(100 days)
The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.
The Saturn 9000-810 is equipped with a digital detector. X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-810 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
This document pertains to the Saturn 9000-810, a digital X-ray system. The information provided is from a 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it relies on the comparison to a predicate device and conformance to industry standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | - Same intended uses | Yes, same intended uses as Saturn 9000. |
| - Comparable in key safety and effectiveness features | Yes, comparable to Saturn 9000. | |
| - Similar design, construction, and interface scheme | Yes, similar to Saturn 9000. | |
| Technological Characteristics | Conformance to applicable medical device performance and safety standards (e.g., IEC 62220-1) | Measured and computed technical characteristic values confirm device performance is compatible with predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not report any clinical test data, including sample size or data provenance for a test set. It explicitly states: "Clinical Tests: Not applicable for special 510(k) procedure." This suggests conformance was primarily based on non-clinical engineering tests and comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Given that no clinical tests were reported for this specific 510(k) procedure, there is no information provided regarding experts or ground truth establishment for a clinical test set.
4. Adjudication Method for the Test Set:
No information is provided as no clinical test set was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done or reported in this document. The submission explicitly states "Clinical Tests: Not applicable."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
This device is an X-ray imaging system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study as described would not be applicable in this context. The document focuses on the performance of the imaging system itself.
7. The Type of Ground Truth Used:
As no clinical tests were performed or reported, there is no mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical evaluation. The primary "ground truth" for evaluating this device appears to be comparison to the predicate device and conformance to non-clinical engineering standards.
8. The Sample Size for the Training Set:
This document describes a medical imaging device (hardware and software for image acquisition and processing), not a machine learning algorithm that typically requires a training set. Therefore, the concept of a "training set sample size" as it applies to AI/ML is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established:
As the device described is not an AI/ML algorithm requiring a training set, this question is not applicable.
§ 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.