(89 days)
The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
The provided document is a 510(k) summary for the ArthrexVIP Web Portal, which is a software device intended for use in preoperative planning for shoulder joint replacement. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.
Here's an attempt to answer the questions based on the limited information available in the document, along with an explanation of why certain information cannot be provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics tied to such criteria. The submission focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing, rather than establishing performance against defined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a test set sample size or data provenance for any clinical performance evaluation. The non-clinical testing performed includes "Software verification and validation," "Regression Testing," "Unit Testing," "Code reviews and checks," and "Integration Testing." These are software development and quality assurance activities, not studies involving human subjects or medical image data in a clinical context.
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)
No information is provided regarding experts, ground truth establishment, or clinical test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding adjudication methods, as no clinical test set 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 study was mentioned or performed. The device is a "software interface" for displaying/editing implant placement and surgical treatment options, not an AI-assisted diagnostic tool that would typically involve improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information is provided about a standalone algorithm performance study. The device is described as a "software interface" and a tool for displaying/editing options generated by "trained COS technicians" and reviewed by "surgeon users," indicating a human-in-the-loop design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of a "ground truth" in a clinical sense for performance evaluation. The testing performed ("Software verification and validation," etc.) would involve internal quality metrics and ensuring the software functions as designed, rather than comparison to a clinical ground truth.
8. The sample size for the training set
No training set is mentioned. This device is not described as an AI/ML algorithm that learns from data in a training set. It is a software interface and planning tool.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm is described.
Summary of what can be extracted from the document regarding acceptance criteria and studies:
The document states:
- Non-Clinical Testing: "The following testing was performed to demonstrate substantial equivalency of the ArthrexVIP Web Portal to the OrthoVis Web Portal: Software verification and validation, Regression Testing, Unit Testing, Code reviews and checks, Integration Testing, Dimensional Validation (performed on predicate device and code has not changed for the subject device)."
- Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between to the predicate."
This 510(k) submission relies on non-clinical software validation and verification activities to establish substantial equivalence to a predicate device, rather than explicit clinical performance criteria with associated studies involving patient data or experts. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and human reader performance is not present in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Custom Orthopaedic Solutions, Incorporated Mr. Keith Grafmever Project Manager 10000 Cedar Avenue Cleveland, Ohio 44106
Re: K153612
Trade/Device Name: ArthrexVIP Web Portal Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, KWS, PHX Dated: December 7, 2015 Received: December 17, 2015
Dear Mr. Grafmeyer:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
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" (21CFR 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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) NA K153612
Device Name ArthrexVIP Web Portal
Indications for Use (Describe)
The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
| 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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510(k) Summary
| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc.10000 Cedar AvenueCleveland, Ohio 44106 |
|---|---|
| CONTACT PERSON: | Keith GrafmeyerProject ManagerCustom Orthopaedic Solutions10000 Cedar Ave.Cleveland, OH 44106Tele: (216) 445 -3403Email: kgrafmeyer@customorthopaedics.com |
| TRADE NAME: | ArthrexVIP Web Portal |
| DATE PREPARED: | 07-Dec-2015 |
| COMMON NAMES: | Image processing system and preoperative software forsimulating / evaluating implant placement and surgicaltreatment options |
| Product | Product Code | Regulation andClassification Name | DeviceClass |
|---|---|---|---|
| ArthrexVIP Web Portal | LLZ | 21 CFR 892.2050Picture Archiving andCommunications System | II |
| ArthrexVIP Web Portal | KWS | 21 CFR 888.3660Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerCemented | II |
| ArthrexVIP Web Portal | PHX | 21 CFR 888.3660Shoulder Prosthesis, ReverseConfiguration | II |
Predicate Devices:
K151501: OrthoVis Web Portal K151568: Arthrex OrthoVis Preoperative Plan K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
Device Description:
The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical
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images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
Intended Use and Indications:
The ArthrexVIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
Basis of Substantial Equivalence:
The ArthrexVIP Web Portal has the same intended use and indications for use as the OrthoVis Web Portal (K151501), with the exception of ArthrexVIP being indicated for use solely with the Arthrex line of shoulder arthroplasty implants.
The subject device is a version of the predicate device with changes to the following:
- Measurement Features
- Viewer Controls
- Implant Controls and Options
- Organization of information
- User Interface (UI)
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the ArthrexVIP Web Portal to the OrthoVis Web Portal:
- Software verification and validation
- Regression Testing
- Unit Testing
- Code reviews and checks
- Integration Testing
- Dimensional Validation (performed on predicate device and code has not changed for the subject device)
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between to the predicate.
§ 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).