(203 days)
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.
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.
This document is a 510(k) premarket notification for a medical device called the "SITTER 3.5mm Versatile System," which is part of the Bonebridge Osteosynthesis Plating System. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The provided text focuses on the non-clinical tests performed to demonstrate this substantial equivalence. It explicitly states that clinical investigations were not required and that usability tests were performed, but not to establish clinical effectiveness or diagnostic performance in the way an AI/ML medical device would. Therefore, the information needed to answer many of your specific questions related to AI/ML device performance and clinical studies (e.g., MRMC studies, standalone algorithm performance, ground truth for training sets) is not present in the provided document.
However, I can extract and present the acceptance criteria and study information for the non-clinical tests detailed in the document.
Here's the breakdown of the information that is available:
Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)
Since this is a mechanical fixation device, the "performance" described relates to material and mechanical properties, not diagnostic accuracy.
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit from "Pass" result) | Reported Device Performance |
|---|---|---|---|
| Sterilization Validation | Gamma irradiation | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ using VDmax25 method and per ISO 11137-2. | Pass (Minimal dose of 25kGy validated, SAL of 10⁻⁶ confirmed). |
| Steam sterilization | Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270°F) for 4 minutes and 20 min drying time. | Pass (Procedures successfully validated). | |
| Packaging Validation | Validation tests (e.g., Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing, Transport simulation) | Meet standards of ISO 11607 1/2, ASTM F1980, ISTA 2A, ASTM F1929, ASTM F1886/1886M, ASTM F88/F88M, DIN 58953-6. | Pass (Validation of sterile packaging successfully performed, transport simulation conducted followed by specified tests). |
| Biocompatibility | Biological Evaluation and toxicological risk assessment (Chemical Characterization, Cytotoxicity, LAL Testing) | Device's biological safety for intended use evaluated in accordance with ISO 10993-series and FDA guidance. | Pass (Evaluation performed, device considered biocompatible, corrosion-resistant, non-toxic). |
| Mechanical Testing | Plates (Static and dynamic comparative testing) | Non-inferiority to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test), meeting predefined acceptance criteria. | Pass (Comparative testing performed, non-inferiority successfully met predefined acceptance criteria). |
| Design verification | Compatibility of implants and instruments, assessment of anatomical shape and appearance successfully completed. | Pass (Design verification successfully completed). | |
| MRI Safety | Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17) | No unsafe displacement or torque in static magnetic fields (e.g., 3.0 Tesla, extrapolated for 30T/m gradient). | Pass (Assessment performed at 3.0 Tesla, extrapolation for 30T/m gradient completed). |
| Assessment of heating effects (ASTM F2182-19e1) | No unsafe heating due to RF-field during MR scans at 1.5Tesla and 3Tesla. | Pass (Assessment performed at 1.5 Tesla and 3 Tesla). | |
| Assessment of image artifacts (ASTM F2119-07 (2013)) | Acceptable image artifacts at 3Tesla. | Pass (Assessment performed at 3 Tesla). |
Information Not Available / Not Applicable for this Device Type:
The remainder of your questions pertain to clinical performance studies, particularly those relevant to AI/ML devices for diagnostic purposes. The provided document explicitly states that clinical investigations were not required for this device, and the focus is on mechanical and material equivalence. Therefore, the following information is not present in the document:
- Sample sizes used for the test set and the data provenance: Not applicable for non-clinical mechanical testing, and no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic ground truth was established.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a passive medical device (bone plate) and not an AI/ML diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable.
§ 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.