(31 days)
The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.
The Metrx Workstation is a software product that is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx Workstation product is not intended to provide medical diagnosis or a recommended treatment approach.
The provided text is a summary of safety and effectiveness for the Metrx Workstation and a 510(k) clearance letter from the FDA. It does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study with quantitative results.
The document states: "A table comparing the Metrx Workstation to the predicate devices is attached. This comparison demonstrates the substantial equivalence of the Metrx Workstation to the predicate devices." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to already legally marketed devices, rather than a performance study against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document because it describes a different type of regulatory submission. The information below reflects what can be inferred or directly stated from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or device performance in a quantitative manner as would be typical for a clinical or performance study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended use.
| Feature/Characteristic | Acceptance Criteria (Inferred from Predicate Device Features) | Reported Device Performance (Metrx Workstation's Capabilities) |
|---|---|---|
| Primary Function | Ability to segment and differentiate tissues/anatomical structures from 2D imaging data, construct accurate 3D models from segmented data, and provide tools to visualize and analyze processed data, without providing medical diagnosis or treatment recommendations. | Intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Provides tools to better visualize and analyze the processed data. Metrx data may be outputted as source data for Preview® Treatment Planning Software. Not intended to provide medical diagnosis or a recommended treatment approach. |
| Compatibility | Able to read data in DICOM format. | Reads data in DICOM format (Yes). |
| Imaging Capabilities | Supports 2D and 3D imaging. | Supports 2D and 3D imaging. |
| Operating Platform | Capability for user-driven modeling on UNIX, with viewing software on DOS/Windows (based on predicate). | Modeling done by user on UNIX. Viewing software run on DOS/Windows. |
| Image Data Source | Retrieval over network via DICOM or via hard media. | Retrieval over network via DICOM or via hard media. |
| Viewing Format | Multiple interactive 2D & 3D views. | Multiple interactive 2D & 3D views. |
| Analysis Capabilities | Measurements performed on image on workstation. | Measurements performed on image on workstation. |
| Data Manipulation | Data modeling performed by end user. | Data modeling performed by end user. |
| Model Manipulation | Manipulation in multiple planes and orientation. | In multiple planes and orientation. |
2. Sample size used for the test set and the data provenance:
Not applicable. The document describes a 510(k) submission based on substantial equivalence to predicate devices, not a performance study with a test set. There is no information about data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a test set is not mentioned in the context of this 510(k) submission.
4. Adjudication method for the test set:
Not applicable. No test set or related adjudication method is 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 MRMC comparative effectiveness study is mentioned. This device is described as a workstation for image segmentation and 3D model construction, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "Metrx Workstation" is a software product that provides tools for users to perform segmentation and model construction. It is inherently human-in-the-loop, as indicated by "Modeling done by user on UNIX" and "Data modeling performed by end user." Therefore, a standalone (algorithm only) performance study would not be relevant or described here.
7. The type of ground truth used:
Not applicable. The document does not describe the use of specific ground truth data for a performance evaluation in the context of a study. The basis for clearance is substantial equivalence.
8. The sample size for the training set:
Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.
