(63 days)
The Radixact Treatment Delivery System 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 Radixact Treatment Delivery System 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 Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).
The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.
This document does not contain an acceptance criteria table or a study description with the requested details. The primary purpose of this document is a 510(k) premarket notification for the Radixact Treatment Delivery System, asserting its substantial equivalence to a predicate device (TomoTherapy Treatment System, K121934).
Here's a breakdown of what is and is not in the provided text, in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not Found: The document does not present a table of specific quantitative acceptance criteria or detailed reported device performance metrics in the format requested.
- What is present: There is a detailed comparison table (pages 5-6) that highlights "General Characteristics" of the predicate device and the subject device (Radixact Treatment Delivery System). This table focuses on technological characteristics (e.g., dimensions, gantry features, radiation delivery modes, imaging parameters, patient couch motion) and largely states "Identical to predicate" or "Functionally equivalent to predicate" for many parameters, or provides specific values for both devices without explicitly stating "acceptance criteria" or a quantitative "performance result" against a pre-defined threshold.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Found: The document states, "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, there is no mention of a test set, its sample size, or data provenance from a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Found: As no clinical tests were required, there is no information about experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Found: No clinical tests, no adjudication method.
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:
- Not Found: No MRMC study was conducted or mentioned, as the device is a radiation therapy delivery system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Found: Not applicable for this type of device. The device itself delivers radiation therapy as directed by a practitioner, it's not an algorithm providing a standalone diagnostic or treatment recommendation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Found: Since no clinical studies were performed for this 510(k), no ground truth establishment is discussed. The device's "performance" is assessed through engineering verification and validation testing against design specifications, conformity to recognized consensus safety standards, and comparison of technological characteristics to the predicate.
8. The sample size for the training set:
- Not Found: This device is a hardware system for radiation delivery, not a machine learning model that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not Found: Not applicable, as it's not an AI/ML device that uses a training set with ground truth.
In summary:
The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Radixact Treatment Delivery System to a predicate device. It relies heavily on comparing technical specifications, intended use, and functioning principles, and states that "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, it does not contain the detailed information about acceptance criteria, clinical study methodology, sample sizes, or ground truth establishment that you've requested, as these were not part of the substantial equivalence pathway for this particular device submission. The performance data mentioned refers to "verification and validation testing confirm[ing] that the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users" (page 8), rather than clinical study results.
§ 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.