(224 days)
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No
The summary describes a mechanical bone plate system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a bone plate system used for fracture fixation, which is a therapeutic intervention.
No
Explanation: The device is a surgical implant (Medoff Sliding Plate System) used for fracture fixation, not for diagnosing medical conditions. Its intended use is described as treating various femur fracture configurations.
No
The device description explicitly lists hardware components such as lag screws, compression screws, locking set screws, and bone plates.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Medoff Sliding Plate System is a surgical implant used for fixing bone fractures in the femur. It consists of plates, screws, and other hardware. This is a device used within the body for structural support and repair, not for analyzing samples outside the body.
The information provided aligns with a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the fracture extends.
Specific indications for the 135 degree 4-hole standard plate design or 6-hole standard plate design include the following fracture configurations:
- Basicervical fractures of the femur.
- Intertrochanteric fractures of the femur.
- Unstable intertrochanteric fractures of the femur.
- High subtrochanteric fractures of the femur just distal to the level of the lesser trochanter.
Specific indications for the supracondylar plate design include the following fracture configurations:
- Low transverse or short oblique supracondylar fractures of the distal femur.
- T condylar fractures of the femur that can be converted to low transverse or short oblique supracondylar fractures by rigid fixation of condylar fragments with screws.
Product codes
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Device Description
The sterile Medoff Sliding Plate System includes lag screws, compression screws, locking set screws, and bone plates consisting of a compression slide and a barreled side plate.
The sterile Medoff Sliding Plate System is manufactured from stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Femur
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Axial Compression Screw, Hawaiian Supracondylar Plate
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 22 1997
Contact Person: Judy English Date Prepared: January 3, 1997
510(k) Summary
Trade Name: Medoff Sliding Plate System (Sterile) Common Name: Metallic bone fixation device Product Classification: = Predicate Devices: Axial Compression Screw and Hawaiian Supracondylar Plate
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Indications for Use
The sterile Medoff Sliding Plate System includes lag screws, compression screws, locking set screws, and bone plates consisting of a compression slide and a barreled side plate.
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the fracture extends.
Specific indications for the 135 degree 4-hole standard plate design or 6-hole standard plate design include the following fracture configurations:
- . Basicervical fractures of the femur_
- . Intertrochanteric fractures of the femur.
- . Unstable intertrochanteric fractures of the femur.
- . High subtrochanteric fractures of the femur just distal to the level of the lesser trochanter.
Specific indications for the supracondylar plate design include the following fracture configurations:
- Low transverse or short oblique supracondylar fractures of the distal femur. .
- . T condylar fractures of the femur that can be converted to low transverse or short oblique supracondylar fractures by rigid fixation of condylar fragments with screws.
Material
The sterile Medoff Sliding Plate System is manufactured from stainless steel.
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