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The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures, including but not limited to:
Querying and retrieving patient information and/or image from other modalities-
X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB², IVP, reflux-cystogram, cystourethrogram, and micturition cystourethrogram combined with uroflow measurements.3
Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).3
Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)2
Application of fistula (kidney/bladder)3
Simple procedures (e.g. urethra, testis, phimosis)3
Intracorporeal shock wave lithotripsy3
Uroflow/urodynamics3
Pediatric radiological and therapeutic applications3(ages 2 to 22 years)

The operating principle of the subject devices, XR-MX/1000, manufactured by STORZ MEDICAL, AG., is identical to the predicate device, Uroview FD, manufactured by Pausch Medical GMBH, cleared via K161019. Both the subject and predicate devices include the following major X-ray components: Basic unit (C-MX C-Arc) X-Ray generator (source) X-Ray tube and housing (column) Collimator (image receptor) Measuring chamber (image receptor) Detector (image receptor) Digital image station (image receptor) The basic unit of the subject devices is comprised of an arm that is shaped in the letter “C” which gives the component its name “C-arc". One end of the C-arc includes an x-ray source and the opposite end includes an image receptor; while the basic unit of the predicate device is comprised of a urological table. The x-ray source emits the focused x-ray energy which is then transmitted through the body and is finally captured by the receptor, providing an image of the desired anatomy. The basic unit in both the subject and predicate devices is able to move, allowing the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy being imaged. Additionally, the subject and predicate devices both include a workstation, which includes a monitor suspension arm that allows dual monitors for image display (radiologic and/or endoscopic) and space that allows other devices (e.g. camera control unit, documentation unit, etc.)

The provided text is a 510(k) summary for the KARL STORZ XR-MX/1000 device, which is an image-intensified fluoroscopic X-ray system. The document states that clinical performance data was not required to demonstrate substantial equivalence to the predicate device. Therefore, the information requested in points 1 through 9 (related to acceptance criteria derived from a clinical study, sample sizes, expert involvement, ground truth, and MRMC studies) is not available in this document.

The manufacturer, KARL STORZ Endoscopy America, Inc., demonstrated substantial equivalence primarily through non-clinical bench testing and by showing that the device complies with recognized consensus standards.

Here's the relevant information from the document regarding the device's testing and acceptance:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria (Implied): Compliance with recognized consensus standards and meeting design specifications.
* Reported Device Performance:
* "The XR-MX/1000 systems follow the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance:
* Electrical Safety and EMC
* IEC 60601-1
* IEC 60601-1-2
* IEC 60601-1-3
* IEC 60601-1-6
* IEC 60601-2-28
* IEC 60601-2-54
* Software Verification and Validation Testing
* Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
* Level of concern: Minor
* "Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the XR-MX/1000 systems have met all their design specifications and are substantially equivalent to the predicate device."

Summary of missing information:

Points 2 through 9 are not applicable or the information is not provided because the submission did not rely on clinical performance data for substantial equivalence. The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

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