(53 days)
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. 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 AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.
The provided text describes the Konica Minolta AeroSync for AeroDR SYSTEM, a software device intended to eliminate the need for an electrical connection between the AeroDR SYSTEM and X-ray generator, thereby detecting X-ray irradiation without cables.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing substantial equivalence to a predicate device (AeroDR SYSTEM, K102349) rather than defining specific new acceptance criteria in terms of numeric thresholds for performance metrics. The core "acceptance criteria" here appear to be demonstrating equivalence to the predicate in key areas.
| Acceptance Criterion (Implicit / Stated Goal) | Reported Device Performance |
|---|---|
| Safety | Complies with IEC 60601-1 Ed.2 (1988) + A1 (1991)+A2(1995) and IEC 60601-1-2 Ed.3 (2007). Risk analysis (ISO14971) shows all identified hazards reduced to acceptable levels (ALARP). Meets FCC Part15 Subpart C, E for RF wireless technologies. |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 Ed.3 (2007). Meets FCC Part15 Subpart C, E for RF wireless technologies. |
| Image Quality (Equivalence to Predicate) | "The results of performance testing shows that the image quality of proposed device is equivalent to the predicate device." (No specific metrics or quantitative comparisons are provided in this summary). |
| Substantial Equivalence to Predicate Device | Demonstrated through comparison of Indications for Use, Configuration, Specifications, Principals of Operation, Risk Analysis, Compliance to Standards, and performance testing. "Comprehensively, we conclude that the AeroSync for AeroDR System has the same technological characteristics as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify the sample size used for performance testing (e.g., number of images, patient cases). It also does not mention the data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on experts used to establish ground truth or their qualifications. Given the focus on "image quality equivalence," it is possible that image quality assessments were performed by qualified personnel, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention an MRMC comparative effectiveness study or any effect size for human reader improvement with/without AI assistance. This is a software device facilitating X-ray detection, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes "performance testing" leading to the conclusion that "the image quality of proposed device is equivalent to the predicate device." This suggests standalone testing of the system's ability to produce images. However, no specific details of this testing (e.g., what was measured, how it was performed) are provided in this summary. The device's primary function is X-ray detection and image generation, not an interpretation independent of a human.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
The document does not specify the type of ground truth used for performance testing. Given the context, ground truth for image quality equivalence would likely involve a comparison against images produced by the predicate device under controlled conditions, possibly evaluated by imaging experts.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This device is described as a "software device" for X-ray detection and image generation, not a machine learning or AI algorithm that typically requires a training set in the conventional sense for feature learning or classification. It adds a "minor change" to an existing system, suggesting an engineering modification rather than a complex algorithm requiring extensive algorithmic training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established.
§ 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.