(130 days)
The OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
The OrthoHelix Clavicle Plating System is a set of metallic, implantable, bone fixation plates. The CPS includes universal plates and indication specific plates of different sizes. All plates are made from implant grade titanium alloy.
The provided text is for a 510(k) premarket notification for a Clavicle Plating System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the rigorous study results one would expect for a new AI/software device.
Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document. The submission aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device through mechanical testing and Finite Element Analysis, not through clinical performance metrics against a defined ground truth.
Here's an interpretation based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from "Substantial Equivalence" Section) |
|---|---|
| Mechanical Equivalence: The implants must perform mechanically similar to predicate devices. | Finite Element Analysis and mechanical testing confirm that the implants within the Clavicle Plating System are substantially equivalent to its predicate devices. |
| Functional Equivalence: The device must meet specified requirements for its intended use. | It meets the specified requirements for its intended use. |
| Safety and Efficacy Equivalence: No new issues of safety or efficacy are identified compared to predicate devices. | No new issues of safety or efficacy have been raised. |
| Indications for Use Equivalence: The device's indications align with those of predicate devices. | The indications for use are specified: fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission relies on mechanical testing and Finite Element Analysis (FEA), not a "test set" of clinical data or images. The "samples" would be the physical implants and associated materials used for mechanical testing and the computational models for FEA. The document does not specify the number of implants tested or the specifics of the FEA models.
- Data Provenance: Not applicable in the context of clinical data. The "provenance" of the engineering data would stem from internal testing and simulations conducted by OrthoHelix Surgical Designs, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No "ground truth" in the clinical AI sense is established. The "ground truth" here is adherence to mechanical and material standards, and equivalence to predicate devices, verified through engineering analyses.
4. Adjudication method for the test set:
- Not Applicable. No human-based adjudication of clinical performance against a "test set" occurred. The assessment is based on engineering principles and regulatory review.
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:
- Not Applicable. This is a hardware medical device (bone plating system), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device; there is no an algorithm or software to evaluate in a standalone manner.
7. The type of ground truth used:
- Engineering Standards and Predicate Device Performance: The "ground truth" for this submission refers to the established mechanical properties, material specifications, and performance characteristics of legally marketed predicate devices, as well as relevant engineering standards for bone fixation implants. The new device is considered "substantially equivalent" if it meets or exceeds these characteristics.
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. There is no "training set" or corresponding ground truth establishment process in the context of this traditional medical device submission.
§ 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.