(104 days)
The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities. The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis NUW -- 2 2005 Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
Due to the limited information in the provided text, a full and detailed description of acceptance criteria and a study proving the device meets them cannot be generated for all aspects. However, I can extract and infer what is available.
The provided text describes a 510(k) summary for the LithoGold extracorporeal shock wave lithotripsy (ESWL) device. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy against pre-defined acceptance criteria in the same way a PMA study might.
Here's an attempt to answer your request based on the provided text:
Acceptance Criteria and Study for LithoGold
The primary "acceptance criteria" for a 510(k) device like LithoGold are to demonstrate substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The study described focuses on achieving this substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k) Process) | Reported Device Performance (LithoGold) |
|---|---|---|
| Intended Use | Fragment urinary stones in kidney (renal pelvis/calyces) and ureter (upper, middle, lower). | Meets: The LithoGold is intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower). |
| Technological Characteristics | Similar design features to predicate device (electrohydraulic method, ECG gating/fixed frequency). | Meets: "Both the LithoGold and the predicate device have similar technical design features..." "The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities." |
| Safety and Effectiveness | Safety and effectiveness outcomes substantially equivalent to predicate lithotripsy devices. | Meets: "The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices." |
| Acoustic Qualities | Conformity to IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998). | Meets: "The LithoGold acoustic qualities have been measured using the methodology described in the consensus standard IEC 61846..." |
| Electrical and EMC Testing | Conformity to recognized consensus standards. | Meets: "...the device has been found to conform to recognized consensus standards for electrical and EMC testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text only mentions "The confirmatory clinical study." It does not provide the number of patients or cases included in this study.
- Data Provenance: Not explicitly stated. It is a "confirmatory clinical study," which generally implies a prospective study conducted for regulatory submission. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For a lithotripsy device, "ground truth" often relates to stone fragmentation success or clearance, which would typically be assessed by treating physicians and follow-up imaging. However, the details of how this was established are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an ESWL device for stone fragmentation, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable as the LithoGold is a medical device for treatment, not an algorithm. Its performance is evaluated on its ability to fragment stones, a function directly delivered by the device in conjunction with human operation.
7. The Type of Ground Truth Used
The "ground truth" implicitly referred to in the clinical study is the safety and effectiveness outcomes for treating patients with renal or ureteral calculi. This would typically involve clinical outcomes data such as:
- Stone fragmentation success (e.g., size reduction, number of fragments)
- Stone clearance rates
- Complications/adverse events
These outcomes would be assessed by clinical examination, imaging studies (e.g., X-ray, ultrasound), and patient follow-up.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device in the same way it would be for an AI algorithm. The LithoGold is a hardware device. Its design and manufacturing processes are likely informed by engineering principles, bench testing, and potentially prior clinical experience with similar devices, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
As the concept of a "training set" is not applicable, the method for establishing its "ground truth" is also 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.”)