(27 days)
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
The Piccolo Composite Nailing System includes nails, screws and a set of instruments. The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.
This document is a 510(k) premarket notification for a medical device called the "Piccolo Composite® Nailing System - Proximal Femur." It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, sections related to study design, sample sizes, ground truth establishment, or expert involvement are not applicable or detailed in this document.
However, the document does mention "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use." This indicates that mechanical testing was performed to demonstrate that the new device performs similarly to existing, legally marketed devices.
Based on the provided document, here's what can be extracted and what information is not included:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that performance characteristics were "comparable to those of predicate devices (as applicable)," but it does not provide specific numerical acceptance criteria or the reported performance values for the Piccolo Composite Proximal Femur Nailing System. It mentions the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static bending of construct comparable to predicate devices | Performed; results comparable to predicate devices. |
| Dynamic bending of construct comparable to predicate devices | Performed; results comparable to predicate devices. |
| Lag screw torque to failure comparable to predicate devices | Performed; results comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components," suggesting mechanical testing rather than a clinical human subject study. The sample size would refer to the number of devices or components tested.
- Data Provenance: Not specified, but the tests would be laboratory-based and conducted by CarboFix Orthopedics Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This document describes engineering performance tests, not a clinical study involving human judgment on images or outcomes. Therefore, there is no "ground truth" to be established by clinical experts in this context.
4. Adjudication Method for the Test Set:
- Not Applicable. As this primarily describes mechanical testing, an adjudication method for a test set based on expert review is not relevant.
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:
- No. This is not an AI-powered device, nor is it a clinical comparative effectiveness study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware medical device (intramedullary nailing system), not an algorithm or AI.
7. The type of ground truth used:
- Not Applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance data of the predicate devices against which the new device's performance is compared. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is mentioned or relevant here.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI or machine learning device being trained.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.