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510(k) Data Aggregation
(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.
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(27 days)
Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.
Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.
The provided text does not contain detailed information regarding specific acceptance criteria, device performance metrics, or study designs with sample sizes, expert qualifications, or ground truth establishment for the Imation Trimax™ Cassette. The submission focuses on substantial equivalence to a predicate device and conformance to voluntary design standards.
Therefore, I cannot populate the table or answer the questions with the requested level of detail regarding performance data.
However, based on the limited information provided, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ANSI standard PH. 1.49(1995) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Conformance to IEC 406(1996) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Conformance to DIN 6832(1992) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Substantial Equivalence to predicate device (DuPont/Sterling Intensifying Screens and Cassettes) | Imation believes the subject device is safe and effective based on comparison to 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)
No information provided. The submission relies on conformance to voluntary standards and comparison to a predicate device, rather than a specific performance study with a 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 applicable, as no specific performance study with a test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
No MRMC study was mentioned. The device is a radiographic film cassette, not an AI-powered system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no specific performance study with a test set requiring ground truth is described. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate device and the adherence to relevant industry standards.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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(83 days)
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
The provided 510(k) summary for the Imation™ MODEL 9410 NETWORK INTERFACE does not contain detailed information regarding specific acceptance criteria or a dedicated study explicitly designed to prove the device meets such criteria in terms of image quality or clinical performance.
Instead, the submission relies on the following points to establish safety and effectiveness, and thus 'acceptance':
1. Acceptance Criteria and Device Performance (Inferred):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Compliance with voluntary safety standards. (Specifically mentioned: UL950, CSA C22.2 No. 950) | The device adheres to UL950 and CSA C22.2 No. 950. The device has no patient contact and does not control, monitor, or affect any devices directly connected to or affecting the patient. Released software undergoes testing, hazard analysis, and approval equivalent to the initial release. |
| Effectiveness (Image Quality Preservation): Maintain or improve image properties (spatial resolution, gray-scale resolution, density uniformity) compared to predicate devices. | "Images communicated by the subject device maintain the same or better image properties in the areas of spatial and gray-scale resolution and in density uniformity as the predicate. No lossy compression is used in this device." |
| Functional Equivalence: Performs as a communications gateway, accepting and transferring image data in specified formats. | The device "accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system." It accepts "DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats." |
| Substantial Equivalence: Demonstrated similarity in technical characteristics and intended use to predicate devices (Cemax-Icon Scanlink V and Merge MVP). | The submission asserts that "The subject device and predicate devices use the same technical design base." and "The subject and predicate device(s) have all been designed to equivalent safety standards." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of image quality performance or clinical evaluation. The statement "Images communicated by the subject device maintain the same or better image properties..." implies an internal assessment, but details about the number of images, their origin, or whether this was a retrospective or prospective collection are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The submission does not describe a study involving expert readers to establish ground truth for image interpretation or diagnosis. The phrase "Images communicated by the subject device and its predicates are reviewed by medical personnel, offering ample opportunity for competent human intervention in case of a malfunction or other failure" suggests that medical personnel ultimately review images, but this is not a ground truth establishment process for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No test set adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. The submission focuses on device functionality and equivalence, not on the impact of the device on human reader performance.
6. Standalone (Algorithm Only) Performance:
The device is a network interface, a hardware/software system for data transfer and conversion. It does not perform diagnostic algorithms in the sense of an AI model that interprets images. Therefore, a standalone (algorithm only) performance study as typically understood for AI-powered diagnostic devices is not applicable. Its performance is based on its ability to accurately transmit and convert data without degradation.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in the context of diagnostic AI algorithms (e.g., pathology, clinical outcomes) is not applicable here. The evaluation of this device is based on technical specifications and faithful transmission/conversion of image data, not on the accuracy of diagnostic findings. The implied 'ground truth' for its performance relates to the integrity of the transmitted image data compared to the original, which would be evaluated through technical measurements rather than clinical expert consensus.
