported by non-clinical bench testing.

Study Details (Based on provided document)

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

Therefore, the following information, which is typically relevant for AI/SaMD clinical validation studies, is not applicable or not provided in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/SaMD performance was used. The reported "performance" comes from bench testing of the physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/SaMD performance was not established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device is its compliance with recognized performance standards and its physical and functional characteristics being comparable (or superior, without raising new concerns) to a cleared predicate.
7. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion: The provided FDA 510(k) clearance documentation for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) pertains to a traditional physical medical device, not a software-as-a-medical-device (SaMD) or AI-enabled device. The clearance is based on a demonstration of substantial equivalence to a predicate device through non-clinical bench testing, not through clinical studies involving human readers or AI algorithm performance analysis. Therefore, the specific criteria and study details related to AI/SaMD validation are absent from this document.

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The SSU Flexible Video-Uretero-Renoscope System is 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.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the performance of the SSU Flexible Video-Uretero-Renoscope System:

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

The document does not explicitly state acceptance criteria in numerical terms for the performance characteristics. Instead, it compares the subject device's performance characteristics to those of a predicate device (KARL STORZ Flexible Video-Uretero-Renoscope System K141250) to demonstrate substantial equivalence. The "Acceptance Criteria" column below will reflect the predicate device's corresponding specifications where applicable, or indicate "Met design specifications" if specific targets for the subject device are not detailed but performance testing was done.

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

The document states, "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that no clinical test set (i.e., human patient data) was used.

The performance was evaluated through non-clinical bench testing. The sample size for these bench tests is not explicitly stated in the provided text, nor is the provenance of the data from these bench tests (e.g., if specific components were sourced from different countries or if testing was done in a specific lab location). The submitter, KARL STORZ SE & Co. KG, is located in Tuttlingen, Germany.

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)

Since no clinical testing was performed, no experts were used to establish ground truth for a clinical test set. The performance was evaluated against design specifications and recognized consensus standards by the technical personnel conducting the bench testing.

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

As no clinical test set was used, no adjudication method was applicable or 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

No MRMC comparative effectiveness study was done. The device itself is an endoscope system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an endoscope system that requires human operation and interpretation. It is not an algorithm performing a standalone task.

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

For the non-clinical bench testing, the "ground truth" implicitly used would be engineering and physical measurements taken against established specifications and recognized consensus standards. For example, "on-axis resolution" would be measured using standardized targets and optical equipment, with the expected values derived from known optical principles and predicate device data.

8. The sample size for the training set

Not applicable. This device is a hardware medical device (an endoscope system), not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its design and performance are based on engineering principles and verified through bench testing.

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

Not applicable. As there is no training set for an AI algorithm.

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The KARL STORZ Flexible Video-Uretero-Renoscope System is 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 Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The system components are the Flexible Video-Uretero-Renoscope and the Image 1 SPIES Camera Control Unit (CCU). The Flexible Video-Uretero-Renoscope uses an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination. The video image is produced by a complementary metal-oxide-semiconductor (CMOS) imaging sensor is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 SPIES CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard HD display monitor. The modifications made to the Flexible Video-Uretero-Renoscope System (K131369) are the conversion to the Image 1 SPIES CCU (K135319), material changes for STERRAD compatibility, a reduction in the insertion portion from 700mm to 675mm, and revision of the reprocessing instructions.

This document is a 510(k) summary for the KARL STORZ Flexible Video-Uretero-Renoscope System. It describes modifications to a previously cleared device (K131369) and asserts substantial equivalence to that predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it describes general compliance with standards and successful testing.

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify a sample size for any test set (e.g., number of devices tested, number of simulated uses, etc.).
• The data provenance is non-clinical testing performed by the manufacturer, Karl Storz Endoscopy-America, Inc. There is no mention of country of origin of the data beyond implied internal testing by the applicant. The testing described is prospective in nature, as it's for a modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not applicable as the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above; no clinical test set was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document states "Clinical testing was not required."

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

• This device is a physical medical instrument (Flexible Video-Uretero-Renoscope System) with an imaging sensor, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The testing described is for the device's physical and functional performance, optical characteristics, and safety.

7. The Type of Ground Truth Used:

• For the non-clinical performance and safety testing, the "ground truth" was established by compliance with recognized international standards (e.g., ISO 14971, ISO 8600, IEC 60601-1, IEC 60601-1-2, ISO 10993) and the validated functional specifications of the device.

8. The Sample Size for the Training Set:

• This device is a physical medical instrument, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable.

9. How the Ground Truth for the Training Set Was Established:

• As above, the concept of a "training set" is not applicable for this device.

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The Karl Storz Flexible Video-Uretero-Renoscope System is 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 Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The crucial components of the system are the Flexible Video-Uretero-Renoscope and the Image 1 HD Camera Control Unit. The Flexible Video-Uretero-Renoscope uses an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination. The video image is produced by a complementary metal-oxide-semiconductor (CMOS) imaging sensor is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 HD CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard SD or HD monitor. The Karl Storz Flexible Video-Uretero-Renoscope System is a Class II device under 21 CFR 876.1500.

The provided text describes a 510(k) summary for the Karl Storz Flexible Video-Uretero-Renoscope System. This device is not an AI/ML medical device, therefore, the information requested in the prompt related to acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical performance and safety testing.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table; rather, it refers to successful testing against established standards. The performance is summarized qualitatively.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device for visualization, not an AI/ML device that uses data for a test set. The validation methods involved physical device testing, not data analysis sets.

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. There is no mention of expert-established ground truth related to diagnostic performance or image interpretation, as the device is for direct visualization.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML diagnostic device with a test set requiring adjudication.

