(44 days)
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician prescribed and approved plan.
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
Here's a breakdown of the acceptance criteria and study information for the TomoTherapy Treatment System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values). Instead, it refers to general conformity to standards and design specifications. Therefore, the table below reflects the qualitative statements made in the document regarding performance.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Overall Performance | Conform to requirements of applicable recognized consensus standards for medical devices. | "The TomoTherapy Treatment System was tested and demonstrated to conform to the requirements of applicable recognized consensus standards for medical devices." |
| Functional Performance | Performance within design specifications for imaging and radiation delivery. | "Results of verification and validation tests, including extensive tests of imaging and radiation delivery functionality, confirm the TomoTherapy Treatment System performance is within design specifications." |
| Safety and Effectiveness | To be as safe and as effective as the predicate device. | "These performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device." |
| Dose Consistency | Improved consistency of dose rate compared to the predicate device (though not altering performance claims for the product). | "Enhancements to the radiation delivery system improve the consistency of the dose rate of the TomoTherapy Treatment System in comparison to the predicate device." |
| Dose Monitoring/Interlock | Operation of the independent dose monitoring/interlock system is completely unchanged from the predicate device, with identical functionality and limits. | "Therefore the dose monitoring/interlocks operation is identical to pre-existing functionality and performance limits." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "verification and validation tests, including extensive tests of imaging and radiation delivery functionality."
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is a premarket notification for a medical device (
510(k)), typically relying on engineering and bench tests for this type of submission rather than large-scale clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish "ground truth" in the context of diagnostic interpretation for the tests performed. The tests described are primarily focused on the engineering and physical performance of the radiation delivery system and imaging functionality, not on diagnostic accuracy requiring expert interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
As the tests described are technical performance evaluations rather than clinical assessments requiring human interpretation or decision-making, an adjudication method (like 2+1 or 3+1) is not applicable and therefore not mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required to establish substantial equivalence." The focus was on demonstrating substantial equivalence to a predicate device through technical performance data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, standalone performance was assessed. The "verification and validation tests" for imaging and radiation delivery functionality would constitute evaluations of the system's performance without human intervention in the primary operational loop being tested (e.g., how accurately the system delivers radiation according to a plan, or how consistently the dose rate is maintained). The device's primary function is radiation delivery, not diagnostic interpretation by an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed would be established by engineering specifications, physical measurements, and recognized consensus standards. For example, the ground truth for dose consistency would be the expected dose output based on the physics of the system and calibration, measured against actual output. Similarly, imaging functionality would be assessed against expected image quality and resolution for megavoltage CT. There is no mention of pathology, outcomes data, or expert consensus related to diagnostic accuracy as the "ground truth" for these tests, as the device is not a diagnostic tool.
8. The Sample Size for the Training Set
The document does not specify a "training set" sample size. This type of device classification (510(k) for a radiation therapy system) generally does not involve machine learning algorithms that require a distinct training set in the way a diagnostic AI would. The performance data comes from verification and validation of the hardware and software systems.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI algorithm is indicated, the concept of establishing ground truth for it is not applicable or mentioned in this document. The system's operation is based on pre-defined physics models and engineering designs, not learned patterns from a training dataset like a typical AI diagnostic tool.
§ 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.