(27 days)
The Newdeal Compression Plate is 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 size and number of the 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 Newdeal Compression Plate (K070447), 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 devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447).
The provided text describes a submission for a medical device called the "Newdeal Compression Plate," not an AI/ML device. Therefore, the acceptance criteria and study described are related to the mechanical properties and substantial equivalence of a physical orthopedic implant, not to the performance of a software algorithm.
Based on the nature of the submission (510(k) for a medical device) and the content, there is no mention of an AI/ML device or any study that would typically be associated with evaluating AI/ML performance (e.g., diagnostic accuracy, reader study, standalone performance against ground truth).
The document focuses on establishing substantial equivalence to a previously approved predicate device (Newdeal Compression Plate, K070447) based on mechanical testing.
Here's a breakdown of why the requested information for an AI/ML device cannot be provided from this document:
- No AI/ML device: The device is a "Newdeal Compression Plate," a physical orthopedic implant.
- No acceptance criteria for AI/ML performance: The acceptance criteria are implicit in demonstrating substantial equivalence in mechanical properties.
- No study proving AI/ML performance: The study performed was "Mechanical tests" to show the equivalency of the modified plate to the unmodified predicate device.
However, I can extract the relevant information from the document regarding the medical device itself:
Acceptance Criteria and Study for the "Newdeal Compression Plate" (Medical Device - Not AI/ML)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties are equivalent to the predicate device. | "Results have shown that the mechanical properties of the modified Newdeal Compression Plate are equivalent to the properties of the unmodified device, Newdeal Compression Plate, K070447." |
| Does not change intended use or fundamental scientific technology. | "The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated for the mechanical tests, but mechanical testing typically involves a set number of samples for various load, fatigue, and other biomechanical assessments.
- Data Provenance: Not specified, but generally refers to in-vitro laboratory testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable. For mechanical testing of a physical device, ground truth is established through standardized engineering test methods and measurements, not expert consensus in the clinical sense.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing data is quantitative measurement, not subjective assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is a medical device (implant) and not a diagnostic or screening tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the mechanical tests, the ground truth would be the quantitative measurements obtained from destructive and non-destructive mechanical tests (e.g., tensile strength, fatigue life, compression resistance, torsional resistance) against established engineering standards and comparison data from the predicate device.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical device being evaluated for mechanical equivalence, not an AI/ML model being trained.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document details a 510(k) submission for a physical orthopedic implant. It does not pertain to an AI/ML device, and therefore, the specific questions related to AI/ML performance evaluation cannot be answered from this text.
§ 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.