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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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SDX - SpiroDynr'X 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 the time when a breath should be held to limit internal motion during treatment.

SDX is a spirometer located in the imaging or treatment room, with software installed on a dedicated workstation located in the control room. In the voluntary breath hold technique, the patient is independently monitoring their breathing pattern and reproduces the effective breath hold level. The patient holds their breath at a defined volumetric level whilst imaging or radiation therapy is being carried out t under the Clinical team supervision.

This 510(k) submission for the SDX - SpiroDynr'X device focuses on its safety and effectiveness through performance testing for physical attributes, rather than on AI performance or clinical diagnostic accuracy. Therefore, many of the requested items related to AI algorithms, expert ground truth, and comprehensive clinical studies are not applicable to this specific submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria and performance evaluation in this document revolves around the physical and electrical safety of the device, and the accuracy of its pulmonary volume measurements.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of this 510(k) submission, the "study" is primarily a series of performance tests on the physical device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in terms of patient count or data points. The performance tests were conducted on the device itself, likely using controlled laboratory conditions and calibrated testing equipment to simulate pulmonary volume changes. This is not a study involving human subjects or patient data.
• Data Provenance: The tests were conducted internally by the manufacturer (DYN'R SAS). No country of origin for patient data applies here as no patient data was used. The tests are prospective in the sense that they were designed and executed to assess the device's performance against pre-defined specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For linearity and stability tests of a spirometer, the "ground truth" is established by using calibrated scientific instruments (e.g., precision flow/volume calibrators) that have their own traceability to national/international standards. Expert clinical consensus is not typically used for establishing the ground truth of instrument physical performance.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among multiple human readers in interpreting clinical information. This level of adjudication is not relevant for objective performance tests of physical device parameters. The outcome of these tests is typically a direct measurement and comparison against a numerical threshold.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This device is a Spirometer and a patient breathing control system; it does not involve AI for interpretation or decision-making, nor does it involve "human readers" in the context of diagnostic image interpretation. Therefore, an MRMC study and AI-assisted improvement metrics are not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. While the device has "software installed on a dedicated workstation," this software's primary function is to visualize the patient's breathing process and guide breath-holding, not to perform autonomous diagnostic or interpretive functions. There is no "algorithm only" performance reported in the context of diagnostic accuracy, as this is not an AI-driven diagnostic device. Its performance is measured by the accuracy and reliability of its physical measurements and its adherence to safety standards.

7. The type of ground truth used:

• For pulmonary volume measures (linearity, stability): Instrumental/Metrological Ground Truth. This would involve precise, calibrated reference instruments to generate known volume changes, against which the SDX - SpiroDynr'X's measurements are compared.
• For electrical safety and EMC: Regulatory/Standard Compliance Ground Truth. This is established by testing against the specific requirements and methodologies outlined in the IEC 60601-1 and IEC 60601-1-2 standards.

8. The sample size for the training set:

• Not Applicable. This device is hardware with supporting software for visualization and control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to this submission.

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