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SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment.

The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment.

The SDX Systems are intended to be used in conjunction with a Radiation Therapy systems (imaging & treatment) requiring operator intervention to start & stop radiation. The Automatic Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment. The Automatic Gating Module provides the direct interface between the SDX Module and the Imaging / Radiation Treatment equipment; providing channels on : device communication / identification, recommendation to start Patient Imaging / Radiation, order (or recommendation) to stop patient Imaging / Radiation. The Automatic Gating Module is connected, via cabling, to the Radiation Therapy systems via their own "external interfacing equipment". The use of the Automatic Gating Module allows the SDX to optimize breathing to limit internal motion during imaging & treatment independent to the breathing method chosen, Breath Hold, Free Breathing, etc. Thus patients breathing pattern allows the selection of the gating levels, facilitate the starting & stopping of the radiation beam between the two defined levels.

Here's a summary of the acceptance criteria and study information for the SDX System with Automatic Gating Module, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance:

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance. The submission refers to "Performance Testing of the Automatic Gating Module" to demonstrate conformance.
   • Data Provenance: Not specified. The testing was conducted to demonstrate conformance to specifications of radiotherapy device manufacturers. The context implies bench or engineering testing rather than a clinical study with patient data.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable for the type of testing performed. The "ground truth" for the performance testing cited would be the technical specifications and safety standards (IEC 60601-1, IEC 60601-1-2, and radiotherapy device manufacturer specifications).

3. Adjudication Method for the Test Set:

   • Not applicable. The reported performance testing appears to be based on engineering and regulatory compliance rather than expert adjudication of clinical outcomes.

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

   • No MRMC comparative effectiveness study was done. The submission explicitly states: "The addition of the Automatic Gating Module to the SDX System has not resulted in a modification of the systems performance with respect to the elements provided in the initial 510(k) submission : K092479 ; thus no system performance testing has been carried out." Performance testing was specifically for the new Automatic Gating Module's conformance to specifications.

5. Standalone (Algorithm Only) Performance Study:

   • A standalone performance study focused on the Automatic Gating Module's conformance to required specifications (safety and functionality criteria set by radiotherapy device manufacturers) was done. However, this is not a standalone clinical performance study of the algorithm without human interaction in the sense of making a diagnosis or clinical decision. Instead, it seems to verify the module's technical operation as an interface.

6. Type of Ground Truth Used:

   • The ground truth for the performance testing was based on technical specifications and regulatory standards:
     • IEC 60601-1 (Electrical Safety)
     • IEC 60601-1-2 (Electromagnetic Compatibility)
     • Required specifications of Radiotherapy device manufacturers (covering safety & functionality criteria for the interface).

7. Sample Size for the Training Set:

   • Not applicable. This 510(k) summary describes performance testing for a device (Automatic Gating Module) that acts as an interface for existing technology (SDX System). There is no mention of machine learning or AI algorithms requiring a "training set" in the context of this submission. The device's function is to facilitate synchronization based on predetermined gating levels, not to learn patterns from data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no training set was mentioned or implied for this device.

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