(147 days)
Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:
- · Open and closed femoral fractures;
- · Pseudoarthrosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures, and tumor resections;
- · Ipsilateral femur fractures;
- · Fractures distal to the hip joint; and
- Nonunions and malunions.
Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:
- · Open and closed tibial fractures;
- · Pseudoarthodlosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures and tumor resections; and
- · Nonunions and malunions.
The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.
An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.
The document describes the device Intramedullary Nail and Screws - NEONAIL, which is an orthopedic implant for fracture fixation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (from document) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Four-Point Bending | Not explicitly stated (comparison to predicates) | "worst case nail... subjected to mechanical performance testing according to ASTM F1264" |
| Static Torsion | Not explicitly stated (comparison to predicates) | "worst case nail... subjected to mechanical performance testing according to ASTM F1264" | |
| Bending Fatigue | Not explicitly stated (comparison to predicates) | "worst case nail... subjected to mechanical performance testing according to ASTM F1264" | |
| Torsional Properties (Screws) | Not explicitly stated (comparison to predicates) | "worst case screws... subjected to mechanical performance testing according to ASTM F543" | |
| Driving Torque (Screws) | Not explicitly stated (comparison to predicates) | "worst case screws... subjected to mechanical performance testing according to ASTM F543" | |
| Axial Pullout Strength (Screws) | Not explicitly stated (comparison to predicates) | "worst case screws... subjected to mechanical performance testing according to ASTM F543" | |
| Self-Tapping Performance (Screws) | Not explicitly stated (comparison to predicates) | "worst case screws... subjected to mechanical performance testing according to ASTM F543" | |
| Material Equivalence | Material Composition | Identical to predicate devices | "All components are made from Ti-6AI-4V alloy," which is stated to be identical to materials in cleared predicate devices. |
| Design Equivalence | Design Principles / Dimensions | Similar to predicate devices | "similar in indications, design, and dimensions" to predicate devices. |
| Intended Use | Match predicate devices | Same intended use as predicate devices | "has the same intended use" as predicate devices. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical study focusing on engineering analysis, dimensional analysis, and mechanical testing. The core strategy is demonstrating substantial equivalence to legally marketed predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the mechanical testing of each individual nail or screw type. It refers to testing the "worst case nail for each indication" and "worst case screws available." This implies a selection of representatives rather than a broad statistical sample of every product variant.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a non-clinical engineering and mechanical testing study, "retrospective" or "prospective" as typically applied to patient data is not directly applicable. The data would have been generated in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The study is a non-clinical, engineering-focused evaluation. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical or diagnostic device studies, not for the mechanical performance testing of an orthopedic implant. The "truth" here is determined by adherence to engineering standards (ASTM F1264, ASTM F543) and equivalence to predicate devices, which is evaluated by regulatory bodies based on submitted technical data.
4. Adjudication method for the test set
This section is not applicable. Adjudication typically refers to the process of resolving discrepancies among experts in clinical data review. For mechanical testing, the results are typically quantitative and objective measurements against defined standards, not subjective interpretations requiring adjudication.
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
This section is not applicable. The device is an orthopedic implant (intramedullary nail and screws) used for fracture fixation, not a diagnostic or AI-driven imaging device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this non-clinical study is defined by:
- Established engineering standards: Specifically ASTM F1264 (for intramedullary fixation devices) and ASTM F543 (for metallic bone screws). The device's performance is compared against the performance of predicate devices which are presumed to meet these standards.
- Predicate device characteristics: The critical "truth" is that the Intramedullary Nail and Screws - NEONAIL performs sufficiently similarly to and is materially and structurally equivalent to the identified predicate devices (Howmedica Osteonics Corp. T2 Femoral Nail, Stryker T2 Femoral Nail, Stryker Trauma AG T2 Tibial Nailing System, Howmedica Osteonics Corp. T2 Proximal Humeral Nail, Howmedica Osteonics Corp. T2 Nailing System) to be considered substantially equivalent by the FDA.
8. The sample size for the training set
This section is not applicable. Since this involves mechanical testing and not machine learning or AI, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no "training set."
§ 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.