(42 days)
The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
The size and number of plate(s) used should be adapted to the specific indication.
The Newdeal Compression Plate will offer the combination of two concepts:
- By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the
- . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473).
The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm.
Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476).
Plates, screws and washers will be provided either sterile or non-sterile.
The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.
The provided text describes a medical device, the "Newdeal Compression Plate," and its regulatory submission (510(k)) to the FDA. The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than an AI-powered device performance study.
Therefore, many of the requested categories about AI device performance will not be applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not an AI Device)
Since this document describes a traditional medical device (compression plate) and not an AI-powered one, the concept of "acceptance criteria" for algorithms and their "reported device performance" in terms of metrics like sensitivity, specificity, or AUC is not applicable. The device's performance is assessed through mechanical tests to demonstrate its physical properties are compatible with its intended use.
| Acceptance Criteria (Mechanical) | Reported Device Performance |
|---|---|
| Mechanical properties compatible with intended use (implicitly, non-inferior to predicate device) | Mechanical tests show compatibility with intended uses and substantial equivalence to predicate devices (Large UNI-CLIP, K061594). |
Study Details (Mechanical Device, Not AI)
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Sample size used for the test set and the data provenance: Not applicable for an AI device. For the mechanical tests, the specifics of the samples (e.g., number of plates tested, type of mechanical stress applied) are not detailed in this summary. Data provenance is not relevant in the context of mechanical testing of a physical device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the physical properties of the device, established through engineering measurements, not expert interpretation.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI device, so MRMC studies involving human readers and AI assistance are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
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The type of ground truth used: For the mechanical tests, the "ground truth" would be established by the physical and material science properties measured during testing and compared against established engineering standards or the predicate device's performance.
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The sample size for the training set: Not applicable. There is no AI model to train.
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How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information for this Traditional Device:
- Device Type: Newdeal Compression Plate (a metallic bone fixation appliance).
- Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.
- Demonstration of Performance: Mechanical tests were carried out, and the results showed that the Newdeal Compression Plate has "mechanical properties compatible with their intended uses." These results were compared with a predicate device, the Large UNI-CLIP (K061594).
- Predicate Devices:
- Conclusion: The device is substantially equivalent to the predicate devices and does not raise new issues of scientific technology, safety, or effectiveness.
This document clearly pertains to a physical medical device and its mechanical testing, not an AI-powered diagnostic or assistive tool.
§ 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.