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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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The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini XXP-HP is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment, Patient Table, Control Desk User Interface. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-arm. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Gemini XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling. The Gemini XXP-HP also includes a camera to view in real time the integrity of the patient to bellows coupling interface.

The provided text describes the 510(k) summary for the Dornier Gemini XXP-HP lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device type, especially one leveraging AI. Therefore, much of the requested information cannot be directly extracted as it pertains to a different type of device assessment (e.g., AI/ML device performance).

However, I can extract information related to the device's performance based on the clinical study mentioned, even if it's not framed as "acceptance criteria."

Here's the breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria in a quantitative table format that would typically be seen for a new AI/ML device being evaluated for specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the clinical study aimed to confirm usability, safety, and effectiveness of the modified lithotripter.

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

• Sample Size: Not explicitly stated in the provided text. The phrase "a confirmatory clinical study was performed" implies a patient cohort was involved, but the number of patients is not given.
• Data Provenance: Not explicitly stated. Clinical studies for such devices are typically multi-site and can involve different countries, but this information is absent. It's likely prospective since it's a "confirmatory clinical study."

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

This information is not applicable as the study described is a clinical study on a medical device, not a study evaluating an AI algorithm where ground truth for imaging or diagnostic tasks would be established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typical for expert review of AI outputs, not for the direct outcome of a lithotripsy procedure.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which doesn't apply to a lithotripter device that directly performs a physical intervention.
• Effect size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Was it done? No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to the clinical outcomes and safety observations from the patients treated with the device. This would typically include:

• Stone fragmentation (assessed via follow-up imaging)
• Stone-free status
• Adverse events (e.g., hematoma, pain, other complications)

This is effectively a form of outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. This device is a physical medical device. It does not involve an AI algorithm with a training set.

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

This information is not applicable for the reasons stated in point 8.

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The STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The Storz Modulith SLK is a modification of the previously cleared Storz Modulith SLK, K011700. The device consists of a Shockwave Generator, an operator interface/touch panel, and a coupling cushion. Shock waves are generated when a rapid current pulse changes the diameter of a cylindrical shaped body. The shock waves are focused by a parabolic reflector. A water circuit is used to for generating the required coupling pressure.

The Modulith SLK has been modified to include an integrated patient table, the Lithotrack optical coupling C-Arm alignment mechanism was replaced with the crosshair manual aiming mechanism used in the Modulith SLX-F2 device (K072788), and an updated user interface that includes patient table movement control. It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney and the upper ureter. The modifications incorporated do not alter the intended use or the fundamental technology and also does not raise any issues of safety and effectiveness.

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

The provided document is a 510(k) Summary for a medical device called the "Storz Modulith SLK," which is an extracorporeal shock-wave lithotriptor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a novel AI algorithm might.

Therefore, the requested information elements related to AI algorithm performance (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for training) are not applicable to this type of submission. This document describes a modification to an existing, cleared device, and the focus is on physical and technical equivalence.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this conventional medical device submission are primarily based on demonstrating that the modified device has substantially equivalent technological characteristics and performance to its predicate device, and that the modifications do not raise new issues of safety or effectiveness.

Here's the table of core technological characteristics and performance parameters, comparing the subject device to its predicate:

Table 1: Acceptance Criteria and Reported Device Performance (Technological Characteristics)

In addition to technological characteristics, specific shock wave acoustic parameters were measured:

Table 2: Acceptance Criteria and Reported Device Performance (Shock Wave Acoustic Parameters)

The document states: "The results are found similar to the predicate device characteristics," implying that these measured values meet the "acceptance criteria" of being comparable to the predicate.

The Study that Proves the Device Meets Acceptance Criteria

The study described is a non-clinical performance and safety testing focused on demonstrating substantial equivalence.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving patient data or images to test an algorithm. It's bench testing of a 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 device performance (e.g., pressure measurements) is established by calibrated instruments and engineering standards, not expert radiologists.

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 not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

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

   • For the physical characteristics and acoustic parameters: Measurement against established engineering standards and specifications. The shock wave characteristics were measured "according to the guideline described in the consensus standard IEC 61846 'Ultrasonics- Pressure pulse lithotriptcrs- Characteristics of fields' (1998)." A glass fiber hydrophone was used for measurements.
   • For safety: Compliance with recognized safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, and IEC61846).

7. The sample size for the training set: Not applicable. This is not an AI device (no training set).

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

In summary, the study described is a comprehensive bench testing and safety evaluation, rather than a clinical trial or an AI performance study. The "acceptance criteria" are the established performance parameters of the predicate device and relevant industry standards for safety and acoustic measurements. The "study" consisted of performing these measurements and tests on the modified device to confirm its equivalence and adherence to safety requirements.

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