(113 days)
Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
Aurora Technology Development (ATD) Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It provides:
• pre-treatment plan delivery verification;
• the ability to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery;
• estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and
• an aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals.
ATD Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
ATD Adaptivo has two (2) primary software modules: (1) the Adaptive Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry (IVD) module. These two (2) modules integrate seamlessly to provide the user full benefit of ATD Adaptivo.
Here's a breakdown of the acceptance criteria and study information for the Adaptivo device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list acceptance criteria in a table format with corresponding reported performance values. Instead, it states that "Test results indicated that ATD Adaptivo complies with predetermined specifications and the applicable standard" and that "Verification and validation activities were conducted to establish the performance and safety characteristics of ATD Adaptivo. The results of these activities demonstrate that ATD Adaptivo is as safe, as effective, and performs as well as or better than the predicate device."
Therefore, I cannot populate a table with specific numerical acceptance criteria and reported performance metrics based on the given information. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general software development and medical device guidelines.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Test results indicated that ATD Adaptivo complies with predetermined specifications."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Therefore, there is no effect size given for how much human readers improve with AI vs without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document describes Adaptivo as a "stand-alone software product." The performance testing described (Bench testing and V&V activities) appears to evaluate the algorithm's performance based on internal specifications. While not explicitly using the term "standalone study," the nature of the software and testing suggests its performance was assessed independently. However, specific metrics of this standalone performance are not provided.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for testing. It refers to "predetermined specifications" and "internal specifications," implying that the device's output was compared against established baselines or expected results, but the nature of these ground truths (e.g., expert consensus, pathology, phantom measurements, etc.) is not detailed.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not explain how the ground truth for the training set was established, nor does it explicitly mention a training set, though it implies software development and validation, which often involve such stages.
§ 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.