(27 days)
The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
This notification is for a modification is the addition of the new MH-700 (ceiling mounted C-Arm). This is the functional equivalent of previous C-Arm MH-400. All options declared under K203535 remain available. The Lateral Angiographic C-arm Support MH-700 allows examination of a patient by fluoroscopy or radiography from different angles with the patient kept in a horizontal position in combination with a Frontal C-arm Support MH-600, an X-ray high voltage unit, X-ray tube unit, X-ray image recording unit (FPD), digital angiography system, catheterization table, etc. The range of available digital receptor panels remains unchanged from our predicate K203535. For installation, ceiling strength is important because the total weight of MH-700 exceeds 1200 kg. The MH-700 features faster movement speeds as compared to the previous model, the MH-400.
The provided document is a 510(k) Premarket Notification for a medical device called "Trinias." It focuses on a modification to the device (addition of a new C-Arm model MH-700) and its substantial equivalence to a predicate device (Trinias K203535).
Based on the information provided, no clinical study was conducted to establish acceptance criteria for device performance related to diagnostic accuracy or interventional outcomes with human-in-the-loop or standalone AI performance. This document primarily focuses on demonstrating substantial equivalence through non-clinical testing, compliance with standards, and comparison of technical specifications.
Therefore, many of the specific points requested regarding acceptance criteria and clinical study details cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the context of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or interventional success rates. Instead, the "performance" described pertains to technical specifications and compliance with safety and electrical standards.
| Feature/Parameter | Acceptance Criteria (Implied: Substantial Equivalence to Predicate, Compliance with Standards) | Reported Device Performance (Modified Trinias) |
|---|---|---|
| Indications for Use | Same as predicate device | Same as predicate: diagnostic imaging and interventional procedures including cardiac, neurovascular, abdominal, peripheral, rotational, multi-purpose angiography, and whole body radiographic/fluoroscopic procedures. |
| Patient Table | Functionally equivalent to predicate | Same as predicate (KS-100, table top can tilt) |
| Biplane C-arm (MH-700) | Safe and effective as predicate MH-400; compliance with standards, faster movement permissible | MH-700 is new, replaces MH-400. Features faster movement speeds. |
| C-arm Rotation Range (LL primary angle) | LAO120 - PA0 | LAO120 - PA0 |
| C-arm Rotation Speed (LL primary angle) | Max 15deg/sec (predicate) | Max 25deg/sec (Faster response) |
| C-arm Rotation Range (RL primary angle) | PA0 - RAO120 | PA0 - RAO120 |
| C-arm Rotation Speed (RL primary angle) | Max 15deg/sec (predicate) | Max 25deg/sec (Faster response) |
| C-arm Rotation Range (LL secondary angle) | CRAN45 - CAUD45 (predicate) | CRAN45 - CAUD45 |
| C-arm Rotation Speed (LL secondary angle) | Max 15deg/sec (predicate) | Max 25deg/sec (Faster response) |
| C-arm Rotation Range (RL secondary angle) | CRAN30°~CAUD30° (predicate) | CRAN45 - CAUD45 |
| C-arm Rotation Speed (RL secondary angle) | Max 15deg/sec (predicate) | Max 25deg/sec (Faster response) |
| SID range/speed | 95cm - 125cm, 8cm/sec max (predicate) | 95cm - 125cm, 10cm/sec max (Faster response) |
| Digital Image Processor | Same as predicate | Same as predicate (DAR-9500f) |
| Digital X-Ray Receptor Panels | No changes; same models and sizes as predicate | Same as predicate (SFD-0808AF, SFD-1212AF, SFD-1612AF with Varex PaxScan panels) |
| X-Ray Generator (Model #, Rated output, Control Method, Voltage, Current, mAs, Time) | Same as predicate | Same as predicate (D150GC-40, 100 kW, 50 kHz Inverter, various kV/mA/mAs/sec specifications) |
| Collimator | Same as predicate | Same as predicate (F-100) |
| US Performance Standard Compliance | Compliance with 21CFR1020.30, 21CFR1020.31, 21CFR2020.32 | Certified to comply with 21CFR1020.30, 21CFR1020.31, 21CFR2020.32 |
| IEC Safety Standards Compliance | Compliance with listed IEC standards | Certified to comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-43, IEC 62366, IEC 62304, EN 60601-1, EN 60601-1-3, EN 60601-1-6, EN 60601-2-43, EN 62304, ANSI/AAMI ES60601-1. |
| Software Validation | Compliance with FDA Guidance: "Content of Premarket Submissions for Software Contained in Medical Devices" | Validated according to FDA guidance issued May 11, 2005. |
| Cybersecurity | Compliance with FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Recommendations from guidance issued Oct 2, 2014, were observed and incorporated. |
| Pediatric Information/Labeling | Compliance with FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications" | Labeling developed per guidance. Includes reference to Image Gently website. |
| Wireless Technology | Compliance with FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices" | Recommendations from guidance issued August 2013, were incorporated into labeling. |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. The testing was non-clinical (bench and standards testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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. No MRMC study was done, nor does the device appear to include AI for interpretation or improvement of human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray system, not an AI algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. For non-clinical testing, "ground truth" would relate to engineering specifications and performance against established standards, confirmed by third-party laboratories.
8. The sample size for the training set: Not applicable. This document does not describe training of an AI algorithm based on a dataset.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary focuses entirely on non-clinical aspects to demonstrate substantial equivalence of a modified X-ray system to its predicate. It explicitly states: "Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards." Therefore, questions related to clinical study design, performance metrics (like sensitivity, specificity), ground truth, expert readers, or AI-related evaluations cannot be answered from this document.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.