(239 days)
The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The VenusX Radiotherapy System is a medical linear accelerator that delivers therapeutic radiation to patient in accordance with the physician's prescription. It supports CRT /IMRT Treatment Techniques (Mode). The system consists of a photon therapeutic 6 MV X-ray radiation beam producing component with a photon diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The provided text describes a medical device called VenusX, a radiotherapy delivery system, and its submission for FDA clearance. However, it does not include detailed information about specific acceptance criteria related to its performance in terms of accuracy or clinical effectiveness as one would expect for a diagnostic AI device or a device with a direct measurable output related to patient diagnosis/treatment efficacy (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Varian UNIQUE and Varian On Board Imaging) by comparing technological characteristics and ensuring adherence to various safety, electrical, software, and biocompatibility standards.
Therefore, many of the requested points cannot be answered based on the provided text. I will answer the points that can be addressed from the document and explicitly state when information is not available.
1. A table of acceptance criteria and the reported device performance
The document primarily discusses compliance with various standards and safety requirements rather than performance metrics like sensitivity, specificity, or quantifiable clinical outcomes. Therefore, a table listing "acceptance criteria" and "reported device performance" in the typical sense for a clinical study is not possible from this text.
The "acceptance criteria" mentioned are related to:
- Electrical Safety and EMC: Compliance with IEC 60601-1-2:2014+AMD1:2020. Reported performance: "The system complies with the following standards."
- Bench Testing: Conformance to various IEC and ANSI AAMI standards (e.g., ANSI AAMIES/IEC60601-1, IEC 60601-1-3, IEC 60601-2-1, IEC 60601-2-68, IEC 62274, IEC 62366-1, IEC 60601-1-6, IEC 60976, IEC 61217). Reported performance: "Test results met all the pre-determined acceptance criteria."
- Cybersecurity: Compliance with security requirement testing, threat mitigation testing, closed box vulnerability scanning, and penetration testing, with reference to IEC 62443-4-1 Section 9.4. Reported performance: "The results of the cybersecurity testing showed that VenusX meets the cybersecurity requirements under Section524B(b) of FD&C Act."
- Hardware and Software V&V: Conformance to 21 CFR §820, ISO 13485, ISO 14971, and FDA guidance "Content of Premarket Submissions for Device Software Functions." Reported performance: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." Also, "there were no software DRs (Discrepancy Reports) remaining which had a priority of Safety Intolerable or Customer Intolerable." The software is considered "enhanced" level of concern.
- Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for the Carbon fiber couch top. Reported performance: "Test results met all the pre-determined acceptance criteria."
The document states that the VenusX device "provides precision radiotherapy" and its "Cone Beam CT Imager device (CBCT) is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks." It does not provide quantitative performance metrics for these functions.
A comparison of technological characteristics between the VenusX and predicate/reference devices is provided (pages 5-8), indicating that the VenusX has similar intended use, indications for use, and core functionalities (e.g., photon energy, maximum treatment field size, patient support, microwave source, interface for external system gating, image registration, data interface, record treatment delivery results, treatment techniques). Some differences are noted, such as FFF mode dose rates, SAD, number of MLC leaves (101 leaves in two orthogonal layers vs. 120), maximum leaf over travel, average leaf transmission (≤ 0.05% for VenusX vs. ≤ 2.0% for predicate), MV Detector size (larger for VenusX: 43cm x 43cm vs. 30cm x 40cm), and MV Pixel (higher resolution for VenusX: 2816x2816 vs. 1024x768). For CBCT, the VenusX also uses the FDK algorithm, with a dose per acquisition ≤ 2cGy (vs. ≤ 1.4cGy for reference device) and a 512x512 reconstruction matrix / 360° acquisition mode.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily non-clinical (bench testing, electrical safety, cybersecurity, hardware/software V&V, biocompatibility). There is no mention of a clinical "test set" in the context of patient data, nor its provenance or design.
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)
This information is not provided in the document. Since no clinical "test set" with patient data requiring ground truth by experts is described, this point is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Since no clinical "test set" requiring adjudication is described, this point is not applicable.
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
This information is not provided in the document. The VenusX is a radiotherapy delivery system, not a diagnostic AI system designed to assist human readers in interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the described device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document refers to the device's technical performance against engineering and safety standards. It does not describe an "algorithm only" standalone performance in the sense of a diagnostic or analytical algorithm reporting a clinical outcome. The device itself (a linear accelerator) performs the function of radiation delivery, and its imaging components (MV, CBCT) are for positional verification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" implicitly refers to the specified technical requirements, standards, and design specifications. For example, in electrical safety, the ground truth is adherence to the IEC 60601-1-2 standard. For hardware/software V&V, it's conformance to requirements specifications and hazard safeguards. There is no mention of ground truth established from clinical data like pathology or outcomes data.
8. The sample size for the training set
This information is not provided in the document. The document describes a medical linear accelerator system, not an AI model that requires a "training set" of data in the typical sense. The software and hardware development involves verification and validation, but not a data-driven training process in the way a machine learning model would.
9. How the ground truth for the training set was established
This information is not provided in the document. As noted in point 8, there is no mention of a "training set" for an AI model.
§ 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.