(77 days)
Indicated for the fragmentation of 5-25 mm kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones > 4mm.
Not Found
The provided document is a 510(k) summary for a medical device (Dornier Compact Alpha Lithotripter) seeking substantial equivalence to predicate devices, rather than a study demonstrating the device meets a specific set of acceptance criteria with reported performance metrics. Therefore, many of the requested categories related to a clinical study demonstrating performance against acceptance criteria cannot be extracted.
The document primarily focuses on establishing "substantial equivalence" of the Dornier Lithotripter S and S-XP with EMSE 220f/220F-P to existing predicate devices (Dornier MFL5000, Dornier Lithotripter S, and Siemens Lithostar C). The argument for safety and effectiveness is based on this substantial equivalence, not on the results of a new study designed to meet specific performance acceptance criteria.
Here's an attempt to answer the questions based on the provided text, with clear indications where the information is not available or not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The submission is a 510(k) for substantial equivalence, which primarily compares the new device's characteristics to predicate devices rather than establishing new performance acceptance criteria and demonstrating achievement through a dedicated study. The document states: "The safety and effectiveness of the Dornier Lithotripter S with the EMSE 220f as well as the Dornier Lithotripter S-XP with EMSE 220F-P is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices..."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available and not applicable as there is no specific "test set" or clinical study described in this 510(k) summary to establish performance against new acceptance criteria. The submission relies on the established safety and effectiveness of predicate devices.
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 information is not available and not applicable as there is no specific "test set" requiring ground truth establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available and not applicable as there is no specific "test set" requiring adjudication 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
This information is not available and not applicable. This device is a lithotripter for kidney stone fragmentation, not an AI-powered diagnostic imaging tool. Thus, MRMC studies and AI-assisted human reader improvement are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available and not applicable. This is a physical medical device (lithotripter), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available and not applicable as no specific study requiring ground truth is described. The basis for safety and effectiveness is substantial equivalence to predicate devices, which would have had their own clinical data or established performance.
8. The sample size for the training set
This information is not available and not applicable as there is no mention of a "training set" for an algorithm in this submission.
9. How the ground truth for the training set was established
This information is not available and not applicable as there is no mention of a "training set" or its ground truth establishment.
Summary of Device Information from the Document:
- Device Name: Dornier Lithotripter S & Dornier Lithotripter S-XP (Compact Alpha Lithotripter)
- Intended Use: Fragmentation of 5-25 mm kidney stones (renal calyx stones, renal pelvic stones) and upper, middle, and lower ureteral stones > 4mm.
- Classification: Class II device with special controls (21 CFR § 876.5990, Product Code: 78 LNS).
- Predicate Devices:
- Dornier MFL5000 (P840008 / S24/S40/S45)
- Dornier Lithotripter S (P840008 / S64)
- Siemens Lithostar C (P870018 / S11)
- Basis for Safety & Effectiveness: Substantial equivalence to predicate devices based on clinical perspective, design specifications, and technological characteristics. The submitter believes "no significant differences exist" and minor differences "should not raise any concerns regarding the overall safety or effectiveness."
§ 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.”)