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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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