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For devices (10970A, 10970B, 10970DS, 10973HD)
Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients >= 12 years of age.

For devices (10900GO,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML)
The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients >= 12 years of age.

The Mediastinoscopes and Instruments submitted in this 510(k) consist of two (2) variants of mediastinoscope devices and compatible instruments relative to either variant:

1. Mediastinoscopes and Adaptor: 10970A, 10970B with optional adapter 10970DS and
2. HD Mediastinoscope: 10973HD
3. Forceps:
   a. Forceps inserts: 10900GO, 10900GP, 10900GR, 10900M, 10900MO, 10900MP
   b. Outer sheath: 10970
   c. Biopsy Forceps: 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H
   d. Sponge and Dissecting Forceps: 10970K, 10970M, 10970ML

MEDIASTINOSCOPES AND ADAPTOR
The surgical stainless steel mediastinoscopes (10970A, 10970B) are non-powered, reusable surgical instruments consisting of a compact handle integrated with a rigid sheath terminating in a spatula-shaped (beveled) distal geometry to provide access to and visualization of the mediastinum and a working channel for atraumatic entry of surgical instrumentation. They rely on externally connected optical and illumination components for visualization and contain no active electronic components.

Visualization may be accomplished either via

1. A light carrier inserted into the mediastinoscopes and connected to an external light source for direct visualization of the surgical field or
2. A surgical stainless steel adaptor (10970DS) attached to the proximal end of the sheath, enabling insertion of a compatible rigid telescope into the mediastinoscopes, which is connected to an external light source and compatible camera heads and control unit (CCU) to provide video visualization of the surgical field.

Note: The mediastinoscopes are a non-spreadable design and may be used with a light carrier.

HD MEDIASTINOSCOPE
(Identical to the HD Mediastinoscope 10973HD cleared under K213194)

The HD Mediastinoscope (10973HD) is comprised of four main components: a CMOS sensor located at the distal end of the endoscope, an oval insertion portion (spatula), a handle, and an internal LED light source. The subject device is unchanged in design, materials, dimensions, optical characteristics, and illumination performance when compared to the HD Mediastinoscope (10973HD) cleared under K213194.

The only difference between the subject device and the cleared device is an expansion of the indicated patient population to include adolescents >=12 years of age.

INSTRUMENTS
The KARL STORZ Mediastinoscopes and Instruments, including forceps and accessories, are manually operated, reusable surgical devices intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients >=12 years of age.

Forceps and sheaths are integral accessories that enable the mediastinoscope to perform its intended diagnostic and therapeutic functions. Sheaths provide a protective channel and maintain visualization while allowing instrument passage, whereas forceps deliver essential capabilities for grasping, cutting, and biopsy of tissue. In combination these instruments complement the mediastinoscope design by facilitating safe tissue manipulation and sampling without requiring additional incisions, ensuring the system operates as a complete solution for mediastinal, pleural, and parenchymal procedures.

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The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

Endoscopic ICG System
Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope.
Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Exoscopic ICG System

VITOM ICG SYSTEM
The KARL STORZ VITOM ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics ≥ 1 month of age.
The VITOM ICG System is intended to provide a magnified view of the surgical field.

RUBINA Lens System
The RUBINA Lens System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics ≥ 1 month of age.
Upon interstitial administration and use of the ICG consistent with its approved label, the RUBINA Lens System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon intradermal administration and use of the ICG consistent with its approved label, the RUBINA Lens System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults undergoing breast surgical procedures for which fluorescence imaging is a component of intraoperative management.
The RUBINA Lens System is intended to provide a wide-angle view of the surgical field.

The RUBINA® Lens supports anatomical visualization under white light and NIR/ICG fluorescence. Its native 16:9 full-screen image eliminates the need for digital zoom, enabling shorter working distances that help maintain fluorescence signal capture during procedures requiring continuous visualization of lymphatic or perfusion-related structures.

The device incorporates a wide-angle optical design and expanded focus range, supporting consistent imaging across variable working distances for applications such as:

• Fluorescence-guided assessment of tissue perfusion
• Visualization of lymphatic pathways and sentinel lymph nodes

The RUBINA® Lens features a 90° direction of view and may be used handheld or mounted to a compatible holding arm. Rotation of the attached camera head allows horizon adjustment to maintain anatomical orientation.

The system provides continuous white-light and NIR/ICG visualization for display on standard operating room monitors. The device achieves optimal illumination at approximately 18 cm and maintains fluorescence visualization across a broad working distance range, supporting use in applications such as perfusion assessment and lymphatic mapping.

