(332 days)
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.
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.
This premarket notification describes a software device (ORTHODOC Model 500 Preoperative Planning Software) and does not provide an acceptance criterion or a study proving that the device meets an acceptance criterion. The document explicitly states:
"There has been no pre-clinical or clinical performance data Performance data: generated upon which to make a decision of substantial equivalence."
Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.
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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.
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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.
§ 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.