(63 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 biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet. The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.
This document, a 510(k) Premarket Notification Summary for the TrueView 100 Pro Specimen Radiography System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.
The information provided does not include:
- A table of acceptance criteria with reported device performance.
- Specific sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
- Information on the number or qualifications of experts, or adjudication methods for ground truth in a test set.
- Details of a multireader multicase (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample size for a training set or how ground truth for a training set was established.
Instead, the submission relies on comparing the technical specifications and performance characteristics of the TrueView 100 Pro to its predicate device, the Trident® HD Specimen Radiography System (K182727), to argue for substantial equivalence.
Here's an analysis of the information available in the provided text:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparative table between the TrueView 100 Pro and the predicate device. While this table lists various technical specifications and operational parameters, it does not explicitly define acceptance criteria for each parameter and then report the TrueView 100 Pro's performance against those criteria. Instead, it compares the TrueView 100 Pro's specifications directly to the predicate's specifications to demonstrate "similarity" or "improvement."
Here's a summary of the technical comparison presented in the document, which can be interpreted as the basis for performance claims relative to the predicate:
| Feature | Predicate (Trident® K182727) | TrueView 100 Pro (Proposed) | Comparison |
|---|---|---|---|
| Indications for Use | Same as proposed | A cabinet X-ray system for digital X-ray images of surgical and core biopsy specimens to verify tissue removal. Improves workflow by reducing patient examination time. | Same |
| Principle of Operation | X-ray imaging principle | X-ray imaging principle | Same |
| Level of Concern | Moderate | Moderate | Same |
| Method of Use | Cabinet X-ray system for imaging small to large biopsy and surgical specimens | Cabinet X-ray system for imaging small to large biopsy and surgical specimens | Same |
| Mechanism of Action | Sample verification: obtain correct margins, specimen of interest, etc. | Sample verification: obtain correct margins, specimen of interest, etc. | Same |
| Physical Construction | Fully integrated system with movable base casters | Fully integrated system with movable base casters | Similar; designed for ease of use and transportation |
| Size (W x D x H) | 24 x 26 x 66.5 (in.) | 23.6 x 28.3 x 64.9 (in.) | Similar: slim design for ease of use and transportation |
| Detector Technology | TFT-based direct capture technology | Active-pixel CMOS | Different |
| Active Imaging Area | 12 cm x 14 cm (MFD), 20 cm x 20 cm (HDT) | 11.4 cm x 14.6 cm | Trident® HD is available with two detectors; TrueView has one size. |
| Pixel Size | 70 µm pixels | 49.5 µm pixels | Similar, TrueView 100 Pro pixel size is 29% smaller |
| Limiting Spatial Resolution | 7.1 lp/mm | 10 lp/mm | Similar, TrueView 100 Pro has 41% more line pairs per mm. |
| Output Image | 14-bit image data | 14-bit image data | Same |
| Display Monitor | 2 MP High luminescence diagnostic monitor | 2.3 MP High luminescence diagnostic monitor | Similar, TrueView 100 Pro slightly improved resolution |
| Operating System | Windows 10 | Windows 10 | Same |
| User Interface | Integrated touch screen, track pad | Integrated touch screen, track pad | Same |
| Energy Range | 20-50 kV | 20-50 kV | Same |
| Anode Type | Tungsten | Tungsten | Same |
| Tube Current | 1 mA | 1 mA | Same |
| Exposure | Up to 20 mAs | Up to 20 mAs | Same |
| Focal Spot Size | 50 µm | 50 µm | Same |
| Exposure Modes | Manual (User selects kV and mAs), Auto (System determines optimum kV and mAs) | Manual (User selects kV and mAs), Auto (System determines optimum kV and mAs) | Same |
| 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.