(35 days)
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
The TomoTherapy Treatment Delivery System with iDMS is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.
The TomoTherapy Treatment Delivery System with iDMS is a modified version of the predicate TomoTherapy Treatment System (last cleared on K121934). The TomoTherapy Treatment Delivery System with iDMS is the same as the predicate device minus the Data Management System and Treatment Planning Station, but substituting the Treatment Delivery Console (TDC) from the Radixact Treatment Delivery System (last cleared on K161146) in place of the predicate Operator Station. The TomoTherapy Treatment Delivery System with iDMS is designed to deliver radiation therapy treatment plans generated on planning systems such as the Accuray Precision™ Treatment Planning System (last cleared on K171086) and stored on data management systems such as the Accuray iDMS™ Integrated Data Management System (last cleared on K161144).
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and explicitly stating what is not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not present a formal table of acceptance criteria with corresponding performance metrics for the TomoTherapy Treatment Delivery System with iDMS. Instead, it relies on a comparison to a predicate device, asserting "substantial equivalence." The document states that the new device has "imaging and treatment capabilities equivalent to those of the predicate" and "employs the same fundamental scientific principles, and have substantially equivalent intended uses, principles of operation, performance specifications and technological characteristics."
The only specific performance data mentioned is a general statement: "Results of verification and validation testing confirm that the TomoTherapy Treatment Delivery System with iDMS conforms to design specifications and meets the needs of the intended users." It also notes compliance with "applicable FDA recognized consensus safety standards for radiation therapy medical devices."
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This implies that there was no separate "test set" in the traditional sense involving patients or biological samples to evaluate the device's performance against specific clinical acceptance criteria. The evaluation was primarily based on technical comparisons to a predicate device and engineering verification and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical or animal tests were performed, there was no "test set" requiring ground truth established by experts in the context of clinical performance. The evaluation was based on engineering and design specifications and a comparison to a previously cleared device. Therefore, this information is not applicable/not provided.
4. Adjudication Method for the Test Set
As no clinical or animal test set was used, an adjudication method for such a set is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
An MRMC study was not done, as the document explicitly states: "No animal or clinical tests were required to establish substantial equivalence." This type of study would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device described is a treatment delivery system, not an algorithm in the AI sense for diagnosis or interpretation. The performance evaluation focused on the physical device's technical specifications and functional equivalence to a predicate device. Therefore, a "standalone algorithm performance" study as typically understood in AI/medical imaging is not applicable/not provided.
7. The Type of Ground Truth Used
The ground truth used for establishing "substantial equivalence" appears to be the design specifications, performance characteristics, and regulatory clearance of the predicate device (TomoTherapy Treatment System (K121934)), along with compliance to relevant consensus safety standards. The new device was deemed substantially equivalent because its technological characteristics, intended use, and fundamental scientific principles were the same as the predicate.
8. The Sample Size for the Training Set
Since no clinical or animal studies were conducted to establish substantial equivalence for this device, there was no training set used in the context of a statistical or machine learning model. The device's "training" would be analogous to its design and manufacturing process, which adheres to established engineering principles and the specifications of the predicate.
9. How the Ground Truth for the Training Set was Established
As there was no training set in the conventional sense, the establishment of "ground truth" for a training set is not applicable/not provided. The device's functionality is based on its design and manufacturing to meet pre-defined engineering and safety standards, which are continuously refined and validated during product development (verification and validation testing).
Summary of the Study and Device Validation:
The validation of the TomoTherapy Treatment Delivery System with iDMS was primarily a non-clinical equivalency study. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (TomoTherapy Treatment System (K121934)).
The study involved:
- Detailed comparison of technological characteristics: This included comparing system configuration, physical dimensions, environmental parameters, gantry mechanical features, photon beam characteristics, imaging capabilities, laser systems, patient couch, power distribution, operator station, machine control software, data interfaces, and safety features.
- Verification and validation testing: This was internal engineering testing to confirm the device conforms to its own design specifications and meets the needs of intended users. Specific details of these tests (e.g., number of test cases, methodologies) are not given in the 510(k) summary, but it's stated that they confirm conformance.
- Compliance with recognized safety standards: Testing was performed by an independent certified testing laboratory to ensure compliance with applicable FDA recognized consensus safety standards for radiation therapy medical devices.
The conclusion is that the minor differences between the new device and the predicate do not raise different questions of safety or effectiveness, and the performance data (from verification, validation, and standards compliance) demonstrates substantially equivalent safety and performance. This approach eliminated the need for animal or clinical studies to demonstrate substantial equivalence for this particular 510(k) 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.