The subject device RUBINA® Lens is compatible with the following components within the KARL STORZ ICG Imaging System:

• IMAGE1 S™ Rubina® camera head (TH121) previously cleared on K201399 and K202925.
• IMAGE1 S™ Camera Control Unit (CCU) (TC201US, TC304US) previously cleared on K212695, K201135, K233333, K232857.
• Fiber Light Cables (495NCSC, 495TIP): used to transmit visible and NIR light from the Power LED Rubina Light Source (TL400) to the RUBINA® Lens. The 495NCSC was previously cleared K201399, and K202925. The 495TIP Fiber Light Cable was most recently cleared in K233333.
• The Power LED Rubina® Light Source (TL400) previously cleared in K201399, K202925, K212695, K232857, and K233333. The TL400 is included as a subject device, as the KARL STORZ ICG Imaging System Indications for Use reflected in the TL400 labeling require revision within this 510(k). No modifications have been made to the TL400 with respect to materials, technological characteristics, performance, reprocessing, or any other essential design features.
• Footswitch (UF101): [Optional] Previously cleared in K201399, K202925, K212695, and K232857.

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The IMAGE1, a camera control unit (CCU), when used with compatible camera heads or videoendoscopes and ancillary equipment, is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures in adults and pediatrics.

The X-to-4U Adapter, as ancillary equipment, is intended to connect compatible camera heads or videoendoscopes to the IMAGE1 CCU.

The IMAGE1 CCU is the next generation KARL STORZ CCU designed for use by medical professionals in an OR setting to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures. The IMAGE1 CCU performs image processing functions including color processing, color filtration, and image enhancement and is compatible with many KARL STORZ C-Line and 4U connector type camera heads. Software extensions and applications can be purchased by the user and downloaded onto the CCU to provide additional features beyond those of the default set.

For compatibility with the X-link connector type camera head and videoendoscopes, IMAGE1 requires the X-to-4U adapter. The X-to-4U Adapter provides an electromechanical interface between the X-Line family of Flexible Videoendoscopes and the 4U-Receptacle of the IMAGE1 CCU.

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The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

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 Intubation Video Endoscope – Sterile (FIVE-S) is 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 (when using the Image1 S CCU), 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 the compatible CCU (Camera Control Unit) 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.

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The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.

The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.

The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.

• The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
• The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
• The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.

The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.

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For telescope (27033AA)
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that utilizes fiber optic technology. The shaft of the endoscope consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. The Miniature Telescope for Urology (27033AA) is just an optic, without a working or irrigation channel. It is always used in combination (e.g. with sheath (or working element and sheath). Thus providing instruments access to the operative site.

The Miniature Telescope for Urology (27033AA) is available in the following:
Direction of View: 0°
Field of View: 72.5°
Diameter: 3.5Fr
Working Length: 21cm

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The ENDOFLATOR + is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas with the following operating modes:

• High Flow and Pediatric modes are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure.
• Pediatric mode is indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure in pediatrics aged 2 and up.
• EVH mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
• taTME mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery.

The ENDOFLATOR + is an insufflation device with integrated smoke evacuation for laparoscopic examinations and surgery as well as transanal endoscopy and endoscopic vessel harvesting. Insufflation creates and maintains a cavity in the patient's body. The subject device offers four operating modes: High Flow, Pediatric, EVH, and taTME.

Smoke evacuation can be used with different flow rates for removal and filtration of CO2 and surgical smoke during operation.

The ENDOFLATOR + is operated directly on the touchscreen. All data required during the surgery is displayed simultaneously on the touchscreen.

The subject device is to be used with one of the following tube sets depending on the selected mode and desired features (smoke evacuation, heating, and humidification) needed: UI610 (standard), UI611 (heating), UI612 (smoke evacuation), UI613 (heating + smoke evacuation), and UI614 (heating + smoke evacuation + humidification).

The tube sets are designed with a radio frequency identification (RFID) transponder technology tube set recognition function, that recognizes the type of tube set that has been connected and which functions are available based on the selection.

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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

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

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

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

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

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

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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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 KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.

Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.

The 510(k) summary explicitly states:

Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.

Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope

As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.

Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.

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

• Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
• Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.

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

Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. An MRMC study was not conducted as no clinical performance study was performed or required.

6. If a Standalone Performance Study (Algorithm Only) Was Done

Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.

8. The Sample Size for the Training Set

Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.

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

Not applicable. No clinical training set was used.

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