(59 days)
The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.
The provided text describes a medical device, the Imation™ Trimatic™ Digital System, and its 510(k) submission for clearance. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or AI effectiveness.
The "Performance Data" section lists voluntary standards related to safety (UL, IEC), laser safety (21 CFR 1040, IEC), and electromagnetic compatibility (EN standards). It does not describe any performance metrics for image quality, diagnostic accuracy, or clinical outcomes that would be typical acceptance criteria for a medical imaging device.
Therefore, many of the requested sections regarding acceptance criteria, performance, and study design cannot be extracted from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| UL1950 (Safety of Information Technology Equipment) | Conforms to standard |
| 21 CFR1040 (Laser Safety Standards) | Conforms to standard |
| IEC825 (Laser Safety Standards) | Conforms to standard |
| EN60601-1-2 Class A (Electro-Magnetic Compatibility) | Conforms to standard |
| EN55011 1991-97 (Radiated and Conducted Immunity) | Conforms to standard |
| EN55014-1 1993-97 (Conducted Immunity) | Conforms to standard |
| EN61000-4-2 1995 (Electro-Static Discharge) | Conforms to standard |
| EN61000-4-3 1996 (Radiated Radio-frequency) | Conforms to standard |
| ENV 50204 1995 (Immunity to RF Telephone Emissions) | Conforms to standard |
| EN61000-4-4 1995 (Electronic Fast Transfer) | Conforms to standard |
| EN61000-4-5 1995 (Surge) | Conforms to standard |
| EN61000-4-6 1996 (Conducted immunity) | Conforms to standard |
| EN61000-4-8 1993 (Power Frequency Magnetic Field) | Conforms to standard |
| EN61000-4-11 1994 (Power Line Fluctuation) | Conforms to standard |
| Faithfully digitizing standard x-rays | "The digitizer has the resolution capable of faithfully digitizing standard... x-rays." (Implied performance) |
| Faithfully digitizing mammographic x-rays | "The digitizer has the resolution capable of faithfully digitizing... mammographic x-rays." (Implied performance) |
| Digital image 12 bit depth | "The digital image has 12 bit image depth" (Technical specification met) |
| DICOM 3.0 format | "The digital image... is in Dicom 3.0 format." (Technical specification met) |
| Scan rate and spot size adjusted for film type | "The scan rate and spot size are adjusted depending on the film type" (Technical specification met) |
| Accurately capture 5 line pairs per mm for standard films | "accurately capture either 5 or 10 line pairs per mm for standard... films" (Technical specification met) |
| Accurately capture 10 line pairs per mm for mammographic films | "accurately capture either 5 or 10 line pairs per mm for... mammographic films" (Technical specification met) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on regulatory compliance, safety, and technical specifications, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. This information would be relevant for an AI or diagnostic performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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:
- No MRMC study was done or reported. This device is a digitizer, not an AI-assisted diagnostic tool. The document explicitly states: "Digital images generated by the Trimatic Digital System are interpreted by competent medical practitioners, offering ample opportunity for competent human intervention where warranted." This indicates no AI assistance for interpretation is part of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a digitizer; it does not perform standalone diagnostic algorithms.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The ground truth for the listed performance data relates to compliance with engineering and safety standards, and whether technical specifications (like resolution, bit depth) are met. It does not involve diagnostic ground truth.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a film digitizer, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.