(44 days)
The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. If is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand.
The detector is not for use for mammography.
The SynePix 4600 is a 17 inch by 17 inch digital detector. It is intended to convert Xrays into electrical signals to create usable images for diagnostic use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Analogic Corporation SynePix 4600 Detector:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the SynePix 4600 Detector. Instead, it relies on a comparison to a predicate device.
Acceptance Criteria (Implied): Substantial equivalence to the legally marketed predicate device (Kodak DirectView DR System Detector, K051483) in terms of technological characteristics and performance.
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (SynePix 4600 Detector) |
|---|---|
| Same technological characteristics as predicate device | "The design of the SynePix 4600 Detector has the same technological characteristics as the predicate device." |
| Performance substantially equivalent to predicate device | "The testing of the SynePix 4600 Detector demonstrates that the performance is substantially equivalent to the predicate device cited above." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The claim of substantial equivalence is made based on "testing," but details of this testing are absent.
3. Number of Experts and Qualifications for Ground Truth Establishment
The provided text does not mention the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a 510(k) submission primarily focused on substantial equivalence based on technological characteristics and non-clinical testing, explicit details about clinical expert reviews for ground truth are often not included unless a specific clinical study with human review is part of the submission.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method for any test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. This device is a digital radiography detector, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance.
6. Standalone (Algorithm Only) Performance Study
The provided text does not describe a standalone (algorithm only) performance study. This device is hardware (a detector) that produces images, not an algorithm that performs interpretations.
7. Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used. Given that the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, it's highly probable that the "ground truth" would be based on technical performance metrics derived from phantom studies, physics measurements, and comparisons of image quality against the predicate device, rather than clinical outcomes or pathology.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. As a digital detector (hardware), rather than an AI/ML algorithm requiring training, the concept of a "training set" in the context of machine learning does not apply here.
9. How Ground Truth for the Training Set Was Established
Since the device is a digital detector and not an AI/ML algorithm, the concept of a "training set" with established ground truth is not applicable to this submission.
§ 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.