(60 days)
This device is a digital radiography/fluoroscopy system use in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
This device in an x-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.
The provided document describes a 510(k) premarket notification for a modified medical device, the INFX-8000V with Wireless Footswitch. The submission is a "Special 510(k)", which typically implies minor modifications to a previously cleared device that do not raise new questions of safety or effectiveness. As such, the study conducted is primarily for verification testing to ensure the modification (addition of a wireless footswitch) does not negatively impact the device's performance compared to the predicate device.
Here's an analysis based on the information provided, specifically regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that the performance of the modified device is "equal to or better than the predicate device." This is a common approach for Special 510(k) submissions where the focus is on maintaining equivalence rather than achieving new performance benchmarks.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Performance of the modified device (INFX-8000V with wireless footswitch) compared to the predicate device. | "The performance of the modified device is equal to or better than the predicate device." |
| No change in Indications for Use or Intended Use due to the modification. | "The addition of the wireless footswitch does not change the indications for use or the intended use of the device." |
| Continued conformance with applicable safety and performance standards (e.g., IEC60601-1, IEC 60601-2-43, IEC 60601-2-28, 21 CFR §1020). | "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-43 and IEC60601-2-28. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report." |
| Safety and effectiveness verified via risk management and application of design controls. | "Safety and effectiveness have been verified via risk management and application of design controls to the modification." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is "verification testing," which for a modification like a wireless footswitch, would likely involve engineering tests, functional tests, and EMC/wireless compatibility tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the modification (a wireless footswitch for an X-ray system), the "ground truth" would likely relate to the functionality and safety of the footswitch (e.g., signal integrity, latency, safety interlocks) rather than diagnostic accuracy requiring expert image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. This type of method (e.g., 2+1, 3+1) is typically associated with studies involving human interpretation of medical images where disagreements among experts need to be resolved to establish a definitive ground truth. Such a process is not applicable to the verification testing of a wireless footswitch's functionality.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies compare the diagnostic performance of human readers, often with and without AI assistance, across a set of cases. This type of study is not relevant to the modification of adding a wireless footswitch to an X-ray system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study was not done in the context of an AI algorithm. The device in question is an X-ray system with a wireless footswitch, not an AI diagnostic algorithm. The "standalone" performance here would refer to the functional performance of the footswitch itself (e.g., responsiveness, signal range, battery life), which would be part of the verification testing. However, the document doesn't detail these specific tests.
7. The Type of Ground Truth Used
For the purpose of verifying the wireless footswitch modification, the "ground truth" would likely be based on:
- Engineering specifications and standards: Confirming the footswitch meets its design requirements.
- Functional performance metrics: Demonstrating reliable operation, accurate signal transmission, and appropriate response times.
- Safety standards conformance: Ensuring electrical safety, electromagnetic compatibility, and risk mitigation related to wireless communication.
The document does not explicitly state the "type of ground truth" using these terms but implies conformance to standards and verification through risk management.
8. The Sample Size for the Training Set
This concept is not applicable to this submission. "Training set" refers to data used to train machine learning models. The device being modified is an X-ray system, and there is no indication that any AI or machine learning component was introduced or significantly altered that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set or AI model development in this submission.
§ 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.