(30 days)
The OTC DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).
This submission is for a MODIFICATION to our predicate device. Instead of supplying a straight arm tube stand we be supplying an overhead tube crane. The imaging components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The OTC DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-rav generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The ULTRA software was most recently cleared in K214012 and has not been changed from the cleared version
The provided document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the way typically found in a clinical performance study for an AI/ML medical device. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and indications for use.
Therefore, many of your specific questions cannot be answered from this content.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the "OTC DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images." The "reported device performance" is essentially that it functions similarly to the predicate device and meets relevant safety and electromagnetic compatibility (EMC) standards.
| Acceptance Criteria Category | Reported Device Performance (as stated in the submission) |
|---|---|
| Indications for Use Equivalence | "SAME Only the name has changed." (Compared to predicate) |
| Functional Equivalence | "The OTC DDR performs the same functions as the predicate..." |
| Technological Equivalence | Uses same imaging components (ULTRA and AeroDR FPD Digital X-Ray Detectors, ULTRA SOFTWARE, Sedecal Generator, Ralco Collimator, AC Line Power Source). The main difference is the tube stand configuration (Overhead Tube Crane vs. Straight Arm). |
| Safety and EMC Standards Compliance | "We performed IEC60601-1 Safety and IEC60601-1-2 EMC testing with satisfactory results." Also complied with IEC 60601-1-3 rev 2.1, IEC 60601-2-54, and NEMA PS 3.1 - 3.20 (DICOM). |
| Image Quality / Product Validation | "Image Quality Testing and Product Validation." "Product validation consisted of assembling and fully functionally testing the entire system." "Each system is tested for proper integration prior to shipment to the customer." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a performance study on a test set of medical cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert ground truth was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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. No MRMC study was conducted or reported. The device is an X-ray system, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an X-ray imaging system, not a standalone AI algorithm. It's a device that produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is primarily based on meeting engineering and safety standards, as well as functional equivalence to the cleared predicate device.
8. The sample size for the training set
Not applicable. This submission doesn't describe an AI training process or dataset.
9. How the ground truth for the training set was established
Not applicable.
§ 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.