(332 days)
Not Applicable
Not Found
No
The description focuses on standard image overlay and measurement tools using pre-defined implant patterns, with no mention of AI/ML terms or capabilities like automated analysis, prediction, or learning from data.
No.
The device is a software for preoperative planning of total hip arthroplasties, aiding in the selection and positioning of femoral components, rather than directly treating a disease or condition.
No
Explanation: The device is a preoperative planning software that uses CT data to help surgeons select and position femoral components for total hip arthroplasties. It aids in surgical planning rather than diagnosing a disease or condition.
Yes
The device description explicitly states, "The device is a software-only product".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ORTHODOC Preoperative Planner is a software device that uses computed tomography (CT) data (imaging data) to aid surgeons in planning hip replacement surgery. It overlays implant patterns onto the CT image to help with selection and positioning.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its input is imaging data, not biological specimens.
Therefore, because the device does not perform tests on samples taken from the human body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.
Product codes
Not Found
Device Description
This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal.
The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography data, CT image
Anatomical Site
femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
There has been no pre-clinical or clinical performance data generated upon which to make a decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
All femoral component templates supplied by femoral component manufacturers. For example, Depuy AML templates and Howmedica Osteolock HA templates.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4800 Template for clinical use.
(a)
Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Premarket Notification
Submitter:
JAN 17
Integrated Surgical Systems, Inc.
510(k) Summary
9601685
Integrated Surgical Systems, Inc. 829 W. Stadium Lane Sacramento, CA 95834 (916) 646-3487
Templating System
ORTHODOCR Model 500 Preoperative Planning Software Trade name:
Common name:
Classification name:
Indications for use:
Legally marketed predicate:
Device description:
Template for clinical use (21 CFR 888.4800) The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.
All femoral component templates supplied by femoral component manufacturers. For example, Depuy AML templates and Howmedica Osteolock HA templates.
This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal.
The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.
12
1
The implant patterns of the predicates are scaled computer-Technological charactistics: generated images that are plotted, photographed, and contact printed to maintain accurate scale. These are held over the xray and moved by hand to position them to assist the surgeon in planning the stem's placement.
The ORTHODOC software contains a library of computergenerated femoral component images which can be called-up and superimposed over a CT image of the patients femur. The images are moved by hand, employing a mouse pointer, to position them to assist the surgcon in planning the stem's placement.
There has been no pre-clinical or clinical performance data Performance data: generated upon which to make a decision of substantial equivalence.