(269 days)
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image. Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
This FDA 510(k) summary for the OSKO Smart Stitching Software System provides limited details about specific acceptance criteria and the study that rigorously proves the device meets those criteria with statistical significance. However, based on the provided text, here's an attempt to extract and infer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against those criteria. It refers to "predetermined acceptance criteria" and successful completion of "in house testing criteria." The primary function described is "auto stitching," so the implicit criterion would be the accurate and functional joining of images.
| Acceptance Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|
| Software functions as intended for stitching multiple medical images | "the software functions as intended" |
| All input functions operate correctly | "passed all in house testing criteria" |
| All output functions operate correctly | "passed all in house testing criteria" |
| All actions performed by the software are correct | "passed all in house testing criteria" |
| Imaging stitching process is documented and correct | "imaging stitching process are documented in the software validation report" |
| Risk analysis verified | "verified and validated the risk analysis" |
| Individual performance results were within predetermined acceptance criteria | "individual performance results were within the predetermined acceptance criteria" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "software validation testing," but no specific number of images or cases used in this testing is provided.
- Data Provenance: Not explicitly stated. Given it's "in house testing criteria" and no clinical testing was performed, the data could be internal test data, possibly simulated or representative images. There is no mention of country of origin, retrospective, or prospective data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Ground Truth Establishment: The document refers to "in house testing criteria" and "predetermined acceptance criteria," suggesting that acceptance was determined by the manufacturer's internal quality and testing procedures, rather than an independent expert panel establishing a separate ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. There is no mention of a formal adjudication process involving multiple reviewers for establishing ground truth, as no clinical testing or reader study is described. The acceptance seems to be based on internal software validation against pre-defined engineering and functional specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly not done. The document states: "No clinical testing is performed."
- Effect Size: Not applicable, as no MRMC study was conducted. Thus, there is no effect size reported for human readers improving with AI assistance.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The "software validation testing" and "auto stitching function and SW compatibility test" described are standalone tests of the algorithm's functionality and performance against its intended design. These tests were conducted without human-in-the-loop performance evaluation in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the device's functionality appears to be based on:
- Engineering Specifications/Design Intent: The software's ability to "allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review."
- Internal Validation Standards: "all in house testing criteria" and "predetermined acceptance criteria."
- Functional Correctness: Verification that the "software functions as intended" and performs its defined input/output operations.
It is not based on expert consensus, pathology, or outcomes data, as no clinical testing was performed.
8. Sample Size for the Training Set
Not mentioned. The document focuses on validation/testing rather than the development or training process of any machine learning components (although it's referred to as "Smart Stitching Software System, Image Processing," implying some algorithmic intelligence, details of its training are absent).
9. How the Ground Truth for the Training Set Was Established
Not mentioned, as details about a training set are not provided.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three parallel lines forming a wing-like shape above a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2017
OSKO, Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K163048
Trade/Device Name: Smart Stitching Software System, Image Processing, Radiological Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2017 Received: July 26, 2017
Dear Mr. Kim:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K163048
Device Name Smart Stitching Software System, Image Processing, Radiological
Indications for Use (Describe)
Smart Stitching software is indicated for use to allow postioning and joining of individual images to produce an additional composite image for two dimensional image review.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a wave or a sine wave. The graphic is composed of two curved lines that intersect in the middle, creating a symmetrical shape. The colors of the graphic are light blue and dark blue.
510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: June 22, 2017
I. SUBMITTER
| Submitter's Name | OSKO, Inc. |
|---|---|
| Submitter's Address | 8085 NW 90TH ST, Medley, Florida 33166, USA |
| Submitter's Telephone | + 1 305-599-7161 |
| Contact person | Name: Thomas KimPosition: Vice PresidentE-mail: thomas@medisoneconet.com |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
| Trade/proprietary Name | Smart Stitching software |
|---|---|
| Common or Usual Name | System, Image Processing, Radiological |
| Regulation Name | Picture archiving and communications system |
| Regulation Number | 21 CFR 892.2050 (Product Code:LLZ) |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| Primary Manufacturer | Cedara Software Corporation |
|---|---|
| Device Name | Cedara I-Soft View |
| 510(k) Number | K022881 |
| Regulation Name | Picture archiving and communications system |
| Regulation Number | 21 CFR 892.2050 (Product Code:LLZ) |
| Regulatory Class | Class II |
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Image /page/4/Picture/0 description: The image contains the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a butterfly or a stylized plus sign, with the top and bottom portions in a darker blue and the left and right portions in a lighter blue.
IV. REFERENCE DEVICE
Primary Manufacturer Device Name
Carestream Health Inc DR Long Length Imaging Software
510(k) Number K130567 Regulation Name Regulation Number Regulatory Class Class II
Solid Stat X-ray Imager 21 CFR 892.1650 (Product Code:MQB)
V. DEVICE DESCRIPTION
Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image.
Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
VI. INDICATIONS FOR USE:
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
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Image /page/5/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a butterfly or a stylized "X". The graphic is composed of two curved shapes, one in a darker shade of blue and the other in a lighter shade of blue, creating a sense of depth and movement.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
| Feature | New DeviceSmart StitchingK163048 | Reference DeviceDR Long LengthImaging SoftwareK130567 | Predicate DeviceCeara I-SoftViewK022881 |
|---|---|---|---|
| Manufacturer | OSKO, Inc. | Carestream HealthInc. | Cedara Software |
| Intended Use | Smart Stitchingsoftware is indicatedfor use to allow post-capture positioningand joining ofindividual images toproduce an additionalcomposite image fortwo dimensionalimage review. | The software intendeduse is to allow post-capture positioningand joining ofindividual images toproduce an additionalcomposite image. Thesoftware is sold onlyfor use on CarestreamHealth Systemsolutions and isavailable as anintegrated featurewithin the DirectViewsoftware | "Two and three dimensionalimage review, manipulation,analysis and therapy planningcapabilities that supportimage management displayneeds in the medicalenvironment from multiplelocations within and outsidethe hospital""Productivity-EnhancingSecond Console Workstations- Workstations designed toperform automated, routinetasks such as image review,printing and archivingas well as post processingcapabilities that enablespecial services for referringphysicians.""Diagnostic ReviewWorkstations - Workstationsdesigned to assist radiologistsand surgeons in conductingprimary diagnostic reviewand planning throughflexible and interactivemanipulation of multi-modality softcopy images.This includes the use ofprosthetic template overlays""Physician's ReviewWorkstations - Workstationsdesigned to give easy andeconomic access to multi-modality softcopy images inmultiple locations within |
| and outside the hospital. (e.g.teleconferencing,teleradiology etc.)" | |||
| How to storepatient data andiagnosticdocuments | Be comprised of acentral database to storepatient data anddiagnostic documents | Be comprised of acentral database tostore patient data anddiagnostic documents | Be comprised of a centraldatabase to store patient dataand diagnostic documents |
| Type of imageformat | Tiff, Raw, and DICOMfile | DICOM file | DICOM file |
| Ability toprovide themanagement,storage andprocessing anddisplay ofpatient,diagnosticimage data | Provide themanagement, storageand processing anddisplay of patient,diagnostic image data | Provide themanagement, storageand processing anddisplay of patient,diagnostic image data | Provide the management,storage and processing anddisplay of patient, diagnosticimage data |
| Function toenhance imagebrightness,contrast andsharpness | Provide functions toenhance image, zoomin/out, brightness,contrast and sharpness | Provide functions toenhance imagebrightness, contrastand sharpness | Provide functions toenhance image brightness,contrast and sharpness |
| Function tosearch toretrievemedicalrecords linedto a specificpatient | a search function toretrieve medical recordslinked to a specificpatient | a search function toretrieve medicalrecords linked to aspecific patient | a search function to retrievemedical records linked to aspecific patient |
| Function toexport andimport data | Include a function toexport and import data | Include a function toexport and import data | Include a function to exportand import data |
| Function toprint out thestored data | Can produce printoutsof the stored data | Can produce printoutsof the stored data | Can produce printouts of thestored data |
| Function toconnect toLAN and haveDICOMinterface | Can connect to LANand have DICOMinterface (by default oras a separate option) | Can connect to LANand have DICOMinterface (by default oras a separate option) | Can connect to LAN andhave DICOM interface (bydefault or as a separateoption) |
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Image /page/6/Picture/0 description: The image shows the logo for OSKO. The word "OSKO" is written in a bold, dark blue font on the left side of the logo. To the right of the word, there is a stylized graphic that resembles a butterfly or a stylized "X". The graphic is composed of two intersecting shapes, one in a darker shade of blue and the other in a lighter shade of blue.
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Image /page/7/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, dark blue font on the left side. To the right of the word, there is a stylized graphic that resembles two intersecting sine waves or curves, one in a lighter blue and the other in a darker blue. The overall design is clean and modern.
VIII. COMPARISON DISCUSSION
The indications for use statement for the subject device is similar to indications for use of the predicate device based on the description and the proposed labeling contained in this submission. Both the subject and the predicate software aligns captured images to stitch and generate a longlength composite image, while fine adjustments can be made using the manual stitch editor. The differences in the indications for use for the subject and predicate device, such as the image file type, do not affect the intended diagnostic use of the software. Smart Stitching software has the same technological characteristics as the reference device and the predicate device, "DR Long Length Imaging Stitching" and Cedara I-Softview "Accustitch" respectively. These devices allow a composite image to be formed from multiple general radiography images acquired separately. The new software device raises no new issues of safety or effectiveness.
No clinical testing is performed.
The complete system configuration has been assessed and tested by the manufacturer and passed all in house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by Smart Stitching Software. Each operational mode and the imaging stitching process are documented in the software validation report.
The auto stitching function and SW compatibility test have been conducted and the result demonstrated that the software functions as intended. In addition, the software validation testing ,from TS-0001 through TS-0017, verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.
Safety and Performance Data:
- IEC 62304 Medical device software Software life-cycle processes : 2006
- ISO 14971 Medical Devices Application of risk management to medical device : 2007
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Image /page/8/Picture/0 description: The image contains the logo for OSKO. The logo consists of the word "OSKO" in bold, blue letters. To the right of the word is a blue graphic that resembles a sine wave or a stylized butterfly. The graphic is made up of two different shades of blue.
- NEMAPS 3.1-3.20 - Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)
CONCLUSIONS IX.
Based on the information above, it is the sponsor's opinion that Smart Stitching software is substantially equivalent to the predicate software in design and performance. The differences between Smart Stitching software and its predicate do not raise different questions of safety and effectiveness.
§ 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).