(88 days)
The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which 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 used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy. The AeroDR Stitching System is an accessory of stationary X-ray system which extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit. The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.
The provided 510(k) summary for the Konica Minolta AeroDR Stitching System (K120752) focuses primarily on substantial equivalence to a predicate device and adherence to general safety and EMC standards. It does not contain detailed performance study data, acceptance criteria, or ground truth establishment relevant to the device's image stitching capability.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document unfortunately does not explicitly state specific acceptance criteria in a quantitative or qualitative manner for the imaging performance of the stitching system, nor does it report detailed device performance metrics against such criteria.
The "Performance-Testing" section states generically that: "Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria..."
However, these predefined acceptance criteria and the corresponding performance results are not detailed in the summary. The focus is on demonstrating substantial equivalence to a predicate device and compliance with safety and EMC standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size of "sample images" used for performance testing (if any were used beyond engineering testing). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical image data used in testing. The phrase "validation results of sample images and non-clinical testing under simulated use conditions" suggests that testing might have involved a limited set of images, possibly generated internally, rather than a broad clinical dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The 510(k) summary does not provide any information regarding the use of experts to establish ground truth for a test set. This type of detail would typically be found in a clinical performance study report, which is not included here.
4. Adjudication Method for the Test Set
Since no information is provided about expert review or a "test set" in the context of clinical evaluation, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus of the submission is on demonstrating substantial equivalence to a predicate device through technological characteristics and safety standards, not on comparative clinical performance with human readers. Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.
6. Standalone (Algorithm Only) Performance Study
While the device's stitching capability is an algorithm, the document does not present a standalone performance study in terms of specific metrics like stitching accuracy, artifact detection, or image quality assessments related only to the algorithm's output. The "Performance-Testing" section vaguely refers to "validation results of sample images and non-clinical testing under simulated use conditions" to confirm "safe, effectiveness and performances," but concrete results of the stitching algorithm's standalone performance are absent.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation. Given the nature of a stitching system for long-length imaging, ground truth might ideally involve physical measurements on phantoms, or expert assessment of stitching lines and image continuity. However, this information is not provided.
8. Sample Size for the Training Set
The document does not provide any information about a training set size. As a 510(k) for a relatively early-stage digital radiography accessory (2012), and based on the summary, it's possible the device relied more on rule-based or deterministic algorithms for stitching rather than extensive machine learning requiring a large training set. Even if machine learning was used, the details are not presented.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, the document also does not explain how ground truth for a training set was established.
Summary of Missing Information:
The provided 510(k) summary is typical for a device primarily seeking substantial equivalence based on technological similarity and compliance with recognized standards. It lacks the detailed performance study information, including acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, that would be expected for a more in-depth clinical performance evaluation or an AI-intensive device requiring specific validation of its intelligent features. The "Performance-Testing" section is very general and does not disclose the specific data or methods used to "confirm the achievement of predefined acceptance criteria."
§ 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.