(45 days)
The Suinsa Diagnostic X-Ray System is 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.
This system is a combination of the following Suinsa manufactured components:
The Hercules Generator, with models from 32 to 80 kW. .
The NOVA Ceiling Mounted Tube Stand .
. The NET4000 series X-ray table
The NBS2100 Bucky Wall Stand .
The provided text is a 510(k) summary for the Suinsa Diagnostic X-Ray System (K083104) and a corresponding FDA clearance letter (K083109 - appears to be a typo for K083104 in the letter).
This submission does not describe a study that uses acceptance criteria in the way typically associated with AI/CADe device performance evaluation. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device. Therefore, many of the requested criteria for a study proving device performance (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or provided in this document.
The "acceptance criteria" here are effectively the demonstration of comparable safety and effectiveness based on bench testing and adherence to standards, rather than clinical performance metrics often seen in AI device submissions.
Here's the information extracted, with explanations for what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" relate to demonstrating equivalence to the predicate device in terms of design, function, and adherence to safety standards. The "reported device performance" is essentially that it meets these criteria by being substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Suinsa Diagnostic X-Ray System) |
|---|---|---|
| Intended Use | Intended for diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts, for adult and pediatric subjects, with patient sitting, standing, or lying prone/supine. | SAME as predicate. (Implies the Suinsa device performs these tasks equally well as the predicate). |
| Configuration | Ceiling Mount (made by Suinsa) | SAME. (Implies similar structural and functional characteristics, leading to comparable performance). |
| Generator | High Frequency Sedecal | High Frequency Suinsa. (While the manufacturer is different, the "High Frequency" characteristic implies a similar type of performance in X-ray generation, indicating functional equivalence). |
| Maximum Output | Various models, 32 to 80 kW | SAME, 32 to 80 kW. (Direct matching of a key performance specification for X-ray power, indicating comparable imaging capabilities). |
| Image Acquisition | Film | Film. (Indicates the same method of image capture, implying similar output quality and handling as the predicate). |
| Collimator | RALCO | SAME. (Indicates equivalent beam shaping and radiation safety characteristics). |
| Safety | UL Listed | CSA listed to US Standards. (Demonstrates compliance with recognized safety standards in the US, indicating an equivalent level of safety testing and assurance). |
| Standards | US Performance Standard + applicable IEC standards | SAME. (Confirms adherence to the same set of regulatory and performance standards, implying equivalent safety and effectiveness based on those standards). |
| Overall | Bench and standards testing demonstrate safety and effectiveness. | "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench and standards testing data, it is the conclusion of Suinsa that the Suinsa Diagnostic X-Ray Systems is as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission does not describe a clinical performance study with a "test set" of patient data. The evaluation is based on bench testing and comparison to the predicate device's specifications and compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment from experts is mentioned for a test set, as no clinical performance study was conducted.
4. Adjudication method for the test set
- Not Applicable. No adjudication method is mentioned, as no clinical performance study was conducted.
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 device is a basic X-ray system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a hardware X-ray system, not an algorithm. Standalone performance as typically understood for AI/CADe devices is not applicable.
7. The type of ground truth used
- Not Applicable. The "ground truth" in this context is the established safety and effectiveness characteristics of the predicate device, against which the new device's specifications and test results (from bench testing) are compared.
8. The sample size for the training set
- Not Applicable. There is no mention of an algorithm or AI component requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for a training set is mentioned.
§ 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.