(43 days)
The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: Moderate to severe Hallux Valgus, Hallux varus
The Basal Dorsal Plate is designed for fixation of basal osteotomy of the 1st metatarsal. Characteristics of the plate have taken into account all the requirements associated with basal osteotomy: Anatomical shape adapted to the dorsal curve of the basis of the 1st metatarsal, in two different lengths for better adaptation to the specific anatomy of the patient. Fixation with CALCANEA 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. The Basal Dorsal Plate and CALCANEA screws are made from titanium alloy (Ti-6AI-4V ELI), which are color-coded for ease of identification. Fixation of the Basal Dorsal Plate is provided by four CALCANEA screws, already cleared with the CALCANEA Plate and Screws system (510(k) K041786). The plates and screws are provided sterile with the Basal Dorsal Plate.
Here's an analysis of the provided text regarding the Basal Dorsal Plate, focusing on acceptance criteria and supporting studies:
It is important to note that the provided text is a 510(k) summary for a medical device (Basal Dorsal Plate). Such summaries are typically a declaration of substantial equivalence to a predicate device, rather than a detailed report of clinical or advanced performance studies. Therefore, direct "acceptance criteria" as one might see for an AI algorithm or a clinical trial endpoint, and "study that proves the device meets the acceptance criteria" in that context, are not fully present. Instead, the document focuses on mechanical testing and comparison to predicate devices to demonstrate equivalence for market clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Bending resistance equivalent to or greater than predicate devices (Synthes Modular Foot System). | An evaluation based on mechanical calculations demonstrated that the bending behavior of the Basal Dorsal Plates will be equivalent or greater than the predicate devices. |
Mechanical tests were carried out, and all results show that the Basal Dorsal Plates have mechanical properties compatible with their intended uses. |
| Material Compatibility:
Manufactured from biocompatible and known materials appropriate for implantation. | Made from titanium alloy (Ti-6AI-4V ELI). This is a standard and well-understood material for implants, implicitly meeting biocompatibility and material strength requirements. |
| Fixation Mechanism Stability:
Screws provide stable fixation and a locking design for system stability. | Fixation with CALCANEA™ 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. These screws are already indicated for use with the CALCANEA™ Plate and Screws system (510(k) K041786), implying their established performance. |
| Substantial Equivalence:
Comparable in intended use, technological characteristics, and safety/effectiveness to predicates. | Substantially equivalent to Newdeal B-BOP Plate, K052152, and Acumed Lower Extremity Congruent Bone Plate System, K033639. The device "do not raise any new issues of scientific technology, safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of physical plates tested for the mechanical evaluation. It refers to "mechanical calculations" and "mechanical tests." For medical implants, this typically involves a set number of units tested to destruction or to defined limits under various load conditions, following recognized ASTM or ISO standards. However, the exact number is not stated.
- Data Provenance: The mechanical testing data would be generated internally by Newdeal SAS or a contracted testing facility. The country of origin for the device developer is France. The data itself is prospective in the sense that the tests were specifically conducted to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of 510(k) submission. For mechanical testing of an implant, "ground truth" is established by engineering specifications, validated test methods (e.g., ASTM standards), and material properties, not by human expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, test results are typically objective measurements, and any "adjudication" would refer to expert engineering review and interpretation of the raw data against predetermined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is relevant for diagnostic imaging AI, where human readers interact with AI assistance. The Basal Dorsal Plate is a surgical implant, not a diagnostic tool requiring human interpretation.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This concept is not applicable to the Basal Dorsal Plate. It is a physical medical device, not an algorithm. The "performance" is its mechanical integrity and function as an implant in the body, which is evaluated through mechanical testing and clinical experience of substantially equivalent predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Engineering specifications and material properties: For aspects like bending resistance and material compatibility. These are defined by established biomechanical principles and regulatory standards.
- Performance of predicate devices: The "expected in vivo specifications performance" is benchmarked against the known safe and effective performance of legally marketed predicate devices. This implicitly means that the clinical outcomes and performance data of those predicates serve as the "ground truth" for what constitutes an acceptable device.
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" for a physical medical implant like a Basal Dorsal Plate in the context of an AI algorithm. The design and manufacturing process are informed by general engineering principles, biomechanical understanding, and lessons learned from previous similar devices, but not through a formal "training set" like one created for machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this is not applicable. The design decision-making relies on established engineering principles, biomechanical requirements for the specific anatomical location (1st metatarsal), and understanding of surgical procedures like basal osteotomy.
§ 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.