(20 days)
Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic images. Revolution XR/d Digital Radiographic Imaging System is not intended for mammographic applications.
The Revolution XR/d with Tomosynthesis is a radiographic x-ray system intended for examinations using digital Tomosynthesis acquisition techniques. Tomosynthesis is a hardware & software option to the Revolution XR/d Digital Radiography System. The Revolution XR/d with Tomosynthesis consists of a elevating radiographic table with integrated digital detector, a radiographic wall stand with integrated digital detector, and an x-ray tube hanger, Overhead Tube Crane or Floor Mounted Tube Stand.
The provided documents, K051967, contain limited information about the acceptance criteria and study details. Based on the "Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c)," here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tomosynthesis diagnostic capability is as good as the predicate Tomo-link linear tomographic device. | "Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device." |
| Key features are consistent with traditional clinical procedures. | "other key features are consistent with traditional clinical procedures." |
Explanation of Implied Criteria: The document explicitly states the goal of the clinical tests was to show the tomosynthesis diagnostic capability is "as good as" the predicate device and that key features are "consistent." While no specific quantitative metrics or thresholds are provided as acceptance criteria, these qualitative statements serve as the basis for the reported performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the clinical tests.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It only states, "Clinical Tests: Clinical tests under the authority of an IRB..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- The document does not indicate that a multi-reader, multi-case (MRMC) comparative effectiveness study was performed or provide any effect size information. The clinical tests simply aimed to compare the diagnostic capability to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a "Digital Radiographic Imaging System with Tomosynthesis," implying it's an imaging hardware and software system, not solely an algorithm. The clinical tests assessed its "diagnostic capability," which inherently involves the output of the system that would then be interpreted by a human. Therefore, a standalone algorithm-only performance assessment in the modern sense (e.g., AI output without human interpretation) is not explicitly described or implied in this context, given the 2005 date of the submission. The "Tomosynthesis" part is described as an "acquisition technique" and a "software option."
7. The Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The comparison is made against the "Tomo-link linear tomographic device," suggesting the predicate device's diagnostic performance served as the benchmark.
8. The Sample Size for the Training Set
- The document refers to a "Revolution XR/d with Tomosynthesis" which is described as a "hardware & software option." Given the 2005 date, it is highly unlikely that "training set" in the context of modern machine learning was applicable in the same way. The document does not mention any training set or data used for algorithm development or machine learning.
9. How the Ground Truth for the Training Set Was Established
- As no "training set" for an AI algorithm is mentioned or implied, there is no information on how its ground truth would have been established.
Summary of the Study:
The provided 510(k) summary for the Revolution XR/d Digital Radiographic Imaging System with Tomosynthesis (K051967) indicates that clinical tests were conducted under the authority of an Institutional Review Board (IRB). The primary finding of these tests was that the "Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device" (K944967), which was the predicate device. Additionally, it was concluded that the device's "key features are consistent with traditional clinical procedures."
It's important to note that this submission dates back to 2005. The level of detail regarding clinical study design, acceptance criteria, and AI-specific performance metrics has evolved significantly in regulatory submissions since then. The information provided in this document is much less detailed than what would typically be required for a modern AI/ML-enabled device submission.
§ 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.