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TAMINA 3.5mm Proximal Humerus System
The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for
· Dislocated two-, three-, and four fragment fractures of the proximal humerus including osteopenic bone

· Pseudarthroses (non-unions) of the proximal humerus
· Osteotomies of the proximal humerus

POYA 3.5mm Lateral Proximal Tibia System
The POYA 3.5mm Lateral Proximal Tibia System is internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

· simple fractures
· comminuted fractures
· lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
· depression fractures
· periprosthetic fractures
· nonunions, malunions, tibial osteotomies and osteopenic bone
· fractures with associated shaft fractures

LORRAINE 3.5mm Distal Humerus System
The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

Device Description

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.

Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surqical use. Non-clinical testing has demonstrated the devices are MR Conditional.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Bonebridge Osteosynthesis Plating System, which includes TAMINA 3.5mm Proximal Humerus System, POYA 3.5MM Lateral Proximal Tibia System, and LORRAINE 3.5mm Distal Humerus System. The submission aims to establish substantial equivalence to previously cleared predicate devices.

However, the document does not describe a study involving an algorithm or artificial intelligence (AI). Instead, it focuses on the non-clinical testing performed to demonstrate the substantial equivalence of the Bonebridge Osteosynthesis Plating System (a medical device for bone fixation) to established predicate devices. The acceptance criteria and "device performance" described relate to the physical and material properties of the bone plates and screws, rather than the performance of a diagnostic or assistive AI system.

Therefore, many of the requested points, which are relevant to AI/algorithm studies (such as sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, and training set details), are not applicable to this document.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Sterilization	Validation using VDmax25 method as described in ISO 11137-2 for gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10^-6. Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time.	Gamma irradiation: The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10^-6.
Steam sterilization: Cleaning and sterilization procedures have been successfully validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time.
Packaging	Validation in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation conducted according to ISTA 2A followed by:
• Dye-Penetration, ASTM F1929
• Visual inspection, ASTM F1886/1886M
• Seal strength, ASTM F88/F88M
• Microbial barrier testing, DIN 58953-6, Chapter 2.14	Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation conducted according to ISTA 2A, followed by successful packaging verification tests (Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing).
Biocompatibility	Biological Evaluation and toxicological risk assessment to evaluate device's biological safety for the intended use, in accordance with ISO 10993-series.	Tests performed (Chemical Characterization, Cytotoxicity, and LAL Testing) successfully demonstrated biological safety.
Mechanical Testing	Non-inferiority of the Bonebridge device compared to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test). The predefined acceptance criteria were successfully met.	Static and dynamic comparative testing has been performed and included statistical analysis and comparative testing to the predicate devices. Non-inferiority of the Bonebridge device compared to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test). The predefined acceptance criteria were successfully met. Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance.
MRI Safety	Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17), heating effects (ASTM F2182-19 at 1.5T and 3T), and image artifacts (ASTM F2119-07 (2013)) to claim MR Conditional for local SAR.	Displacement force and torque effects assessed, heating effects assessed during MR scans at 1.5T and 3T, and image artifacts assessed at 3T. The tested implant and associated product family can be claimed as MR conditional considering local SAR.
Summative Usability	No significant usability issues are observed due to the study acceptance criteria of the primary objectives prior to Application/Usability Risk Assessment update.	Summative usability evaluation according to IEC 62366-1 shows that the Bonebridge Osteosynthesis Plating System has no significant usability issues. The study participants were able to use the products safely and effectively.

Regarding the AI/Algorithm specific questions:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document is not about an AI/algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not about an AI/algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document is not about an AI/algorithm.
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 document is not about an AI/algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This document is not about an AI/algorithm.
The sample size for the training set: Not applicable. This document is not about an AI/algorithm.
How the ground truth for the training set was established: Not applicable. This document is not about an AI/algorithm.

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