(39 days)
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
- Periprosthetic fractures
- Comminuted fractures
- Fractures in osteopenic bone
- Nonunions
- Malunions
The NCB Straight Narrow Shaft Plates are a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the bone surface, reducing the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.
The provided document is a 510(k) summary for the Zimmer NCB Straight Narrow Shaft Plates, which are medical devices for internal bone fixation. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing and comparison to predicate devices, rather than clinical studies with human readers or AI.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a medical device for bone fixation, and the "acceptance criteria" are related to mechanical performance and substantial equivalence to existing devices. The document does not explicitly state acceptance criteria in a quantifiable table format, but rather describes the types of tests performed and the conclusion that the device performs similarly to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance and Conclusions |
|---|---|
| Mechanical Properties (Stiffness, Fatigue Strength) | Engineering analysis and comparative fatigue testing of the NCB Straight Narrow Shaft Plate against the Synthes 4.5 mm Locking Compression Plates (predicate devices) "resulted in very similar mechanical properties of both devices." Plate testing/analyses included: plate stiffness (bending and torsion), plate fatigue strength, screw/plate construct strength, construct strength with compatible cables and Cable Button, and compression slot resistance to screw pull-through. |
| Safety and Effectiveness | Results of non-clinical (lab) performance testing "demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." |
| Suitability for Use in Osteopenic Bone | A literature review was conducted and concludes that the proposed device is suitable for use in osteopenic bone. |
| Substantial Equivalence (Intended Use, Materials, etc.) | The NCB Straight Narrow Shaft Plates are "similar in intended use, materials, sterility, and performance characteristics to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact "sample sizes" for the mechanical tests (e.g., number of plates tested for fatigue). It mentions "comparative fatigue testing" and "plate testing/analyses," but not the quantity of items tested.
- Data Provenance: The tests are described as "non-clinical (lab) performance testing," indicating they were conducted in a laboratory setting. There is no mention of country of origin for the data beyond the manufacturer being Zimmer GmbH in Switzerland, and the FDA review being in the US. The data is prospective in the sense that the tests were performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device and submission. "Ground truth" established by experts typically pertains to diagnostic accuracy studies (e.g., radiologists interpreting images) for AI or diagnostic devices. For mechanical fixation devices like the NCB Straight Narrow Shaft Plates, the "ground truth" is based on established engineering principles, material science, and biomechanical testing standards, not expert interpretation of results in the same way. The "experts" involved would be those conducting the engineering analysis and testing, but their number and specific qualifications are not detailed in this type of submission summary.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human disagreement on "ground truth" (e.g., disease presence in an image) needs to be resolved. For mechanical testing, the results are typically quantitative and objective, following established protocols, and do not involve human adjudication in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is for evaluating diagnostic accuracy, often comparing human performance with and without AI assistance. This document describes a medical device for bone fixation, and its performance evaluation is mechanical. It does not involve human "readers" or AI assistance for diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is relevant for AI algorithms. The device described here is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is derived from:
- Established engineering and biomechanical principles: For tests like stiffness, fatigue strength, and construct strength.
- Material science standards: For evaluating the titanium alloy.
- Literature review: To substantiate the use in osteopenic bone, indicating reference to existing scientific knowledge and clinical outcomes data from similar devices/materials.
- Comparative data: The device's performance is compared directly to predicate devices, where the predicate devices' established performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical implant and does not involve AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 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.