(67 days)
Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, 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.
The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body. image information is obtained for medical diagnosis and treatment.
The provided text is a 510(k) summary for the Toshiba KALARE (DREX-KL80) X-Ray Diagnostic Table System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a new, independent device evaluation.
Therefore, the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available within this document.
Here's an explanation based on the provided text:
Acceptance Criteria and Study Information Unavailable
The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not to perform novel clinical or performance studies with predefined acceptance criteria.
Key points from the document indicating this:
- Section 11. SUBSTANTIAL EQUIVALENCE: States, "The KALARE (DREX-KL80) is of comparable type and is substantially equivalent to the GE Precision 500D R&F X-ray (K081091)." This is the primary "proof" for a 510(k) device.
- Section 13. CONCLUSION: Re-affirms, "The KALARE (DREX-KL80) complies with the same or equivalent standards and has the same intended use as the predicate device."
- FDA Response Letter: States, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."
Because this is a substantial equivalence submission for an X-ray diagnostic table system (a hardware device), the FDA clearance is based on the device meeting established electrical, radiation safety, and performance standards as outlined in 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard and IEC60601-1 standards and its collateral standards, and demonstrating that its specifications are comparable to the predicate device.
Therefore, the following information is not present in the provided text:
- Table of acceptance criteria and reported device performance: Not applicable for a substantial equivalence claim based on predicate device comparison for a hardware system. Performance is assumed to be equivalent to the predicate, and compliance is to safety standards.
- Sample size used for the test set and the data provenance: No clinical test set data is provided. Compliance is based on technical specifications and standards.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. This type of study is more common for diagnostic algorithms or imaging techniques where reader performance is a direct output. This is a hardware system.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware system, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as there's no machine learning algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document demonstrates that the KALARE (DREX-KL80) device meets the regulatory requirements for market clearance by proving its substantial equivalence to an existing predicate device and by conforming to applicable safety and performance standards for X-ray equipment. It does not contain a study with specific clinical acceptance criteria and performance metrics for a novel evaluation.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.