(38 days)
The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.
The Horizon® Series Imagers are dry, thermal, grey scale (Gs model) and grey scale/color (Ci model) direct thermal printer/imagers. The devices produce continuous tone, diagnostic quality B/W images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality.
This document describes the Codonics Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA PRINTERS (Horizon® Ci and Gs Medical Multimedia Dry Imagers). These devices are dry, thermal printer/imagers designed to produce continuous tone, diagnostic quality B/W images on transmissive film and reflective media, and color images via dye-diffusion technology. They are intended for high-resolution hard copy imaging from various medical imaging modalities for medical image diagnosis and referral.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit, quantitative acceptance criteria in a table format with corresponding reported performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it describes performance characteristics related to image quality and substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Fidelity / Diagnostic Quality | "The devices produce continuous tone, diagnostic quality B/W images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality." |
| Spatial Resolution | Pixel size: 79µ, resulting in a pixel resolution of 12.6 pixels/mm or 320 dpi. |
| Grey Scale Resolution | Produces a palate of 4096 levels of discernable grey. The SMPTE resolution and contrast pattern and uniform density response function confirms quality suitable for the intended medical imaging use. |
| Color Palate Resolution | Produces 256 levels of 16.7 million colors. |
| Modulation Transfer Function (overall image quality) | Spatial frequency response, grey scale resolution, density response, and full image field uniformity combine to affect the final image. Characteristic response of thermal print head and film response must be mapped and compensated for to achieve suitable performance. The SMPTE resolution and contrast pattern and uniform density response function confirms quality suitable for the intended medical imaging use. |
| Safety and Effectiveness (Substantial Equivalence) | "The characteristics of the Horizon® Series Imagers compare substantially to the Codonics NP-1660 Series Medical Printers (K003481), FUJI FM-DP 2636 Dry Imager (K962967), AGFA DryStar Models 3000 & 4500M (K012941), and Seiko ColorPoint 1720 (K991282) in system function and intended uses." |
| Electrical Compliance and Electromagnetic Standards | Passed a series of electrical safety tests including UL 2601-1, CAN/CSA-C22.2 No 601.1-M90, IEC EN-60601-1, TUV/EN-60950:1992 and EN 60950/A1:1993. Complies with electromagnetic standards defined in EN-60601-1-2. |
| Data Integrity (Interpolation and Scaling) | "Interpolation and scaling of images without Lossy data compression is employed in this device to maintain data integrity." |
| Validated Linear Routines & Look Up Tables (LUTs) | "Validated digital linear and visual linear routines and verified industry/modality specific Look Up Tables (LUTs) are applied to optimize color and CRT image hardcopy display results." |
| Hazard Analysis (Level of Concern) | Hazard analysis concluded that potential hazards are not different from other multiformat hardcopy image components, primarily related to computer system component failure, not expected to materially contribute to patient death or injury. Concluded "level of Concern" is "Minor". |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical studies" but does not specify the sample size of a test set (e.g., number of images or cases) used for clinical evaluation of diagnostic performance. The provenance of this data (e.g., country of origin, retrospective or prospective) is also not provided. The focus of the reported "clinical studies" appears to be on verifying effective application and consistent results with predicate devices, rather than a diagnostic accuracy study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The study design described does not involve establishing ground truth for a diagnostic test set in the conventional sense of a clinical diagnostic study for sensitivity/specificity.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance attributes. There is no information about how much human readers improve with or without AI assistance, as this is a medical printer, not an AI-driven diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
As this device is a medical hardcopy printer, the concept of a "standalone (algorithm only)" performance study for diagnostic accuracy is not directly applicable. The "algorithm" here refers to image processing for printing, not a diagnostic algorithm. The performance described (e.g., pixel resolution, grey scale levels) relates to the output quality of the printed image itself.
7. Type of Ground Truth Used
The document does not describe the use of a formal diagnostic ground truth (e.g., pathology, outcomes data, expert consensus) tied to a specific diagnostic performance study. The "clinical studies" mentioned seem to verify the functionality and consistency of the printed output compared to existing devices. The "ground truth" for evaluating the printer's performance refers to physical image quality metrics (e.g., SMPTE pattern resolution, density response, color matching) and consistency with predicate device output.
8. Sample Size for the Training Set
This information is not applicable. The device is a printer that processes images based on established algorithms and look-up tables, not a machine learning algorithm that requires a "training set" in the context of AI/ML models for diagnostic tasks.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.