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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.

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.

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The Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Gemini FPD is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.

The Gemini FPD is composed of the following modules:

• Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment: .
• Patient Table: .
• Control Desk User Interface; and .

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 housing can be positioned with its back close to the room wall and has wide side doors for easy service.

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. the FPD image receptor module, and a high resolution camera 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 FPD's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. It is the same as in the predicate device.

The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

This document is a 510(k) summary for the Gemini FPD Lithotripter, detailing its substantial equivalence to predicate devices rather than providing a study proving its acceptance criteria. Therefore, the information requested regarding acceptance criteria, device performance results, and study methodology for proving acceptance is not present in the provided text.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a new device's performance in a clinical study. The device is evaluated against conformance to existing international standards and substantial equivalence to predicate devices.
• Reported Device Performance: Not provided. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, not on new clinical performance data for the Gemini FPD.

2. Sample Size for Test Set and Data Provenance:

• This information is not available in the provided document. The 510(k) summary describes modifications to an existing device and compares it to predicate devices, rather than an independent clinical study with a test set.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not available. No clinical study with ground truth established by experts is described for this device.

4. Adjudication Method:

• This information is not available. No clinical study with an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done according to this document. The document focuses on demonstrating substantial equivalence based on device design and intended use, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone performance study was not done. The Gemini FPD is a medical hardware device, not an AI algorithm.

7. Type of Ground Truth Used:

• This information is not applicable/not available. The document does not describe a performance study that would require ground truth determination. The evaluation is based on technical specifications and regulatory standards compliance.

8. Sample Size for the Training Set:

• This information is not applicable/not available. The Gemini FPD is a hardware device, and the document is a 510(k) summary for a modification, not a description of an AI algorithm's development.

9. How the Ground Truth for the Training Set was Established:

• This information is not applicable/not available for the same reasons as above.

Summary of what the document does describe regarding compliance and equivalence:

The document asserts that:

• The Gemini FPD device, as well as the predicate device, complies with a list of international standards (e.g., IEC 60601-1 for electrical safety, IEC 60601-2-36 for extracorporeally induced lithotripsy, ISO 13485 for Quality Management System).
• It also complies with all 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.
• The Gemini FPD is substantially equivalent to its predicate devices (Dornier Gemini Lithotripter K121656 and Dornier Genesis K122768) because it has similar technological characteristics and the same intended use. The primary modification is the use of a flat panel detector for X-ray imaging, which is identical to the system used in the cleared Dornier Genesis (K122768). The shock wave source and supporting electronics are identical to the predicate Gemini device.

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