(31 days)
The Digital X-ray Capture Device Saturn 8000 Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
The "Digital X-ray Capture Device (Saturn 8000 System)" (as Saturn 8000 System) is equipped with digital detector. X-ray generator interface, and image acquisition. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray inout. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. Interfacing with generator can be achieved by Automatic Exposure Detection ("AED") technology which allows detector to automatically detects X-ray exposure. The Saturn 8000 System contains the operation workstation software, which is installed on acquisition workstation ("AWS"), which contains 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.
Based on the provided text, the Saturn 8000 System is a general-purpose diagnostic X-ray system. The document describes a 510(k) submission to the FDA, indicating that the device aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and clinical study design is not present in these documents.
Here's a breakdown of what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given documents. The submission focuses on demonstrating substantial equivalence to a predicate device (Samsung LTX240AA01-A) through bench testing and electrical safety assessments, rather than presenting a clinical study with specific performance acceptance criteria.
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. As no clinical study is detailed, there's no mention of a test set, sample size, or data provenance.
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. There is no mention of a ground truth established by experts for a test set in these documents.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. There is no mention of a test set or adjudication method.
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:
An MRMC comparative effectiveness study was not mentioned or described in the provided text. The device is a digital X-ray capture system, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of this device. The Saturn 8000 System is a hardware device (digital X-ray capture system) combined with acquisition workstation software. It generates images for human interpretation, not an algorithm that performs standalone diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. No ground truth for a clinical evaluation is discussed.
8. The sample size for the training set:
This information is not provided. There is no mention of a training set, as this is a 510(k) submission for a hardware device, not an AI/machine learning algorithm that requires training data.
9. How the ground truth for the training set was established:
This information is not provided. No training set or ground truth for it is mentioned.
Summary of available information:
The provided documents describe a 510(k) submission for the Saturn 8000 System, a "Digital X-ray Capture Device."
- Device Function: Generates digital X-ray images for general radiographic applications, excluding fluoroscopic, angiographic, and mammographic uses. It replaces traditional film-screen based general radiography systems.
- Mechanism: Uses a flat panel detector where X-ray photons are absorbed by a scintillator layer, creating visible light photons, which are then absorbed by a TFT-array to create an electrical charge representing the X-ray input. This charge is converted into an electrical signal and processed by acquisition workstation software.
- Substantial Equivalence Claim: The device claims substantial equivalence to the Samsung LTX240AA01-A (cleared as 510k K090742).
- Proof of Equivalence: Substantiated through "Bench testing and electrical safety."
- Safety and Effectiveness Concerns: Electrical, mechanical safety, and performance testing were conducted according to standards EN/IEC 60601-1 (ed.2);am1;am2, and EMC testing according to IEC 60601-1-2: 2007 (ed.3). All test results were reported as "satisfactory," and the device "does not raise any new significant issues of safety, effectiveness or performance" compared to predicate devices.
- FDA Clearance: The FDA issued a substantial equivalence determination (K120380) dated March 9, 2012, based on the submitted information.
In essence, the document serves as a regulatory submission demonstrating the safety and effectiveness of a new medical device by comparing it to an already cleared device, rather than providing details of a clinical trial with specific performance metrics and acceptance criteria for a novel technology.
§ 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.