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The GEMSS UROCAMP ASADAL-M1, Extracorporcal Shockwave 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 GEMSS UROCAMP Medical Systems Co., Ltd., ASADAL-M1 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, and flexibility. The ASADAL-M1 device consists of a Shockwave Generator, an operator interface 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 soil, 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 shock waves and cooling of the generator. For the ESWL operation to be fully functional, two or three subsystems are provided. 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 in all three axes.

The GEMSS UROCAMP ASADAL-M1 Extracorporeal Shock Wave Lithotripter is indicated for fragmentation of kidney stones and ureteral stones. The provided text details a clinical study to support its safety and effectiveness, but it does not explicitly state specific acceptance criteria (e.g., stone-free rate, complication rate thresholds) with numerical targets. Instead, the clinical study aims to demonstrate that the device is "safe and without follow-up complications."

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, the submission does not explicitly define numerical acceptance criteria for clinical performance (e.g., target stone-free rates or complication rates). It focuses on safety and comparison to predicate devices. The "reported device performance" from the clinical study is qualitative in terms of safety.

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

• Sample Size: 200 patients (142 male and 58 female).
• Data Provenance: The studies were performed at "two sites." The country of origin is not explicitly stated for the clinical sites, but the company is based in Korea. The study appears to be prospective as it describes "clinical investigations were performed... with one and two week follow-ups."

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

• The text mentions "The experiences of physicians have shown that patients treated by the ASADAL-M1 are safe and without follow-up complications."
• The number and specific qualifications of the physicians/experts are not detailed. It refers to "physicians" generally, implying the clinicians who performed the treatments and follow-ups.

4. Adjudication Method for the Test Set:

• The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The safety and lack of complications appear to be assessed by the treating physicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was NOT done. The study described focuses on the device's safety and effectiveness in a standalone clinical investigation demonstrating its performance post-treatment. There is no mention of comparing human readers' performance with and without AI assistance. This device is a lithotripter, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable as the device is a medical device for therapeutic intervention (lithotripsy), not an algorithm for diagnosis or image interpretation. The clinical study described evaluates the device's performance directly on patients.

7. The Type of Ground Truth Used:

• The "ground truth" for the clinical study was based on clinical outcomes and physician assessment of safety and absence of complications among treated patients, observed during follow-up visits. This is an outcomes data approach, specifically focusing on the absence of adverse events and perceived safety/effectiveness by clinicians.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device (lithotripter), not an AI algorithm that requires a training set of data.

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

• Not applicable. As the device is not an AI algorithm, there is no training set or ground truth establishment relevant to an AI model's training.

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