(37 days)
AeroPilot is a software device that is used in conjunction with REGIUS Unitea to control Konica Minolta Digital Radiography systems. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/ screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroPilot is a software device that is used in conjunction with our REGIUS Unitea. K071436, to control Konica Minolta Digital Radiography systems. The AeroPilot is the software designed to be installed in Off-the-shelf PC (operation console) which is one of component of REGIUS Unitea and works with Konica Minolta Digital Radiography systems to be an interface with X-ray generator or between REGIUS Unitea and the specified Konica Minolta Digital Radiography systems, and to acquire X-ray images like the specified Konica Minolta Digital Radiography systems do.
The provided text is a 510(k) Summary for the AeroPilot device, which is a software device used to control Konica Minolta Digital Radiography systems. The document focuses on establishing substantial equivalence to predicate devices and does not detail a study with specific acceptance criteria, test set characteristics, expert involvement, or adjudication methods for evaluating algorithm performance. Instead, it relies on demonstrating equivalence in configuration, specifications, and principle of operation, along with performance testing to show equivalent image quality.
Therefore, many of the requested fields cannot be extracted or are not applicable from the provided document.
Here's a summary of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- The document states that a "Risk Analysis for the AeroPilot (software) was conducted on the basis of ISO14971...the risk associated with all of the identified hazards was reduced to an acceptable level or ALARP." This is a high-level acceptance criterion related to risk management.
- It also states, "the results of performance testing show that the image quality of proposed device is equivalent to the predicate device." This implies an acceptance criterion for image quality, but specific numerical criteria (e.g., sensitivity, specificity, resolution, contrast) are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Risk Level | Reduced to an acceptable level or ALARP (As low as reasonably practicable) based on ISO14971. |
| Image Quality | Equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read ground truth study is described for the device's performance. The comparison is against predicate device performance, implying technical specifications and image quality rather than diagnostic accuracy by humans.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 MRMC study was mentioned. The device is a control software for a digital radiography system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "performance testing" to show "image quality... equivalent to the predicate device." This suggests a standalone evaluation of the device's technical output (image quality), but specific metrics and a detailed study design are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance testing appears to be the image quality and functionality of the predicate device. The new device's performance is compared against the established performance of existing Konica Minolta Digital Radiography systems.
8. The sample size for the training set: Not applicable, as this is a software device for controlling hardware and acquiring images, not a machine learning algorithm that requires a training set in the typical sense.
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.