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510(k) Data Aggregation
(33 days)
TRACTUS CORPORATION
The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
The TissueMapper Image Recording System is an electronic image recording and storage system. The device is an accessory to standard ultrasound systems and allows the digital recording images from those standard ultrasound devices, along with the spatial position coordinates of the recorded images. The images are recorded from the video out port of the standard ultrasound device. The images are recorded as output from the video output of the standard ultrasound imaging device. Brightness, contrast, and gamma are not adjusted by the program. lmages are recorded using Video Graphics Array (VGA) or Digital Video Interface (DVI) video output formats. Images are displayed and saved as uncompressed, 8-bit grayscale images. No loss of data occurs with this image format. The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Tractus TissueMapper Image Recording System are primarily related to its accuracy in locating regions of interest and its ability to identify masses in phantoms.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Absolute location of a region of interest: Within one-half of the width of the ultrasound probe. | The device is intended to allow identification of a region of interest in a subsequent review and allow accurate placement of an ultrasound probe in another, subsequent, diagnostic ultrasound procedure. The absolute location of the probe is accurate within one-half of the width of the ultrasound probe. For the Ultrasonix L141-5W/60 60mm linear transducer, this is within 3 cm. |
| Image location relative to a previously recorded image: Within 1 mm. | Image location, relative to the previously recorded image is accurate to within 1 mm. |
| Registration accuracy: Similar to or better than the Civco predicate device. | Registration accuracy tests were performed, and the results demonstrated that the selected target location based on the registration calculation is within the same tolerance range or better than the Civco predicate device. |
| Mass identification in breast phantoms: All masses successfully identified. | System Validation Testing was performed on 2 breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The test set for the "mass identification in breast phantoms" criterion involved 2 breast phantoms with 11 masses total. The data provenance is internal testing conducted in-house by trained personnel in a simulated work-environment, using phantoms. This suggests it's a prospective test of the device's performance in a controlled setting. The country of origin of the data is not explicitly stated.
For the other accuracy criteria (absolute and relative image location, registration accuracy), the document mentions that "testing was conducted in-house by trained personnel in a simulated work-environment using phantoms." It does not specify a distinct "test set" sample size in terms of number of phantoms or measurements for these individual criteria, but implies these were evaluated as part of the overall performance, verification, and validation testing.
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)
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth of the test set (the phantoms). It only mentions that testing was conducted "in-house by trained personnel." Given that phantoms were used, the "ground truth" would likely be the known, engineered positions of the masses or regions within the phantoms, rather than clinical expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described for the test set. The ground truth for the test set (phantoms) would be the precisely known physical properties and locations within the phantoms,
eliminating the need for expert 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
No multi-reader multi-case (MRMC) comparative effectiveness study was reported. This device is an image recording device with spatial tracking capabilities, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance testing was done. The performance data focuses on the intrinsic accuracy and functionality of the device itself (the "algorithm only" in terms of its spatial tracking and image recording). The "System Validation Testing of the Tractus TissueMapper Image Recording System was performed on 2 breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified" is an example of standalone performance relative to a known ground truth. The device's ability to accurately locate a region of interest within a specified tolerance also describes its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for the performance testing was phantom-based ground truth. The document explicitly states that testing was performed "using phantoms." This implies that the locations of masses and reference points within these phantoms were precisely known and served as the absolute ground truth against which the device's measurements were compared.
8. The sample size for the training set
The document does not mention a training set nor any machine learning or AI components that would require a training set. The device is described as an "electronic image recording and storage system" and an "accessory to standard ultrasound systems" that tracks spatial position coordinates. Its functionality relies on electromagnetic tracking and digital image recording, not on learned parameters from a training dataset.
9. How the ground truth for the training set was established
As no training set is mentioned or implied by the device's described functionality,
there is no information on how its ground truth would have been established.
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(42 days)
TRACTUS CORPORATION
The Tractus TissueMapper Reviewer Application provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications.
