(63 days)
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No
The description focuses on mechanical components and materials, with no mention of AI/ML terms or functionalities.
Yes
Explanation: The device is intended to stabilize fractures, which is a therapeutic purpose.
No
The device, a Synthes SSEF, is described as stabilizing fractures of the distal radius. This is a therapeutic function (treatment of a condition), not a diagnostic one (identification or analysis of a condition).
No
The device description explicitly lists hardware components (Schanz screws, clamps, rods, end caps) made of various materials (titanium alloy, stainless steel, carbon fiber reinforced epoxy, polyvinyl chloride).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize fractures of the distal radius." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The components listed (Schanz screws, clamps, rods, end caps) are all physical implants and external fixation components used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
This device is a surgical implant/external fixation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride. It is anticipated that the most common use of the device would be as follows: 1. A small incision is made over the second metacarpal and radius. 2. Using the Parallel Drill Guide for soft tissue protection and positioning, a pair of Self-Drilling Schanz Screws are inserted into the second metacarpal and radius. 3. An adjustable clamp is slid over each pair of Schanz Screws and tightened to lock on the pins. 4. An appropriately sized rod is slid through each clamp. 5. End caps are applied to each end of the rod to captivate the clamps. 6. The fracture is reduced. 7. The remaining screws on both adjustable clamps are tightened to hold the reduction.
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 the mechanical testing, Synthes SSEF is at least equivalent to the EBI's Orthofix Pennig Dynamic Wrist Fixator in performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 stylized figure inside. A small circle with a dot in the center is located to the upper right of the word.
NOV 1 2 1996
Summary of Safety and Effectiveness Information Attachment IX:
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri September 1996
Synthes SSEF is compared to the EBI's Orthofix Penning Dynamic Wrist Fixator.
The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. It is anticipated that the most common use of the device would be as follows:
-
- A small incision is made over the second metacarpal and radius.
-
- Using the Parallel Drill Guide for soft tissue protection and positioning, a pair of Self-Drilling Schanz Screws are inserted into the second metacarpal and radius.
-
- An adjustable clamp is slid over each pair of Schañz Screws and tightened to lock on the pins.
-
- An appropriately sized rod is slid through each clamp.
-
- End caps are applied to each end of the rod to captivate the clamps.
-
- The fracture is reduced.
-
- The remaining screws on both adjustable clamps are tightened to hold the reduction.
The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.
The EBI's Orthofix Penning Dynamic Wrist Fixator also stabilizes fractures of the distal radius. It is manufactured from stainless steel and anodized aluminum.
Based on the results of the mechanical testing, Synthes SSEF is at least equivalent to the EBI's Orthofix Pennig Dynamic Wrist Fixator in performance.