FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for:
· Dislocated two-, three-, and four fractures of the proximal humerus including fractures involving osteopenic bone.

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

The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the 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

The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia.

The DALVAZZA® 2.5mm Distal Ulna System is indicated for

· fixation of fractures
nonunions
of the distal ulna.

The LEPORELLO® 3.5mm Olecranon System is indicated for

fractures
· osteotomies
non-unions
of the olecranon and proximal ulna.

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 (ISO 5832-1 or ASTM F138 or ASTM F899), 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. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, the information typically requested regarding acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies is not directly applicable or available in this document.

However, the document does list various performance tests conducted to establish substantial equivalence. I will present the information related to device performance and the testing conducted, framed within the principles of acceptance criteria where possible.

Here's a breakdown of the requested information based on the provided text, acknowledging the limitations inherent in a 510(k) summary:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance like sensitivity or specificity, as it's not a diagnostic device. Instead, it describes various engineering and material tests. The acceptance criterion for these tests is generally that the device performs equivalently to or better than the predicate device, or meets relevant international standards.

Test Category	Acceptance Criteria (Implied from text)	Reported Device Performance
Sterilization Validation	Gamma irradiation: Achieve a Sterility Assurance Level (SAL) of 10^-6 as per ISO 11137-2 (VDmax25 method).

Steam sterilization: Successfully validated according to ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes with 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 | Successful validation according to ISO 11607 1/2 and ASTM F1980. Includes transport simulation (ISTA 2A) followed by specific packaging verification tests (Dye-Penetration, Visual Inspection, Seal Strength, Microbial Barrier Testing). | Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Furthermore, a transport simulation was conducted according ISTA 2A followed by these packaging verification tests: Dye-Penetration, ASTM F1929; Visual inspection, ASTM F1886/1886M; Seal strength, ASTM F88/F88M; Microbial barrier testing, DIN 58953-6, Chapter 2.14. |
| Mechanical Testing | Plates: Predefined acceptance criteria for static and dynamic testing successfully met, including statistical analysis and comparative testing to predicate devices.

Screws: Successfully tested in accordance with ASTM F543 and includes comparative testing to predicate devices.

Design Verification: Compatibility of implants and instruments, and assessment of anatomical shape and appearance successfully completed. | Plates: Static and dynamic testing has been performed and included statistical analysis and comparative testing to the predicate devices. The predefined acceptance criteria were successfully met.

Screws: Tested successfully in accordance with ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws and includes comparative testing to predicate devices.

Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance. |
| MRI Safety | MR conditional status based on tests for displacement force and torque, heating effects due to RF-field, and image artifacts. (Tests according to ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a, ASTM F2119-07). | The Bonebridge Osteosythesis Plating System is MR conditional considering local SAR based on the following tests: Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla. Additionally, the expected magnetic force in a stronger magnetic field gradient of 30T/m was extrapolated. (According to ASTM F2052-15 and ASTM F2213-17); Assessment of heating effects due to the RF-field during MR scans at 1.5Tesla and 3Tesla according to ASTM F2182-11a; Assessment of image artifacts at 3Tesla according to ASTM F2119-07 (2013).
| Usability | No significant usability issues are identified, meeting predefined acceptance criteria from the study. Study participants must be able to use the products safely and effectively. | Summative usability evaluation studies in accordance with IEC 62366-1 support that there are no significant usability issues due to the study acceptance criteria of the primary objectives prior Application/ Usability Risk Assessment update. Therefore, the summative usability evaluation studies of the Bonebridge Osteosythesis Plating System are considered as successful. The study participants were able to use the products safely and effectively. |
| Biocompatibility | Assessment performed in accordance with ISO 10993-1. | A biological assessment has been performed in accordance with ISO 10993-1. |
| Clinical Evaluation| Not required if existing interventions for relevant indications match surgical technique, device design, and material, and if verification and validation activities are conclusive. | Based on the results of the literature review and the results of verification and validation activities it has been concluded that clinical investigations are not required, since surgical technique, device design and material match established interventions for the relevant indications. |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The document refers to "testing" performed (e.g., static and dynamic testing for plates, testing for screws, packaging validation, MRI safety tests), but it does not specify the sample sizes of devices or materials used for these engineering tests. There's no "test set" in the context of diagnostic data.

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)

This information is not applicable/provided as this is an orthopedic implant (osteosynthesis plating system), not an AI/diagnostic device that would require expert-established ground truth for a test set. Usability studies were conducted with "study participants," but their qualifications or number for establishing ground truth are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided. As noted above, this device is not an AI/diagnostic device.

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 information is not applicable/provided. This is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided. This is an orthopedic implant, not an algorithm/AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided in the context of diagnostic accuracy. For the engineering tests, the "ground truth" would be established by the specifications of the materials, the design requirements, and the standards (e.g., ISO, ASTM) against which the device was tested. For usability, the ground truth is the successful and safe operation by participants.

8. The sample size for the training set

This information is not applicable/provided. This device is an orthopedic implant and does not involve AI or a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, it is not an AI device.

Summary

Regulation Number and Section

§ 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.