(28 days)
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.
This document describes the PRECICE Trauma Nail System, which is an intramedullary nail for fixing long bone fractures, pseudoarthrosis, mal-unions, and non-unions. The submission is a Special 510(k) focusing on modifications to an already cleared predicate device (PRECICE Trauma Nail System, K113695).
Based on the provided text, the device itself is a mechanical intramedullary nail system and thus the studies performed are not human-in-the-loop AI studies, nor does the device rely on AI/ML, algorithms, or data for ground truth establishment. Instead, the studies are focused on demonstrating the mechanical and functional equivalence of the modified device to its predicate.
Here's an analysis based on the provided text, with clarifications where the requested information is not applicable to this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, etc.). The "performance" here refers to the physical and functional attributes of the modified nail.
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Design Equivalence | Same intended use | Identical intended use |
| Same principles of operation | Same principles of operation | |
| Similar materials | Same materials as modified PRECICE Nail in PRECICE Intramedullary Limb Lengthening System | |
| Similar technological characteristics | Same technological characteristics as modified PRECICE Nail in PRECICE Intramedullary Limb Lengthening System | |
| Physical/Functional Equivalence | Mechanical Testing (e.g., strength, fatigue) | Performed on referenced PRECICE Intramedullary Limb Lengthening System |
| Design Verification Testing | Performed on referenced PRECICE Intramedullary Limb Lengthening System | |
| Magnetic Field Safety Testing | Performed on referenced PRECICE Intramedullary Limb Lengthening System | |
| Packaging and Shelf-life Validation | Performed on referenced PRECICE Intramedullary Limb Lengthening System | |
| Sterilization Validation | Performed on referenced PRECICE Intramedullary Limb Lengthening System | |
| Biocompatibility Testing | Performed on referenced PRECICE Intramedullary Limb Lengthening System | |
| Specific Modifications | Incorporation of design changes from PRECICE Intramedullary Limb Lengthening System | Achieved |
| Addition of 8.5mm diameter nail | Included in product offerings | |
| Supplied pre-distracted by 10mm | Confirmed for compression fracture reduction techniques |
Study Details:
The study described is not a clinical trial or an AI/ML performance study. It's a benchtop and engineering study demonstrating that the modifications to the PRECICE Trauma Nail System (specifically, adopting design changes from the PRECICE Intramedullary Limb Lengthening System and adding an 8.5mm diameter) do not alter the substantial equivalence to the previously cleared predicate PRECICE Trauma Nail System. The core studies (mechanical, design verification, magnetic field safety, packaging/shelf-life, sterilization, biocompatibility) were performed on the referenced PRECICE Intramedullary Limb Lengthening System, and these results were deemed applicable because the modified PRECICE Trauma Nail is identical in design to the PRECICE Nail in that system, with the only difference being the pre-distraction feature.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of "test set" for data-driven AI/ML models. The "test set" here refers to the actual physical devices (or components) subjected to various engineering and performance tests. The document doesn't specify the exact number of nails or components tested, but it implies standard engineering testing practices where a sufficient number of samples are used to ensure statistical confidence in results (though specific numbers aren't provided in this summary).
- Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective clinical data for AI/ML. The "data" comes from laboratory and benchtop testing of the specific medical device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context is established by engineering specifications, validated test methods, and regulatory standards for mechanical and material performance, not by expert consensus on clinical findings. The evaluation is done by engineers and scientists, not clinical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" in an engineering context would refer to internal validation and review processes by qualified engineers to ensure test protocols were followed and results were interpreted correctly, but this is not typically detailed in 510(k) summaries in the same way as clinical adjudication.
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
Not applicable. This is not an AI/ML device and does not involve human readers or image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established engineering specifications, material properties, and performance standards for intramedullary fixation rods. For example, the ground truth for mechanical testing would be the breaking point, fatigue life, or magnetic field compatibility as defined by relevant ISO or ASTM standards, and comparative performance to the predicate device's established performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth.
§ 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.