(78 days)
The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross-sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes.
This device is designed to provide and control the sweep speed and angle of a tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient.
The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.
The Medstone, Radiographic Linear Tomography Option is designed as an 'add-on' optional device to enable the production of radiologic images of a specific linear cross-sectional plane of the body by blurring or eliminating detail from other planes. A high degree of emphasis for the design of this device was placed on error detection and reliability as well as usability and safety.
The provided 510(k) summary for the Medstone Linear Tomography Option does not include the typical acceptance criteria and a detailed study proving the device meets those criteria, as one might expect for a modern AI/software as a medical device (SaMD).
Instead, this submission primarily relies on substantial equivalence to a predicate device (Pausch Corporation Microtom, Tomographic Option) based on non-clinical performance data and an absence of clinical performance data being deemed necessary.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a linear tomography option rather than an AI/SaMD, the "acceptance criteria" are more about functional equivalence and safety rather than performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Medstone Linear Tomography Option) |
|---|---|
| Functional Equivalence: | |
| - Tomographic Movement Type | LINEAR |
| - Input/Line Voltage | 110 VAC 1-phase |
| - Input/Line Frequency | 50/60 Hz |
| - Patient positioning and image production capabilities | Enables production of diagnostic radiologic images of a specific linear cross-sectional plane. |
| Performance Parameters (within acceptable deviation): | |
| - Fulcrum Range | 0 mm to 250 mm |
| - Tomographic Angles | 20°, 10°, 5° |
| - Exposure Times (controlled by X-Ray Generator) | 0.2 to 1.6 secs. |
| - Operational performance ('sweep time' per 'sweep angle') | Within 20% differential of predicate, equivalent with respect to imaging output. |
| Safety and Effectiveness: | |
| - Error detection and reliability | High degree of emphasis placed on these. |
| - Usability and safety | High degree of emphasis placed on these. |
| - Absence of new questions of efficacy or substantial risk | No new questions of efficacy or substantial risk raised. |
Note: The reported performance is primarily a comparative statement against the predicate device, asserting "complete equivalence" in safety and effectiveness.
2. Sample Size for Test Set and Data Provenance
- Not Applicable. The submission states: "It has been concluded that clinical performance data for the Medstone Linear Tomographic, device was not needed for this 510(k) process. The determination of substantial equivalence is, therefore, not based on an assessment of clinical performance for the purpose of this 510(k) process."
- There is no mention of a "test set" in the context of clinical data or image analysis. Performance was assessed via non-clinical comparisons and engineering specifications.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. As no clinical performance study was conducted, there was no need for expert review to establish ground truth from clinical data. The assessment was based on engineering and functional comparisons.
4. Adjudication Method for Test Set
- Not Applicable. No clinical test set or adjudication process was required or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. No MRMC study was conducted or mentioned. The device is a hardware option for an X-ray table, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This device is a mechanical/electronic add-on option for an X-ray table, not a standalone algorithm or software. It facilitates image acquisition, not interpretation.
7. Type of Ground Truth Used
- Technical Specifications and Functional Equivalence. The "ground truth" for this submission was implicitly defined by the technical specifications and operational performance of the predicate device. The Medstone device had to demonstrate comparable technical parameters and functional output (e.g., sweep speed, angles, fulcrum range, image output).
8. Sample Size for Training Set
- Not Applicable. As there is no AI/machine learning component, there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not Applicable. No training set was used.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.