(52 days)
The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments.
The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.
The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors.
Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations.
This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Photon Radiosurgery System (PRS):
Overall Assessment:
The provided document (K992577) is a 510(k) premarket notification for the Photoelectron Corporation's Photon Radiosurgery System (PRS). This document seeks to expand the indications for use of an already cleared device and introduce new accessories. A 510(k) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data or detailed performance acceptance criteria in the same way a PMA (Premarket Approval) might.
As such, the document does not describe traditional clinical acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. Instead, it focuses on dosimetry data to demonstrate the performance of the new applicators and substantial equivalence to existing radiation therapy devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly tied to the dosimetry data demonstrating the performance of the Spherical Applicators. There are no explicit, quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for a diagnostic outcome, as this is a therapeutic device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Uniformity of dose delivered to tumor margins by Spherical Applicators | "Photoelectron submitted dosimetry data on the Spherical Applicators that demonstrates the uniformity of dose delivered to tumor margins." (Excerpt, Section 7.0 Testing) |
Note: The document provides no specific numerical values or detailed results of the dosimetry data beyond this statement.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a patient test set for an AI/ML diagnostic. The "test set" here refers to the physical characterization of the device through dosimetry. The document does not specify how many tests or measurements were conducted for the dosimetry data.
- Data Provenance: Not applicable. This is not patient-derived data but rather engineering and physics characterization of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for dosimetry measurements is derived from physical measurement techniques, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication needed for physical dosimetry measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a radiation therapy system, 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
This question is not directly applicable. The device itself is a standalone therapeutic system. The "performance" being evaluated is its ability to deliver radiation, not an algorithm's diagnostic output. The dosimetry data is a measure of the device's standalone performance in terms of radiation delivery characteristics.
7. The Type of Ground Truth Used
The ground truth used for the evaluation mentioned (dosimetry) is based on physical measurements and scientific principles related to radiation dose distribution. This is a form of objective, empirical data to characterize the device's output.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system trained on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML system.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.