(67 days)
The KODAK Digital Science 9000D Medical Laser Printer is a laser printer designed to produce hard-copy films of digitized medical images. It is a newly designed printer to be added to Kodak's family of medical laser printer products that is intended for the centralized network printing solution for high volume sites for maximum productivity. This printer will be environmentally friendly by eliminating wet chemistry, site concerns, costs and will reduce chemical disposal problems. This is accomplished by using a totally proprietary imaging process.
Images printed on film from the laser printer will be used for primary diagnosis, similar to other laser printers and CRT mult-format cameras. Evaluation of the hard copy output by trained health care professionals provides adequate opportunity for competent human intervention. Laser printers are not represented to be of use in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury.
The Kodak Digital Science 9000D Medical Laser Printer (MLP 9000D) is a secondary imaging device that receives data from various modalities that can be stored and then printed on film for evaluation by a radiologist. The MLP 9000D is an integrated system which is based on the overall system concept of the Kodak Ektascan 2180 Laser Printer (KELP 2180), Common Protocol (CP) interfaces and the Kodak X-Omat 180LP/LPS Processor system. The MLP 9000D's film transport and exposure mechanisms will be a modification of the current KELP 2180 design. The Kodak X-Omat 180LP/LPS will be replaced by a dry thermal processor that will be used to develop a new photothermographic film.
The MLP 9000D will consist of many components which are similar to the KELP 2180. Examples are various input sections that are either video, digital, digital video, or network interfaces that interact between the host and the MLP 9000D to perform its tasks. The operator interfaces with the system by either using a keypad to store and print images or with an autofilming link to perform the same storing and printing functions at a system console.
The general hardware configuration of the KODAK Digital Science 9000D Medical Laser Printer contains the following major components / subsystems:
Modality Interfaces Laser Printing System Processor with optional Film Sorter
OPTIONAL ACCESSORIES:
Image Buffer Controller / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
High Capacity Image Buffer Disk / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
Memory Board / 6 MP / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
Seismic Kit / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
Standard Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
Basic Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
Enhanced Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical.Laser Printer and KODAK EKTASCAN 2180 Laser Printer
High Capacity Enhanced Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer
The provided documentation describes the Kodak Digital Science 9000D Medical Laser Printer (MLP 9000D), a secondary imaging device. The focus of the document is on the device's design, features, and regulatory compliance, particularly its substantial equivalence to a predicate device (Kodak Ektascan 2180 Laser Printer).
The document does not contain information regarding objective acceptance criteria related to medical imaging performance (e.g., diagnostic accuracy, sensitivity, specificity) or any study that quantitatively proves the device meets such criteria.
Instead, the "study" referred to is the submission for 510(k) clearance, which demonstrates substantial equivalence to a legally marketed predicate device. This process primarily involves comparing the new device's technological characteristics, indications for use, and safety and effectiveness profiles with those of the predicate. The provided text outlines the features of the new device and compares them to the predicate, and lists the regulatory standards it is designed and tested to conform with, rather than presenting a clinical performance study.
Therefore, many of the requested specific details concerning medical imaging performance studies, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of medical imaging performance metrics (e.g., diagnostic accuracy, sensitivity, specificity). Instead, the "acceptance" is implicitly tied to regulatory compliance and substantial equivalence to the predicate device (Kodak Ektascan 2180 Laser Printer - KELP 2180). The "performance" described is in terms of the device's technical specifications and features.
| Feature / Criterion (Implicit) | Acceptance Criterion (Based on Predicate) | Reported Device Performance (MLP 9000D) |
|---|---|---|
| Imaging Features | ||
| Laser Type | Red Diode | Red Diode |
| Deflection | Polygon | Polygon |
| Image Matrix | 4096x5120 | 4096x5120 |
| Bits/Pixel | 12/12 | 12/12 |
| Pixel Pitch (Microns) | 79 | 79 |
| Laser Power | 5mw | 50mw |
| Tone Scale Features | ||
| Density Max | 3.2 | 3.2 |
| Curve Shape | 6 | 6 |
| Interpolation | Cubic/Rep/ | |
| Sharp Cubic/Bilinear | Cubic/Rep | |
| Sharp Cubic/Bilinear | ||
| Physical Features | ||
| Footprint (in.) | 31 x 52 | 31 x 52 |
| Kodak Processor | 180LP Wet | Thermal |
| Roomlight Film Supply | Yes | Yes |
| Film Sizes | 4 | 4 |
| Productivity | ||
| Lockout Time (sec) | 0 | 0 |
| Cycle Time (sec) | 20 | 30 |
| Print Time | 12 | 26 |
| Memory Capacity (MB) | 4G | 4G |
| Autoprint | Yes | Yes |
| Random Erase | Yes | Yes |
| Multiple Inputs | ||
| Max Inputs | 8 | 8 |
| Volatile Memory | No | No |
| Keypad/Autofilm | Yes | Yes |
| Regulatory Compliance | Conformance to listed standards | Designed and tested in conformance with listed standards (EN 60601-1, EN 60825, CSA C22.2 No. 601.1, UL 2601-1, Title 21CFR 1040.10, EN 55011, EN 50082-1, EN 60950, EN 61000-3-2, EN 61000-3-3, IEC 801-2, IEC 801-3, IEC 801-4, California Seismic requirements) |
| Indication for Use | Primary diagnosis by trained healthcare professionals | Primary diagnosis by trained healthcare professionals (similar to predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable in the context of a clinical performance study. The document describes a comparison of product specifications and regulatory compliance, not a clinical trial with a "test set" of patient data.
- Data Provenance: Not applicable. The document refers to the design and testing of the device against engineering and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The document does not describe the establishment of a "ground truth" for a medical imaging test set. The device's output (printed film) is intended for evaluation by trained healthcare professionals for primary diagnosis, implying human clinical interpretation, but this is the intended use, not part of a validation study described here.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done or described in this document.
- Effect Size: Not applicable. This device is a printer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a printer and its output is intended for human interpretation (human-in-the-loop). It does not perform diagnostic algorithms independently.
7. The type of ground truth used
- Type of Ground Truth: Not applicable. The document focuses on the technical specifications and regulatory compliance of a medical film printer. The "ground truth" in terms of clinical diagnosis is derived from subsequent human interpretation of the printed films in a clinical setting.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This document does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): 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.