(612 days)
The OCTAVIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:
- IMRT patient plan verification
- periodic QA procedures, e.e. constancy checks
- beam data analysis according to international therapy dosimetry protocols
- measurements after repair or replacement of major treatment unit components
The OCTAVIUS System is comprised of a two-dimensional ion chamber based detector array, uniformly arranged as a matrix and a separate detector interface for data acquisition. The detector array can be placed either in a static cubic or octagonal phantom or in a linear rotational phantom. For the measurement of moving radiation sources (e.g. the rotating gantry of a LINAC), the rotational phantom rotates synchronously with the gantry. An inclinometer, fixed to the gantry, delivers the gantry angle values which are used to align the rotating detector to the gantry. The whole system is controlled with software for data display and processing.
The provided text describes the OCTAVIUS System, a device for dosimetry measurements in radiotherapy, and its FDA 510(k) premarket notification. However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment methods for training or test sets, or standalone algorithm performance.
Therefore, much of the requested information cannot be extracted directly from this document. Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "The FDA has not published any performance standards for this product," meaning specific quantitative acceptance criteria set by the FDA are not provided in this document. The document primarily focuses on verifying that the device "fulfills the design specification and its intended use."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Fulfills design specification | Demonstrated through software verification and validation testing. |
| Fulfills intended use | Demonstrated through software verification and validation testing. |
| Electrical safety compliance | Certified in compliance with IEC 61010-1:2010. |
| Electromagnetic compatibility (EMC) compliance | Certified in compliance with IEC 61326-1:2012 and 47 CFR Part 15 Subpart B. |
| Biocompatibility (for operator contact) | Biologically uncritical due to contact with uninjured skin and non-critical materials. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing seems to be internal verification and validation of the device's functionality rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The "ground truth" for this device appears to be its internal design specifications and the expected physical measurement outcomes, rather than expert-labeled data for an AI algorithm.
4. Adjudication method for the test set:
- Not applicable as no expert-based ground truth establishment or adjudication method 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:
- No, an MRMC comparative effectiveness study is not mentioned. The OCTAVIUS System is a dosimetry measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device's software was tested in isolation ("software verification and validation testing results were conducted and submitted"). The device itself is a measurement system, and its "performance" is its ability to accurately collect beam data. It's not an AI algorithm in the traditional sense that operates autonomously on diagnostic data or has a "human-in-the-loop" for interpretation.
7. The type of ground truth used:
- The implicit "ground truth" for the OCTAVIUS System's performance would be the physical reality of radiation dose distributions and the design specifications of the device for measuring these distributions accurately. The verification and validation process likely involved comparing the device's measurements against known or highly calibrated standards.
8. The sample size for the training set:
- Not applicable. The OCTAVIUS System is a physical measurement device, not an AI system that undergoes "training" on a data set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.