(25 days)
VitalBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital 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, 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, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, trigeminal 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, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
VitalBeam is a medical linear accelerator.
The system consists of two major components, a photon, electron, and 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 VitalBeam device is a medical linear accelerator for radiation therapy. The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results for acceptance criteria in the way a clinical trial for a new drug or diagnostic might.
Based on the provided information, the acceptance criteria and performance are related to engineering and safety standards, as well as verification and validation (V&V) testing. There is no information about clinical performance or studies involving human readers, training sets, or ground truth established by experts in the context of AI or diagnostic performance metrics like sensitivity/specificity.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding device performance values. Instead, it focuses on adherence to engineering and safety standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Quality Management System | FDA Quality System Regulation (21 CFR §820) | Hardware and software verification and validation bench testing conducted according to this regulation. |
| ISO 13485 QMS standard | Testing conducted according to this standard. | |
| ISO 14971 Risk Management Standard | Testing conducted according to this standard. | |
| Electrical Safety & EMC | IEC 60601-1 (safety) | The system complies with this standard. |
| IEC 60601-1-2 (EMC) | The system complies with this standard. | |
| AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012; C1:2009/(R)2012 & A2:2010/ (R)2012 | Conforms in whole or in part. | |
| Software V&V | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for "major" level of concern) | Software V&V conducted and recorded as recommended. Test results showed passing criteria was met for conformance to applicable requirements specifications and assured hazard safeguards functioned properly. |
| Biocompatibility | ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1" | No change to patient-contact materials, therefore no change in conformance. |
| Other Conformances | IEC 60601-1-3: 2013 | Conforms in whole or in part. |
| IEC 60601-1-6: 2013 | Conforms in whole or in part. | |
| IEC 60601-2-1: 2014 | Conforms in whole or in part. | |
| IEC 60825: 2007 | Conforms in whole or in part. | |
| IEC 61217: 2011 | Conforms in whole or in part. | |
| IEC 62274: 2005 | Conforms in whole or in part. | |
| IEC 62304: 2006 | Conforms in whole or in part. | |
| IEC 62366:2015 | Conforms in whole or in part. | |
| IEC 60976: 2007 | Conforms in whole or in part. |
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 describes "Hardware and software verification and validation bench testing." This implies internal engineering tests, rather than a clinical study with patients or patient data. Specific sample sizes for these bench tests are not provided, nor is information about the provenance of any "data" in the context of clinical images or patient data (as this is an equipment submission, not an AI diagnostic algorithm).
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 to the type of safety and engineering testing described in the 510(k) summary for a linear accelerator. The "ground truth" here refers to whether the device meets its engineering specifications, not a medical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study assessing diagnostic performance requiring adjudication of labels.
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
Not applicable. The VitalBeam is a radiation therapy delivery system, not an AI diagnostic or assistive tool for human readers. The document highlights new features like 'Hyperarc™ new automated treatment type' and 'CBCT changes' which involve advanced imaging and treatment delivery techniques. While these are technological advancements, their evaluation in this 510(k) does not involve MRMC studies in the typical sense of AI diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "Software verification and validation testing" for a "major" level of concern software. This testing demonstrates the software's ability to function correctly according to its specifications. While this is testing the "algorithm only" in a sense, it's about the performance of the machine control software, not a diagnostic algorithm where "standalone" performance typically refers to metrics like AUC, sensitivity, or specificity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) testing involved adherence to engineering specifications and safety standards. For example, ensuring that radiation doses are delivered accurately, safety interlocks function as designed, and imaging systems perform within established parameters. This is verified against engineering and physics principles, not medical diagnostic ground truths like pathology.
8. The sample size for the training set
Not applicable. This is a V&V summary for a medical device (linear accelerator), not an AI algorithm development where a specific training set size would be relevant.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI algorithm.
§ 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.