(40 days)
LITHOSTAR Modularis with Shockwave System Coplis is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Siemens LITHOSTAR MODULARIS with Shockwave System Collis is a modification to our predicate device. The shockwave head has been modified to provide an increased penetration depth for a more obese patient population. The penetration depth has been increased from 120mm to 140mm..
The provided text describes a 510(k) submission for a medical device called "LITHOSTAR MODULARIS with Shockwave System Collis." This device is a modification of a previously approved lithotripter, designed to increase penetration depth for obese patients.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
The document states that the device is "safe and effective and comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21)." This implies that the acceptance criteria are met if the modified device performs equivalently to the predicate device in terms of safety and effectiveness for its stated indications for use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "safe" |
| Effectiveness | "effective" |
| Comparability to Predicate Device | "comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21)." |
Study Details
The document mentions "The confirmatory clinical study," indicating that a clinical study was performed. However, it provides very limited details about this study.
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Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions a "confirmatory clinical study" but does not detail how ground truth was established within this study, nor does it refer to experts establishing ground truth for a test set in the context of an AI/algorithm-driven device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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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:
- The document does not mention or suggest that an MRMC comparative effectiveness study was performed. The device described is an extracorporeal shockwave lithotripter, not an AI-assisted diagnostic or interpretation tool. The comparison is between the new device and a predicate device for stone fragmentation, not between human readers with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument (lithotripter) used for therapeutic procedures, not a diagnostic algorithm. Therefore, "standalone algorithm performance" is not relevant to this device's evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document states "The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSTAR MODULARIS with Shockwave System Colls is safe and effective." This implies that the ground truth for "effectiveness" would likely be based on outcomes data related to stone fragmentation and clearance, and "safety" based on documented adverse events. However, specific metrics or methods for establishing this ground truth are not detailed.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept is relevant to machine learning models, not physical medical devices like a lithotripter.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary, the provided information is for a conventional medical device (lithotripter) modification, not an AI/ML-driven device. Therefore, many of the requested details pertaining to AI/ML evaluation (like training sets, expert adjudication for algorithms, MRMC studies for AI, etc.) are not present in the document. The evaluation focuses on the physical and clinical performance of the modified device compared to its predicate.
§ 876.4890 Urological table and accessories.
(a)
Identification. A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.(b)
Classification. (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.