(27 days)
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
The Gemini 220 XP is a modular urological work station designed for extracorporeal shock wave lithoripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini 220 XP is composed of the following modules: Basic Unit with integrated X-rav C-arm and Therapy Arm for Shockwave Treatment; Patient Table; Control Desk User Interface. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Gemini 220 XP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithoriosy and urological procedures.
The provided text describes a 510(k) submission for the Gemini 220 XP Lithotripter, a medical device. However, it does not include detailed "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one would typically expect for an AI/ML device performance evaluation (e.g., sensitivity, specificity, accuracy, F1-score with associated confidence intervals).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices and compliance with recognized medical device standards. The performance data section primarily lists the standards the device complies with, rather than presenting specific quantitative performance metrics against pre-defined clinical acceptance criteria.
Therefore, I will extract the information available and note where specific details regarding AI/ML-style performance evaluation are absent.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, quantitative acceptance criteria for clinical performance (like sensitivity or specificity) are not present in this document. The "acceptance criteria" here are implied by compliance with established medical device standards and demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety (IEC 60601-1:2007) | Device is in compliance with this standard. |
| Electromagnetic compatibility (IEC60601-1-2:2007) | Device is in compliance with this standard. |
| Radiation protection (IEC 60601-1-3:2008) | Device is in compliance with this standard. |
| Usability (IEC 60601-1-6:2008) | Device is in compliance with this standard. |
| Safety of high-voltage generators (IEC 60601-2-7) | Device is in compliance with this standard. |
| Safety of X-ray source assemblies (IEC 60601-2-28) | Device is in compliance with this standard. |
| Extracorporeally induced Lithotripsy (IEC 60601-2-36:1997) | Device is in compliance with this standard. |
| Safety of X-ray equipment (IEC 60601-2-32:1995) | Device is in compliance with this standard. |
| Quality management system (ISO 13485:2003+AC:2007) | Device is in compliance with this standard. |
| Ultrasonics - Pressure pulse lithotripters (IEC 61846) | Device is in compliance with this standard. |
| Acoustic output of the EMSE | "fully addressed by demonstrating compliance with the appropriate standards." |
| Electrical safety of the system | "fully addressed by demonstrating compliance with the appropriate standards." |
| Electromagnetic compatibility issues | "fully addressed by demonstrating compliance with the appropriate standards." |
| Overall safety or effectiveness (compared to predicate devices) | "minor differences do not raise any concerns regarding the overall safety or effectiveness." |
| Intended Use | "indicated for the fragmentation of urinary tract stones..." (matched predicate) |
| Technological characteristics | "similar technological characteristics as the predicate" |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of AI/ML evaluation (i.e., a dataset used to evaluate an algorithm's performance). The performance evaluation here is based on compliance with engineering and safety standards, and comparison to predicate devices, which does not typically involve a patient data test set in the same manner.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. There is no mention of a "test set" with ground truth established by experts for performance evaluation in the AI/ML sense.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The document describes a medical device (a lithotripter) and its components, not an AI system designed to assist human readers. Therefore, there's no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable in the AI/ML sense. The "ground truth" for this device's performance is compliance with established engineering and medical device safety standards, and functional equivalence to legally marketed predicate devices, as assessed by engineering tests and comparison of specifications.
8. Sample Size for the Training Set
Not applicable. This is a manufactured device, not a machine learning model that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of what the document does provide in terms of performance substantiation:
The application for the Gemini 220 XP Lithotripter is a Special 510(k) Notice indicating it is a modification to a previously cleared device (Dornier Gemini Lithotripter, K121656). The primary method of demonstrating performance and safety is through substantial equivalence to predicate devices and compliance with a comprehensive list of international and national medical device standards.
- Substantial Equivalence: The Gemini 220 XP shares similar technological characteristics, intended use, and core components (e.g., identical shock wave source "EMSE" as K011183, same patient table and X-ray unit as K121656) with its predicate devices. The claim is that "minor differences do not raise any concerns regarding the overall safety or effectiveness."
- Compliance with Standards: The manufacturer states they have "complied with all of the requirements described in FDA's Guidance for the Content of Premarket Notifications (510k's) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi." They explicitly list compliance with:
- Electrical safety standards (IEC 60601-1)
- Electromagnetic compatibility standards (IEC 60601-1-2)
- Radiation protection standards (IEC 60601-1-3)
- Usability standards (IEC 60601-1-6)
- Specific X-ray and high-voltage generator safety standards (IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32)
- Standards specific to extracorporeally induced lithotripsy (IEC 60601-2-36)
- Quality management system (ISO 13485)
- Ultrasonics characteristics (IEC 61846)
- Verification Testing: The document mentions that "during the design and verification testing, the acoustic output of the EMSE, the electrical safety of the system and any electromagnetic compatibility issues were fully addressed by demonstrating compliance with the appropriate standards." This implies internal testing was conducted to meet these standards.
In essence, for this type of device and submission, the "study that proves the device meets the acceptance criteria" is the process of comparing it to predicate devices, demonstrating the equivalence of its functional components, and successfully undergoing internal design and verification testing to meet relevant safety and performance standards. No extensive clinical trial or AI/ML-style performance study is detailed here, as it's not typically required for a 510(k) modification demonstrating substantial equivalence through engineering changes and standard compliance.
§ 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.”)