(49 days)
Not Found
No
The description focuses on software tools for segmentation and virtual implantation based on CT scans, without mentioning AI or ML algorithms for these processes. The performance study is a bench test, not a validation of an AI/ML model.
No.
The OrthoVis Preoperative Plan is a software-generated document used for surgical planning and visualization of implant placement, not for directly treating a disease or condition. It facilitates the surgical procedure but does not perform a therapeutic function itself.
No
The device is described as a "preoperative plan document" generated by software that facilitates accurate preoperative planning and intraoperative placement of components. It does not diagnose a condition.
Yes
The device is described as "OrthoVis software" that processes CT scans to create a "preoperative plan document". While this plan is used in conjunction with physical implants, the device itself is the software and the resulting digital document. There is no mention of hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create a preoperative plan document to facilitate accurate placement of shoulder replacement components during surgery. This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Device Description: The device processes patient CT scans to create a virtual model and a plan document. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Input: The input is a patient CT scan, which is an imaging modality, not a biological sample.
- Output: The output is a preoperative plan document, not a diagnostic result or measurement from a biological sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description. It is a surgical planning software and associated output document.
N/A
Intended Use / Indications for Use
The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components.
The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) K123122.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into 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. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, 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 provided to the ordering surgeon.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient CT scan, MRI imaging data
Anatomical Site
glenoid, shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ordering surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed to demonstrate substantial equivalency of the OrthoVis Preoperative Plan to the predicate devices.
- Software verification and validation
- Dimensional validation
- Sawbones study
The software verification and validation studies were performed to show that bones segmented in the OrthoVis software were segmented accurate to their actual size.
The dimensional validation performed on the software showed that known lengths of actual CT scanned objects could be accurately measured and portrayed within the OrthoVis software.
The Sawbones study was a bench testing study of simulated use of the OrthoVis Software & Preoperative Plan as well as of the full Glenoid IRIS system. Three different surgeons performed the study on two instances each of 9 different pathologies (ranging from mild deformity to severe). Results of the study showed that the OrthoVis Preoperative Plan improved accuracy of guide pin placement in version by 4.5° (±1° s.d.)(p
§ 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).
0
KB3367
510(k) Summary
DEC 2 0 2013
| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc. |
|---|---|
| A subsidiary of Cleveland Clinic | |
| 10000 Cedar Avenue | |
| Cleveland, Ohio 44106 | |
| CONTACT PERSON: | Justin Baker, PhD |
| Regulatory & Quality Manager | |
| 10000 Cedar Ave | |
| Cleveland, OH 44106 | |
| Tele: (216) 445 - 2164 | |
| Fax: (216) 445-6514 | |
| Email: jbaker@customorthopaedics.com | |
| DATE PREPARED: | 16-September-2013 |
| TRADE NAME: | OrthoVis Preoperative Plan |
| Product | Product Code | Regulation and
Classification Name | Device Class |
|-------------------------------|--------------|--------------------------------------------------------------------|--------------|
| OrthoVis Preoperative
Plan | LLZ | 21 CFR 892.2050
Picture Archiving &
Communications
System | II |
Preoperative Planning tool
PREDICATE DEVICES:
COMMON NAMES:
Custom Orthopaedic Solutions Glenoid IRIS (K123122) Materialise N.V. SurgiCase (K073449)
DEVICE DESCRIPTION:
The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into 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. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, 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 provided to the ordering surgeon.
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INTENDED USE AND INDICATIONS:
The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Preoperative Plan is indicated for use with the DePuy Global AP " Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta Xtend'™ Reverse Shoulder metaglene components.
The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) K123122.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The OrthoVis Preoperative Plan is substantially equivalent to the Glenoid IRIS and Materialise SurgiCase system in function, intended use, input, and sterility. The OrthoVis Preoperative plan is substantially equivalent in function for in that the subject and predicate devices are based off patient specific CT image data that allows segmentation of desired bony anatomy. In all of the systems the purpose of the subject and predicate devices is to provide a preoperative plan to influence surgical planning and accuracy. The Materialise SurgiCase system is also able to use MRI imaging data; however, we do not believe this difference impacts the substantial equivalence of the OrthoVis Software & OrthoVis Preoperative Plan to the Materialise SurgiCase system. The subject device in this 510(k) is also substantially equivalent to the Glenoid IRIS predicate device because the OrthoVis Software & OrthoVis Preoperative plan is used with the same DePuy implant systems as the Glenoid IRIS system. The Materialise SurgiCase system allows .stl files (cutting guides, etc.) to be loaded into the preoperative planning environment and the location of the loaded geometry is able to be evaluated for preoperative planning purposes. In this case, both the subject and predicate devices allow preoperative evaluation of implant (model .stl files) size and placement as well as improved visualization of the segmented bones that would otherwise be obscured by surgical exposure constraints. The OrthoVis Preoperative Plan is substantially equivalent to the Glenoid IRIS in that both are used to preoperatively plan the location of the 2.5 mm guide pin for glenoid implant preparation. Finally, the subject and predicate devices are substantially equivalent because in all three systems the surgeon is required to approve the final preoperative plan.
