(25 days)
The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
The provided text lacks the detailed information required to fill out all the sections of the request regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety tests, rather than a specific clinical performance study with defined acceptance criteria for diagnostic accuracy.
Here's an attempt to extract and present the available information, with many sections marked as "Not Applicable" or "Information Not Provided" due to the nature of the given text:
Acceptance Criteria and Study for Remex KA6
The document primarily describes a substantial equivalence determination for the Remex KA6 mobile X-ray system, comparing it to the predicate device MinXray TR90BH. The focus is on demonstrating that the Remex KA6 is at least as safe and effective as the predicate, rather than meeting specific diagnostic performance acceptance criteria in a clinical study with detailed metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Software Validation | "met all requirements of the standard [ISO 14971]" | "Remex KA6 completed software validation and was determined to be a moderate level of concern software. The risk management test was performed in accordance with ISO 14971 and met all requirements." |
| Electrical Safety | "met all requirements for electrical safety" (for standards: 60601-1, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54) | "KCTL Inc. performed tests for 60601-1, 60601-1-3, 60601-1-6, and 60601-2-28, and 60601-2-54 and met all requirements for electrical safety." |
| Electromagnetic Compatibility (EMC) | "met all requirements for safety" (for standard: 60601-1-2) | "KCTL performed tests for 60601-1-2 and met all requirements for safety." |
| Radiation Protection (Bench Testing) | "met the test requirements" | "Performance tests for radiation protection in x-ray equipment was completed by an outside laboratory, KCTL, and met the test requirements." |
| Diagnostic Quality (Clinical Evaluation) | "were approved for diagnostic quality" | "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." |
2. Sample size used for the test set and the data provenance
- Sample Size: Information not provided. The term "images" is used without a specific count.
- Data Provenance: Information not provided, but implicitly, as it's a clinical evaluation, the images would be derived from human subjects. Whether they were retrospective or prospective, or from a specific country, is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board certified radiologist" (singular).
- Qualifications: "board certified radiologist". No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication method for the test set
- Adjudication Method: "None" or "Not Applicable" as only one expert was used for evaluation. The document states "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." This implies a single-reader assessment.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The document describes an evaluation of device-generated images for diagnostic quality, not a comparative study of human readers with and without AI assistance.
- Effect Size: Not Applicable, as no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. The Remex KA6 is a mobile X-ray system that produces images; it is not an AI algorithm. The diagnostic quality of the images generated by the device was evaluated by a human radiologist.
7. The type of ground truth used
- Ground Truth: "Expert consensus" in a very limited sense, as it was a single "board certified radiologist" who "approved for diagnostic quality." This is closer to expert opinion on image quality rather than a true ground truth established by pathology or long-term outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not Applicable. The Remex KA6 is an X-ray imaging device, not an AI or machine learning algorithm that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not Applicable, as there is no training set for this type of device.
§ 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.