(71 days)
DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
The provided text is a 510(k) summary for the NICAL SPA NDR+/DIVA-D digital image acquisition system. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, specific device performance, or a clinical study proving its performance. The document is primarily a comparison of features and intended use between the NDR+/DIVA-D and the INFIMED Platinum ONE (ORION) system.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets specific acceptance criteria based solely on the provided text. The document does not describe any specific performance study, sample sizes, ground truth establishment, or multi-reader multi-case studies.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and the Reported Device Performance:
This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through feature comparison with a predicate device, rather than presenting specific performance metrics against pre-defined acceptance criteria from a study.
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 available in the provided document. No test set or clinical study details are mentioned.
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 available in the provided document. No ground truth establishment related to a clinical study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. No adjudication method for a test set is mentioned.
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:
This information is not available in the provided document. The device is a digital image acquisition system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not available in the provided document. The device is an image acquisition and processing system, not an algorithm with standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document, as no specific clinical study or ground truth establishment is described.
8. The sample size for the training set:
This information is not available in the provided document, as no machine learning or AI training is described.
9. How the ground truth for the training set was established:
This information is not available in the provided document, as no machine learning or AI training is described.
Summary of what is available from the document:
- Device Trade Name: NDR+/DIVA-D
- Common Name: Digital image acquisition system
- Intended Use: "DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUNCTION WITH AN IMAGE INTENSIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION." (This indicates it's a system for acquiring, digitalizing, reviewing, and formatting X-ray images, not a diagnostic AI device requiring a clinical performance study with "acceptance criteria" in the typical sense for a new diagnostic claim.)
- Predicate Device: INFIMED Platinum ONE (certified under the name ORION) (K012490)
- Comparison with Predicate Device features: The document primarily lists technical specifications and features of the NDR+/DIVA-D and compares them to the predicate device to establish substantial equivalence. These features include:
- Image Acquisition (CCD camera 1024x1024 12 bit for both)
- Speed Acquisition (NDR+/DIVA-D: 1024x1024 at 25 fps for FLUORO and all radiographic exams; INFIMED: Up to 30 fps for FLUORO acquisition and up to 15 fps for spot acquisition)
- Edge Enhancer (NDR+/DIVA-D: Completely hardware in real time; INFIMED: Software package)
- Noise Reduction (NDR+/DIVA-D: Dynamic recursive filter; INFIMED: Standard recursive filter)
- Image Storage, Post Processing, DSA Application, Multi Image, DICOM Functions, Laser Interface, Interface Commands.
The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through technical comparison and compliance with relevant standards, rather than extensive clinical performance studies to meet specific "acceptance criteria" for a diagnostic accuracy claim.
§ 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.