(56 days)
The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.
The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program
The provided text is a 510(k) summary for a medical device called "CO Pilot" and the associated FDA clearance letter. It states that the CO Pilot is a software intended for installation on REGIUS Unitea (a Picture Archiving Communications System) and provides functions for creating annotations (line, curve, character information), measuring distances and angles, and transferring GUI data. It can process and display images from various modalities but "must not be used for primary image diagnosis in mammography."
The summary explicitly states: "Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized. The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have."
This indicates that Konica Minolta relied on demonstrating substantial equivalence to predicate devices rather than conducting a separate study with specific acceptance criteria and performance metrics for the CO Pilot itself. The summary does not include a detailed study that defines specific acceptance criteria, test sets, ground truth establishment, or multi-reader studies for the CO Pilot's performance. Instead, it argues that its performance is equivalent to already cleared devices through verification and validation activities.
Therefore, many of the requested details cannot be extracted directly from the provided text because these types of studies were not presented in this 510(k) summary as a means to prove the device meets acceptance criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for the CO Pilot's performance beyond stating that its "function quality" is substantially equivalent to predicate devices. It doesn't report specific performance metrics like sensitivity, specificity, accuracy, or measurement precision for the CO Pilot itself.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to "Verification and Validation" but does not detail the datasets or studies used for these activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
A MRMC comparative effectiveness study is not mentioned. The device's primary function is annotation and measurement, not necessarily to assist human readers in diagnosis in a way that would typically be evaluated by an MRMC study demonstrating improved diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe a standalone performance study in the traditional sense for diagnostic accuracy. The device "primarily facilitates processing and presentation of medical images on display monitors" and provides "display-use annotation" and "measuring" functions. Its performance would likely be assessed on the accuracy of these functions rather than diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. Given the device's functions (annotation, measurement), ground truth would likely refer to the accuracy of these measurements relative to a known standard or expert measurement, but the details are not here.
8. The sample size for the training set
This information is not provided. Given the device's functions as annotation and measurement tools, it's less likely to involve a "training set" in the context of machine learning, unless specific automation features exist that weren't elaborated.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information regarding acceptance criteria and study:
The 510(k) summary for CO Pilot (K133730) does not present specific acceptance criteria in a quantitative manner or a detailed study with performance metrics for the device itself. Instead, it relies on demonstrating substantial equivalence to its predicate devices (REGIUS Unitea K071436, Acies K101842, Opal-RAD TM K063337) through "Verification and Validation."
The core argument is:
- Acceptance Criteria (Implicit): The CO Pilot's "function quality," safety, effectiveness, and performance should be equivalent to or not inferior to the legally marketed predicate devices.
- Study Proving Acceptance (Method): "Verification and Validation" activities were conducted. These activities "showed equivalent evaluation outcome with the predicate devices" and confirmed "no impacts in technological characteristics" and "no differences were found" in comparison to the predicates.
No specific data related to test sets, ground truth, expert involvement, or quantitative performance metrics for the CO Pilot itself are provided in this summary.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).