(25 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 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.
These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV, with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.
The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.
This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.
However, I can extract and infer some information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
- Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Met: Same intended use as predicate devices: diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts for adult and pediatric subjects, in various patient positions. |
| Configuration | Met: Similar configuration (U-Arm mount only) to predicate K062335. Differs from K042876 (U-Arm or Ceiling Suspension) but is considered a minor technological difference not impacting safety/effectiveness. |
| Positioning Controls | Met: "Enhanced, same as X Plus LP Plus" (predicate K062335), an improvement over K042876's "Standard" but still within the scope of safe and effective operation for an X-ray system. |
| Performance Standard | Met: Adheres to 21 CFR 1020.30 (Performance standards for ionizing radiation emitting products - radiographic equipment). This is a statutory requirement for all such devices. |
| Generator | Met: High frequency made by Sedecal, same as both predicate devices. |
| Collimator | Met: Manual (Ralco) or Automatic (Huestis). Offers an automatic option, which is an enhancement over the manual-only collimators of the predicate devices but is a common and accepted component in X-ray systems. |
| Image Acquisition | Met: Utilizes CANON panels (multiple models: 50C, 50G, 40C & 40G). This is a key technological difference from predicate K062335 (Film) and an update from K042876 (Digital CANON 50G). The use of cleared Canon digital panels (referenced by K numbers K060433, K031633, K031447, K023750) demonstrates their established safety and effectiveness. |
| Electrical Safety | Met: Adheres to IEC-60601 UL listed. This is a standard safety requirement for medical electrical equipment. |
| Overall Conclusion | "as safe and effective as the predicate device, have few technological differences, and has 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 (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided.
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, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. This isn't an AI/machine learning device that requires a training set.
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.