(199 days)
The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.
The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is intended for use in photon and electron radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal wall. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to the patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.
The provided text is a 510(k) Summary of Safety and Effectiveness for the OARtrac® System. It outlines the device's indications for use, its technical characteristics, and how it compares to a predicate device to demonstrate substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study (non-clinical performance data) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OARtrac® System are primarily based on demonstrating substantial equivalence to its predicate device (RadiaDyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954) and meeting relevant safety and performance standards. While the text doesn't explicitly list "acceptance criteria" as a separate table, the "Dose Accuracy" row in Table 1 functions as a key performance criterion, with other general and specific tests confirming safety and effectiveness.
Here's a table derived from the provided information:
| Acceptance Criterion (Implicit) | Reported Device Performance/Met Standard |
|---|---|
| Dose Accuracy | Photon and Electron based therapies: ±5% (2 sigma) |
| HDR based therapies: ±6% (2 sigma) | |
| Overall Design & Specifications | Meets all requirements (confirmed through testing) |
| Sterilization | Meets requirements (same test protocols as predicate) |
| Biocompatibility | Meets requirements (tested per ISO 10993-1, Parts 5, 10, and 11) |
| Packaging | Meets requirements (same test protocols as predicate) |
| Shelf-Life | Meets requirements (tested per ASTM F1090-07) |
| Electrical Safety | Meets requirements (tested per IEC 60601-1) |
| EMC (Electromagnetic Compatibility) | Meets requirements (tested per IEC 60601-1-2) |
| Software Verification & Validation | Meets requirements (per IEC 62304) |
| Bioburden | Meets requirements (per ISO 11137-1) |
| Cleaning and Disinfection | Meets requirements (per AAMI TIR 12 and AAMI TIR 30) |
| Device Risk Analysis | Per ISO 14971 |
| Dose Range Verification Testing | Performed and met criteria (details not specified) |
| Electron-based Radiation Testing | Performed and met criteria (details not specified, crucial for new indication) |
| Endorectal Balloon Verification Testing | Performed and met criteria (details not specified) |
| Compatibility with Predicate's Standards | The proposed device was subjected to the same test protocols and standard validation studies as the predicate device (K162954), which were previously accepted by FDA. Meets criteria under the same national and international test standards as the predicate device. Performance data demonstrated substantial equivalence in performance and fundamental technology, and is as safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "10. Clinical and Animal Performance Data - Not Conducted" (Page 6).
This means there was no human or animal test set/data in the traditional sense for this 510(k) submission. The data provenance is therefore entirely from non-clinical (laboratory/bench) testing, which includes validation against standards and previous predicate device data. The data provenance would be from the manufacturer (RadiaDyne) through their internal testing and third-party lab certifications for standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical or animal performance data was collected, there was no expert adjudication for a ground truth derived from clinical cases. The "ground truth" for the non-clinical tests would have been established by the engineering specifications and the established standards (e.g., IEC, ISO, ASTM) against which the device performance was measured. These standards were developed and validated by relevant expert bodies in the field.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method applied to clinical data. The evaluation was based on compliance with pre-defined engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The document explicitly states "Clinical and Animal Performance Data - Not Conducted." The purpose of this submission was to demonstrate substantial equivalence through non-clinical data, not to show improvement over human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a radiation dose verification system, not an AI/algorithm for diagnosis or image interpretation. While it contains software, its core function is to measure physical radiation dose. Therefore, the concept of "standalone algorithm only performance" as typically applied to AI/ML devices for medical image analysis does not directly apply in this context. The device's performance was evaluated based on the accuracy of its dose measurements. The software processes these measurements, but it's not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance evaluation was primarily physical measurements against established radiation dosimetry standards and validated test procedures. This is analogous to physical/engineering ground truth rather than clinical ground truth (like pathology, expert consensus, or outcomes data). For example, a known dose from a calibrated radiation source served as the "ground truth" for the device's dose accuracy measurements.
8. The Sample Size for the Training Set
Since this is not an AI/ML device that requires a training set in the typical sense of machine learning algorithms for pattern recognition (e.g., image classification), the concept of a "training set" is not applicable. The device's calibration and design would rely on physical principles and potentially pre-calibrated sensors, but not a data-driven training set like an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the AI/ML context, this question is not applicable. The "ground truth" for the device's development and calibration would be derived from the fundamental physics of radiation detection and dosimetry, using highly calibrated and traceable radiation sources and measurement standards.
§ 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.