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 is not an AI-assisted device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an endoscope system that is used with a human in the loop for live visualization and procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its physical and optical performance characteristics as measured against engineering specifications and international standards (e.g., ISO 8600, IEC 60601 series).

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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The Schoelly Uretero-Renoscopes are indicated for the transurethral examination and treatment of the upper urinmary tract, including the uterer and kidney, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Schoelly Uretero-Renoscopes

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Schoelly Uretero-Renoscopes." This document primarily addresses the substantial equivalence determination for the device and its intended use. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed device submission.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This FDA letter is a regulatory approval document based on the device's substantial equivalence to a predicate device, not a detailed technical or clinical study report.

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The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.

• transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
• tumor diagnostics and / or biopsy
• removal of foreign bodies .

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.

The uretero-renoscope may be inserted with the introduction sheath, 8706.042 to view the renal pelvis. The introduction sheath remains stationary while the ureterorenoscope may be removed and replaced by a flexible uretero-renoscope when reaching the upper calyx group.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Compact Operating Uretero-Renoscope with Insertion Sleeve":

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device did not have explicit, quantifiable acceptance criteria or associated performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance benchmarks.

• Atraumatic tip
• Sharp, brilliant image quality
• Autoclavable/steam sterilizable (134°C / 273°F) | "atraumatic tip for problem free introduction into the uteri ostium."
  "sharp, brilliant quality over the entire image."
  ". autoclavable / steam sterilization 134°C / 273°C" |
  | Substantially equivalent to predicate device (K963855) | "The submitted devices are substantially equivalent to existing devices sold by Richard Wolf." |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. No clinical or performance tests were conducted on a 'test set' as defined for typical device performance studies (e.g., diagnostic accuracy, efficacy).
• Data Provenance: Not applicable. No data from a test set was generated from specific countries or in a retrospective/prospective manner.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No ground truth was established for a test set, as no clinical performance studies were performed. The submission relies on design and testing to assure safety and effectiveness, and claims substantial equivalence.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical performance studies were performed that would require an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical tests performed were not performed." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No standalone performance study was done. This device is a physical medical instrument (uretero-renoscope), not an algorithm or AI-powered system, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

• Not applicable in the context of clinical performance or diagnostic accuracy. The "ground truth" for the device's claims of safety and effectiveness, and substantial equivalence, appears to be based on:
  • Engineering design and testing ("These devices are designed and tested to assure their safety and effectiveness...")
  • Comparison to a predicate device already on the market (K963855).

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that would require a training set of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As this is not an AI/ML device, there is no training set or ground truth for it.

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The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

The submitted devices are thin endoscopes with fiber image bundle and an oval channel for irrigation and for use of one or two instruments simultaneously.

The devices have a direct view, an oblique or an offset eyepiece.

A single or double instrument port is needed for the insertion of the auxiliary instruments. For lithoclast application an additional guide is used.

The longer endoscopes are called uretero-renoscopes and are used for procedures in ureter and kidney. The shorter ones are called ureteroscopes and are used for procedures in ureter (and for procedures in kidney, if the urinary tract is short enough).

The provided text describes a 510(k) summary for "Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes" by Richard Wolf Medical Instruments Corporation.

Based on the provided document, the following observations can be made regarding acceptance criteria and device studies:

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

The document mentions two performance tests, but does not explicitly state numerical acceptance criteria for them. General statements about performance are made.

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

• Sample size for test set: Not specified. The document states "tests performed by Richard Wolf" for the steam sterilization, implying internal testing, but no number of units tested is given.
• Data provenance: The performance data described (mechanical load test, steam sterilization) appears to be from internal laboratory testing conducted by Richard Wolf Medical Instruments Corporation. The country of origin of the data is implicitly the USA, where the company is located. The tests are retrospective in the sense that they were conducted on the device models being submitted, not as part of a prospective clinical trial.

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

This information is not provided in the document. The performance tests described (mechanical bending, optical quality after sterilization) are objective engineering tests, not subject to expert interpretation for ground truth.

4. Adjudication method for the test set:

This information is not applicable/provided. The performance tests are objective engineering assessments; adjudication by experts would not typically be relevant for these types of tests.

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 comparative effectiveness study was done. This is a hardware medical device (endoscope), not an AI-powered diagnostic tool. The document explicitly states: "No clinical tests performed."

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

Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the reported performance tests seems to be based on:

• Mechanical integrity: The device not fracturing under normal use (for the bending test).
• Optical quality preservation: The optical quality not being influenced by steam sterilization.
  These are objective, direct physical measurements or observations.

8. The sample size for the training set:

Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

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The KSEA 'Gelet' uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.

The KSEA 'Gelet' uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eveniece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.

The provided text is a 510(k) summary for a medical device (semi-rigid ureteroscope and accessory). It focuses on establishing substantial equivalence to a predicate device, rather than detailing performance studies and acceptance criteria for a novel AI/software solution. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document.

The document indicates that:

• Device Identification: Karl Storz 'Gelet' Uretero-Renoscopes and Karl Storz Alken motion control device.
• Indication: To view the ureter and perform diagnostic and therapeutic procedures using accessories. The Alken device guides the introduction of instruments.
• Device Description: Semi-rigid endoscopes and an attachment for instrument channel control. Manually operated, reusable surgical devices.
• Substantial Equivalence: Claimed due to "basic features, design and intended uses are the same or similar" to predicate devices. Minor dimensional differences are stated to raise no new issues of safety and effectiveness and have no effect on performance, function, or intended use.

This type of submission typically bypasses the need for extensive clinical performance studies that establish acceptance criteria against specific metrics, as it relies on the known safety and efficacy of the predicate device. Therefore, the information requested in your numbered points is not present in this 510(k) summary.

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