(302 days)
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
The provided document, K041971, is a 510(k) premarket notification for the WIMRT Radiation Treatment Planning System. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI devices with quantifiable performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this submission focuses on establishing substantial equivalence to predicate devices based on design, construction, intended use, and performance characteristics. The "performance" discussed here refers to functional capabilities and algorithms rather than statistical accuracy against a ground truth.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics (like sensitivity, specificity, accuracy) are reported for WIMRT against a defined ground truth, nor are explicit acceptance criteria for such metrics stated. The document compares technical specifications of WIMRT with predicate devices.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process for a test set is described.
- Adjudication method for the test set: Not applicable as no test set or ground truth adjudication is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this document.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not reported. The device is a treatment planning system, implying human interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for performance evaluation is mentioned.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.
Summary of Device Features (from the provided table, which serves as a comparison of specifications rather than performance metrics against a ground truth):
| Specification | WIMRT Module |
|---|---|
| Application (Use) | Inverse Planning |
| Imaging Modalities Supported | CT, MR, PET-Spec |
| Dose Calculation Algorithm | Super-position Convolution |
| Optimization Engine | Simulated Annealing and Descending Gradient |
| IMRT Modalities Supported | Sliding Window and Step and Shoot |
| Operating System | Windows |
| Image Registration | Automatic |
| Automated Planning | Yes |
| Inhomogeneity Corrections | Yes |
| Forward IMRT via Field within a Field technique | Yes |
| Forward IMRT via MLC Based compensators | Yes |
§ 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.