(22 days)
The Preview® Treatment Planning Software is intended to provide accurate, alternative two-dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® product offers the physician the capability to view existing scan data in a format that is more user friendly, and thus enhances the physician's capability to plan treatment. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.
The Preview® Treatment Planning Software is intended to provide accurate, alternative two-dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® product offers the physician the capability to view existing scan data in a format that is more user friendly, and thus enhances the physician's capability to plan treatment. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.
This Premarket Notification (510(k)) for the Preview® Treatment Planning Software describes the device and claims substantial equivalence to a predicate device, the Preview™ Surgery Planning Software. It does not contain a study demonstrating that the device meets acceptance criteria. The document is primarily a comparison against a predicate device to establish substantial equivalence for regulatory approval.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison of features between the new device (Preview® Treatment Planning Software) and its predicate (Preview™ Surgery Planning Software) to show substantial equivalence, rather than a direct table of acceptance criteria and performance against those criteria. The implicit acceptance criteria are that the new device performs at least as well as, or offers additional features beyond, the predicate device.
| Feature | Predicate Device Performance (Original MMS Preview™ Surgery Planning Software) | New Device Performance (Modified MMS Preview® Treatment Planning Software) |
|---|---|---|
| Imaging technique | SSD | SSD |
| Reformatted 2D images from 2D axial images | Yes | Yes |
| Sequential viewing of 2D images | Yes | Yes |
| Random viewing of 2D slices | Yes | Yes |
| Rendered 3D model | Yes | Yes |
| Multi-color objects in model | Yes | Yes |
| 2D measurements | Yes | Yes |
| 3D measurements | Yes, same | Yes, generated from 2D images. |
| Interactive 3D model | Yes | Yes |
| Rotate model | Yes | Yes |
| Add 2D image to 3D model | Yes | Yes |
| Control transparency of objects in model | Yes | Yes |
| User placed markers in model | Yes. Same | Yes. Marks placed in 2D images appear in 3D model. |
| Color display, 256 colors from 16.7 million Color | Yes | Yes |
| Accept input data from multiple formats (e.g., CT, MRI) | Yes | Yes |
| Accept input data from multiple vendors | Yes | Yes |
| Create & save surgical plans | Yes | Yes |
| Supports mouse & keyboard interface | Yes | Yes |
| Operating platform | Modeling done on Linux platform. Viewing only on Windows OS. | Modeling done at MMS on UNIX. Viewing software run on Macintosh OS or DOS/Windows. |
| Capability to link to hospital computer network | Yes | Yes |
| MSVG feature | No | Yes |
| 'Click-Drag' feature | No | Yes |
| Standardized Mark and Calculation types | No | Yes |
| Centerline Tensioning/morphing | No | Yes |
Study Proving Device Meets Acceptance Criteria:
The provided document does not describe a specific study designed to prove the device meets pre-defined acceptance criteria in the manner usually associated with an AI/ML medical device performance study. Instead, it relies on a comparison to a predicate device to establish substantial equivalence. The "study" here is essentially the comparison table provided, demonstrating that the new device possesses capabilities that are either identical to or enhanced compared 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):
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned. The document describes software for viewing existing scan data, implying it could use various clinical image data, but no specific dataset for testing is detailed.
- Retrospective or prospective: Not mentioned.
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):
- Number of experts: Not mentioned.
- Qualifications of experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not mentioned.
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 is not described. The device is a "Treatment Planning Software" intended to provide "accurate, alternative two-dimensional images, as well as three-dimensional models" and enhance the physician's capability to plan treatment, not to provide medical diagnosis. It's a visualization and measurement tool, not an AI diagnostic algorithm that assists human readers in lesion detection or diagnosis.
- Effect size: Not applicable, as no such study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a software tool for physicians to use with existing scan data. Its purpose is to enhance the physician's capability, not to operate as an autonomous diagnostic algorithm. Therefore, a "standalone algorithm-only" performance study in the sense of an AI diagnostic tool is not applicable and not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given the nature of the device as a visualization and measurement tool, the "ground truth" for its accuracy would likely relate to the fidelity of its reformatted images, 3D models, and measurements compared to the input 2D scan data and established anatomical references. However, the specific method for establishing this ground truth is not described in the document.
8. The sample size for the training set:
- Sample size for training set: Not mentioned. This document describes a software product, not necessarily an AI/ML algorithm that requires a "training set" in the conventional sense. While it processes existing scan data, the text does not indicate that it uses machine learning trained on a dataset.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable/Not mentioned, as a training set and its associated ground truth are not described for this software product.
