(65 days)
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No
The device description and performance studies focus on the mechanical properties and design of a bone plate, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an orthopedic plate intended for fracture fixation, which is a structural support device rather than one that performs a therapeutic function to treat a disease or condition.
No
Explanation: The device, Synthes Ti Alloy VDRP, is described as a plate intended for fixation of fractures and osteotomies of the distal radius. Its function is to provide structural support and stability, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical implant (plate, screws, pins) made of Ti Alloy, intended for surgical fixation of fractures. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens 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 Ti Alloy VDRP is a surgical implant (a plate and screws/pins) intended for fixing bone fractures. It is a physical device used within the body, not for analyzing samples outside the body.
- Intended Use: The intended use is for "fixation of fractures and osteotomies of the distal radius," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Synthes Ti Alloy VDRP is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Ti Alloy VDRP 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
The plate is T-shaped (with the head 10° from perpendicular to the shaft), pre-contoured, and available in right and left versions. The head can be cut to size, and has up to six threaded holes that accept either 2.4 mm cortex screws or 1.8 mm buttress pins. The shaft can also be cut to size, has up to five compression holes (two being elongated shaft holes to facilitate positioning), and accepts 2.7 mm cortex screws. As is stated in its name, the plate is manufactured from a Ti Alloy.
Synthes Ti Alloy 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 Practice: Steam Sterilization and Sterility Assurance."
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the results of mechanical testing, Synthes Ti Alloy VDRP and Synthes VDRP is at least equivalent to the Synthes STP.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 bold, black letters. To the left of the word is a circular logo with a design inside. The logo appears to be a stylized representation of a person or object. The word "SYNTHES" is written in a sans-serif font and is slightly slanted to the right. There is a small dot or mark above and to the right of the letter "S" in "SYNTHES".
Attachment VIII:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli. PA 19301
Contact: Angela Silvestri (610) 647-9700 September 1996
NOV 2 7 1996
Synthes Ti Alloy VDRP is compared to Synthes VDRP and Synthes STP.
Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. The plate is T-shaped (with the head 10° from perpendicular to the shaft), pre-contoured, and available in right and left versions. The head can be cut to size, and has up to six threaded holes that accept either 2.4 mm cortex screws or 1.8 mm buttress pins. The shaft can also be cut to size, has up to five compression holes (two being elongated shaft holes to facilitate positioning), and accepts 2.7 mm cortex screws. As is stated in its name, the plate is manufactured from a Ti Alloy.
Synthes Ti Alloy 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 Practice: Steam Sterilization and Sterility Assurance."
The VDRP is identical to the device described above but it is manufactured from CP Titanium.
The Synthes STP is also intended for fixation of fractures and osteotomies, including, but not Inmed to, the distal radius. It is manufactured from 316L stainless steel. This plate is also Tshaped, 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.
3ased on the results of mechanical testing, Synthes Ti Alloy VDRP and Synthes VDRP is at least equivalent to the Synthes STP.