FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.

The DR 800 is not intended for manimography applications.

Device Description

Agfa HealthCare's DR 800 is an image-intensified fluoroscopic x-ray system (product code JAA) intended to capture images of the human body. The DR 800 is a floor-mounted R/F system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA Dynamic™ image processing and flat-panel detectors for digital and wide dynamic range image capture. It is capable of replacing other direct radiography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Usability and Functionality	Support a radiographic and fluoroscopic workflow, including dynamic and static imaging, continuous and rapid sequence exams, calibration, and positioning.	"The results of these tests fell within the acceptance criteria for the DR 800 R/F X-ray system and some improvements will be implemented based on these results; the DR 800 supports a radiographic and fluoroscopic workflow including dynamic and static imaging, continuous and rapid sequence exams, calibration, and positioning."
Full Leg Full Spine (FLFS)	Mount stitch grid, imaging ranges of a certain tolerance, and transversal collimation, and medical ruler exposure. The FLFS software for NX Luna compared to current FLFS software on the market should be "equal to or better". FLFS landscape functional design meets user needs.	"The FLFS clinical validation for the mount stitch grid, imaging ranges of a certain tolerance and transversal collimation, and medical ruler exposure fulfilled the acceptance criteria and passed the assessment with minor fails that will be solved."
"The results of the FLFS comparison test for NX Luna concluded that the FLFS software is equal to or better than the current FLFS software currently on the market. The results of the FLFS landscape validation for the NX Luna concluded that the FLFS landscape functional design meets to user needs."
Dose Control	None of the detector doses would measure higher than the DIN-norm or exceed the dose limit curve for adult and pediatric phantoms with pulsed and continuous fluoroscopy exams.	"The results fulfilled the acceptance criteria that none of the detector doses would measure higher than the DIN-norm or exceed the dose limit curve."
Image Quality (Dynamic)	Pulsed and continuous fluoroscopy imaging with MUSICA Dynamic should be between "good and excellent" and pass acceptance criteria.	"The test results indicated that the pulsed and continuous fluoroscopy imaging of the DR 800 R/F X-ray system with MUSICA Dynamic was between good and excellent and passed the acceptance criteria."
Image Quality (Static)	MUSICA3 Abdomen+ images should be suitable for diagnosis with overall higher image quality. Static images made with the R/F flat-panel detector (FL4343) should demonstrate clinical acceptability.	"The test results showed MUSICA3 Abdomen+ images were suitable for diagnosis with an overall higher image quality. The test results proved clinical acceptability for static images made with the R/F flat-panel detector (FL4343)."
Software Risk (NX4.0)	No risks identified in the "Not Acceptable Region"; medical risk no greater than conventional x-ray film.	"For the NX4.0 (NX Luna) there are a total of 274 risks in the broadly acceptable region and 26 risks in the ALARP region with only three of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk. The medical risk is no greater than with conventional x-ray film previously released to the field." (Note: This is a statement of compliance with risk assessment findings rather than a performance metric.)
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, and FDA Subchapter J (21 CFR 1020.30 – 1020.32).	"The DR 800 with MUSICA Dynamic is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 – 1020.32." (Implied compliance with IEC standards through testing.)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact numerical sample sizes for the test sets used in the various evaluations (usability, FLFS, dose control, image quality). It mentions the use of "anthropomorphic phantoms" for image quality testing.
Data Provenance: The data is described as "Laboratory data" and "image quality evaluations conducted with independent radiologists."
- Country of Origin: Not explicitly stated, but the company is Agfa HealthCare N.V. (Belgium), and the submission is to the FDA (USA), implying development might be international but for the US market. The use of "DIN-norm" suggests European origin or influence for some standards.
- Retrospective or Prospective: Not explicitly stated. The nature of the "bench testing" and "clinical image quality evaluations" using phantoms suggests a controlled, prospective testing environment rather than retrospective analysis of patient data. "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld." confirms prospective, non-clinical study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts:
- Usability and Functionality: "qualified independent radiographers and internal experts." (Number not specified)
- FLFS Clinical Validation: "qualified internal radiographer." (One identified)
- FLFS Comparison Test: "several qualified internal experts." (Number not specified, but more than one)
- Dose Control Validation: "qualified internal expert." (One identified)
- Image Quality Validation: "qualified independent radiographers and internal experts." (Number not specified)
Qualifications of Experts: The experts are consistently referred to as "qualified independent radiographers" or "qualified internal experts" (or radiographer). Specific years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies among expert opinions. Evaluations often involved "qualified independent radiographers and internal experts," implying consensus or individual assessment, but a specific arbitration process is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as being performed to compare human readers with and without AI assistance.
The study focused on showing equivalence or improvement of the new device (DR 800 with MUSICA Dynamic) compared to reference images and predicate devices/software, and its ability to meet acceptance criteria for performance, not on AI-assisted human reading performance. The "MUSICA Dynamic" is described as software for image processing, not necessarily an AI for diagnostic assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are primarily standalone evaluations of the device's technical performance and image quality. These evaluations assessed the output of the DR 800 system with MUSICA Dynamic processing (which is an algorithm) directly, using phantoms and comparing its output to reference images and predicate devices. There is no indication of a human-in-the-loop performance study where the algorithm's output is then interpreted by a human and compared to human interpretation without the algorithm.

7. Type of Ground Truth Used

The ground truth used appears to be:

Expert Consensus/Opinion: For image quality, usability, and FLFS validation, the assessments by "qualified independent radiographers and internal experts" served as the ground truth for determining acceptability.
Technical Standards/Benchmarks: For dose control, "DIN-norm" and "dose limit curve" served as the objective ground truth.
Reference Images/Predicate Device Performance: For image quality validation, comparisons were made to "reference images using anonymized phantoms" and against predicate device performance, implying these served as a comparative ground truth.
Pre-defined Requirements: For usability and functionality, the 'acceptance criteria' themselves served as the ground truth of what the device needed to achieve.

There is no mention of pathology or long-term outcomes data as ground truth.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is likely because the device is an X-ray imaging system with image processing software (MUSICA Dynamic), and the focus of the 510(k) submission is on demonstrating substantial equivalence and validation of its performance, not on a machine learning model that would require a distinct training set. The "MUSICA Dynamic" algorithms are described as "similar to those previously cleared" or "identical to the predicate device" in terms of dynamic image processing.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or detailed for a machine learning model, there is no information on how its ground truth would have been established. The image processing algorithms are likely based on established signal processing techniques, rather than learned directly from a labeled dataset in the way a modern AI model might be.

Summary

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.