(41 days)
External Beam Radiation Therapy is typically delivered to patients from a linear accelerator or from a radioactive source (high and low dose rate variants). Aktina Medical Physics Corporation has designed and manufactured software to aid in the verification of the delivery process prior to patient treatment. The software analyzes and compares the predicted data from a radiotherapy treatment planning system and measured dose measurements.
The intended purpose of the Protos Software is to provide a Radiation Therapy Quality Control (QC) tool that allows for the automated and rapid comparison of predicted and measured radiation dose values. The software is intended for the QC of external beam radiation treatments. Measured data will be acquired from radiographic films. Predicted data will be calculated in a Radiotherapy Treatment Planning System (RTPS) and transferred to the software via a Digital Imaging and Communications in Medicine (DICOM) protocol.
The provided 510(k) summary for the Protos Software describes its intended use and technological characteristics in comparison to a predicate device, but it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Radiological Imaging Technology, Inc., RIT 113 Film Analysis System, K935928). It highlights that both systems share similar technological characteristics and are used for the same purpose: providing a Radiation Therapy Quality Control (QC) tool for comparing predicted and measured radiation dose values.
Therefore, I cannot populate the requested table or answer most of your detailed questions regarding acceptance criteria and performance studies based on the provided text.
Here's what information I can extract and what is missing:
| Information Category | Details from Document | Missing Information |
|---|---|---|
| Acceptance Criteria & Reported Performance | Not explicitly stated. The document established substantial equivalence to a predicate device, implying similar performance is expected. | Specific numerical acceptance criteria (e.g., accuracy, precision) are not mentioned, nor are specific performance results against such criteria. |
| Sample size (test set) & Data Provenance | Not mentioned. | No details on the size or origin (country, retrospective/prospective) of any test data. |
| Number & Qualifications of Experts (Ground Truth) | Not mentioned. | No information on experts or how ground truth was established for a test set. |
| Adjudication Method | Not mentioned. | No details on any adjudication method. |
| MRMC Comparative Effectiveness Study | Not mentioned. | No information on an MRMC study or effect size with AI assistance. |
| Standalone Performance Study | Not explicitly mentioned as a formal "study." The document describes the software's function ("automated and rapid comparison of predicted and measured radiation dose values") which suggests standalone operation. | A formal standalone performance study with specific metrics is not described. |
| Type of Ground Truth Used | The device compares "predicted data from a radiotherapy treatment" with "measured dose measurements" from radiographic films. This implies physical measurements are a form of ground truth. | Not explicitly stated in terms of common ground truth types like "pathology" or "outcomes data." The "measured dose measurements" are the reference. |
| Sample Size (Training Set) | Not mentioned. | No information on the size of a training set. |
| Ground Truth for Training Set | Not mentioned. | No information on how ground truth was established for a training set. |
§ 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.