(168 days)
No
The description mentions "IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing." While this involves analysis of anatomical data, the summary explicitly states that "the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates." This indicates a pre-processing step for design, not a dynamic AI/ML algorithm used during clinical application or for patient-specific decisions. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is clearly indicated for the treatment of fractures and non-unions, which falls under the definition of therapy.
No
This device is a plating system used for the surgical fixation of fractures and non-unions, not for diagnosing conditions.
No
The device is a plating system comprised of physical plates and screws, which are hardware components. While software (IntelliFIT Technology) was used in the design process, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a plating system comprised of plates and screws, which are implanted into the body to stabilize bone. This is a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Comprehensive® Proximal Humeral Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus.
Product codes
HRS, HWC
Device Description
The Comprehensive® Proximal Humeral Plating System is comprised of anatomic plates in seven lengths and non-locking, locking and variable angle screws in multiple lengths. Plate sizing and contouring was developed through the use of Biomet's IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance Test Summary-New Device:
Characteristic: Plate Strength
Standard/Test/FDA Guidance: Engineering Analysis
Results Summary: Equivalent to predicate
Comparative Performance Information Summary:
Characteristic: Plate Strength
Requirement: Meet or exceed predicate
New Device: Meet
Predicate Device: K062494
No mechanical or clinical testing was necessary for a determination of substantial equivalence. The results of engineering analysis indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
Magnetic Resonance (MR) Environment:
Biomet® has performed non-clinical Magnetic Resonance Imaging (MRI) studies on Plating Systems manufactured of 316L Stainless Steel per ASTM F138. These Plating Systems are determined to be MR Conditional in accordance to ASTM F2503-08 Standard Practice for Marking Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Conditional refers to an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.
Key Metrics
Not Found
Predicate Device(s)
K062494 - EBI OptiLock® Upper Extremity Plating System, K082625 - Synthes (USA) 3.5mm LCP Periarticular Proximal Humeral Plates
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0