(104 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 Trident® HD Specimen Radiography System is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The Trident® HD system includes the following major components: an image display monitor, touch-screen control display, 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.
Dedicated specimen radiography systems are intended for use in the following environments:
- The surgical suite
- The stereotactic biopsy suite
- The pathology lab
Specimen radiography units are utilized to confirm removal of the intended tissue, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution X-ray of the specimen, the presence of a lesion or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
The provided document is a 510(k) summary for the Hologic Trident HD Specimen Radiography System. It describes the device's technical specifications and a comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy.
The "Summary of Testing" section explicitly states: "No clinical studies have been performed. Substantial equivalence has been demonstrated by nonclinical testing." The testing mentioned focuses on system design control verification, validation tests, compliance with engineering standards (IEC 61010), and bench testing (functional and usability).
Therefore, based solely on the provided text, I cannot fulfill the request for:
- A table of acceptance criteria and the reported device performance: No acceptance criteria related to diagnostic performance are stated, nor are any diagnostic performance results reported.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth was established for a test set.
- Adjudication method for the test set: Not applicable.
- 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, as this is a specimen radiography system, not an AI-assisted diagnostic device, and no clinical studies were performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): No clinical ground truth was used.
- The sample size for the training set: Not applicable, as no training set for a clinical algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (Trident Specimen Radiography System, K111508) based on engineering, performance, and safety rather than clinical efficacy or diagnostic accuracy. The key message for demonstrating substantial equivalence is that the new device has the same intended use, general configuration, principles of operation, and operating parameters, with minor changes that do not raise new questions of safety or effectiveness.
§ 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.