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

The Gemini is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini is composed of the following modules: (1) basic unit with integrated X-ray C-arm and therapy arm for shockwave treatment; (2) patient table; (3) control desk – user interface; and (4) ultrasound unit.

The provided document is a 510(k) summary for the Gemini Lithotripter, detailing modifications to previously cleared predicate devices. It describes the device's intended use, technological characteristics, and conformance to various safety and performance standards. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the way a clinical performance study would.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for clinical performance (e.g., stone fragmentation rates, stone-free rates, re-treatment rates). Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with a list of recognized standards and internal design control processes.

The "reported device performance" is primarily stated as: "In all instances, the Gemini Lithotripter functioned as intended and results observed were as expected." and "the system met all acceptance criteria" during internal design control.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention a clinical "test set" in the context of human patients or image data for evaluating an AI/algorithm's performance. The testing described focuses on engineering verification and validation against standard requirements and internal acceptance criteria during the design control process. There is no indication of retrospective or prospective clinical study data provenance mentioned for the submitted data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth is described. The "ground truth" for the engineering performance was established by the design specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is described.

5. 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

No. This document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study or any AI component designed to assist human readers. The device is an extracorporeal shock wave Lithotripter, a physical medical device for stone fragmentation, not a diagnostic AI system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical Lithotripter, not solely an algorithm. While it has software for control and image storage, the "performance" described pertains to the overall system's operation and safety, not a diagnostic algorithm operating in a standalone mode. The "assessment demonstrated that the system is capable of locating the shock wave focus area with sufficient accuracy," which is an algorithm-driven function, but its evaluation isn't detailed as a standalone algorithm performance study.

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

For the engineering and safety tests, the "ground truth" refers to the pass/fail criteria defined by the recognized standards (IEC, ISO) and the device's design specifications. For the "accuracy of stone localization methodology," the ground truth would have been derived from physical measurements against known targets or possibly phantom studies. No patient outcomes data, pathology, or expert consensus on clinical findings is mentioned as ground truth for the provided performance data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that would typically have a "training set" in the context of deep learning models for image analysis or diagnosis. The device's underlying technology (electromagnetic shock wave emitter, X-ray, ultrasound) is well-established.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary of the Document's Approach:

The K121656 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Dornier Lithotripter (Doli) and Doli 140) based on:

• Identical Intended Use/Indications for Use.
• Similar Technological Characteristics/Principles of Operation: The core component (140f EMSE shock wave source) is identical to those in cleared devices. Other components (patient table, X-ray unit) are "similar to that of other cleared stationary Lithotripters" and "perform the same function and operate in the same manner."
• Compliance with Recognized Standards: A comprehensive list of IEC and ISO standards for electrical safety, EMC, radiation protection, usability, and specific Lithotripter requirements were met.
• Internal Design Control Testing: The company states that the system and its software were tested and validated, meeting "all acceptance criteria" during their design control process. Specific mention is made of the anti-collision system performing as designed and the stone localization methodology demonstrating sufficient accuracy.

This type of 510(k) submission, particularly a Special 510(k) as indicated, often relies heavily on demonstrating that modifications do not raise new questions of safety or effectiveness, rather than requiring extensive de novo clinical trials or AI performance studies with large, expert-adjudicated datasets. The "study" proving the device meets acceptance criteria is the sum of the documented engineering tests and validations against the listed standards and internal specifications, demonstrating its functional equivalence and safety compared to the predicates.

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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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The Delta™ 2000 Series Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The DELTA lithotripter utilizes well known spark gap technology. To generate a shock wave utilizing this method, an electrical discharge is created between two electrodes submerged in water. This sudden discharge of the enormous amount of energy lasts less than 1 microsecond. During this time an evaporation of water surrounding the gap between the electrodes occurs. The evaporation causes an instant expansion of vapor which produces a shock wave. In an extracorporeal lithotripter, the two wire electrodes are embedded in a plastic tube filled with insulating material. On one end of the tube the tips of the wire are bent towards each other with a small gap between them. A source of electrical energy is connected to each wire on the other end of this tubular structure. This electrode assembly is placed inside an ellipsoidal reflector in such a way that the gap between the two conductors coincides with the first focal point of the reflector. The reflector is filled with water and covered with a thin elastic membrane. After discharging the energy, reflected shock waves are transmitted to the second focal point through noncompressible medium, such as water in the reflector and in human tissue. The energy generated at the first focal point is recaptured at the second focal point of the ellipsoidal reflector with only minimal losses. When the second focal point is positioned on the treatment area such as the kidney stone inside the body, the repeated impact of the shock waves on the stone, at various energy levels, causes its disintegration.

This document describes a 510(k) premarket notification for the "Delta™ 2000" Series Lithotripter, seeking substantial equivalence to a predicate device. This is primarily a regulatory submission, not a study report that details specific acceptance criteria and performance data in the structured way requested. Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is the information that can be extracted, along with explanations for what cannot be provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., stone fragmentation rate, success rate, energy delivery accuracy) nor independent "reported device performance" against such criteria. The basis of acceptance is substantial equivalence to a predicate device (EDAP Technomed Sonolith Praktis, K003529).

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

• Sample Size (Test Set): Not specified. The document states "clinical experience demonstrates that the device is equivalent," but it does not provide details about a specific clinical study with a defined test set sample size.
• Data Provenance: Not specified. It refers to "clinical experience" generally, without indicating country of origin, or whether it was retrospective or prospective.

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

• Not applicable. This is a medical device approval document based on substantial equivalence, not an AI/diagnostic algorithm study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

• Not applicable for the same reason as above.

5. 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-assisted diagnostic device, nor does the document describe an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device, not a standalone algorithm.

7. The Type of Ground Truth Used:

• The concept of "ground truth" as typically used in AI/diagnostic evaluation is not directly applicable here. The "truth" for this device's approval is its substantial equivalence to an already legally marketed predicate device, based on comparable characteristics, standards compliance, and overall safety and effectiveness ("clinical experience").

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable for the same reason as above.

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