(52 days)
The TCA 5R / 5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics, simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures.
The TCA 5R / 5S are mobile C-arms specifically designed for x-ray imaging. The TCA 5R / 5S consists of two mobile units: a C-Arm and a Monitor Trolley which holds one or two monitors, an image processing system and possible accessories. The C-Arm stand supports the highvoltage generator, x-ray controls, and the "C" shaped arm which supports the x-ray tube and the image intensifier. The C-Arm is designed to move in various directions to allow for proper positioning with the patient based on the procedure.
Here's an analysis of the provided 510(k) summary regarding the TCA 5R / 5S device, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain specific acceptance criteria or quantitative performance data for the TCA 5R / 5S device beyond a general statement of compliance with applicable performance standards.
The document states:
- "The TCA 5R / 5S comply with the applicable performance standards listed in Section 8 Performance Data: (Declaration of Conformity)"
- "Based on a comparison to the predicate device determined to be substantially equivalent through the 510(k) premarket notification process, Dornier MedTech America, Inc., concludes that the TCA 5R / 5S are as safe, as effective, and performs as well as other legally marketed C-arm devices."
This indicates a declaration of conformity to general performance standards for fluoroscopic and mobile x-ray systems and a claim of substantial equivalence to predicate devices. However, no specific metrics or thresholds are provided for acceptance, nor are any performance results reported in a quantitative manner.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific clinical study or test set with a defined sample size for performance evaluation. The submission relies on a comparison to predicate devices and adherence to general performance standards rather than a de novo clinical performance study with a dedicated test set. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
As there is no specific clinical study or test set described in the 510(k) summary, there is no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
Since no specific test set or clinical study is described, there is no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The submission focuses on substantial equivalence to predicate devices and compliance with technical standards for the device itself, not on an evaluation of human reader performance with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described, TCA 5R / 5S, is a hardware-based fluoroscopic imaging system (C-arm). It is not an AI algorithm, and therefore, the concept of a "standalone" algorithm performance study is not applicable to this submission. The 510(k) pertains to the safety and effectiveness of the imaging system itself.
7. The Type of Ground Truth Used
Given that this is a submission for a hardware imaging device and not an AI algorithm or a diagnostic tool requiring interpretation, the concept of "ground truth" in the traditional sense of a diagnostic outcome (like pathology or clinical follow-up) is not applicable or discussed in this type of 510(k) summary. The evaluation likely revolved around objective technical performance metrics (e.g., image quality, radiation dose, mechanical stability) and safety standards.
8. The Sample Size for the Training Set
As this is a hardware device submission, there is no concept of a "training set" in the context of machine learning. Therefore, no sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
In summary, the provided 510(k) summary for the Dornier MedTech America, Inc. TCA 5R / 5S C-arm system primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with applicable performance standards for medical imaging hardware. It does not describe a clinical performance study with defined acceptance criteria, test sets, or expert evaluations in the way one would expect for a diagnostic AI device.
§ 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.