(429 days)
These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, 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.
Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included.
The provided text describes a 510(k) premarket notification for "Sedecal Mobile Digital Diagnostic X-Ray Systems (various models)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like sensitivity or specificity.
Therefore, many of the requested elements for a study that proves a device meets acceptance criteria cannot be extracted from this document, as it is not the type of study described.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.
| Characteristic | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Sedecal Mobile Digital Diagnostic X-Ray Systems) |
|---|---|---|
| Intended Use | Same as K090322 | SAME (Identical to predicate) |
| Configuration | Same as K090322 | SAME (Identical to predicate) |
| Performance Standard | 21 CFR 1020.30 (for predicate device) | SAME (Compliance with 21 CFR 1020.30) |
| Generator | High frequency made by Sedecal | SAME (Identical to predicate) |
| Generator power levels | 20 to 50 kw (4 models) | 20 to 50 kw (8 models) - Technological difference noted, but considered equivalent |
| Collimator | Ralco R221 DHHS | SAME (Identical to predicate) |
| Image acquisition | Digital CANON 50G | Trixell or Varian - Technological difference noted, but considered equivalent |
| Electrical safety | Electrical Safety per IEC-60601. UL listed | SAME (Compliance with IEC-60601. UL listed) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "bench, test laboratory results, and clinical image comparisons," but does not provide details on the number of images or subjects included in these comparisons.
- Data provenance: Not explicitly stated. It's implied that the clinical image comparisons would involve human subjects, but specifics regarding country of origin or whether the data was retrospective or prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "clinical image comparisons" but does not detail how ground truth was established or if experts were involved in a formal review process for comparing the new device's images to the predicate's images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No. This document describes an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical imaging device, not a standalone algorithm. The performance evaluation focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, not on an algorithm's diagnostic performance in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the context of "clinical image comparisons" for an X-ray system, the "ground truth" would likely be derived from the diagnostic interpretations of the images by qualified medical professionals using the predicate device, against which the images from the new device would be compared for qualitative assessment.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning device that requires a "training set."
Summary of Study:
The "study" described in the 510(k) summary is a substantial equivalence comparison against a predicate device (Sedecal Easy Moving Digital K090322 and K091364, DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH). The primary method used to demonstrate equivalence was:
- Bench testing: Laboratory tests to verify technical specifications and performance.
- Test laboratory results: Further laboratory-based evaluations.
- Clinical image comparisons: Qualitative assessment presumably comparing images acquired by the new device to those acquired by the predicate device to ensure comparable diagnostic quality.
The conclusion is that "bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices," with "few technological differences" and "no new indications for use." The focus is on demonstrating that the new device performs equivalently to the predicate in terms of safety and imaging capabilities, rather than achieving specific quantitative performance metrics against a defined ground truth.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.