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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.

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:

1. 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."

2. 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.

3. 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).

4. 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.

5. 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."

6. 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.

7. 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.

8. 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."

9. How the ground truth for the training set was established:

   • Not Applicable. As no training set was used.

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The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, 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, nonunions, malunions and reconstructions.

The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, nonunions, 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, malumions and reconstructions.

The SIGNEX Foot System is indicated for fixation of foot (tarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions and reconstructions.

The SIGNEX plates and screws are intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibia, tibia, femur and clavicle.

This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67), Ti-6Al-4V ELI Titanium alloy (ASTM F136), and Screws are made of Ti-6A1-4V ELI Titanium alloy (ASTM F136). The plates and screws are single-use only, non-sterile products. so, those must be sterile before use.

The provided text describes the 510(k) summary for the SIGNEX device, which comprises plates and screws for bone fixation. It details the substantial equivalence comparison to predicate and reference devices, along with performance data. However, it does not describe an AI/ML-based device. The information provided is purely for a mechanical medical device (bone fixation plates and screws). Therefore, I cannot extract information related to AI/ML acceptance criteria or a study proving an AI/ML device meets those criteria from this document.

The document discusses:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Systemic toxicity, Genotoxicity, Pyrogen testing, Implantation testing, all conforming to ISO 10993 series.
• Mechanical testing: Torsion test (ASTM F543), Axial pullout strength test (ASTM F543), Driving torque test (ASTM F543), 4-Point bending test (ASTM F382).
• Clinical Studies: Explicitly states "No clinical data were necessary for the demonstration of substantial equivalence."

Since the request pertains to "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically for an AI/ML device, and the provided text describes a mechanical bone fixation device, I am unable to fulfill the request as an AI/ML component is not present in the given information.

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