(23 days)
The intended uses of the Horizon XL are identical to the Codonics Horizon® Series Medical Hardcopy Dry Imagers (premarket notification K021054); high resolution hard copy imaging of digital image source material combining color, film, reflective media in one imager. 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 addition of 14" x 36" and 14" x 51" true size "long" film and (TBD) reflective Direct Vista Paper media permits digital direct orthopaedic application hardcopy including diagnosis and analysis of scoliosis, weight bearing spine/hip/knee, and long bone/hip Prosthetic and orthopedic appliances work-up and surgical planning. Horizon XL is applicable to true-size hardcopy of whole body CT, MRI and Angiographic and Venous flow imaging procedures.
The Horizon® Series Imagers are dry, thermal, grey scale and grev scale/color (Ci model) direct thermal printer/imagers. The devices produce continuous tone, diagnostic quality BM images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality.
The Horizon® XL provides the capability to image True Size Long films used in Orthopedic applications, particularly in spine and long bone studies. These have been traditionally performed utilizing contact-screen film radiography utilizing special long, light-sensitive x-ray films in special long film/screen cassettes. As more imaging departments and centers become committed to PACS implementation and the application of digital radiography (CR and DR) acquisition, Horizon® XL brings long films into the all-digital world.
Here's a breakdown of the acceptance criteria and study information for the Codonics Horizon® XL Medical Long Film Imager, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Electrical Safety | UL 2601-1 | Passed |
| CAN/CSA-C22.2 No 601.1-M90 | Passed | |
| IEC EN-60601-1 | Passed | |
| TUV/EN-60950:1992 | Passed | |
| EN 60950/A1:1993 | Passed | |
| Electromagnetic Standards | EN-60601-1-2 | Complied |
| Clinical Effectiveness | Consistent with predicate devices | Documented effective application and expected results |
| Printer Resolution | Pattern Testing | Verified |
| Proper Operation & Intended Functions | N/A (General verification) | Verified |
| Image Quality | Diagnostic quality images on transmissive film and reflective media; Photographic medical color matched quality (for color models) | Produced |
| Interpolation and scaling without Lossy data compression | Employed to maintain data integrity | |
| Data Integrity | Use of validated digital linear and visual linear routines and verified industry/modality specific Look Up Tables (LUTs) | Applied to optimize color and CRT image hardcopy display results |
| Hazard Analysis | No hardware or software component latent design defect expected to result in death or injury of the patient. "Level of Concern" is "Minor". | Concluded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for "test sets" in the context of clinical studies for a new device. Instead, it refers to:
- Clinical studies, results and outcomes: "Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution." This implies a comparison to existing data or performance benchmarks, but doesn't detail a separate test set for the XL model itself.
- Data Provenance: Not specified. The document describes a general set of tests performed by the manufacturer (Codonics, Inc. in Middleburg Heights, Ohio, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The filing focuses on the technical and physical characteristics of the printer and its substantial equivalence to a predicate device, rather than detailed human-readability studies for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided. As detailed above, there isn't a clearly defined "test set" with ground truth established by experts and requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, nor any reference to AI assistance. This device is a medical hardcopy printer, not an AI-powered diagnostic tool. The focus is on the quality of printed images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a printer that outputs images for human interpretation, not an algorithm performing a standalone diagnostic function.
7. The Type of Ground Truth Used
For the clinical tests mentioned ("documented effective application and expected results consistent with predicate devices"), the ground truth would implicitly be the established diagnostic interpretations and clinical utility associated with the images produced by the predicate devices. The document does not specify if pathology or outcomes data was used for direct validation of the XL model against a specific disease.
For the technical criteria (electrical safety, electromagnetic standards, printer resolution), the ground truth is established by the respective industry standards and testing protocols.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning. This device does not employ data-driven machine learning in the conventional sense. Its "training" would be related to engineering design and calibration processes.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" with established ground truth in a machine learning context is not applicable to this hardcopy imager. The functionality relies on established physics of thermal printing, image processing algorithms (interpolation, scaling), and adherence to industry standards for image display and transmission (DICOM, LUTs).
§ 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.