(51 days)
The VitalBeam System is intended to provide stereotactic radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The VitalBeam System may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial), gastrontestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid turnors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
The VitalBeam™ Radiotherapy Delivery System is a medical linear accelerator based on the previously cleared TrueBeam Radiotherapy system and associated accessories.
The system consists of two major components: a beam-producing component that is installed in a radiation-shielded vault (hereafter referred to as the treatment room) and a control console located outside the treatment room.
The provided text describes the VitalBeam Radiotherapy Delivery System, a medical linear accelerator system. It is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's safety and effectiveness to a predicate, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic AI device.
Therefore, much of the requested information (acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, etc.) is not present in this document because it pertains to the performance evaluation of a diagnostic or algorithmic device, not a therapeutic hardware device like a linear accelerator.
The document mostly discusses the device's technical specifications, intended use, indications for use, and a comparison to a predicate device based on features and adherence to recognized standards.
Here's an attempt to answer the questions based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) paired with reported performance results as would be typical for a diagnostic algorithm. Instead, the "acceptance criteria" for a radiotherapy delivery system in a 510(k) context largely revolve around demonstrating substantial equivalence to a predicate device and conformance to applicable safety and performance standards.
The document states:
- Acceptance Criteria (Implicit): Conformance to applicable requirements specifications, assurance of hazard safeguards functioning properly, and compliance with recognized consensus standards (listed below). The ultimate "acceptance criterion" for 510(k) clearance is demonstrating that the device is as safe and effective as a legally marketed predicate.
- Reported Device Performance: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."
| Acceptance Criteria (Implicit from 510(k) context) | Reported Device Performance |
|---|---|
| Conformance to applicable requirements specifications | "conformance to applicable requirements specifications" |
| Hazard safeguards function properly | "assured hazard safeguards functioned properly" |
| As safe and effective as the predicate device (TrueBeam Radiotherapy System) | "is as safe, effective and perform as well as or better than the legally marketed device" |
| Conformance with FDA recognized consensus standards: | "conforms in whole or in part with the following FDA recognized consensus standards:" (followed by a list of IEC, AAMI/ANSI standards) |
2. Sample size 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. The document describes a medical device (linear accelerator) for delivering radiation, not a diagnostic algorithm that would typically use test data sets of patient images or clinical records. The "testing" mentioned is likely engineering verification and validation testing of the hardware and software components, not clinical data analysis in the sense of AI performance evaluation.
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 applicable and is not provided. The device described is a radiotherapy delivery system, not a diagnostic tool requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided for the same reasons as above.
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 applicable and is not provided, as the VitalBeam Radiotherapy Delivery System is not a diagnostic AI device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and is not provided. The VitalBeam is a hardware system for delivering radiation therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and is not provided. "Ground truth" in the context of diagnostic performance is not relevant for this type of device submission.
8. The sample size for the training set
This information is not applicable and is not provided. The device is a hardware system, not an AI model that would have a "training set."
9. How the ground truth for the training set was established
This information is not applicable and is not provided for the same reasons as above.
§ 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.