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The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.

Medispec Ltd.'s Econolith™ EM1000 system is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.

The EM1000 device includes a shock wave generator which is based on an Electromagnetic shock wave head and is to be used in conjunction with a multi axes Motorized Treatment Table, a C-Arm X-ray/fluoroscope imaging unit, an ECG monitor, and an anesthesia apparatus, which may be supplied by the user. The device also contains the necessary interface for optional Ultrasonic imaging devices. The EM1000 includes the following components for patient handling, positioning and shock wave generation:

• Shockwave Generator
• Electromagnetic Shock wave head,
• High-Voltage System.
• Water System,
• Treatment Table Control,
• ECG System.
• Control and Timing Circuitry, and
• Front Panel Controls

The provided text describes a 510(k) premarket notification for the Medispec Econolith™ EM1000, an Extracorporeal Shock Wave Lithotripter (ESWL). This document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI diagnostic might.

No specific acceptance criteria values or a detailed study proving the device meets them are provided. The submission relies on establishing substantial equivalence to existing devices and compliance with FDA guidance and performance standards.

Here's an analysis based on the provided text, addressing the requested points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "All specifications are in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards." However, it does not list these specific criteria or the EM1000's performance against them.

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission for a medical device (lithotripter), not an AI diagnostic algorithm. There is no mention of a "test set" in the context of evaluating an algorithm's performance on data. The evaluation for this device would typically involve bench testing, engineering specifications, and a comparison to predicate devices, not data-driven performance metrics on a specific dataset.

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

Not applicable. As this is not an AI diagnostic, there is no "ground truth" established by experts on a test set in the sense of image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging systems or AI software, often comparing human reader performance with and without AI assistance. This document describes a physical medical device (lithotripter) and does not involve human readers interpreting data.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical lithotripter system, not a standalone algorithm. Its operation inherently involves a human operator (e.g., a urologist) and other medical equipment.

7. Type of Ground Truth Used

Not applicable in the context of an AI diagnostic. For this medical device, the "ground truth" would relate to its engineering specifications, safety, and effectiveness in fragmenting stones, which would be evaluated through pre-clinical testing (e.g., in vitro stone fragmentation studies, animal studies) and clinical experience with predicate devices, rather than a diagnostic 'ground truth'. The document confirms the device's "Intended Use" as "non-invasive fragmentation of upper urinary tract stones."

8. Sample Size for the Training Set

Not applicable. As this is not an AI diagnostic, there is no "training set."

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

Not applicable.

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