(260 days)
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:
- 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:
- Indications for Use: The new device has similar intended uses to predicate devices.
- Technological Characteristics: The new device has similar geometry, design, and sizing to predicate devices.
- Materials: The new device uses materials (Stainless Steel, Radel, Aluminum) comparable to those in predicate devices.
- 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.
§ 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.