The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.

The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.

The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

Device Description

The Arthrex OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Arthrex OrthoVis Preoperative Plan, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes a "Non-Clinical Testing" section that outlines the studies performed to demonstrate substantial equivalency to a predicate device. The primary performance metric mentioned is related to central guide pin placement accuracy as improved by the preoperative plan.

Given the information, we can infer the acceptance criteria and reported performance qualitatively from the "Inter and Intra User Surgical Planning Comparison Study". The goal of this study would be to show that the Arthrex OrthoVis Preoperative Plan, with the new Arthrex implants, provides comparable or improved accuracy in planning features (like the central glenoid guide pin) compared to the predicate device with its original implants.

Inferred Acceptance Criteria Table:

Acceptance Criteria Category	Specific Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Software Functionality	The OrthoVis software, with the integration of Arthrex implants, functions reliably and as intended, producing accurate preoperative plan documents.	"Software verification and validation" was performed, indicating the software meets its functional specifications and presumably operates without critical errors. The creation of a .pdf document with text, images, and a rotatable 3D model, as described, implies successful functionality.
Planning Accuracy	The Arthrex OrthoVis Preoperative Plan facilitates comparable or improved central glenoid guide pin placement accuracy compared to the predicate device.	An "Inter and Intra User Surgical Planning Comparison Study" was conducted. While no numerical results are provided in this summary, the assertion of substantial equivalence based on this testing implies that the study demonstrated satisfactory accuracy. The document states both the subject and predicate devices "aim to improve central guide pin placement accuracy," suggesting the subject device achieved this aim.
User Consistency	Preoperative plans generated by different users (inter-user) and by the same user multiple times (intra-user) are consistent.	An "Inter and Intra User Surgical Planning Comparison Study" was performed. The execution of this study suggests that consistency in planning across different users and within the same user was evaluated and found to be acceptable for substantial equivalence.

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 specified in the provided document. The "Inter and Intra User Surgical Planning Comparison Study" is mentioned, but details on the number of cases or users included are absent.
Data Provenance: Not specified. There is no information regarding the country of origin of the CT scans or whether the data was retrospective or prospective.

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 how ground truth was established, nor does it specify the number or qualifications of experts for the test set. The study type ("Inter and Intra User Surgical Planning Comparison Study") suggests that potentially human planners (surgeons or trained personnel) were involved in generating plans, which were then compared, but it does not clarify if these plans themselves served as a ground truth or if an independent "true" surgical plan was used for comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The adjudication method is not specified.

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

The document mentions an "Inter and Intra User Surgical Planning Comparison Study." This study design often involves multiple users (readers/planners) creating plans for multiple cases, which aligns with the "multi-reader multi-case" concept. However, it's not strictly an AI-assistance study in the sense of comparing human performance with and without an AI diagnosis/recommendation. Instead, the device is a planning tool that facilitates planning.
The study's goal was to demonstrate substantial equivalence to a predicate device. It's likely comparing the planning outcome (e.g., pin placement accuracy) when using the OrthoVis software with the new Arthrex implants versus potentially the predicate device's software with its specific implants, or against a manual planning method.
Effect Size: The document does not provide any effect size or numerical improvement metrics for human readers using the device. It only states that the testing was performed to demonstrate substantial equivalency.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study is not described. The device is explicitly a "preoperative plan created via the OrthoVis software" that "facilitates accurate preoperative planning and intraoperative placement." This implies a human-in-the-loop process where the software is a tool for a planner/surgeon. The "Inter and Intra User Surgical Planning Comparison Study" further supports this by involving human users.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The type of ground truth is not explicitly stated. For a planning tool, ground truth would ideally be the "optimal" or "correct" surgical plan/placement. This could be established by:
- Expert Consensus: Multiple highly experienced surgeons or planners agreeing on an optimal plan.
- Pathology/Intraoperative Images: Post-operative imaging or intraoperative photos confirming the actual placement of components (though this is more for verification than establishment of the preoperative ground truth).
- Biomechanical Simulation: Computational models determining ideal placement based on patient-specific anatomy and biomechanics.
Given the nature of the device, it's most probable that an expert consensus or a gold-standard manual planning method was used as a reference for comparison, but the document does not confirm this.

8. The sample size for the training set

The document does not refer to a training set. This product is described as software that uses patient CT scans to create a preoperative plan. While the software itself would have been developed and "trained" in a broader sense (e.g., development of segmentation algorithms), this 510(k) summary focuses on the validation of the software's output for a specific clinical application (new implants). There is no mention of machine learning or deep learning models that require a distinct "training set" in the context of this regulatory submission. "Software verification and validation" generally refers to traditional software engineering testing.

9. How the ground truth for the training set was established

As no training set is mentioned in the context of this regulatory submission, there is no information on how its ground truth would have been established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2015

Custom Orthopaedic Solutions, Inc. % Mr. Peter O'Neill President 10000 Cedar Avenue CLEVELAND OH 44106

Re: K151568

Trade/Device Name: Arthrex OrthoVis Preoperative Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2015 Received: July 8, 2015

Dear Mr. O'Neill:

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 device-related adverse events) (21 CFR 803); 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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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/Resourcesfor You/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 yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K151568

Device Name Arthrex OrthoVis Preoperative Plan

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X 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.A subsidiary of Cleveland Clinic10000 Cedar AvenueCleveland, Ohio 44106
CONTACT PERSON:	Peter O'NeillPresident10000 Cedar AveCleveland, OH 44106Tele: (216) 406-6149Email: poneill@customorthopaedics.com
DATE PREPARED:	1-June-2015

TRADE NAME: Arthrex OrthoVis Preoperative Plan

COMMON NAMES:

Preoperative Planning tool

Product	Product Code	Regulation andClassificationName	Device Class
Arthrex OrthoVisPreoperative Plan	LLZ	21 CFR 892.2050Picture Archiving&CommunicationsSystem	II

PREDICATE DEVICES:

Custom Orthopaedic Solutions OrthoVis Preoperative Plan (K133367)

DEVICE DESCRIPTION:

This 510(k) submission is identical to the OrthoVis Preoperative Plan (K133367) submission and clearance with the exception of the following modifications:

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-The intended use of the OrthoVis Preoperative Plan for the K133367 clearance was for the Depuy family of glenoid components (Global APG, Global StepTech, and Delta Xtend). These components have now been replaced in the OrthoVis software with the Arthrex family of glenoid components which include:
- O Univers™ II and Univers™ Apex Keeled Glenoid.
- o Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.

Ortho Vis can produce a preoperative plan document (.pdf file) that contains text, images. and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan is provided to the ordering surgeon.

INTENDED USE AND INDICATIONS:

The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Arthrex OrthoVis Preoperative Plan is substantially equivalent to 510(k) K133367 because the indications for use and intended use are identical with the exception of replacing the Depuy family of glenoid components with the Arthrex family of glenoid components in the OrthoVis software. Both the Depuy and Arthrex shoulder implant systems use a central guide pin to guide the subsequent preparation of the glenoid surface prior to implant placement. Both the subject device and predicate device aim to improve central guide pin placement accuracy by providing a surgeon with a preoperative plan in the form of a PDF document.

Non-Clinical Testing

The following testing was performed to demonstrate substantial equivalency of the Arthrex OrthoVis Preoperative Plan to the predicate device.

. Software verification and validation
Inter and Intra User Surgical Planning Comparison Study .

Regulation Number and Section

§ 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).