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The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

The Lite-Med LM-9300 Plus 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 Plus system consists of a shockwave generator, an operator interface (industrial PC with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, two more optional 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 Plus 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.

The provided text describes a medical device, the Lite-Med LM-9300 Plus Lithotripter, and its clearance by the FDA based on substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or any study involving AI or human readers.

The document specifically states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices." This indicates that no clinical performance study, multi-reader multi-case study, or standalone algorithm performance assessment was conducted or submitted for this device in the context of its 510(k) clearance. The clearance is based on the device's technical characteristics being similar to a previously cleared predicate device and compliance with relevant safety standards.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and technical equivalence, not clinical performance data or AI model evaluation.

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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."

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The Lite-Med LM-9200ELMA 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.

The Lite-Med LM-9200 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-9200 ELMA device consists of a Shockwave Generator, an operator interface/touch panel, and a water circulation subsystem. 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 ficld 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.

For the ESWL operation to be fully functional, two or three optional subsystems are needed. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved electrically in all three axes.

The provided document describes the Lite-Med LM-9200 ELMA Lithotripter, an Extracorporeal Shock Wave Lithotripter (ESWL) for fragmenting kidney and ureteral stones.

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria for clinical performance are not explicitly stated as numerical targets in the provided text. Instead, the study reports an "overall success rate" against which its performance is implicitly measured, and also highlights safety and compliance with standards.

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

• Sample Size for Test Set: 40 patients (30 male, 10 female)
• Data Provenance: Not explicitly stated, but the company is based in Taipei City, Taiwan. The clinical investigations were performed at 2 sites, implying prospective data collection for the purpose of this application.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document refers to "experiences of physicians" but does not specify the number of experts used to establish a formal "ground truth" for the test set, nor their specific qualifications (e.g., years of experience). The assessment of device function and safety, as well as the success rate, would presumably be based on clinical evaluations by the treating physicians at the two sites.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the success rate or safety outcomes. Clinical outcomes were reported, implying a direct assessment by the treating physicians without an explicit external adjudication panel.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the LM-9200 ELMA Lithotripter alone.

6. Standalone Performance Study

Yes, a standalone study was performed. The clinical investigation directly assessed the performance of the LM-9200 ELMA Lithotripter without human-in-the-loop assistance for the primary function of stone fragmentation. The clinical success rate of 85% for stone fragmentation and the safety profile were assessed based on the device's use.

7. Type of Ground Truth Used

The ground truth appears to be based on clinical outcomes as assessed by treating physicians. The "overall success rate" would be defined by the clinical fragmentation of kidney and ureteral stones, likely confirmed through imaging or other medical follow-ups. Safety was also assessed based on clinical observations and patient evaluations.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the concept of a training set as typically applied to machine learning models is not relevant here.

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

As noted above, the device is a physical lithotripter, not an AI/ML algorithm. Thus, there is no "training set" or ground truth establishment method for a training set in this context. The physical and technological characteristics of the device were established through measurements based on standards like IEC 61846.

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