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510(k) Data Aggregation
(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.
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