(146 days)
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP System is intended for buttressing multifragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, ad non -unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and nonunions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system
The Synthes Curved Condylar Plates are intended for buttressing multi-fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
The Synthes (USA) Brainlab Compatible Instruments consist of manual insertion handles and aiming arms which are used to facilitate the surgical technique related to the Synthes Lateral Entry Femoral Nail, LISS, LCP Distal Femur Plate, Locking Condylar Plate, and Curved Condylar Plate systems. The instruments primarily facilitate the manual insertion of the bone plate and intramedullary nail implants included in the predicate systems, but also include a design feature which allows attachment of system accessories to the Brainlab Trauma navigation system.
The provided document is a 510(k) summary for the "Synthes Brainlab Trauma Compatible Instruments". This submission is to modify existing cleared systems to introduce manual accessory instruments intended for compatibility with the Brainlab Trauma Navigation System.
The document does not contain acceptance criteria in the traditional sense of performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study performed is a simulated use study and dimensional tolerance analyses, not a clinical study to assess performance against specific acceptance criteria for an AI or diagnostic tool.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or inferred from the provided text, while explicitly noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the document. The submission is focused on demonstrating substantial equivalence, meaning the modified instruments perform as intended and do not raise new questions of safety or effectiveness compared to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for performance metrics. The implicit "acceptance criterion" is to demonstrate substantial equivalence, meaning no adverse effects on safety and effectiveness. | "Dimensional tolerance analyses and simulated use studies were conducted and the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the predicate systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This was a simulated use study and dimensional tolerance analysis, not a test set of medical cases. The number of instruments or surgical simulations is not specified.
- Data Provenance: Not applicable. The study involved engineering analysis and simulated use, likely conducted in a lab environment. No information on country of origin for patient data or retrospective/prospective nature is relevant here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for diagnostic or AI studies is not relevant here. The study involved engineering assessments and potentially surgical technique evaluations by product developers or surgical experts, but their number and specific qualifications for establishing 'ground truth' are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of study does not involve adjudication of expert readings or diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not an AI or diagnostic device designed to improve human reader performance. It's a surgical instrument modification.
- Effect Size of AI vs. Without AI Assistance: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done: Not applicable. This is a manual surgical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of diagnostic or AI performance. The "ground truth" for this submission would be defined by engineering standards, functional requirements for instrument compatibility and surgical technique, and safety assessments.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: 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.