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| APR 2 3 2004 | Preview® Treatment Planning SoftwareSummary of Safety and Effectiveness |
|---|---|
| Submitter Name: | Medical Media Systems, IncK040852 |
| Submitter Address: | 12 Commerce AvenueWest Lebanon, NH 03784 |
| Contact Person: | William F. GreenroseSenior Vice President |
| Phone Number:Fax Number: | 603-298-5509 x 303603-298-5055 |
| Date Prepared: | April 1, 2004 |
| Device Trade Name: | Preview® Treatment Planning Software |
| Classification Name,Number & Pro Code: | System, Image Processing, Radiological (21 CFR 892.2050; LLZ) |
| Predicate Device: | Preview™ Surgery Planning Software, by Medical Media Systems, Inc. |
| Device Descriptionand Statement ofIntended Use | The Preview® Treatment Planning Software is intended to provideaccurate, alternative two-dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® productoffers the physician the capability to view existing scan data in a formatthat is more user friendly, and thus enhances the physician's capabilityto plan treatment. The Preview® product is not intended to providemedical diagnosis or a recommended treatment approach. |
| Summary ofTechnologicalCharacteristics | A table comparing the Preview® Treatment Planning Software to theoriginal Preview™ predicate device is attached. |
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| K040852Substantial Equivalence Comparison | ||
|---|---|---|
| Viewing Software | Modified MMS Preview®Treatment PlanningSoftware | Original MMSPreview™ SurgeryPlanning Software(K# 953616) |
| Imaging technique | SSD | SSD |
| Reformatted 2D images from 2D axialimages | Yes | Yes |
| Sequential viewing of 2D images | Yes | Yes |
| Random viewing of 2D slices | Yes | Yes |
| Rendered 3D model | Yes | Yes |
| Multi-color objects in model | Yes | Yes |
| 2D measurements | Yes | Yes |
| 3D measurements | Yes, generated from 2Dimages. | Yes, same |
| Interactive 3D model | Yes | Yes |
| Rotate model | Yes | Yes |
| Add 2D image to 3D model | Yes | Yes |
| Control transparency of objects in model | Yes | Yes |
| User placed markers in model | Yes. Marks placed in 2Dimages appear in 3Dmodel. | Yes. Same |
| Color display, 256 colors from 16.7 millionColor | Yes | Yes |
| Accept input data from multiple formats(e.g., CT, MRI) | Yes | Yes |
| Accept input data from multiple vendors | Yes | Yes |
| Create & save surgical plans | Yes | Yes |
| Supports mouse & keyboard interface | Yes | Yes |
| Operating platform | Modeling done at MMS onUNIX. Viewing softwarerun on Macintosh OS orDOS/Windows. | Modeling done onLinux platform.Viewing only onWindows OS. |
| Capability to link to hospital computernetwork | Yes | Yes |
| MSVG feature | Yes | No |
| 'Click-Drag' feature | Yes | No |
| Standardized Mark and Calculation types | Yes | No |
| Centerline Tensioning/morphing | Yes | No |
2D = 2-Dimensional; 3D = 3-Dimensional; SSD = Surface shaded display; MSVG = Manufacturer Specific Virtual Graft
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2004
Medical Media Systems, Inc. % Ms. Patsy J. Trisler, J.D., RAC Regulatory Consultant 5610 Wisconsin Avenue, #304 CHEVY CHASE MD 20815
Re: K040852
Trade/Device Name: Preview® Treatment Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communication system Regulatory Class: II Product Code: 90 LLZ Dated: March 30, 2004 Received: April 1, 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 I ou may, there controls 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 (PMA), 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 r roas be a nood was a determination that your device complies with other requirements of the Act many liederal 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) This letter will allow you to begit marketing your device of your device of your device to a legally
premarket notification. The FDA in a leasifies for your device and thus premarket notification. The FDA inding of substantial of 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 If you desire specific advice for your device on our laboling organized on the regulation number at the top of the letter.
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note of tags of the general Office of Compliance at (301) 394-4037. Also, production of obtain. Other general
by reference to premarket notification" (21 CER Part 807.97) you may obtain of Sma by reference to premarket notification (21C. I i in 0017779 your de mail.
information on your responsibilities under the Act may be obtained from the Uiving (800) 638-2041 information on your responsibilities under Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free increasing Manufacturers, International and Colisumer / Esistance a creative and contributional dismamain.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
Page 2
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Indications for Use Statement
510(k) Number (if known):
Ko40852
Device Name:
Preview® Treatment Planning Software
Indications for Use:
The Preview® Treatment Planning Software is intended to provide accurate, The Freviews Treatment Flanning on well as three-dimensional models, of allemative two-dimensional images, as wo-dimensional scan data of organs and patient Specific anatomy from oxisting the and offers the capability to view existing tissues. The i reviews prosunor prosunore user friendly, and thus enhances the SCan data in a formia that is more nent. The Preview® 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) Over-The-Counter OR X Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number _
§ 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).