(217 days)
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No
The device description and performance studies focus on mechanical properties and equivalence to a predicate device, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes
The device is described as a plate for fixation of fractures and osteotomies, which are therapeutic interventions.
No
Explanation: The device is a surgical implant designed for fixation of fractures and osteotomies. It does not perform any diagnostic function such as detecting, monitoring, or predicting a condition.
No
The device description clearly states it is a physical plate manufactured from titanium, intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Synthes Volar Distal Radius Plate is a surgical implant used for the fixation of fractures and osteotomies of the distal radius. This is a physical device implanted into the body to provide structural support.
- Intended Use: The intended use is for surgical fixation, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.
Product codes
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Device Description
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. It is manufactured from commercially pure titanium. The plate is T-shaped, with the head 10° from perpendicular to the shaft, is precontoured, and is available in right and left versions. The head can be cut to size; it has up to six threaded holes, and accepts either 2.4 mm Cortex Screws or 1.8 mm Buttress Pins. The shaft can also be cut to size, and has up to five compression holes, two being elongated shaft holes to facilitate positioning, and accepts 2.7 mm Cortex Screws.
Synthes Volar Distal Radius Plate will be provided both sterile and non-sterile. The sterile device will be sterilized by gamma radiation. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Steam Sterilization and Sterility Assurance." The recommended steam Practice: sterilization parameters for the non-sterile device are as follows:
Method: Steam; Cycle: Pre-vacuum; Time: 6 minutes; Temperature: 132° - 135°C
Method: Steam; Cycle: Gravity Displacement; Time: 15 minutes; Temperature: 132° - 135°C
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
distal radius
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
mechanical testing: Based on the results of mechanical testing, Synthes Volar Distal Radius Plate is at least equivalent to the Synthes Small T-Plate.
Key Metrics
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Predicate Device(s)
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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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A registered trademark symbol is located to the right of the word.
295-7644
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
| SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301 | (610) 647-9700
Contact:
Angela Silvestri
August 4, 1995 |
| ------------------------------------------------------- | ------------------------------------------------------------------ |
|---|
Device: Synthes Volar Distal Radius Plate is compared to Synthes Small T-Plate.
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. It is manufactured from commercially pure titanium. The plate is T-shaped, with the head 10° from perpendicular to the shaft, is precontoured, and is available in right and left versions. The head can be cut to size; it has up to six threaded holes, and accepts either 2.4 mm Cortex Screws or 1.8 mm Buttress Pins. The shaft can also be cut to size, and has up to five compression holes, two being elongated shaft holes to facilitate positioning, and accepts 2.7 mm Cortex Screws.
Synthes Volar Distal Radius Plate will be provided both sterile and non-sterile. The sterile device will be sterilized by gamma radiation. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Steam Sterilization and Sterility Assurance." The recommended steam Practice: sterilization parameters for the non-sterile device are as follows:
| Method | Cycle | Time | Temperature |
|---|---|---|---|
| Steam | Pre-vacuum | 6 minutes | 132° - 135°C |
| Steam | Gravity | ||
| Displacement | 15 minutes | 132° - 135°C |
The Synthes Small T-Plate is also intended for fixation of fractures and osteotomies, including, but not limited to, the distal radius. It is manufactured from 316L stainless steel. This plate is also T-shaped, is pre-contoured, and is reversible for right and left application. The plate can be cut to size, and has round head and shaft holes (with an elongated shaft hole) that accept 3.5 mm Cortex Screws and 4.0 mm Cancellous Screws.
Based on the results of mechanical testing, Synthes Volar Distal Radius Plate is at least equivalent to the Synthes Small T-Plate.