(47 days)
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)
The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).
The Angio-CT MIYABI system is a combination of a CT and an Angiography system The SOMATOM Plus 4 system is a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
The provided text describes the Angio-CT MIYABI system, which combines a CT and an Angiography system. However, it does not include details about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for substantial equivalence.
Therefore, I cannot populate the table or answer most of the questions using the provided text. The submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than providing performance data against predefined acceptance criteria for the combined system.
Here's what I can extract based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria Value | Reported Performance |
|---|---|---|
| Intended Use Equivalence | To perform interventional radiological techniques and whole-body x-ray computed tomography scanning on a single patient without movement, especially during or after interventional procedures (e.g., stenting, coiling, local chemical therapy, embolization). | The Angio-CT MIYABI is a combined system that allows interventional radiological techniques and whole-body x-ray computed tomography scanning on a single patient without movement, especially after or during interventional surgery (e.g., stenting, coiling, local chemical therapy, embolization). |
| Technological Characteristics Equivalence | Combination of a CT (SOMATOM Plus 4) and an Angiography system (Multistar Plus). | The Angio-CT MIYABI system is a combination of a CT and an Angiography system, specifically the SOMATOM Plus 4 and Multistar Plus. |
| Safety Standards Compliance | Meet 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard; 21 CFR § 1020.30 and § 1020.33; ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1; UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY. | All components are certified to meet these requirements. The SOMATOM is designed to meet IEC 601-1 and UL 187. An initial report as per 21 CFR § 1002.10 will be filed. |
| Substantial Equivalence (to predicate devices) | Operating with SOMARIS 4 (SOMATOM Plus 4) and SW-Version 3.0 (Multistar Plus) software, substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M in commercial distribution. | Deemed substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M (in commercial distribution) by the FDA. |
| Diagnostic Image Quality (e.g., resolution, contrast) | Not specified in the provided text. | Not specified in the provided text. |
| Accuracy of Procedures (e.g., precise localization for interventions) | Not specified in the provided text. | Not specified in the provided text. |
| Radiation Dose Levels | Not specified in the provided text. | Not specified in the provided text. |
Detailed Answers to Specific Questions:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document is a 510(k) submission for substantial equivalence. It does not describe a clinical study generating specific performance data against a test set. Equivalence is primarily based on comparing the new device's technical characteristics and intended use to existing predicate devices.
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)
- Not applicable / Not provided. No specific clinical study or test set with expert-established ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No specific clinical study or test set requiring adjudication is 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. This document describes a combined imaging system, not an AI-assisted diagnostic tool. There is no mention of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a medical imaging system (CT and Angiography), not an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. No specific clinical “ground truth” from a study is mentioned. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This document does not describe a machine learning algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there's no training set mentioned, this question is not relevant to the provided text.
Conclusion based on the provided text:
The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Angio-CT MIYABI system to already marketed CT and Angiography systems. It does not contain information about a specific performance study against defined acceptance criteria for the combined system beyond compliance with regulatory standards and the equivalence of its technical characteristics and intended use to its predicate devices. There is no mention of AI, machine learning, or detailed clinical efficacy trials with expert ground truth or test sets.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.