Search Results

The Life Spine External Fixation System is intended for Adults:

Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid

Treatment of fractures including:

Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or metatarsals (including jones fractures), ankle and distal tibia

Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation

Reconstruction of deformities including: Neuropathic deformities Charcot reconstruction with or without corrective osteotomies Diabetic Charcot Reconstruction Prevention and treatment of contracture of joints and tendons in equinus

Treatment of infection unions, nonunions, or malunions

Offloading and or immobilization of ulcers and/or wounds of the foot or ankle

Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs, and transfers both deep and or superficial around the foot and ankle including posterior tibial , tibialis anterior, flexor digitorum longus, achilles, flexor hallucis longus, peroneus longus, extensor hallucis longus, extensor digitorum longus

Tumor and neoplasm resection and reconstruction

Stabilization associated with rotation flaps, free flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives.

Pseudoarthrosis or non-unions of long bones.

Correction of bony or soft tissue deformities Correction of segmental or nonsegmental bony or soft tissue defects Use on long bones including tibia and fibula Use with or without IM nail in the ankle in Charcot patients

The Life Spine External Fixation System is a component system of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize bone segments for indications within the foot and ankle. The External Fixture system is fabricated of both Radel, Stainless Steel (316L) and Aluminum. The implant components are fabricated and manufactured from the following:

1. Stainless Steel (316L)

All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the External Fixation System components with components from any other system or manufacturer. The External Fixation System components should never be reused under any circumstances.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Life Spine External Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria for a specific device's performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical outcomes.

Instead, this document focuses on demonstrating substantial equivalence based on:

1. Indications for Use: The new device has similar intended uses to predicate devices.
2. Technological Characteristics: The new device has similar geometry, design, and sizing to predicate devices.
3. Materials: The new device uses materials (Stainless Steel, Radel, Aluminum) comparable to those in predicate devices.
4. Performance Data (Mechanical Testing): Mechanical testing was performed according to ASTM F1541 to show the physical performance of the device is equivalent to predicate devices. This is not a clinical study or a study measuring diagnostic accuracy.

Therefore, I cannot extract the information required in your request (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this 510(k) summary does not contain that type of information. It's a regulatory document for a physical medical device (an external fixation system), not a diagnostic or AI-driven device a requesting such information would typically apply to.

In summary, the document states:

• Acceptance Criteria & Reported Performance: No specific acceptance criteria for diagnostic performance or clinical outcomes are provided. The "performance" discussed is in terms of mechanical testing for substantial equivalence, not clinical efficacy or diagnostic accuracy.
• Sample Size and Data Provenance: Not applicable for clinical or diagnostic performance studies. The document refers to "mechanical testing according to ASTM F1541".
• Number of Experts & Qualifications: Not applicable as this is not a study requiring expert interpretation or ground truth establishment in a clinical sense.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned or implied.
• Standalone Performance: Not applicable for a non-AI surgical device.
• Type of Ground Truth: Not applicable beyond mechanical property validation against standards.
• Training Set Sample Size: Not applicable.
• Ground Truth for Training Set: Not applicable.

The document's "Performance Data" section mentions: "Mechanical testing according to ASTM F1541 including Static and Dynamic Compressions, Dynamic Axial Compression Testing, Static Torsion Testing and Static 4-point Bending was presented to demonstrate the substantial equivalency of the External Fixation System." This indicates the type of study performed, but not the specific design or results in a way that answers your questions about clinical performance or AI evaluation.

Ask a specific question about this device

External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.

External fixation devices, such as the external fixation bar clamps described herein, are specially designed components used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability.

The provided text is a 510(k) Summary for External Fixation Systems. This type of document is for medical devices that are found to be substantially equivalent to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes, expert ground truth adjudication, or AI performance metrics.

The document states:

• "The principle of operation of these reprocessed devices is very similar to that of the predicates. There are no changes in intended use, performance specifications or method of operation. The reprocessed devices utilize similar designs, the same materials and technological characteristics when compared to the predicate devices."
• "The intended use of the reprocessed external fixation bar clamps is identical to that of the Smith & Nephew Unilateral Fixator (K994143) and the Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures (K994143). The design and the function of the subject devices are very similar to the predicate devices and they are manufactured from the same materials."

Based on this, the device is considered substantially equivalent to existing predicate devices (Smith & Nephew Unilateral Fixator K994143 and Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures K994143) because there are no changes in intended use, performance specifications, or method of operation. Therefore, a new study to prove device performance against specific acceptance criteria, in the way a novel AI device might, is not presented or required for a 510(k) submission of this nature.

Thus, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or AI-related metrics because the document does not contain this type of study. The demonstration of safety and effectiveness for this device relies on its substantial equivalence to previously cleared devices.

Ask a specific question about this device