(60 days)
The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices. In addition to planning and treatment, RadVision also allows volume and dose calculations, 2D and 3D analomy and dose visualizations, and post treatment seed localization.
RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.
The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.
The provided document is a 510(k) summary for the RadVision Dose Planning and Treatment System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and details verification and validation testing of its features. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a clinical or simulated clinical setting. The document primarily confirms that the software functionalities were tested and passed.
Therefore, for aspects related to "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number and qualifications of experts," "adjudication method," "MRMC study," "stand-alone study," and "ground truth establishment," the information is not available in the provided text.
Here's a breakdown of what is available and what is not:
1. A table of acceptance criteria and the reported device performance
Not Available. The document states that "RadVision passed all the verification and validation tests successfully," but it does not specify the quantitative or qualitative acceptance criteria for these tests, nor does it provide detailed performance metrics against those criteria. The tests listed are functional and system-level checks rather than performance against pre-defined clinical or dose calculation accuracy thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Available. The document does not mention a "test set" in the context of clinical data, nor does it refer to any human subjects or patient data. The "verification and validation testing" refers to software and system testing, not a study involving patient data.
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)
Not Available. As there is no mention of a test set involving human data or expert review, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Available. This is not applicable as no test set with expert 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
Not Available. This document describes a brachytherapy dose planning and treatment system, which is a software tool, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. There is no mention of AI or human reader improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not Available. While the document describes the functions of the software, it does not present a "standalone" study in the typical sense of evaluating algorithm performance on a dataset against ground truth. The "Verification and Validation test procedures" are functional tests of the software system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Available. No "ground truth" in the clinical data sense is mentioned or implied for the testing described. The "verification and validation" likely used predetermined correct outputs for the software functions (e.g., correct dose calculations for given inputs, proper display of images).
8. The sample size for the training set
Not Available. There is no mention of a "training set" or machine learning in the document.
9. How the ground truth for the training set was established
Not Available. There is no mention of a "training set" or associated ground truth.
§ 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.