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The device is a transportable Electromagnetic Extracorporeal Shock Wave Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem. Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices. The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.

AI/ML Overview

The provided text is a 510(k) summary for the DUET MAGNA Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria as would be expected for an AI/ML device.

Therefore, many of the requested items related to AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable or available in this document.

However, I can extract the information relevant to the performance testing and substantial equivalence described, which serves as the basis for device acceptance in this context.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for devices like the DUET MAGNA in a 510(k) process are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective. This typically involves meeting recognized standards for safety, performance, and functionality.

Acceptance Criterion (Implicit from 510(k) process)	Reported Device Performance (from document)
Intended Use Equivalence	"The intended use of Duet Magna is respectively similar to those of the predicate devices." (Fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter).
Functional Equivalence	"The device is a modification of Tripter Compact Duet and is functionally similar to Tripter Compact Duet, except for shockwave generation that is similar to that of Integra." (Incorporates SWAG, MFT, Control subsystem, interfaces for ECG, fluoroscopic, and sonographic imaging. Software control for separate operation of bottom/top transducers in "B", "T", or "A" modes.)
Safety and Performance Standards Compliance	"Furthermore, the Duet Magna has been tested and been found to conform, as do the predicate devices, to FDA recognized standards, including electrical safety testing per IEC 60601-1, EMC testing per IEC 60601-1-2, localization accuracy testing and road testing per the lithotripter special control guidance document." Also lists compliance with: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 606001-2-36, IEC 61846, IEC 60601-2-38, ANSI/AAMI/ISO 10993-1, CISPR 11, IEC 60601-1-4, and the "Guidance for the Content of Premarket Notifications (...) for Extracorporeal Shock Wave Lithotripters".
No New Safety/Efficacy Issues	"Based on an analysis of similarities and differences, we believe that Duet Magna is substantially equivalent to its predicate devices without raising new safety and/or efficacy issues."

Study Information (as applicable for a non-AI/ML device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI/ML software. The document describes compliance with performance and safety standards, but it does not involve a "test set" in the context of AI/ML performance evaluation. The testing would have involved engineering and functional tests on the device itself.
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 / Not Provided: Ground truth and expert review are concepts relevant to AI/ML model validation, not typically for a physical medical device like a lithotripter being evaluated for substantial equivalence in this manner.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
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 / Not Provided: This is not an AI-assisted diagnostic or interpretation device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided: This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For this device, "ground truth" would relate to the physical properties and functional performance measured against established engineering and medical device standards (e.g., shockwave pressure, localization accuracy, electrical safety, biocompatibility, etc.). These are assessed through physical testing, not expert consensus on diagnostic images or pathology.
The sample size for the training set
- Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable / Not Provided: No "training set" or corresponding ground truth establishment is described.

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