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510(k) Data Aggregation
(253 days)
The Exactech® Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type I, IIA, and IIB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine.
The 3.5mm diameter and 2.7mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.
The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.
The Exactech® Equinoxe® Scapula Fracture System with EPIC Screws and Straight Plates is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the acromion and scapular spine. The Exactech® Equinoxe® Scapula Fracture System includes a range of sizes and options of scapula fracture plates and screws to accommodate varying patient anatomy and needs. Previously cleared components to be used with the Exactech® Equinoxe® Scapula Fracture System include the Exactech® EPIC Locking Screws, EPIC Non-Locking Screws, and EPIC Straight Plates. All components work together in various configurations to address scapular ORIF procedures.
The provided FDA 510(k) clearance letter for the Equinoxe® Scapula Fracture System does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.
This 510(k) clearance is for a physical medical device (bone fixation system), not a software or AI-enabled device that would typically undergo performance testing requiring a test set, ground truth experts, or MRMC studies. The letter reviews the substantial equivalence of the Scapula Fracture System to a legally marketed predicate device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing and analyses performed to demonstrate the device's functional integrity and safety as a bone fixation system.
Here's a breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are demonstrated through adherence to performance standards and achieving results comparable to the predicate device in specific non-clinical tests.
| Acceptance Criteria (Demonstrated by) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Mechanical Performance (Fatigue Resistance) | Demonstrated by Clinically relevant cycled bend testing. Implies performance is sufficient for intended use and comparable to predicate. |
| Screw Mechanical Performance | Demonstrated by Screw Testing per ASTM F543. Implies screws meet established strength and torque standards. |
| Corrosion Resistance | Demonstrated by Corrosion assessment per ASTM F897. Implies material resists degradation in the body. |
| Biocompatibility | Demonstrated by Biocompatibility per ISO 10993-1:2018. Implies the materials are not harmful when implanted. |
| Design Integrity for Worst-Case Scenarios | Demonstrated by Cross-sectional and finite element analysis for worst-case sample selection. Ensures the design holds up under extreme conditions. |
| Substantial Equivalence to Predicate | All tests and analyses collectively support the conclusion that "the Exactech® Equinoxe® Scapula Fracture System performs as intended and is substantially equivalent to the identified predicate devices." |
Study Details (Non-Clinical Testing for a Physical Device)
Since this is a physical implantable device, the questions related to AI/software performance metrics (sample size for test/training sets, experts for ground truth, adjudication, MRMC studies) are not applicable in this context.
- Sample size used for the test set and the data provenance: Not applicable. Performance was evaluated through non-clinical laboratory testing and engineering analysis rather than a "test set" of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and material properties is established by recognized engineering standards (ASTM, ISO) and laboratory measurements, not expert consensus in a clinical diagnostic sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Laboratory testing results are objectively measured against pre-defined engineering standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done because this is a physical implant (bone plate and screw system), not a diagnostic algorithm or AI-enabled device that assists human readers.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used:
- The "ground truth" for this device's performance relies on established engineering standards (ASTM F897, ASTM F543, ISO 10993-1:2018) and objective laboratory measurements of mechanical properties, biocompatibility, and corrosion resistance. It's about demonstrating that the device meets defined physical and material specifications, not about diagnostic accuracy against a clinical reference standard.
- The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
In summary, the FDA 510(k) clearance document confirms that the Equinoxe® Scapula Fracture System met its "acceptance criteria" by demonstrating substantial equivalence to a predicate device through rigorous non-clinical bench testing and engineering analyses that confirm its mechanical, material, and biological safety properties are fit for its intended use in scapula fracture repair. The nature of this device means the type of "study" to prove acceptance is fundamentally different from what would be done for an AI/software medical device.
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(269 days)
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.
The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.
This 510(k) summary describes a medical device, the Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws, and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria and a study proving device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.
This document is for a physical orthopedic implant (plate and screw system for bone fixation), not an AI or software device. The "performance criteria" and "testing" described are for mechanical and biocompatibility aspects of the physical hardware, not for diagnostic accuracy, sensitivity, specificity, or other performance metrics usually associated with AI/SaMD.
Therefore, I cannot provide the requested information in the format specific to AI/SaMD for this document. The concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not applicable to the information provided in this 510(k) summary for a physical orthopedic device.
If you have a document related to an AI/SaMD, I would be happy to analyze it for the requested information.
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