(478 days)
The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery .
- . Fracture 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
The size and number of the plate(s) used should be adapted to the specific indication.
The Newdeal Compression Plates 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.
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.
This document describes a 510(k) premarket notification for a medical device, the "Modified Newdeal® Compression Plates." This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through clinical studies. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are not directly applicable to this type of regulatory filing.
Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not applicable:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the primary acceptance criteria for the modified device are demonstrating mechanical performance at least equivalent to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: Modified Newdeal Compression Plates must demonstrate mechanical properties that are substantially equivalent to the predicate Newdeal Compression Plates (K070447). | "Static and dynamic 4-point bending mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plates are substantially equivalent to the properties of the predicate devices: unmodified Newdeal Compression Plates, K070447, cleared on March 29, 2007." |
| No change in fundamental scientific technology. | "The proposed device does not change the intended use or fundamental scientific technology of the predicate device..." |
| No new issues of safety or effectiveness raised. | "...and does not raise any new issues of safety or effectiveness." |
| Indications for Use remain consistent or comparable to the predicate. | The Indications for Use for the modified device are provided and are consistent with bone fixation and reconstruction. The document states the modified device is substantially equivalent, implying the indications are also equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The document does not specify the exact number of plates or tests performed during the static and dynamic 4-point bending mechanical tests. It only states that tests "have been carried out."
- Data provenance: The document does not explicitly state the country of origin of the mechanical test data. Given the submitter's address is in France (Newdeal SAS), it is likely the testing was conducted in Europe. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission, not by analyzing past clinical data. This is a pre-clinical (bench-top) study, not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This point is not applicable. The "ground truth" concept (e.g., expert consensus on clinical diagnoses) is relevant for studies involving human interpretation or clinical outcomes. This submission is based on mechanical (bench-top) testing, where the "ground truth" is established by engineering standards and measurements, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This point is not applicable. Adjudication methods are used in clinical trials or studies where human assessment of outcomes or conditions requires agreement or arbitration. Mechanical testing does not involve such human adjudication in the same way.
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
This point is not applicable. This submission is for a medical implant (bone plate), not an AI-powered diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This point is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established mechanical properties and performance standards for bone fixation plates, as generally understood in the orthopedic device industry and often guided by international standards (though not explicitly mentioned here) for such testing. The comparison is made against the measured mechanical properties of the predicate device.
8. The sample size for the training set
This point is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.
9. How the ground truth for the training set was established
This point is not applicable for the same reason as point 8.
§ 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.