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DEC 1 3 2004
Metrx Workstation Summary of Safety and Effectiveness
| Submitter Name: | Medical Metrx Solutions, Inc | 510(k) Number | K040852 | K032748 | |
|---|---|---|---|---|---|
| Submitter Address: | 12 Commerce AvenueWest Lebanon, NH 03784 | Manufacturer | Medical Metrx Solutions, Inc. | Medical Metrx Solutions, Inc. (formerly Medical Media Systems, Inc.) | Vital Images, Inc. |
| Contact Person: | William F. GreenroseSenior Vice President | Classification # &Product Code | 21 CFR 892.2050LLZ | 21 CFR 892.2050LLZ | 21 CFR 892.2050LLZ |
| Phone Number: | 603-298-5509 x 303 | Indications for Use | The Metrx Workstation isintended for users tosegment and differentiatetissues and anatomicalstructures from two-dimensional imaging data,and to construct accurate,three-dimensional modelsfrom these segmenteddata. Metrx also providesthe user with tools tobetter visualize andanalyze the processeddata. Metrx data may beoutputted as the sourcedata for Preview®Treatment PlanningSoftware. The Metrxproduct is not intended toprovide medical diagnosisor a recommendedtreatment approach. | The Preview® TreatmentPlanning Software isintended to provideaccurate, alternative two-dimensional images, aswell as three-dimensionalmodels, of patientspecific anatomy fromexisting two-dimensionalscan data of organs andtissues. The Preview®product offers thephysician the capability toview existing scan data ina format that is more userfriendly, and thusenhances the physician'scapability to plantreatment. The Preview®product is not intended toprovide medicaldiagnosis or arecommended treatmentapproach. | Vitrea™ 2 is a medicaldiagnostic workstationthat allows theprocessing, review,analysis,communication andmedia interchange ofmulti-dimensional digitalimages acquired from avariety of imagingdevices. In addition,Vitrea™2 has thefollowing specificindications:VScore™ (K990442);Automated VascularMeasurement(K002519; TumorVolume Measurement(K002519; CT BrainPerfusion (K003639);ImageCheckerCT |
| Fax Number: | 603-298-5055 | ProductComponents | Software | Software | Software & computersystem |
| Date Prepared: | November 9, 2004 | Read data inDICOM format | Yes | Yes | Yes |
| Device Trade Name: | Metrx Workstation | Imaging | 2D and 3D | 2D and 3D | 2D and 3D |
| Classification Name,Number &Product Code: | System, Image Processing, Radiological21 CFR 892.2050LLZ | Operating platform | Modeling done by user onUNIX. Viewing softwarerun on DOS/ Windows | Modeling done at MMS onUNIX. | Windows XP |
| Predicate Devices: | Preview® Treatment Planning Software; Medical Metrx Solutions, Inc.Vitrea 2; Vital Images, Inc. | Source of imagedata | Retrieval over network viaDICOM or via hard media | Retrieval over network viaDICOM or via hard media | Retrieval over networkvia DICOM |
| Device Descriptionand Statement ofIntended Use | The Metrx Workstation is a software product that is intended for users tosegment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensionalmodels from these segmented data. Metrx also provides the user withtools to better visualize and analyze the processed data. Metrx datamay be outputted as the source data for Preview® Treatment PlanningSoftware. The Metrx Workstation product is not intended to providemedical diagnosis or a recommended treatment approach. | Viewing format | Multiple interactive 2D &3D views | Multiple interactive 2D &3D views | Multiple interactive 2D &3D views |
| Summary ofTechnological | A table comparing the Metrx Workstation to the predicate devices isattached. This comparison demonstrates the substantial equivalence of | Analysis | Measurements performedon image on workstation | Measurements performedon image on workstation | Measurementsperformed on image onworkstation |
| End user datamanipulation | Data modeling performedby end user | Data modeling performedat MMS | Data manipulationsperformed by end user | ||
| Model manipulation | In multiple planes andorientation | In multiple planes andorientation | In multiple planes andorientation |
the Metrx Workstation to the predicate devices.
1
Characteristics
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2D = 2-Dimensional; 3D = 3-Dimensional
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and body. The eagle is facing to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
Medical Metrx Solutions, Inc. % Ms. Patsy J. Trisler Regulatory Consultant · 5610 Wisconsin Avenue, #304 CHEVY CHASE MD 20815
Re: K043134
Trade/Device Name: Metrx Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: November 10, 2004 Received: November 12, 2004
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that. do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5.0
Indications for Use Statement
510(k) Number (if known):
K0/3134
Device Name:
Metrx Workstation
Indications for Use:
The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software.
The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Per 21 CFR 801.109)
| Nancyc Brogdon | ||
|---|---|---|
| (Division Sign-Off) | (Optional Format 1-2-96) | |
| Division of Reproductive, Abdominal, and Radiological Devices | 4043134 |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).