(60 days)
The SALGINA 2.5mm Distal Radius System is indicated for
- · Intra-articular fractures of the Distal Radius.
- · Extra-articular fractures of the Distal Radius
The CASCELLA 3.5mm Superior Clavicle System is indicated for:
- fixation of fractures of the clavicle shaft
- fixation of fractures of the lateral clavicle
- malunions of the clavicle
- · non-unions of the clavicle
The LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- osteotomies
- nonunions
of the olecranon and proximal ulna.
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 surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.
The provided text describes a 510(k) premarket notification for the Bonebridge Osteosynthesis Plating System. The focus of the submission is on demonstrating substantial equivalence to predicate devices through non-clinical testing. This document does NOT describe a study that proves a device meets acceptance criteria for an AI/software-as-a-medical-device (SaMD) product, nor does it provide information relevant to a multi-reader, multi-case (MRMC) study or the establishment of ground truth by expert consensus for an AI model.
The information provided pertains to the mechanical, material, and labeling aspects of a physical bone fixation system, not a diagnostic AI device. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC study details from this document.
The document only states that:
- Clinical investigations were not required due to a clinical evaluation including a literature review and verification/validation activities.
- Usability evaluation was successfully completed in accordance with IEC 62366-1, with no significant usability issues identified.
The non-clinical tests summarized are related to the physical properties and safety of the implantable device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in a table format with specific quantitative metrics for the "acceptance criteria" and "reported device performance" in the context of an AI device. Instead, it lists various non-clinical tests performed on the physical implant and states whether they "Pass" or "Fail" against their respective standards. These are not performance metrics for an AI algorithm.
| Non-Clinical Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Minimal dose of 25kGy validated using VDmax25 method (ISO 11137-2) for SAL of 10-6. Cleaning and sterilization procedures validated (ISO 17664, ISO 17665-1) at 132°C for 4 minutes with 20 min drying time. | Pass |
| Packaging Validation | Validation of sterile packaging in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation (ISTA 2A) followed by Dye-Penetration (ASTM F1929), Visual inspection (ASTM F1886/1886M), Seal strength (ASTM F88/F88M), and Microbial barrier testing (DIN 58953-6, Chapter 2.14). | Pass |
| Biocompatibility | Biological Evaluation and toxicological risk assessment for biological safety according to ISO 10993-series and FDA guidance. | Pass |
| Mechanical Testing | Static and dynamic comparative testing demonstrating substantial equivalence of each subject plate variant to corresponding predicate devices with respect to maximum force (static) and maximum force for a given number of cycles (dynamic). Predefined acceptance criteria for mechanical performance successfully met. Design verification successfully completed for compatibility, anatomical shape, and appearance. | Pass |
| MRI Safety | Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla (ASTM F2052-21, ASTM F2213-17). Assessment of heating effects due to RF-field during MR scans at 1.5Tesla and 3Tesla (ASTM F2182-19). Assessment of image artifacts at 3Tesla (ASTM F3110-24). The tested implant and associated product family can be claimed as MR conditional. | Pass |
2. Sample size used for the test set and data provenance:
Not applicable. This is for a physical device, and no AI test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for an AI algorithm is not established in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
No MRMC study was done or mentioned, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the provided FDA 510(k) clearance letter and associated summary pertain to the substantial equivalence of a physical bone fixation system with existing predicate devices based on non-clinical engineering and material properties testing. It does not contain any information about acceptance criteria or studies related to AI or software-as-a-medical-device.
§ 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.