The TissueMapper Reviewer Application is an electronic image review and reporting software program intended to operate on a Windows Operating System (OS) computer. The device allows the review of previously recorded ultrasound examinations which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally.
The images are displayed on a computer monitor. The images may be reviewed individually or as a self-playing sequence (video clip). Certain image functions may be adjusted by the software, such as image brightness, image contrast and image size magnification or reduction. The speed of the video presentation may be adjusted by the software.
The device software presents sequences of mapped ultrasound images to review previously-recorded hand-held ultrasound examinations, which can be transferred to a computer using a media storage device (USB). Each image is mapped anatomically with respect to a user-identified anatomical landmark, such as the nipple or navel. The image mapping information allows anatomic location of useridentified regions of interest for comparison with other imaging techniques or for procedure planning purposes.
The device software allows the user to measure the size, on two user-defined axes, of the region of interest. The device software allows the user to create and store electronic reports on each region of interest.
The provided text describes the Tractus TissueMapper Reviewer Application, a software device intended for image review, manipulation, and analysis to assist medical professionals in screening, diagnosis, planning, and performing image-guided interventional procedures using Ultrasound images.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity). Instead, the performance evaluation focuses on functional requirements and accuracy relative to a predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Requirements Met | "Testing for TissueMapper Reviewer Application was performed to ensure that all functional requirements have been met, and that core functions execute as expected." |
| Accuracy of Registration (Ultrasound to Phantom) | "Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was identical to that of the Aegis predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device." |
| Mass Identification Capability (Clinical Relevance) | "System Validation Testing of the Tractus TissueMapper Reviewer Application was performed on a two breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified." |
| Function as Intended | "In all instances, the TissueMapper Reviewer Application functioned as intended and the operation observed was as expected." |
| Safety and Effectiveness (Substantial Equivalence to Predicate) | "The results of these tests demonstrate that the TissueMapper Reviewer Application validation is within specification. |
| As such, TissueMapper Reviewer is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today. The software performs as well as, or better than legally marketed predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For the "System Validation Testing," two breast phantoms containing a total of 11 masses were used.
- For the registration accuracy tests, the number of target locations or phantoms used is not specified beyond "targeting locations within a phantom."
- Data Provenance: The data was generated in-house ("in-house by trained personnel in a simulated work-environment using phantoms"). This indicates it was synthetic data from phantoms, not human clinical data. No country of origin is explicitly stated beyond "in-house," but given the US FDA submission, it's presumed to be within the US. The nature of phantom testing makes it akin to a prospective simulation.
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)
The document does not specify the number of experts or their qualifications used to establish ground truth. Given that the testing involved phantoms, the "ground truth" for mass locations and registration might have been established during the phantom's creation or by engineering measurements, rather than clinical expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. Given the nature of phantom testing, a formal adjudication process involving multiple human readers as typically seen in clinical studies is not applicable or 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance testing described is a technical validation against phantoms and a comparison of functionality to a predicate device, not a study involving human readers with and without AI assistance to measure improvement. The device is intended to "assist users," but its impact on human performance is not quantified in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The performance testing described primarily evaluates the standalone functionality and accuracy of the software in a simulated environment using phantoms. While the device is intended to assist human users, the tests described (functional checks, registration accuracy, mass identification in phantoms) assess the algorithm's performance on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was based on the known characteristics of phantoms. For the mass identification test, the "11 masses total randomly positioned" in the breast phantoms would have had their locations and existence known from the phantom design specification. For registration accuracy, it would be based on the known physical targets within the phantom. This is a form of "engineered truth" or "phantom truth", rather than clinical ground truth like pathology or expert consensus from patient data.
8. The sample size for the training set
The document does not provide information regarding a training set. This submission focuses on the performance and substantial equivalence of the TissueMapper Reviewer Application, but it does not detail its development pipeline, including any machine learning training sets.
9. How the ground truth for the training set was established
Since no training set information is provided, how its ground truth was established is not mentioned.
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