(100 days)
OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities". OTP 1.2 contains the following Activities: Anatomy Module: Structure Definition, Target Definition, Image Registration. Beam Module. Connectivity Module. DICOM Import / Export. Dose Module. Evaluation Module: Plan Evaluation, Volume Rendering. In addition, various system utilities are available. The software runs on a Windows XP platform.
This appears to be a 510(k) premarket notification for a radiation therapy planning system (OTP 1.2). The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics.
The document is a summary of safety and effectiveness information, comparing the device to a predicate device (TheraPlan Plus, K970236) to demonstrate substantial equivalence. It describes the device's intended use and technological considerations but does not present a performance study with detailed acceptance criteria and results in the way a medical device submission often would for novel performance claims.
Therefore, most of the requested information cannot be extracted from this document. I will fill in what can be inferred or explicitly stated, and note where information is missing.
Here's a breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or quantified in this document. The submission focuses on substantial equivalence to a predicate device (TheraPlan Plus, K970236) rather than demonstrating specific performance metrics against pre-defined acceptance thresholds for accuracy, sensitivity, or specificity.
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, dose calculation discrepancies) are reported in this summary. The assessment of equivalence relies on the device having the same intended use and similar technological characteristics to the predicate.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| (Likely functional and safety criteria implied by being a radiation therapy planning system) | (Performance is implied to be equivalent to the predicate device, TheraPlan Plus, K970236) |
| (e.g., Dose calculation accuracy within X%) | (No numerical data provided) |
| (e.g., Image registration accuracy within Y mm) | (No numerical data provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not mentioned. No specific test set or study validating performance is described.
- Data Provenance: Not mentioned, as no specific performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable, as no ground truth establishment for a specific test set is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no performance study with a test set requiring adjudication is described.
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
- MRMC Study: No, this document does not describe an MRMC study or any study involving human readers or AI assistance in that context. The device is a "Radiation Therapy Planning System," not typically an AI-assisted diagnostic or interpretation tool in the sense of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not described in this document. The submission focuses on substantial equivalence based on intended use and technological features, rather than a standalone performance evaluation against pre-defined metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, as no performance study using ground truth is described.
8. The sample size for the training set
- Sample Size (Training Set): Not mentioned. This device is a "Radiation Therapy Planning System" software, which typically involves algorithms for dose calculation, image processing, and 3D rendering. It's not explicitly stated to be an "AI" or machine learning device that would have a traditional "training set" in the common understanding of those terms. If it uses internal parameters or lookup tables, the data used to derive these is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as no training set or its ground truth establishment is described.
§ 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.