(63 days)
The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.
The NEOVIEW® Plating System is composed of the NEOVIEW® plates and the associated NEO screws. The NEOVIEW® plate is design to adequately maintain the bone fragments of distal radius and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The fixation of NEOVIEW® plate to the bone is performed by the associated NEO screws that are available on locking or not locking versions. Sizes: The NEOVIEW® plates include 4 different designs. The associated NEO screws are available in one diameter and a large range of lengths packaged individually of in a kit. Material: The NEOVIEW® plates are made of PEEK according to standard ASTM F2026 and include a marker made of tantalum according to ASTM F560. The NEO screws are made of Titanium alloy Ti-6Al-4V according to ISO 5832-3 and ASTM F136. Single use: The NEOVIEW® Plating System is designed for single use only. Sterilization: The NEOVIEW® Plating System is supplied sterile, using gamma irradiation. Place of use: The NEOVIEW® Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
This document is a 510(k) premarket notification for the In2Bones NEOVIEW® Plating System. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study of the device's performance in meeting specific acceptance criteria like those found in AI/ML performance studies.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document in the typical sense of AI/ML device evaluations.
However, I can extract information related to the performance testing that was done and the overall conclusion regarding acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Met acceptance criteria | The NEOVIEW® Plating System met the acceptance criteria in mechanical bench testing. |
| Similar to predicate device | Similar in intended use, design, material, technological characteristics, and principles of operation to the predicate device. |
| Safe and effective for its intended use | Determined to be substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document only mentions "mechanical bench testing."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was "performed by an independent test laboratory."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for mechanical bench testing typically relies on engineering specifications and physical measurements, not expert clinical consensus in the way AI/ML studies do.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication as described (e.g., 2+1) is relevant for human interpretation of clinical data, not mechanical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. An MRMC study is not relevant for this type of device (metallic bone fixation system) or the type of performance testing reported. The document explicitly states "animal and clinical testing being considered not applicable."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was it done?: Not applicable. This device is a physical implant, not an algorithm. The reported testing is for the physical and mechanical properties of the implant.
7. Type of Ground Truth Used:
- The ground truth for the "mechanical bench testing" would be based on engineering specifications and established biomechanical standards for bone fixation plates, which define acceptable strength, fatigue life, and other mechanical properties.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of Conclusions from the Document:
The document concludes that "Based on the comparison of indications for use and technological characteristics and the results of the testing performed, the NEOVIEW® Plating System is substantially equivalent to the predicate device identified in the 510(k) submission." This substantial equivalence is based on:
- Similarities in intended use, design, material, technological characteristics, and principles of operation to the predicate device (Piccolo Composite™ Distal Volar Radius Plate, K102597).
- Results from mechanical bench testing performed by an independent test laboratory, which indicated that the NEOVIEW® Plating System met its acceptance criteria.
- The absence of a need for animal and clinical testing for this specific type of device and 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.