(85 days)
Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology.
System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the Qfix® SBRT Solution and Accessories including, Ofix's kVue™, Stradivarius™, VacQFix™ and DoseMax™ inserts, overlays, and standalone devices which are intended to immobilize, position patients undergoing radiation therapy including SBRT.
Ofix has developed an improved device. the Ofix® Abdominal/Thoracic Motion Control System, to promote shallow breathing in patients undergoing radiation therapy including electron, photon, and proton treatments and general radiology and imaging applications including MR and CT image acquisition. The Ofix® Abdominal/Thoracic Motion Control System is intended to be used either independently or in conjunction with a number of existing devices and accessories in the Ofix portfolio to create a comprehensive solution for stereotactic body radiation therapy.
The Ofix® Abdominal/Thoracic Motion Control System features belts and paddles of varying size, an air bladder, and a hand pump with gauge. The belts come in multiple sizes to accommodate wide range of patient girths. The rigid foam paddles are designed with geometry that conforms to the region beneath the xibhoid process, in order to provide relatively comfortable compression that does not compress the ribs themselves. The paddles also feature embedded fiducial markers, providing another means of positional localization.
Compression is achieved via a bladder attached to the paddles, designed to maintain a flat profile even when fully inflated in order to achieve uniform pressure on the paddle through the course of the procedure. The bladder, which is inflated with a detachable small hand pump with gauge, features a pressure-holding valve and a quick release at the junction of the pump and the inflation tubing. This allows the Abdominal/Thoracic Motion Control System to reliably hold its pressure without the pump in place, enabling more flexibility and versatility in studies and procedures. At the time of this submission. the Ofix® Abdominal/Thoracic Motion Control System is patent pending.
The Qfix® Abdominal/Thoracic Motion Control System can be used in conjunction with other devices already in the Qfix Product Portfolio to achieve further body immobilization or greater degrees of compression with the Qfix® SBRT Solution and Accessories. It combines a rigid, low attenuating support structure in the form of a couchtop insert or overlay with a series of interchangeable devices such as supportive cushions, compression devices, and other immobilization devices, including the Qfix® Abdominal/Thoracic Motion Control System, allowing clinicians to provide superior immobilization customized to the unique treatment plan of each patient.
The provided text describes the Qfix® Abdominal/Thoracic Motion Control System, a device intended to apply abdominal compression for managing internal body motion during respiration and promoting shallow breathing in radiation therapy and radiology. The submission focuses on demonstrating substantial equivalence to a predicate device and includes details on non-clinical testing.
However, the provided document is a 510(k) summary for a physical medical device (Abdominal/Thoracic Motion Control System), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested elements pertaining to AI/SaMD studies (e.g., test set sample size, expert ground truth, MRMC studies, training set details) are not applicable to this submission and are not present in the document.
The document describes performance testing to show the device meets its intended use, but it's not in the context of an AI/SaMD acceptance criteria table. I will extract the relevant information from the document as best as possible, focusing on the described performance testing and what could be interpreted as "acceptance criteria" for a physical device.
Here's an attempt to structure the information based on the provided text, while acknowledging the limitations due to the nature of the device:
Device: Qfix® Abdominal/Thoracic Motion Control System
Primary Intended Use (relevant to performance testing): To apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient, and to promote shallow breathing in radiation therapy or radiology.
Acceptance Criteria and Reported Device Performance
The document describes non-clinical bench testing and customer preference validation. The "acceptance criteria" for a physical device like this are typically derived from its functional requirements and safety standards. The document implicitly states meeting these through the testing results.
| Acceptance Criteria (Implied from Testing) | Reported Device Performance |
|---|---|
| MR Safety and Compatibility: | |
| No magnetically induced displacement force issues. | Passed acceptance criteria for magnetically induced displacement force. |
| Conditionally safe for use in MR field strengths up to and including 3T. | Demonstrated conditionally for use in MR field strengths up to and including 3T. |
| No image artifacts produced by the device in an MRI scanner. | Did not artifact or produce image artifacts when imaged in a 3T MRI scanner. |
| Shallow Breathing Efficacy: | |
| Statistically significant reduction in inspiratory capacity and tidal volume when the device is applied and pressurized. (Correlates to decreased motion of diaphragm, promoting shallow breathing.) | Healthy volunteers exhibited a statistically significant reduction in inspiratory capacity and tidal volume while wearing the pressurized Qfix® Abdominal/Thoracic Motion Control System, which correlates to a decrease in motion of the diaphragm, and therefore shallow breathing. |
| Overall Performance & Safety: | |
| Meets all acceptance criteria for testing conducted and validated per its intended use (general statement). | The Qfix® Abdominal/Thoracic Motion Control System met all acceptance criteria for testing conducted and was validated per its intended use. |
Study Details (as inferable from the document)
-
2. Sample size used for the test set and the data provenance:
- MR Safety and Compatibility Testing: No specific number of samples (devices) or tests is provided, but it states methodology from ASTM F2119-07 and F2052-15 was used. The provenance of the data is internal non-clinical bench testing.
- Shallow Breathing Efficacy: "Healthy volunteers." The exact number is not specified in the document. The data provenance is internal testing with human subjects.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly. For a physical device like this, "ground truth" establishment isn't in the sense of expert annotation of images. For the shallow breathing study, ground truth would be objectively measured physiological parameters (inspiratory capacity, tidal volume). For MR safety, ground truth is established by physics principles and standards.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to subjective assessments or disagreements in AI model output or human reader performance. The testing mentioned is objective measurement or adherence to standards.
-
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, not performed. This is an AI/SaMD specific study type and not relevant for this physical device submission.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm for standalone performance. The device's "performance" is its mechanical and physiological effect.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the shallow breathing efficacy, the ground truth was physiological measurements (inspiratory capacity and tidal volume) obtained from healthy volunteers.
- For MR safety and compatibility, the ground truth was based on physical standards and objective testing (e.g., quantifying magnetic displacement force, checking for artifact generation).
-
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
-
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.