(77 days)
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No
The summary describes a mechanical clamp for external fixation and does not mention any AI or ML components or functionalities.
Yes
The device is used to construct an external fixation frame for the treatment of long bone fractures, indicating its role in therapy.
No
Explanation: The device is used for external fixation of long bone fractures, which is a treatment method, not a diagnostic one.
No
The device description clearly states it is a physical clamp manufactured from a Titanium Alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the construction of an external fixation frame for treating long bone fractures. This is a surgical/orthopedic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical clamp made of titanium alloy used to connect pins and rods/tubes. This is a physical device used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on biological or chemical tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to an 11 mm carbon fiber rod or stainless steel tube. The Ti Universal Clamp is available in 2 sizes: four and six possible pin positions, which allow variable pin spreads in a two pin model.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to an 11 mm carbon fiber rod or stainless steel tube. The Ti Universal Clamp is available in 2 sizes: four and six possible pin positions, which allow variable pin spreads in a two pin model. The device is manufactured from a Titanium Alloy.
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
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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 mechanical test results, the Ti Universal Clamp has been found to be substantially equivalent to the Double Adjustable Clamp.
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.
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 a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small circle with a dot in the center is located to the upper right of the word "SYNTHES".
X 960269 K960069
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647-9700 Contact: Angela J. Silvestri January 16, 1996
Synthes Ti Universal Clamp is compared to Synthes Double Adjustable Clamp.
Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to an 11 mm carbon fiber rod or stainless steel tube. The Ti Universal Clamp is available in 2 sizes: four and six possible pin positions, which allow variable pin spreads in a two pin model. The device is manufactured from a Titanium Alloy.
Synthes Double Adjustable Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to a carbon fiber rod or stainless steel tube. The Double Adjustable Clamp has three possible pin positions, to allow variable pin spreads in a two pin model. The device is manufactured from stainless steel.
Based on mechanical test results, the Ti Universal Clamp has been found to be substantially equivalent to the Double Adjustable Clamp.