(62 days)
The Omni V SBRT Positioning System from Bionix Development Corporation is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
The Bionix Omni V stereotactic body radiation therapy (SBRT) positioning system is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. This device has been most likely classified as Class II by the FDA Panel on Radiology, falling under CFR 892.5050.
The Omni V SBRT positioning system from Bionix Development Corporation has several component parts that are designed to work together to provide an easy to use means of reproducibly positioning a patient undergoing external beam stereotactic radiation therapy. The system includes a thermoformed base, body support vacuum cushion, upper arm support, thigh and foot bolster, breath-suppression arch, and fiducial arch. These components work together to immobilize the patient and provide an external reference system for stereotactic localization.
The provided text is a 510(k) summary for the Bionix Omni V SBRT Positioning System. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria through quantitative performance metrics.
Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set sizes) cannot be fully extracted from this document because it is not typically included in a 510(k) summary for a device of this nature (a patient positioning system).
Here's what can be gathered and why other information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative performance metrics in this 510(k). The criteria rely on similarity to predicate devices rather than numerical thresholds. | The Bionix Omni V SBRT Positioning System is described as "similar in design, features, radiolucency, and function" to the legally marketed BodyFix and BodyLoc systems. It performs "as well as" these predicate devices for stereotactic localization and positioning. |
Explanation of "Acceptance Criteria" for this device:
For this type of device (a patient positioning system, classified as an accessory to an accelerator), the "acceptance criteria" for 510(k) clearance are primarily demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. The FDA does not have voluntary standards for this specific device type, meaning there are no pre-defined numerical thresholds the device needs to meet.
The document demonstrates equivalence by comparing:
- Intended Use: Identical.
- Design and Function: Similar components (base-plate, vacuum cushions, fixation/immobilization methods, reference systems).
- Materials: Both use radiolucent materials (carbon fiber/foam composite for BodyFix, acrylic sheet for BodyLoc, acrylic/PVC alloy for Omni V).
- Performance (qualitative): The Omni V is designed to achieve reproducible patient positioning and localization, minimize organ movement (via breath-suppression), and provide an external reference system, similar to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not provided. The 510(k) summary does not describe a performance study with a test set of patients or medical images.
- Data Provenance: Not applicable/Not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable/Not provided. No ground truth establishment is described for a performance study.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not provided. No test set adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This type of study is typically done for diagnostic imaging devices where human readers interpret results, comparing performance with and without AI assistance. This device is a physical positioning system, not an imaging interpretation algorithm.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone Performance Study (Algorithm Only):
- Standalone Study: No. This device is physical hardware, not a software algorithm used for standalone performance assessment. The "performance" is implicitly tied to its physical properties and design, verified through comparison to predicate devices, rather than a standalone algorithm test.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable/Not provided. No performance study requiring ground truth is described. For this device, "ground truth" would relate to its physical properties (e.g., attenuation, rigidity, reproducibility of indexing), which are assessed through engineering design and comparison to existing products, rather than clinical outcomes or pathology from a dataset.
8. Sample Size for the Training Set:
- Sample Size: Not applicable/Not provided. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Established: Not applicable/Not provided. As above, no training set or associated ground truth is relevant for this device type.
In summary: The provided 510(k) summary is for a physical medical device (patient positioning system) demonstrating substantial equivalence to predicate devices using design, function, and material comparisons. It does not contain information about studies involving patient data, expert reviews, or algorithm performance metrics, as these are not typically required for this classification of device seeking 510(k) clearance by this method. The "acceptance criteria" are met by demonstrating the device is as safe and effective as the already-marketed predicate devices.
§ 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.