(15 days)
The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.
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The provided text is a 510(k) summary for the Dornier Lithotripter 140, which is a medical device for fragmenting urinary tract stones. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with detailed statistical analysis as would be done for an AI/ML diagnostic device.
Therefore, many of the requested categories for AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this 510(k) summary for a lithotripter.
However, I can extract the relevant information based on what is available in the document.
Acceptance Criteria and Device Performance for Dornier Lithotripter 140
As this is a 510(k) submission for a physical medical device (lithotripter), the "acceptance criteria" are not reported as quantitative performance metrics (like sensitivity/specificity for AI models) but rather as the device's functional equivalence and safety compared to predicate devices. The study proving this typically involves demonstrating that the new device's technological characteristics and overall performance are substantially equivalent to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criterion (Implied) | Reported Device Performance (Dornier Lithotripter 140) |
|---|---|---|
| Intended Use | Same as predicate devices | Indicated for fragmentation of urinary tract stones (renal calyceal, renal pelvic, and upper ureteral stones), which is the same as the predicate devices. |
| Technological Characteristics | Substantially equivalent to predicate devices with no significant differences that raise safety/effectiveness concerns | The submitter states that "the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices." |
| Overall Performance | Substantially equivalent to predicate devices with no significant differences that raise safety/effectiveness concerns | The submitter states that "the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices." |
| Safety and Effectiveness | Demonstrated to be safe and effective, similar to predicate devices. | The safety and effectiveness are based on a determination of substantial equivalence to the predicate devices. The minor differences are believed to "not raise any concerns regarding the overall safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) for a physical medical device, not a data-driven AI/ML device requiring a test set of data. The submission relies on comparison of design specifications and technological characteristics to predicate devices.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable. This type of submission typically involves engineering and clinical review of device specifications and clinical indications, rather than expert-based ground truth for a diagnostic output.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC study was not done. This is a physical lithotripter, not an AI-assisted diagnostic device for human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance (PMA or 510(k)). The substantial equivalence argument relies on the assumption that if the new device is sufficiently similar, it will also be safe and effective for the stated indications.
8. The sample size for the training set
- Sample Size: Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
§ 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.”)