(29 days)
Indications for Use: Sedecal Portable X-Ray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric 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.
SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.
The provided text describes a 510(k) summary for the SEDECAL SPS-HF-4.0-D Portable X-ray Units with Detector. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not directly applicable or explicitly detailed in the provided document, as the submission relies on the established safety and effectiveness of the predicate devices.
However, I can extract the relevant information where available and note when the information is not present or not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices in terms of intended use, safety, and effectiveness.
The "reported device performance" is a comparison of characteristics to the predicate devices.
| Characteristic | Intended Use | Size | Weight | Energy Source | User Interface | Exposure Times | Ma. (Current) | KvP (Voltage) | Resolution | Method of Control | Performance Standard | Electrical Safety |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acceptance Criteria (Implied) | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | Substantially equivalent to predicate | SAME as predicates | SAME as predicates |
| SEDECAL SPS-HF-4.0-D Performance | Portable general purpose diagnostic X-ray unit | Same (Combined device) (A stand has been added) | 207 lb. (Combined device) | Same (Combined device) | Same (Combined device) - Combines predicates' UI and Canon's touch screen | Same (Combined device) | Same (Combined device) (5-100 Ma.) | Same (Combined device) (40-115 KvP) | Same (Combined device) (160x160 micron pixel, 6M pixels, 4096 gray scale) | Same as CANON. Or original Dedicated Touch Panel | 21 CFR 1020.30 | UL 2601, IEC 60601-1 |
Note: The term "SAME" in the table for "reported device performance" refers to being the same as or comparable to the predicate devices, which is the basis for substantial equivalence. The specific resolution is from the Canon CXDI-50G predicate, which the combined device utilizes.
Study Details (Based on the provided document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are as safe and effective as the predicate devices..."
- No specific sample size for a "test set" from a clinical performance study is mentioned. The "tests" refer to bench testing, user testing (which might involve testing the combined user interface and functionality), and compliance with standards.
- Data provenance is not specified. These are likely internal company tests.
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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 / Not specified. This document is not a clinical study report that establishes ground truth for a test set based on expert review. It's a 510(k) summary focused on substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. As no clinical "test set" requiring ground truth establishment or adjudication is described, this information is not present.
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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 is not an AI-assisted device, and no MRMC study is mentioned. This is a submission for a combined X-ray unit (hardware and controlling software).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device with associated control software, not an algorithm being tested in a standalone capacity. Its performance is intrinsically linked to its intended use by a human operator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not specified. The validation focuses on comparison of technical specifications and compliance with safety standards rather than diagnostic ground truth in a clinical performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
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The sample size for the training set
- Not applicable. This submission describes a medical device (X-ray unit), not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established
- Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
§ 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.