(19 days)
The Merete MetaFix Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
The Merete MetaFix Small Fragment Locking Plate System consists of profile T-Oblique plates, right or left, of various sizes and 3.0 mm locking screws. The system is available in titanium (ASTM F-136). Locking plates/screws incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction.
The provided text is a 510(k) summary for the Merete MetaFix™ Small Fragment Locking Bone Plate System. This type of submission is for medical devices that aim to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, or clinical outcome data) is not present in this document.
Instead, the submission focuses on comparing the new device's technological characteristics, materials, and intended use to existing predicate devices to show that it raises no new questions of safety or effectiveness.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
This document does not report specific acceptance criteria or device performance data in the way a clinical study or a performance test for a diagnostic device would. For orthopedic implants like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence based on material properties, mechanical testing (often referenced by standards), and similarity of design and indications for use to predicate devices.
The document states:
| Criterion Type | Substantial Equivalence Claim |
|---|---|
| Material Composition | "The MetaFix-system is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3." This indicates compliance with established material standards for biocompatibility and mechanical properties, similar to predicate devices. |
| Technological Characteristics | "The components of the Merete MetaFix Small Fragment Locking Plate System are similar to legally marketed predicate devices listed above in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics." |
| Indications for Use | The stated indications for use (fixation of fractures, osteotomies, non-unions of specific bones, particularly in osteopenic bone, for adult and pediatric patients) are essentially identical to the scope of predicate devices. |
| Design/Function | The description "incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction" describes a common and accepted technological characteristic also found in predicate locking plate systems. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. This 510(k) submission does not describe a "test set" in the context of clinical data or AI model evaluation. It relies on a comparison to predicate devices and adherence to established material and manufacturing standards. There is no patient data or test data of that nature described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Applicable. As there is no test set in the sense of clinical or diagnostic data, there are no experts establishing ground truth for such a set within this submission. The "experts" involved would be the engineers and regulatory specialists who developed and documented the device, ensuring it met relevant standards and was comparable to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. There is no test set or adjudication method described for clinical outcomes or diagnostic accuracy.
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:
Not Applicable. This is an orthopedic implant, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" for demonstrating substantial equivalence primarily relies on:
- Established material standards: (ASTM F-136, ISO 5832/3 for Ti-6Al-4V).
- Mechanical performance data (implied): While not explicitly presented, the similarity to predicate devices implies that the mechanical properties (e.g., strength, stiffness, fatigue resistance) of this system would have been internally tested to ensure they meet performance benchmarks comparable to existing, safe, and effective devices in this class. These tests are typically conducted according to recognized ASTM or ISO standards for bone plates and screws.
- Historical clinical outcomes of predicate devices: The safety and effectiveness of the Merete system are inferred from the long-standing safe and effective use of its predicate devices with similar designs, materials, and intended uses.
8. The sample size for the training set:
Not Applicable. There is no "training set" in the context of AI or machine learning for this device.
9. How the ground truth for the training set was established:
Not Applicable. As there is no training set for AI, this question is not applicable.
§ 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.