(14 days)
The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.
The LifeJet™ Printer 400 is an inkjet printer designed to produce high quality color and gray-scale referral medical images. Together with specifically designed medical paper and inks (LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges) the LifeJet™ Printer 400 forms the LifeJet™ 400 System, which is an innovative, convenient and work-flow improving medical printing platform, based on the state of the art inkjet technology, capable of delivering superior and reliable printed images for any medical documentation requirement.
The provided text describes the 510(k) premarket notification for the Ferrania LifeJet™ Printer 400. This document focuses on demonstrating substantial equivalence to a predicate device (Kodak Digital Science 1200 Distributed Medical Imager) rather than establishing novel safety and effectiveness through the demonstration of specific acceptance criteria from a clinical study.
Therefore, many of the requested categories for a study proving device acceptance criteria are not applicable in this context. The available information relates to performance testing for comparison, not an efficacy or diagnostic accuracy study against predefined clinical acceptance criteria.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This product is an inkjet printer. The "acceptance criteria" here are largely implicit in demonstrating substantial equivalence to a predicate device, focusing on technical specifications and basic performance (printing time, optical density, image artifacts). There are no specified clinical acceptance criteria in terms of diagnostic accuracy or clinical outcomes.
| Feature/Specification | Acceptance Criteria (Implicit for Equivalence) | Reported Device Performance (LifeJet™ Printer 400) |
|---|---|---|
| Printing Technology | Ink-jet | Ink-jet |
| Operating System | Windows NT 4.0 (for predicate, but broader stated for LifeJet) | Windows NT 4.0 |
| Printing Resolution | 1200x1200 dpi | 1200x1200 dpi |
| Tones | Color and gray scale | Color and gray scale |
| Number of Colors | 256 x CMYK | 256 x CMYK |
| Standards | UL, CSA, FCC, CE Mark, IEC 60601-1, Energy Star (Similar to predicate) | UL, CSA, FCC, CE Mark, IEC 60601-1, Energy Star |
| Interfaces | Parallel: IEEE 1284 | Parallel: IEEE 1284 |
| Cartridges | Specific DMI Ink cartridges (Predicate) | Black LifeJet™ Medical Ink Jet Cartridge, Color LifeJet™ Medical Ink Jet Cartridges |
| Printing Media | Coated paper (and film for predicate) | Coated paper |
| Sheet sizes | A4, A5, A6, US letter, 4"x6", etc. (Similar or greater range to predicate) | A4, A5, A6, US letter, 4"x6", personalized |
| Supply Tray Capacity | 45 sheets (Predicate) | 50 sheets |
| RAM | Not available (Predicate) | 2 MB |
| Time to print one 203x203 mm SMPTE image | Substantially equivalent to predicate device | Testing confirmed substantial equivalence |
| Printed maximum optical density | Substantially equivalent to predicate device | Testing confirmed substantial equivalence |
| Image mottling and bleeding @ 100% density | Substantially equivalent to predicate device | Testing confirmed substantial equivalence |
| Overall Performance | Safe, effective, and performs as well as or better than the predicate device (based on comparison of features and performance test results). | The LifeJet™ Printer 400 is considered safe, effective, and performs as well as or better than the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set: Not applicable for a clinical test set. The performance testing was based on printing a "203x203 mm image of a SMPTE pattern (512x512 pixel)". This implies a very limited "sample size" of images (likely a single standard test pattern) for objective measurements.
- Data provenance: Not specified, but given the company's location (Ferrania S.p.A., Italy), it is likely the testing was conducted in Italy. It's a lab-based performance test, not a clinical data set.
- Retrospective/Prospective: Not applicable, as this was a controlled laboratory performance test, not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the performance tests (printing time, optical density, mottling, bleeding) would be derived from objective measurements using calibrated instruments, not expert human assessment of diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance testing involved objective measurements of technical printing characteristics, not subjective interpretation requiring adjudication among experts.
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
Not applicable. This device is a medical inkjet printer, not an AI-powered diagnostic tool. There was no MRMC study, nor any assessment of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a printer, not an algorithm. Its "performance" is inherent to its printing capabilities, not an algorithmic output that could be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" was based on objective physical measurements for quantitative metrics like printing time, optical density, and visual assessment of physical defects (mottling, bleeding) against a known standard (the SMPTE pattern).
8. The sample size for the training set
Not applicable. This device is an inkjet printer. It does not use a "training set" in the context of machine learning. The design and engineering process might involve iterative testing, but not a dataset used for algorithmic training.
9. How the ground truth for the training set was established
Not applicable (as there is no training set for this type of device).
§ 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.