(124 days)
The VersaVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The Faxitron VersaVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 8X) from the
The provided text is a 510(k) premarket notification for the Faxitron VersaVision device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in the context of clinical performance (e.g., diagnostic accuracy for an AI/CAD system).
Instead, the document details the technical specifications, intended use, and nonclinical performance data testing against regulatory standards for an X-ray system. It does not describe a study involving specific acceptance criteria for diagnostic performance, sample sizes for test sets, ground truth establishment, or human reader performance.
Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission presented.
However, I can extract information related to the device's technical specifications and compliance with regulatory standards.
Here's the closest interpretation of your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic study. Instead, it refers to compliance with performance standards for X-ray systems.
| Acceptance Criteria (Regulatory Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1020.40 (Cabinet X-ray Systems Performance Standards) | Designed and tested to comply. Testing and performance data included in submission. |
| Compliance with Laser performance standards 21 CFR 1040.10 and 21 CFR 1040.11 (if applicable) | Designed and tested to comply. Testing and performance data included in submission. |
| Compliance with European EMC Directive (Electromagnetic Compatibility) | Successfully tested to the European EMC Directive. |
| Compliance with Safety testing to IEC 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use) | Successfully tested to IEC 61010 third edition. |
| Focal Spot Size |
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.