(202 days)
The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
This product is intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibula, tibia, femur and clavicle.
This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67) or Ti-6Al-4V ELI Titanium alloy (ASTM F136), and screws are made of Ti-6Al-4V ELI Titanium alloy (ASTM F136).
The plates and screws are single-use only, non-sterile products. So, those must be sterile before use.
This FDA 510(k) clearance letter and summary for the SIGNEX device (K243469) primarily relies on bench testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the typical criteria for evaluating AI/ML-based medical devices, such as performance on a clinical test set, MRMC studies, or multi-reader studies, are not applicable or not reported in this document.
The document focuses on comparing the physical and mechanical properties of the SIGNEX plates and screws to legally marketed predicate devices.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to demonstrating performance comparable to the predicate devices through material and mechanical testing standards. The reported "performance" is that the device met these standards and was found to be substantially equivalent.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity (ISO 10993-5) | Met standard |
| - Sensitization (ISO 10993-10) | Met standard |
| - Irritation/Intracutaneous Reactivity (ISO 10993-10) | Met standard |
| - Systemic Toxicity (ISO 10993-11) | Met standard |
| - Genotoxicity (ISO 10993-3) | Met standard |
| - Pyrogen Testing (ISO 10993-6) | Met standard |
| - Implantation Testing (ISO 10993-11) | Met standard |
| Material Composition: | |
| - Conform to ASTM F67 (Pure Titanium) for plates | Conform to ASTM F67 for plates (also ASTM F136) |
| - Conform to ASTM F136 (Ti-6Al-4V ELI Titanium alloy) for plates/screws | Conform to ASTM F136 for plates and screws |
| Mechanical Performance: | |
| - Torsion Test (ASTM F543) | Met acceptance criteria |
| - Axial Pullout Strength Test (ASTM F543) | Met acceptance criteria |
| - Driving Torque Test (ASTM F543) | Met acceptance criteria |
| - 4-Point Bending Test (ASTM F382) | Met acceptance criteria |
| Equivalence in Indications for Use | Same as primary predicate |
| Equivalence in Anatomical Sites | Same as primary predicate |
| Equivalence in Sterilization, Single Use/Reuse | Same as primary predicate |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of bench tests (biocompatibility and mechanical testing) comparing the SIGNEX device to its primary and additional predicate devices.
Detailed Information:
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A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria for these bench tests would be the specific quantitative thresholds defined by the ASTM/ISO standards and/or the comparative performance to the predicate devices. The document states "The acceptance criteria for the mechanical testing were all met." and "SIGNEX's materials conform to ASTM F67 or ASTM F136 respectively for chemical composition."
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Sample sizes used for the test set and the data provenance:
- Test Set (Bench Testing): The document does not specify the exact number of samples (e.g., number of plates and screws) used for each bench test. These are typically performed on a statistically relevant sample size of components according to the respective ASTM/ISO standards.
- Data Provenance: The tests were conducted to verify compliance with international standards (ISO, ASTM) and substantial equivalence to US-legally marketed predicate devices. The manufacturer is OSTEONIC Co., Ltd. from Korea, South. The document doesn't specify if the testing itself was performed in Korea, the US, or elsewhere, but it's common for medical device manufacturers to use accredited labs globally. The nature of the device (implants) means this testing would be "prospective" in terms of newly manufactured devices. It is not "retrospective" as that term usually applies to analysis of existing clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical/biocompatibility test, not a clinical study requiring expert interpretation of images or patient outcomes. The "ground truth" is established by the specifications of the materials (ASTM) and the physical/mechanical properties measured against the standards (ISO/ASTM).
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Adjudication method for the test set:
- Not Applicable. As this is not a study involving human reader interpretations, there is no adjudication process. Test results are quantitative measurements against predefined standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not done. This device is a bone fixation plate and screw system, not an AI-powered diagnostic or assistive tool for human readers. "No clinical data were necessary for the demonstration of substantial equivalence."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance demonstration is based on established engineering standards for materials (ASTM) and mechanical performance (ASTM) and biocompatibility (ISO), as well as comparison to the physical and mechanical properties of legally marketed predicate devices. No clinical or pathology-based "ground truth" was used.
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The sample size for the training set:
- Not Applicable. This device is hardware (plates and screws), not a software/AI algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As no training set was used.
§ 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.