(151 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Pulmonary Volume Measurement | Linearity of pulmonary volume measures | "Well within the required specifications." |
| Stability of pulmonary volume measures | "Well within the required specifications." | |
| Electrical Safety | Compliance with IEC 60601-1 | "Compliant with IEC 60601-1 Electrical Safety of Medical Electrical Device." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "Compliant with IEC 60601-1-2 ElectroMagnetic Compatibility of Medical Electrical Device." |
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.