(54 days)
The OsteoCentric® Unifi MI® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including but not limited to periarticular and intraarticular fractures.
The OsteoCentric® UnifiMI® TCS Plating System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bone and bone fragments. The purpose of the submission is for a line extension of the OsteoCentric Bone Plate and Screw System, which includes 2.7mm angle iron plates, additional screw sizes, and the inclusion of titanium as a material. The principal benefit of the proposed 2.7mm angle iron new plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. This line extension has the same Indications for Use as the original system. This Line Extension will be known as the OsteoCentric® UnifiMI® TCS Plating System. The system features angle plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.
This 510(k) clearance letter for the OsteoCentric® UnifiMI® TCS Plating System describes an orthopedic plating system, not an AI/software device. Therefore, the information typically found in a study proving acceptance criteria for an AI-based medical device (such as those involving performance metrics like sensitivity, specificity, or AUC, and details about training/test sets, expert ground truth, and reader studies) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone plates and screws) by assessing its mechanical performance.
Here's a breakdown based on the provided document, addressing the closest applicable points:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates."
While specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly laid out in a table in this summary, the implicit acceptance criterion is:
- Acceptance Criterion: The mechanical strength and stability of the new 2.7mm angle iron plates and additional screw sizes must be equivalent to or better than the predicate devices, and not present a "new worst-case" scenario.
- Reported Device Performance: The data demonstrates substantial equivalence to the predicates in terms of mechanical strength and stability.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the public summary document. For mechanical testing of physical devices, this typically refers to the number of individual plates/screws tested.
- Data Provenance: Not applicable in the context of data acquisition for AI/software. The "data" here refers to the results of mechanical engineering tests (e.g., fatigue testing, static testing) performed on the physical devices. This testing would be done in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device clearance based on engineering testing, not clinical data requiring expert review for ground truth. The "ground truth" here is established by standardized mechanical testing methodologies (e.g., ASTM standards) and engineering principles.
4. Adjudication method for the test set:
- Not applicable. Mechanical test results are objective measurements (e.g., force, displacement), not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is a physical device, and MRMC studies are relevant for software/AI devices where human readers' performance with and without AI assistance is evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence for this physical device is based on engineering analysis and standardized mechanical testing results. The performance of the subject device (strength, stability) is compared against the known performance characteristics of the predicate devices, likely derived from similar benchtop testing or regulatory submissions.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary specific to this device type (physical orthopedic implant):
The "acceptance criteria" for this type of device primarily revolve around mechanical performance and material biocompatibility to ensure it is as safe and effective as existing legally marketed predicate devices. The study proving this involves:
- Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case." This would typically include:
- Mechanical Testing: Such as static compression/tension/torsion tests, fatigue testing, push-out/pull-out tests for screw fixation. These tests are often conducted according to relevant ASTM or ISO standards for bone plates and screws.
- Material Characterization: Ensuring the Titanium and Stainless Steel meet medical-grade specifications (ASTM F136, ASTM F138).
- Comparison to Predicates: The test results are then compared to the performance envelopes of the predicate devices. The "acceptance" is achieved if the new device's performance falls within an acceptable range, demonstrating it is "substantially equivalent" and does not introduce new safety or effectiveness concerns due to its mechanical properties or new geometry.
The document implicitly states that the acceptance criterion was met as the data demonstrated substantial equivalence to the predicates, particularly in showing that the "new bone plates and screws did not present a new worst-case."
§ 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.