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510(k) Data Aggregation
(71 days)
DDRVERSA MOTION
The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, 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)
ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed.
The provided text describes a 510(k) summary for the ddRVersa™ Motion Digital Diagnostic X-Ray System (K123005), which is a modification of a predicate device. The information focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software component.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned in the provided text for device performance. The submission aims to show "substantial equivalence" to a predicate device, meaning it performs "as well as or better than" the legally marketed predicate.
Instead, the "acceptance criteria" are implied by the comparative nature of the 510(k) process, which focuses on demonstrating equivalence to the predicate device in terms of safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety (conformance to IEC 60601-1) | The modified unit has undergone electrical safety testing and conforms to IEC 60601-1. |
| Electromagnetic Compatibility (conformance to IEC 60601-1-2) | The modified unit has undergone electromagnetic compatibility testing and conforms to IEC 60601-1-2. |
| Software Validation | Software validation was performed. |
| Risk Analysis | Risk analysis was performed. |
| Technical Characteristics of New Panel (Bench Testing) | Technical characteristics of the new panel (Trixell 4343 RC or Pixium Portable 3543 EZ, with 148 microns pixel size, 2880 x 2880 pixels, 16 bit A/D conversion, spatial resolution 3.5 lp/mm, sensitivity up to 850 LSB/μGy) were measured and included in bench testing information. This implies performance equal to or better than the predicate's panel (Samsung LTX240AA01-A, spatial resolution 3.0 lp/mm, sensitivity > 120 LSB/μGy). |
| Diagnostic Quality (Clinical Study of Images) | Clinical images were obtained and evaluated by professional radiologists, who found them to be of good diagnostic quality. This indicates that the image quality is clinically acceptable and comparable to the predicate. |
| Substantial Equivalence to Predicate (Overall Safety & Effectiveness) | Nonclinical and clinical tests demonstrated that the device is "as safe, as effective, and performs as well as or better than" the predicate device (ddRElement™ K110828 and Suinsa K083109). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Clinical images were obtained." However, it does not specify the sample size (i.e., number of images or patients) used for the clinical evaluation.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states images were "evaluated by professional radiologists." It does not specify the exact number of radiologists involved.
- Qualifications of Experts: The experts are described as "professional radiologists." No further specific qualifications like years of experience or subspecialty are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert readers or for establishing a definitive ground truth from the radiologists' evaluations. It simply states they "evaluated" the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No. The document does not mention a MRMC comparative effectiveness study to assess how much human readers improve with AI vs without AI assistance. This device is an X-ray system, not an AI-powered diagnostic aide.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No. The device is a digital X-ray system that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.
7. Type of Ground Truth Used
The ground truth for the clinical evaluation was established by "professional radiologists" who found the images to be of "good diagnostic quality." This implies an expert consensus/opinion on image diagnosticity, rather than pathology, outcomes data, or a pre-defined reference standard.
8. Sample Size for the Training Set
The document does not refer to a "training set" as this device is a hardware system undergoing modifications and demonstrating substantial equivalence, not a machine learning model requiring a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an algorithm in this submission.
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