(261 days)
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No
The description focuses on the mechanical aspects and performance of an external fixator, with no mention of AI or ML capabilities.
Yes
The device is described as treating acute fractures and supporting reconstructive surgery.
No
Explanation: The device is a fixator used for the treatment of fractures and reconstructive surgery, which are therapeutic and surgical interventions, not diagnostic procedures.
No
The device description explicitly states it is made from a combination of aluminum and stainless steel, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of acute fractures and reconstructive surgery of all long bones." This describes a surgical intervention and treatment, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a "wire connected ring or frame fixator" used for "static fixation procedures" and applying "distraction or compression." This is a mechanical device used externally on the body to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Berlin External Fixator does not fit this description.
N/A
Intended Use / Indications for Use
The range of indications includes treatment of acute fractures and reconstructive surgery of all long bones.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Berlin External Fixator is a wire connected ring or frame fixator. It can be used as a static fixator or dynamically applying distraction or compression. The Berlin Fixator has been designed as a modular construction system. Through the use of a few individual components, simple static fixation procedures can be achieved. This devices is made from a combination of aluminum and 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
all long bones
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)
Three different assemblies of the Berlin Fixator, along with the Ilizarov fixator, were tested in static and dynamic compression. The Berlin Fixator test assemblies consisted of the small, medium and large diameter rings. This testing showed that the static load to failure for the Berlin and Ilizarov fixators was the same, i.e. 600 N. At a maximum cyclic load of 300 N the three Berlin Fixator assemblies survived 226,000, 194,000 and 253,000 cycles. This compared to the Ilizarov at 346,000 cycles.
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.
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Summary of Safety and Effectiveness
MAY 1 6 1996
Encore Orthopedics®. Inc. 8920 Business Park Drive Suite 380 Austin, TX 78759 512-795-8696 J.D. Webb
Trade Name: Berlin External Fixator
Common Name: External Fixator
Classification Name:
Description and Indications: The Berlin External Fixator is a wire connected ring or frame fixator. It can be used as a static fixator or dynamically applying distraction or compression. The Berlin Fixator has been designed as a modular construction system. Through the use of a few individual components, simple static fixation procedures can be achieved. The range of indications includes treatment of acute fractures and reconstructive surgery of all long bones. This devices is made from a combination of aluminum and stainless steel.
Comparable Features to Predicate Device(s): This device is similar in indications and characteristics to the Ilizarov device marketed by Smith-Nephew Richards.
Test Results: Three different assemblies of the Berlin Fixator, along with the Ilizarov fixator, were tested in static and dynamic compression. The Berlin Fixator test assemblies consisted of the small, medium and large diameter rings. This testing showed that the static load to failure for the Berlin and Ilizarov fixators was the same, i.e. 600 N. At a maximum cyclic load of 300 N the three Berlin Fixator assemblies survived 226,000, 194,000 and 253,000 cycles. This compared to the Ilizarov at 346,000 cycles.