(29 days)
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
The provided text is a 510(k) summary for the BeamSite™ System, V 1.5. This document focuses on demonstrating substantial equivalence to a predicate device due to minor technological changes. It does not present acceptance criteria or detailed study results for device performance in the typical sense of clinical or standalone algorithm performance.
Here's an analysis of the provided text in relation to your request:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided document describes a Special 510(k) submission where the subject device (BeamSite™ System, V 1.5) is compared to a predicate device (BeamSite System, K200940). The primary purpose of this type of submission is to demonstrate that minor changes to a previously cleared device do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" discussed are largely related to maintaining the performance and safety characteristics of the predicate device. The "study" referenced is primarily a set of non-clinical performance tests designed to confirm that the modified device performs comparably to the predicate and meets relevant safety and quality standards, rather than a study to establish novel performance metrics or clinical efficacy.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, a table like the one requested, with specific quantitative acceptance criteria and corresponding reported device performance for clinical or diagnostic metrics, cannot be fully constructed. The document focuses on confirming that the changes in the device (specifically the "always on" imaging mode) do not negatively impact its existing, established performance.
Instead, the document details performance testing repeated on the modified device to support substantial equivalence. The implication is that the performance criteria for these tests were either identical to those successfully met by the predicate device or standard regulatory requirements for device safety and functionality.
| Acceptance Criteria (Implied / Regulatory Standard) | Reported Device Performance (Summary) |
|---|---|
| Functional Verification (System, Software, Firmware) | "BeamSite functional verification testing (system, software and firmware)" was repeated on the proposed device. (Implied: Passed, demonstrating continued functionality and consistency with predicate) |
| Accelerated Age Testing (Service Life) | "Accelerated age testing to support expected service life claim for the BeamSite Camera" was repeated. (Implied: Passed, demonstrating maintained device longevity and durability) |
| Electrical Safety (IEC 60601-1:2005 / (R) 2012) | "Electrical Safety Evaluation as per IEC 60601-1:2005 / (R) 2012 and A1: 2012" was conducted. (Implied: Complies with relevant electrical safety standards) |
| Electromagnetic Compatibility (IEC 60601-1-2: 2014) | "Electromagnetic Compatibility testing as per IEC 60601-1-2: 2014" was conducted. (Implied: Complies with relevant EMC standards) |
| Software Verification & Validation (IEC 62304) | "Software Verification and Validation as per IEC 62304:2006 / A1: 2016" was performed. (Implied: Software functions correctly and safely, in accordance with V&V best practices for medical device software) |
| Usability Testing (IEC 60601-1-6 & IEC 62366-1) | "Usability Testing as per IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1: 2015" was performed. (Implied: The device remains safe and effective for use by radiotherapy professionals, and the new feature does not introduce usability issues) |
| No new safety/effectiveness concerns | The submission concludes that "the differences in technological characteristics do not raise different questions of safety and efficacy." (Implied: All performance testing confirmed that the modified device maintained the safety and efficacy profile of the predicate device, thereby meeting the implicit "acceptance criteria" of substantial equivalence.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists non-clinical performance test types, such as functional verification, accelerated age testing, electrical safety, EMC, software V&V, and usability testing. These are primarily engineering and regulatory compliance tests, not data-driven clinical studies with "test sets" in the diagnostic performance sense. Therefore, information regarding:
- Sample size for a "test set" (of patient data/images) is not applicable and not provided.
- Data provenance (country of origin, retrospective/prospective) is not applicable and not provided for this type of non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided and is generally not required for the type of non-clinical, substantial equivalence testing described in this document. The device is a "visualization tool" to show the beam on the patient; it's not performing diagnostic or analytical measurements that would require expert-established ground truth on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the nature of the non-clinical performance testing 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
- No, an MRMC comparative effectiveness study was not done. The BeamSite system is a visualization tool, not an AI-powered diagnostic or decision-support system intended to improve human reader accuracy. The purpose of the submission is to demonstrate substantial equivalence of a modified version of a previously cleared device, not to prove clinical efficacy or reader benefit.
- The document does not mention any AI components in the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. The device's function is to provide "live visualization" for "radiotherapy professionals" to "visually monitor radiation therapy." It is inherently a human-in-the-loop system. The non-clinical tests described focus on hardware, software, safety, and usability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the non-clinical nature of the testing described (functional verification, safety, EMC, V&V, usability), the concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly relevant to the information provided. The "ground truth" for these engineering tests would be established by reference standards, regulatory requirements, and engineering specifications.
8. The sample size for the training set
- Not applicable and not provided. The BeamSite system, as described, does not appear to be an AI/ML device that requires a "training set" of data for algorithm development. Its function is optical imaging of Cherenkov light and patient surface anatomy.
9. How the ground truth for the training set was established
- Not applicable and not provided, as there is no mention of a training set or AI/ML algorithm requiring this.
In summary: The provided FDA 510(k) summary is for a Special 510(k) submission, which focuses on demonstrating that a modified device is substantially equivalent to a predicate device and that the changes do not raise new safety or effectiveness concerns. The "performance testing" described comprises standard engineering and regulatory compliance tests (e.g., electrical safety, EMC, software validation) to confirm the continued safety and functional performance of the device after minor modifications, primarily the addition of an "always on" imaging mode. It does not contain information related to diagnostic performance, clinical efficacy studies, or AI/ML algorithm performance metrics that would involve patient data, expert ground truth, or MRMC studies.
§ 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.