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

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."

2. Sample size used for the test set and the data provenance

The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.

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

This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.

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 MRMC comparative effectiveness study was done or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.

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

This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.

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

For the described tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
• Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
• Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.

8. The sample size for the training set

Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.

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

Not applicable, as there is no mention of a training set.

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

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table;
• . Control Desk - Image Processing.

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.

Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.

Here's an analysis based on the provided text, addressing the points you requested where relevant:

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

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.

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 describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.

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)

This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.

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

This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes requiring expert adjudication.

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

This section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

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

This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.

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

For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III Lithotripter is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk Image Processing.

The provided document is a 510(k) summary for the Dornier Delta III Lithotripter, detailing its substantial equivalence to predicate devices. It mentions a retrospective confirmatory clinical study, but it does not provide specific acceptance criteria or the study's detailed results in a format that allows for a table of acceptance criteria vs. device performance.

Here's an analysis of the information available and what is not present in the document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A retrospective confirmatory clinical study was performed using the Delta III Lithotripter. As compared to the currently cleared Dornier Lithotripters, the overall treatment results were comparable for the subject device. The complication rate was extremely low."

However, specific numerical acceptance criteria (e.g., stone-free rate, fragmentation rate, complication rate thresholds) and precise reported device performance metrics against those criteria are not provided in this 510(k) summary. The summary only gives a qualitative statement of comparability and low complication rates.

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

The document does not specify the sample size for the retrospective confirmatory clinical study. It is stated to be a "retrospective confirmatory clinical study." The country of origin of the data is not specified.

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

This information is not provided in the document. The type of ground truth used (e.g., imaging, clinical outcomes) is also not detailed for the clinical study.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The clinical study described is a "retrospective confirmatory clinical study" to compare overall treatment results and complication rates, not specifically to evaluate human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is an extracorporeal shock wave lithotripter, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable and not mentioned. The performance data section refers to compliance with standards for acoustic output, electrical safety, and electromagnetic compatibility for the hardware device itself.

7. Type of Ground Truth Used

For the retrospective clinical study, the document broadly refers to "overall treatment results" and "complication rate." It does not explicitly state the method by which ground truth for treatment success or stone fragmentation was established (e.g., follow-up imaging, clinical assessment, pathology).

8. Sample Size for the Training Set

The Delta III Lithotripter is a hardware device for lithotripsy, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, this concept is not applicable and not provided. The device development involved design and verification testing, and compliance with standards.

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

As above, the concept of a "training set" for an AI algorithm is not applicable to this device.

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