(64 days)
The Metaizeau™ Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to:
- Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia . in children,
- Forearm fractures in children and young adolescents, and
- Fractures of the humerus in adults. .
The Metaizeau™ Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design. The nail is available in five diameters and two lengths.
This document {0} and {1} is a 510(k) summary for the Metaizeau™ Nailing System, an intramedullary nail for temporary stabilization of bone fractures.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain explicit acceptance criteria or reported device performance metrics in the way one would typically find for a diagnostic or imaging device.
Instead, the submission is focused on demonstrating substantial equivalence to an existing predicate device. This means the primary "acceptance criterion" for this type of submission is:
- Acceptance Criterion: The Metaizeau™ Nailing System must be substantially equivalent to a legally marketed predicate device (an existing intramedullary nailing system) in terms of intended use, design, materials, and operational principles.
- Reported Device Performance: The document states, "The supporting information included in following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles."
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data or patient samples. The substantial equivalence determination for this device likely relies on engineering and material testing, design comparisons, and possibly non-clinical performance data, rather than clinical trial data. Therefore, details about sample size (for a test set of data) and data provenance (country of origin, retrospective/prospective) are not applicable or provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this 510(k) summary. "Ground truth" established by experts is typically relevant for diagnostic devices that interpret medical images or signals. For an intramedullary nail, the "ground truth" of its substantial equivalence would be based on engineering principles, material science, and comparison to the predicate device's specifications, all reviewed by regulatory experts within the FDA.
4. Adjudication Method
This information is not applicable as there is no mention of a test set requiring adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted or described in this document. MRMC studies are typically performed for diagnostic or imaging devices to evaluate the performance of human readers with and without AI assistance. This device is a surgical implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the Metaizeau™ Nailing System is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
As discussed, the concept of "ground truth" in clinical terms (like pathology, expert consensus, or outcomes data) is not relevant for this type of 510(k) submission. The "ground truth" for substantial equivalence is based on:
- Comparison of technical specifications: Materials, dimensions, mechanical properties, manufacturing processes.
- Intended Use comparison: Showing the new device serves the same purpose as the predicate.
- Operational Principles comparison: Demonstrating it functions in a similar manner to the predicate.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.