(23 days)
This device is a digital radiography system used in diagnostic X-ray angiography system configuration.
This X-ray anglography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
The provided 510(k) summary for the Toshiba Solid State X-Ray Imager (DFP-8000D / FPD) does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.
Here's an analysis based on the provided text, highlighting the absence of some requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, resolution, contrast-to-noise ratio) for the new device. It primarily relies on the concept of "substantial equivalence" to the predicate device. Therefore, a table for acceptance criteria and reported performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific test set or any associated sample sizes. The concept of "substantial equivalence" as presented here implies that the new device's performance is expected to be similar to the predicate device, but no independent testing with a defined test set is detailed. Consequently, data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no specific test set is described, there is no mention of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set:
With no described test set or expert evaluation, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device itself and its equivalence, not on the impact of the device on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is a "Digital Radiography System," which by its nature is an imaging system, not an independent algorithm. Therefore, the concept of a "standalone" algorithmic performance study as typically understood for AI algorithms does not apply directly in this context. The document describes the system's ability to process, display, and record digital images, implying its standalone function as an imaging device.
7. The Type of Ground Truth Used:
Since no specific test or evaluation is described to establish performance against an independent ground truth, no type of ground truth is mentioned.
8. The Sample Size for the Training Set:
The document does not mention any training set or sample sizes related to it. This suggests that the device, being an imaging system, was likely developed and validated through engineering specifications and conformity to standards, rather than through a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Device Acceptance and "Study" (as implied):
The acceptance of the Toshiba Solid State X-Ray Imager (DFP-8000D / FPD) is based on a demonstration of substantial equivalence to an existing legally marketed predicate device:
- Predicate Device: DFP-8000D (K013608) with Image Intensifier (model RTP9211J-G11) (K993038).
- Key Change: The new device replaces the Image Intensifier technology with a Flat Panel Detector (FPD).
- Implied "Study": The "study" that proves the device meets the acceptance criteria is the 510(k) premarket notification process itself, which involves providing sufficient information to the FDA to demonstrate that the new device is as safe and effective as the predicate device. This typically involves:
- Technical Benchmarking: Comparing technical specifications of the FPD with the Image Intensifier, ensuring comparable image quality metrics (though not explicitly detailed in this summary).
- Clinical Intended Use Equivalence: Demonstrating that the new device performs the same diagnostic and interventional cardiac examinations as the predicate.
- Safety Considerations: Ensuring that the FPD technology does not introduce new or different questions of safety or effectiveness.
The letter from the FDA (AUG 23 2013) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" and the outcome of the "study" in this context.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.