8. Sample Size for the Training Set:
Not applicable. This device is a network interface and does not involve AI/machine learning models that require a "training set" in the typical sense for image interpretation. Its software converts data formats and manages communication, which is developed through standard software engineering practices rather than data-driven machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI algorithm.
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(88 days)
The Imation™ SE-196 laser imager is intended use as a high quality hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Imation™ SE-196 Laser Imager, formatted to address your specific questions.
It's important to note that the provided document is a 510(k) summary from 1997 for a laser imager, not a modern AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of submission for this particular device. The "Performance Data" section discusses traditional imaging characteristics rather than AI algorithm performance.
Acceptance Criteria and Study for Imation™ SE-196 Laser Imager (K972163)
The device described is a laser imager, which is a physical device for printing medical images. Its performance criteria are related to image quality reproduction, not diagnostic accuracy of an AI algorithm.
1. Table of Acceptance Criteria
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Spatial Frequency Response (DPI) | - Subject Device (Imation™ SE-196): 325 dpi (pixel size) - Predicate Devices: 325 dpi (pixel size) Similar to predicate devices. |
| Gray Scale Resolution | - Subject Device (Imation™ SE-196): 12 bit - Predicate Devices: 8 or 12 bit Equivalent to or better than predicate devices (only 12 bit, which is the higher end of predicate). Image properties are "same or better". |
| Density Uniformity | - Subject Device (Imation™ SE-196): Same or better than predicate devices. - Mechanism: Built-in density test patterns and AIQC (Automatic Image Quality Control) that maintains density uniformity over time and changes in film media. Image properties are "same or better". |
| Safety (Voluntary Standards Compliance) | - UL544 - IEC601-1 - IEC 825 - Imation™ SE-196 Engineering Specification (Part B) - Predicate Devices: Designed to UL1950. Subject device designed to UL1950 (same as predicate) and other applicable standards. |
| Reliability, Qualification, Validation | - Successfully concluded field test. - Successfully concluded internal tests for qualification, validation, and reliability. No specific numerical performance metric is given for these, but successful conclusion is stated as the criteria for final release. |
| AIQC (Automated Image Quality Control) | - Matches printing power with film characteristics to provide consistently high image quality. - Assure consistency between input signals and output density. This is a feature that contributes to image quality (density uniformity) and is incorporated in both subject and predicate devices. |
Study Details:
The document describes "field tests and internal tests for qualification, validation and reliability." However, it does not provide detailed information about these studies in the context of AI/ML device evaluations. This is a traditional medical device submission, focusing on equivalence to predicate devices based on technological characteristics and functional performance related to image output quality.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified for an AI algorithm. This document describes a laser imager, a hardware device for printing images. The "performance data" refers to characteristics of the printed output, not a diagnostic algorithm's performance on a dataset of patient images.
- The "field test" and "internal tests" would likely involve evaluating printed films, but the specific methodologies, sample sizes (of films or images), or data provenance (country, retrospective/prospective) are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The device is an imager, not a diagnostic AI tool. Ground truth in the context of an AI algorithm's diagnostic performance is not relevant here. The evaluation involves technical image properties, possibly assessed by engineering or quality control personnel against specifications.
- Medical personnel review the images displayed by the device, and their "competent human intervention" is mentioned as a safety mechanism, but not as part of establishing a ground truth for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept of adjudication is specific to evaluating diagnostic AI algorithms where expert consensus is needed to establish ground truth for ambiguous cases. It is not relevant to a laser imager's performance evaluation as described.
