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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated.

The Flexible HD Cysto-Urethroscope System consists of the following key components:
11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel
TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing

The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock.

The FDA 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) describes the acceptance criteria and supporting studies as follows:

This submission is a Special 510(k), indicating a modification to a previously cleared device. Therefore, the focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the acceptance criteria are largely based on adherence to recognized consensus standards and demonstrating that the modified device maintains the same technological characteristics and performance as the predicate devices, or that any differences do not impact safety or effectiveness.

• Type of scope (Flexible)
• Insertion Shaft Diameter (5.5 mm)
• Insertion Shaft Length (37 cm)
• Working Channel Diameter (2.3 mm)
• Deflection (Up: 210°, Down: 140°) |
  | Optical Characteristics (e.g., Type of Imager, Field of View, Direction of View, Depth of Field, On-axis Resolution, Light Source) | Same as primary predicate (K191357) for:
• Type of Imager (CMOS)
• Field of View (100°)
• Direction of View (0°)
• Depth of Field (3-50 mm)
• On-axis Resolution (40 lp/mm @ 3 mm, 2.5 lp/mm @ 50 mm)
• Light Source (Internal LED) |
  | Material / Design Characteristics (Differences from Predicate) | Suction Port / Channel: Proposed device has "No" (due to permanent stainless steel housing plug), while primary predicate has "Yes". This difference is described as due to "lack of clinical need" for the suction channel.
  Luer Type: Proposed device has "Permanent T-Luer", primary predicate has "Bayonet with removable T-Luer or Stopcock assembly". This is a minor modification. |
  | Cleaning, Disinfection and Sterilization Methods | Same as primary predicate for Manual Cleaning, and High-Level Disinfection (Revital-Ox RESERT).
  Sterilization: Proposed device supports STERRAD 100NX (FLEX and DUO cycles), STERRAD NX (Advanced Cycle), V-PRO maX (Flexible Cycle), V-PRO 60. The primary predicate supported these with additional support for SSIE (Standard Cycle). The proposed device's methods are a recognized subset. |
  | Electrical Safety and EMC | Compliance with recognized consensus standards:
• IEC 60601-1:2005/(R)2012, Ed. 3.1
• IEC 60601-1-2:2014, 4th Ed.
• IEC 60601-2-18:2009, Ed. 3.0 |
  | Optical/Mechanical Performance | Compliance with recognized consensus standards:
• IEC 62471:2006
• ISO 8600 |
  | Biocompatibility | Compliance with recognized consensus standards:
• ISO 10993-1:2009/(R) 2013
• ISO 10993-5:2009/(R) 2014
• ISO 10993-10:2010
• ISO 10993-11:2006/(R) 2010 |
  | Reprocessing | Compliance with recognized consensus standards:
• AAMI TIR 12:2010
• ISO 15883-5:2005
• AAMI TIR 30:2011
• AAMI/ANSI/ISO 11737-1:2006/ (R)2011
• ASTM E1837-96:2014 |
  | Substantial Equivalence to effectiveness | Supported by comparison of images and standard image quality characteristics, including the performance testing listed. The differences do not raise new or different questions of safety and effectiveness. |

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

The document does not detail specific "test set" sample sizes or data provenance in the context of clinical or image-based studies for the current 510(k). This submission relies on a comparison to predicate devices and adherence to established performance standards.

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

Not applicable. The submission focuses on engineering specifications and adherence to standards, not a clinical study requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. No clinical or image-based test set with 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:

Not applicable. This device is an endoscope system for visualization and operative access; it does not involve AI assistance for human readers in diagnostic interpretation.

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

Not applicable. This device is not an algorithm-only device. It is a medical instrument.

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

Not applicable in the context of diagnostic performance. The "ground truth" for this submission are the established performance parameters of the predicate device and the requirements of recognized consensus standards for medical devices.

8. The sample size for the training set:

Not applicable. As a medical device, and specifically a modification through a Special 510(k), there is no "training set" in the context of machine learning.

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

Not applicable. See point 8.

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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

The provided information is a 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on AI performance or clinical efficacy. The changes submitted in this 510(k) are related to adding new sterilization methods (Sterilization V PRO-60 and High Level Disinfection).

Therefore, the document does not contain the kind of information requested regarding acceptance criteria and performance studies for an AI/ML driven device, specifically:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-driven device, but rather refers to reprocessing validation and biocompatibility.
• Sample size used for the test set and the data provenance: Not applicable as there's no mention of a test set for AI performance. The studies mentioned are non-clinical (biocompatibility and reprocessing validation).
• Number of experts used to establish the ground truth...: Not applicable as there's no AI component or ground truth establishment for diagnostic performance.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly 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 means no MRMC study was performed.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Acceptance Criteria from the Provided Document:

The acceptance criteria and performance data in this 510(k) summary are related to the safety and functionality of the endoscope itself, particularly regarding its reprocessing and biocompatibility, as opposed to diagnostic performance of an AI component.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify sample sizes for the biocompatibility or reprocessing validation tests. These tests are typically performed on a limited number of device samples or representative materials.
• Data provenance is not specified beyond being "non-clinical bench testing." There's no mention of country of origin or retrospective/prospective nature as this applies to clinical study data, which was explicitly not required.

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

• Not applicable. Ground truth establishment by experts pertains to diagnostic or clinical performance evaluations, which were not part of this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable.

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. The document explicitly 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 device is an endoscope system, not an AI-driven diagnostic tool.

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

• Not applicable. This is not an algorithm or AI-driven device.

7. The type of ground truth used:

• Not applicable in the context of diagnostic performance. For biocompatibility and reprocessing, the "ground truth" is adherence to established international standards and FDA guidance for these types of non-clinical tests.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable.

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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 091011-20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US). The Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)) is a reusable, flexible video scope with an insertion shaft OD of 5.5 mm and length of 37 cm, a working channel OD of 2.3 mm, and a suction channel. Users can choose to attach either a LUER port with stopcocks (Part Number: 11014L) or a double LUER port (Part Number: 11014LU) to the working channel port. In terms of optics, it has direction of view of 0 degrees and field of view of 100 degrees.

The provided document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on the substantial equivalence of the Flexible HD Cysto-Urethroscope System to predicate devices based on non-clinical performance data, primarily concerning electrical safety, EMC, biocompatibility, and reprocessing validation.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific performance metrics like sensitivity, specificity, or image quality scores that would typically be associated with acceptance criteria for diagnostic devices. Instead, the "performance" is demonstrated through compliance with various safety and technical standards for medical devices.

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

No sample size for a "test set" in the context of diagnostic performance (e.g., patient data, image dataset) is mentioned. The studies performed were non-clinical bench testing to evaluate electrical safety, EMC, biocompatibility, and reprocessing. These tests involve laboratory procedures on device components or the entire device, not on human subjects or patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. Since the studies were non-clinical bench tests (e.g., electrical measurements, material testing, sterilization efficacy), there was no "ground truth" to be established by experts in the diagnostic sense. The results of these tests are typically evaluated against established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above. There was no need for expert adjudication for non-clinical bench testing.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly 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 there was no human reader study, and therefore, no effect size of AI assistance could be determined.

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

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

7. The Type of Ground Truth Used:

As noted, there was no "ground truth" in the diagnostic context. For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and regulatory standards (e.g., specific voltage limits for electrical safety, acceptable cytotoxicity levels for biocompatibility, sterility assurance levels for reprocessing).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as above.

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