(134 days)
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."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Standards Compliance: | |
| IEC 60601-1 (Electrical safety) | Compliant |
| IEC 60601-1-2 (EMC) | Compliant |
| IEC 60601-1-3 (Radiation protection) | Compliant |
| IEC 60601-2-36 (Lithotripsy safety) | Compliant |
| IEC 60601-2-28 (X-ray tube assemblies) | Compliant |
| IEC 60601-2-54 (X-ray equipment safety) | Compliant |
| IEC 62366-1 (Usability engineering) | Compliant |
| IEC/TR 62366-2 (Usability guidance) | Compliant |
| Bench Testing (Functional Validation): | |
| New ultrasound device provides visual and accurate images for stone visualization | Performance assured; provides visual and accurate images |
| New camera image quality is equal to or better than the predicate | Image quality equal to or better than the predicate |
| UIMS software with AGFA package does not impact equipment functioning and processes X-ray images | Does not impact functioning; provides ability to further process X-ray images |
| Electrical safety, EMC, functional usability are fully addressed | Demonstrated compliance with standards and equivalent performance to predicate |
| No unanticipated new risks identified | No unanticipated new risks identified |
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.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)