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. This is not an AI-assisted diagnostic device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser imager. It does not contain a standalone AI algorithm for diagnostic interpretation. Its "AIQC" is an Automated Image Quality Control system, managing printing power and film characteristics, not a diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the reported performance characteristics (spatial frequency response, gray scale resolution, density uniformity), the "ground truth" would be established through technical specifications, calibrated measurement tools, and industry standards for image quality. For example, dpi is measured directly, and gray scale is a technical specification of the digital-to-analog converter and laser modulation. Density uniformity would be measured using a densitometer against a calibrated test pattern. This is not medical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. The device is a laser imager, not an AI/ML algorithm that requires a training set of medical images. The "AIQC" system is likely rule-based or uses internal calibration data, not a "training set" in the context of deep learning.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML training set in the modern sense, the concept of establishing ground truth for it does not apply.
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(37 days)
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. The integrated automatic x-ray film processor can also be used as a stand-alone processor.
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods. The software used to control the operation of the subject device has added capabilities over the software used in the predicate device. Encoded in the bar codes on the x-ray film cassettes are the x-ray film size, type and the correct processing conditions for that particular film. This information drives the operation of the device. Remote diagnostics via phone line is also an added feature in the subject device. The control panel controls both the load / unload process and the automatic x-ray film processor.
The provided text describes a medical device, the 3M Trimatic™ Advanced Processing System, which is an automatic x-ray film loading and processing system. However, the document is a 510(k) Summary from 1996, which pre-dates the current expectations for detailed performance data for AI/ML-enabled devices.
Based on the information provided, it is not possible to fully answer all components of your request as a modern AI/ML device study would. The document focuses on technological characteristics and safety/performance standards typical for non-AI hardware at the time.
Here's an attempt to answer based only on the provided text, highlighting what is missing for a complete response relating to AI/ML acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not explicit for AI/ML performance. The document focuses on electromechanical function and safety standards. | This document does not provide specific quantitative performance metrics like sensitivity, specificity, or accuracy that would be expected for an AI/ML device. The "Performance Data" section references general standards and internal validation. |
| Voluntary Standards Adherence: | UL 122, IEC 950, IEC 801-2, 3, 4, 5, EN 22011 |
| Internal Qualification/Validation (Software): | Successfully concluded field test and internal qualification/validation tests. |
| Software Final Release Approval: | Approved by product team for production after successful tests. |
| (Implied) Equivalence to Predicate Device: | "The subject device has moved and altered some of the internal mechanisms to reduce the size of the film magazine modules." "The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods which are similar to the predicate processor." "The software used to control the operation of the subject device has added capabilities over the software used in the predicate device." (This suggests performance is at least equivalent, if not improved, for the described functions). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "field test" and "internal qualification / validation tests" but does not quantify the number of films, operational cycles, or any other relevant units for the test set.
- Data Provenance: Not specified, but implied to be from internal testing and field tests of the device itself. No mention of country of origin for data. Retrospective or prospective is not specified; "field test" implies prospective, but "internal qualification/validation" could be either.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The device processes x-ray film and unloads/reloads cassettes; it does not interpret medical images or perform a diagnostic function that would require expert ground truth for its core operation as described.
4. Adjudication method for the test set
- Not applicable as no expert-derived ground truth is described for the device's function. The "adjudication" seems to be internal engineering and product team approval based on functional testing.
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, an MRMC study was not done. This device is an automatic film processor, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is phrased for an algorithm's performance. The device itself operates "standalone" in its film processing function without human intervention during the processing cycle. However, this is not an "algorithm-only" performance in the context of AI/ML. The "software" mentioned controls mechanical processes rather than performing diagnostic or interpretive tasks.
7. The type of ground truth used
- For the described functions (unloading, processing, reloading film, remote diagnostics), the "ground truth" would be functional correctness and adherence to specifications. For example, did the film successfully load? Was it processed correctly? Was the correct film type/size detected from the bar code? Was the remote diagnostic function operational? This is not pathology, outcomes data, or expert consensus in the typical AI/ML sense.
8. The sample size for the training set
- Not applicable. This device predates the common use of "training sets" for AI/ML algorithms. The software described is control software for electromechanical functions, not a learned algorithm.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as #8. Ground truth for control software would be established through engineering specifications and functional testing of each component and the integrated system.
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