The OrthoVis Preoperative Plan is substantially equivalent to the Glenoid IRIS system and Materialise SurgiCase system in its intended use. The intended use of the OrthoVis Software & OrthoVis Preoperative Plan is identical to that of the Glenoid IRIS system and differs only in that the Glenoid IRIS system contains other components (rapid prototyped bone models and a separate instrument). The intended use of the OrthoVis Preoperative Plan and the Materialise SurgiCase system is similar in that both are intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner and that both are intended to be used as preoperative planning software for simulating/evaluating implant placement and surgical treatment options. There are minor differences between the Materialise SurgiCase system and the OrthoVis Preoperative plan, one being that Materialise SurgiCase may use MRI data. Lastly, the OrthoVis Preoperative Plan is more specific than the Materialise SurgiCase system as it uses the actual implant files for three DePuy shoulder replacement systems and the SurgiCase system is not limited to just the shoulder or to specific implant systems. We believe that just because the OrthoVis Preoperative Plan is more focused on a specific joint and implant systems does not alter its substantial equivalence to the predicate devices.
The OrthoVis Preoperative Plan is substantially equivalent to the predicate devices because it shares the same input modality as the predicate devices. Both the subject and predicate devices use patient CT images as input. All of the systems use the CT images to create a virtual model of the segmented, desired bony anatorny. Both the OrthoVis Preoperative Plan and the Glenoid IRIS system generate a 3D virtual model in the OrthoVis software and capture images that the surgeon may use for visual reference in preoperative planning and carrying out the planned surgery. Both the subject device and predicate
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devices must have the preoperative plans reviewed and approved by the ordering surgeon prior to delivery of the final device product. The differences between the subject and predicate systems are minor. First, the SurgiCase system is able to use CT images, 2D radiographs, as well as MRI. Second, the Glenoid IRIS system and Materialise SurgiCase system use the preoperative plan and images to create instruments (bone models or patient specific cutting guides) that aid in carrying out the plan. In this case, the OrthoVis Preoperative Plan does not go beyond creating visual reference images for carrying out the plan; however, we feel that these differences are outweighed by the substantial similarities between the systems and thus do not make the OrthoVis Preoperative Plan not substantially equivalent.
Finally, the OrthoVis Preoperative Plan is substantially equivalent to the predicate devices because in all systems the preoperative plan or software for creating the preoperative plan is provided non-sterile. While in the Glenoid IRIS system there are extra components that are provided sterile, the OrthoVis Preoperative Plan as a stand-alone product does not make use of these extra components.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the OrthoVis Preoperative Plan to the predicate devices.
- . Software verification and validation
- . Dimensional validation
- Sawbones study
The software verification and validation studies were performed to show that bones segmented in the OrthoVis software were segmented accurate to their actual size. Furthermore, the OrthoVis Software for producing the OrthoVis Preoperative Plan was verified and validated for quality purposes according to the guidance on Software in Medical Devices. In this case, the OrthoVis Preoperative Plan software is substantially equivalent to the predicate devices in that all the systems were required to undergo similar software verification and validation activities to ensure accuracy and quality in the products intended use and function.
The dimensional validation performed on the software showed that known lengths of actual CT scanned objects could be accurately measured and portrayed within the OrthoVis software.
The Sawbones study was a bench testing study of simulated use of the OrthoVis Software & Preoperative Plan as well as of the full Glenoid IRIS system. While the full Glenoid IRIS system is not pertinent to this 510(k), an intermediate aspect of this study evaluated the effect of the OrthoVis Preoperative Plan as a stand-alone tool in helping various surgeons to accurately achieve a preoperatively planned implant location in mock total shoulder arthroplasty procedures. Three different surgeons performed the study on two instances each of 9 different pathologies (ranging from mild deformity to severe). Results of the study showed that the OrthoVis Preoperative Plan improved accuracy of guide pin placement in version by 4.5° (±1° s.d.)(p KI33367 510(k)
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