(518 days)
The NOVAC7 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Know as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC7 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. Applicators direct the electron beam to the surgical area of interest.
The NOVAC7 is an electron accelerator for intraoperative radiation therapy that can be used in the operating room without making major adjustments to the room. Beam energies are 3, 5, 7, and 9 MeV. It is a mobile, hinged accelerator that can be moved to the patient's location and placed in the appropriate position for performing the required radiotherapy inside a surgical theatre. X-ray leakage into the environment and other related radiation protection problems have been minimized by eliminating diffusion filters which in conventional accelerators widen the beam. Hard docking is performed in an easy way, reaching any site of the body. Two applicators are used, one is located over the patient area to be treated and the other is permanently mounted on the radiating head. Only the patient applicator comes in contact with the surgery site. The time required for performing docking and scanning irradiation is under five minutes.
The provided text describes the HITESYS NOVAC7 Electron Linear Accelerator and its comparison to a predicate device, the MOBETRON. However, it does not contain the specific information requested about acceptance criteria and a study proving device performance in the context of diagnostic accuracy, which would involve metrics like sensitivity, specificity, or reader performance.
The "Performance Evaluation" section (Item 7) focuses on safety and regulatory compliance, rather than diagnostic or treatment efficacy metrics typically associated with acceptance criteria for device performance. It mentions conformance to electrical patient safety standards (IEC 60601 series) and software development guidelines.
Therefore, I cannot provide a table of acceptance criteria, reported device performance (in terms of clinical efficacy), or details about a study evaluating such performance based on the provided document.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: The document only mentions safety standards and software development processes, not performance metrics (e.g., accuracy, precision, error rates) or specific acceptance criteria for the therapeutic outcome of the radiation.
- Sample size used for the test set and the data provenance: No test set or clinical data for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for accuracy is not discussed.
- Adjudication method for the test set: Not applicable as a test set for performance evaluation is not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No MRMC study is mentioned. The comparison is between the technical specifications and operational aspects of the NOVAC7 and the MOBETRON, not a comparative clinical effectiveness study involving human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a linear accelerator for radiation therapy, not an AI algorithm.
- The type of ground truth used: Not applicable as there's no discussion of diagnostic or therapeutic accuracy ground truth in the document.
- The sample size for the training set: Not applicable as this is not an AI/ML device being "trained."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on:
- Device description and intended use.
- Comparison with a predicate device based on technical design and operational features.
- Compliance with electrical safety and software development regulatory standards.
- A conclusion of substantial equivalence to the predicate device based on these factors.
It does not provide evidence of performance against clinical acceptance criteria using patient data or expert evaluations.
§ 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.