(87 days)
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.
The ACCENT system is composed of: a mobile C-Arm that includes: an image intensifier with CCD video camera, an x-ray generator and controller, an x-ray tube mounted in the same housing as the x-ray generator, a beam-limiting device, optional: a Laser beam alignment device, optional: a dose area product meter and display. and a monitor cart that includes: TV monitors, an image digital processing and storage system, may be of different models, optional: VCR and video printers.
The provided text is a 510(k) summary for the ACCENT Mobile X-ray System, which is a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity for a particular clinical task. Instead, it focuses on demonstrating that the device is safe and effective by complying with established standards and being substantially equivalent to existing devices.
Therefore, many of the requested sections about acceptance criteria, study design, and ground truth establishment are not applicable to the information contained in this 510(k) summary.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic aid. Instead, it refers to compliance with safety and performance standards relevant to X-ray systems.
| Acceptance Criteria (Compliance/Safety Standards) | Reported Device Performance/Compliance |
|---|---|
| All construction and materials compliant with UL 2601-1, and IEC 601-1 equipment standards. | Compliant: "All construction and materials are compliant with UL 2601-1, and IEC 601-1 equipment standards." |
| Design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1. | Meets/Exceeds Standards: "The design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1." Additionally, includes "hardware redundancies to prevent single point failures (such as x-ray emission and C-Arm motion)". |
| Exposure levels comply with 21CFR 1020.30 - 31 - 32. | Compliant: "Systems comply with the requirements of 21CFR 1020.30 - 31 - 32." Specifics include: Maximum rated peak tube potential: 110 kV, Fluoroscopic Entrance Exposure Rate (EER): less than 10 R/min., Radiography: 160 mAs maximum, manual setting. |
| Controls for potential hazards (x-ray, mechanical, electrical). | Controlled: "The potential hazards (x-ray, mechanical and electrical) are controlled by compliance with the federal x-ray standard, adherence to industry standards (UL 2601-1) and with the recommendations of other industry experts as described in the labeling." |
| Substantial Equivalence to Predicate Devices (STENOSCOP 2, Model 6000 and 9000). | Substantially Equivalent: "The ACCENT systems are substantially equivalent to the above listed devices. The energy source, exposure levels and principles of operation are very similar." The device performs the same functions and replaces the listed units. (This is the primary "acceptance criterion" for a 510(k) pathway, rather than a clinical performance study). |
2. Sample size used for the test set and the data provenance:
- Not Applicable: This document does not describe a performance study with a test set of patient data. The evaluation is based on engineering compliance and substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No ground truth was established from clinical experts for this type of submission.
4. Adjudication method for the test set:
- Not Applicable: No test set or adjudication process for clinical outcomes 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:
- Not Applicable: This device is a mobile X-ray system, not an AI-powered diagnostic aid. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is hardware (X-ray system), not an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the context of clinical ground truth): The "ground truth" for this submission would be regulatory standards and the specifications of predicate devices, against which the ACCENT system's design and operating parameters were compared.
8. The sample size for the training set:
- Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable: No training set was used.
In summary: The provided text is a regulatory submission demonstrating the safety and effectiveness of a mobile X-ray system through compliance with established engineering and radiation safety standards, and by demonstrating substantial equivalence to legally marketed predicate devices. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, or ground truth as would be associated with a new diagnostic algorithm or AI-enabled 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.