(16 days)
The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.
The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This Tomolmage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.
When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning, and helical radiation therapy treatment capabilities into a single comprehensive IMRT system.
The HI-ART System's planning station or operator station is used by the physician to prescribe and enter the radiation therapy plan. A diagnostic CT image imported via a DICOM protocol from another diagnostic CT device or a TomoImage (MVCT) scan is used as the basis for the plan. The regions of interest, regions to avoid, and other prescribing information are entered in a manner that is similar to other commercially available planning systems.
The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The linear accelerator along with the primary collimator, multi-leaf collimator (MLC), detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.
The primary collimator and the MLC control the beam dimensions during radiation delivery so that the range of collimated beam size can vary from 0 to 400 mm wide by 5 to 50 mm at the isocenter. The MLC is constructed of 64 tungsten leaves that open and close as determined by the radiation therapy plan. The intensity of the radiation beam is proportional to the length of time that a particular leaf is open. The opening and closing of various leaves as the radiation is delivered in this helical pattern allows for an IMRT plan to be delivered with precise control. The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue.
Because the HI-ART System is operating in a helical mode similar to CT systems, it inherently has the ability to obtain a CT image. The system utilizes the linear accelerator to obtain a megavoltage (MVCT) scan of the region of interest prior to the delivery of radiation therapy. This MVCT image is then used to ascertain that the patient is correctly positioned prior to treatment. The radiation dose to the patient from an MVCT scan is comparable to diagnostic CT or portal imaging.
The provided text describes a medical device, the TomoTherapy HI-ART System®, which is a radiation therapy system. However, the document primarily focuses on regulatory approval (510(k) submission for substantial equivalence) and does not contain specific acceptance criteria or an in-depth study proving the device meets those criteria in the manner typically expected for AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, the "Validation" section describes a more general approach, focusing on system functionality and compliance with safety standards rather than quantitative performance metrics against a defined ground truth for a diagnostic or AI-driven task.
Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample size for the test set," "Number of experts for ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Sample size for training set," and "How ground truth for training set was established," the provided document does not contain this information.
It is important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance principles, rather than presenting detailed clinical trial results or AI/ML performance metrics.
Here's a summary of what can be extracted or inferred from the provided text, along with the information that is not present:
Acceptance Criteria and Study for TomoTherapy HI-ART System® (modified)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Functionality Validation: |
- Planning
- Imaging
- Delivery
- Database Management
- DICOM Communications | "The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc."
(Evaluation against IMRT phantoms, ion chambers, and other test phantoms.) |
| Safety Compliance: - IEC 60601-1 (Medical electrical equipment - General requirements for safety)
- IEC 60601-2-1 (Medical electrical equipment - Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV)
- IEC 60601-1-2 (Medical electrical equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- IEC 60601-1-4 (Medical electrical equipment - Collateral standard: Programmable electrical medical systems)
- EN ISO 14971:2000 (Medical devices - Application of risk management to medical devices) | "The HI-ART System is designed to comply with relevant sections of the IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4 safety standards and EN ISO 14971:2000."
"Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use." |
| Intended Use Fulfillment: - Integrated system for planning and delivery of IMRT.
- Precise radiation delivery to tumors/targeted tissues.
- Minimizing radiation delivery to vital healthy tissue.
- Physician/oncologist prescribes plan; system calculates; physician approves.
- Therapist selects/implements plan.
- TomoImage (MVCT) scan for patient positioning confirmation and repositioning assist (not for diagnostic use).
- Delivers radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery in helical tomographic pattern. | The conclusion states: "Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use." This implicitly means it meets the stated intended uses. |
| Substantial Equivalence: | "The HI-ART System with modifications is substantially equivalent to the HI-ART system [Predicate Device: K042739]." (As determined by the FDA.) |
Note: The document provides high-level statements about meeting safety standards and demonstrating safety/effectiveness for intended use, rather than specific numerical performance metrics for acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not present in the document. The validation section mentions "IMRT phantoms, ion chambers and other test phantoms," which are physical objects rather than patient data. There is no mention of a test set of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not present in the document. Since there is no mention of a patient-related test set or
ground truth establishment using experts, this information is not applicable.
4. Adjudication method for the test set
- Not present in the document.
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 present in the document. This type of study is not mentioned. The device is a radiation therapy system, not an AI diagnostic tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present in the document. The device is an integrated system (planning, imaging, delivery) that is always used with human operators (physicians/oncologists and therapists). The concept of "standalone algorithm performance" (e.g., for a diagnostic AI) does not directly apply here. The system's imaging component (MVCT) is explicitly stated "is not for diagnostic use."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not present in the document in the context of patient data. For the system's "functionality validation," the ground truth seems to be derived from physical measurements using tools like "IMRT phantoms, ion chambers and other test phantoms" against expected physical radiation dose distributions and system behaviors.
8. The sample size for the training set
- Not present in the document. The document describes a radiation therapy delivery system, not a machine learning model that would typically have a "training set" of data.
9. How the ground truth for the training set was established
- Not present in the document. (See point 8).
In conclusion, the provided FDA 510(k) summary focuses on regulatory compliance, system functionality, safety standards, and substantial equivalence to a predicate device for a radiation therapy system. It does not include the detailed performance metrics, patient data study designs, or AI/ML-specific validation information that would be expected for a diagnostic AI device.
§ 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.