(96 days)
A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.
The provided FDA submission for the TrueView Core 100Pro-US Core Specimen Radiography System is not an AI/ML device. It is a cabinet X-ray system used for digital X-ray imaging of surgical and core biopsy specimens. Therefore, the specific criteria requested for AI/ML devices regarding acceptance criteria, study details, human reader improvement, and ground truth establishment (for training/test sets) are not applicable to this submission.
The document discusses performance data related to the device's electrical safety, mechanical hazards, and electromagnetic compatibility, as shown by compliance with IEC 61010 standards and various functional and usability tests.
Here is a summary of the information that is applicable and found in the document:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on compliance with standards rather than specific acceptance criteria in the context of diagnostic accuracy for AI/ML.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ANSI UL 61010-1 3rd Ed, May 12, 2012 | Complies |
| IEC 61010-2-091:2019 | Complies |
| IEC 61010-2-101:2018 | Complies |
| IEC 61326-1 Ed 3.0 2020-10 | Complies |
| IEC 61326-2-6 Ed 3.0 2020-10 | Complies |
| ISTA 3B-2017 | Complies |
| 21 CFR 1020.40 | Complies |
| Functional testing | Successfully performed |
| Usability testing | Successfully performed |
| Time to Preview |
§ 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.