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The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

The Lite-Med LM-9000 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 ELMA system consists of a shockwave generator, an operator interface (industrial computer with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, one or two more subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 ELMA both X-ray and ultrasound are used for patient positioning and monitoring purposes.

Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the LM-9300 ELMA Lithotripter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for a diagnostic device. Instead, it describes performance based on the clinical outcome of stone fragmentation. The key performance indicator is the "stone-free ratio."

It's important to note that these "acceptance criteria" are derived from the observed clinical performance and are presented as evidence of the device's efficacy, rather than pre-defined thresholds the device had to meet to be approved. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

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

• Sample Size: 44 patients with 44 stones.
• Data Provenance: The study was a prospective clinical investigation performed at 2 sites. The country of origin is not explicitly stated, but the manufacturer is Lite-Med Inc. from Taipei City, Taiwan.

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

This information is not provided in the document. For a lithotripter, ground truth would typically refer to the confirmed presence and size of stones before treatment, and the assessment of stone fragmentation and stone-free status after treatment. This assessment would usually be done by medical professionals (e.g., urologists, radiologists) using imaging techniques (X-ray, ultrasound). The document states "follow-up to support this application," implying expert assessment, but does not detail the number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• No, a multi-reader multi-case comparative effectiveness study was not conducted.
• The study described is a clinical investigation focused on the LM-9300 ELMA's performance, not a comparison of human readers with and without AI assistance. The LM-9300 ELMA is a physical medical device (lithotripter) that treats stones, not a diagnostic AI algorithm.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not conducted in the context of an AI algorithm.
• The LM-9300 ELMA is a physical lithotripter. The performance study refers to its efficacy in fragmenting stones in human patients.

7. Type of Ground Truth Used

The ground truth implicitly used for the clinical study was based on clinical outcomes/assessments of stone presence, size, fragmentation, and "stone-free" status at 1, 2, and 4 weeks follow-up. This likely involved medical imaging (X-ray, ultrasound) and clinical judgment by treating physicians, although specific methods are not detailed.

8. Sample Size for the Training Set

The document describes a clinical investigation (the "test set" or evaluation dataset), but it does not mention a separate "training set" for an algorithm. This is consistent with the device being a physical lithotripter rather than a machine learning or AI-driven diagnostic tool.

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

Since no training set for an algorithm is mentioned, this information is not applicable.

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