(116 days)
The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.
The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.
The provided text describes a 510(k) summary for the SimonDR DRP digital X-ray imager, comparing it to two predicate devices: a Kodak/Carestream film-screen system and a Canon CXDI-55G digital X-ray imager. The document focuses on demonstrating substantial equivalence based on technical characteristics rather than clinical performance or AI integration. Therefore, much of the requested information regarding AI-specific studies, training sets, and expert adjudication methods is not present in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the substantial equivalence to the predicate devices, particularly in technical specifications like MTF and Dynamic Range.
| Characteristic | Acceptance Criteria (Predicate 1: Lanex Detail Screen/Film System) | Acceptance Criteria (Predicate 2: Canon CXDI-55G) | Reported Device Performance (SimonDR Inc. Model DRP) |
|---|---|---|---|
| MTF | 4-5 lp/mm 35% | MTF@2 lp/mm 40% | 4.0 lp/mm 35% |
| Dynamic Range | Approximately 20 (about 5 bits) | (linear A/D: 14 bit), (output data: 12 bit) | Up to 16 bit capture, display ranging from 8 to 12 bits |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The comparison is based on technical specifications (MTF, Dynamic Range) rather than a clinical study with a test set of images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided as there is no mention of a human-read test set or ground truth establishment by experts in this technical comparison.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-read test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The document describes a digital X-ray imager, which is a hardware device, not an AI algorithm assisting human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
A standalone performance study for an AI algorithm was not mentioned in the provided document. The device is a digital X-ray imager.
7. The Type of Ground Truth Used
The ground truth or comparison for the device's performance relies on technical specifications (MTF and Dynamic Range) of legally marketed predicate devices, not clinical ground truth (like expert consensus, pathology, or outcomes data).
8. The Sample Size for the Training Set
This information is not provided. The document describes a hardware device, implying no AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there's no mention of a training set or AI model.
§ 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.