(31 days)
The Tornier Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
The Tornier Aequalis Humeral Nail System includes intramedullary nails and screws. The Tornier Aequalis Humeral Nail is a straight, cannulated intramedullary nail with a tapered distal diameter. Nails are provided in right and left configurations with a 9mm diameter and 130mm length. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated or non-cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the nail incorporates one screw hole for distal locking using 4.5mm screws. The nail and screws are manufactured from anodized Ti-6Al-4V alloy: The purpose of this 510(k) is to add 7mm or 8mm proximal diameter nails in lengths of 130mm, 210mm, 230mm, 250mm, and 270mm lengths to the predicate system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tornier Aequalis Humeral Nail System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary is for a medical device (intramedullary nail), not a software or AI-based device. Therefore, the "acceptance criteria" and "reported device performance" are based on non-clinical engineering and material testing, not diagnostic performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria Category | Details/Metric | Reported Device Performance/Conclusion |
|---|---|---|
| Non-clinical Laboratory Assessment/Testing | Evaluated device performance per design requirements and risk analysis. | "All tests met the pre-established acceptance criteria." |
| Bending Calculation Comparisons | Comparison of bending properties. | Not explicitly detailed, but implied to have met criteria within "All tests met the pre-established acceptance criteria." |
| Torque Testing | Evaluation of torque resistance. | Not explicitly detailed, but implied to have met criteria within "All tests met the pre-established acceptance criteria." |
| Technological Characteristics Equivalence | Material, design, sizing, indications, sterilization, and failure strength compared to the predicate device (K082754). | "The technological characteristics... of the Tornier Aequalis Humeral Nail System are substantially equivalent to the predicate device." |
| Overall Equivalence to Predicate Device | Based on risk analysis and acceptable results from testing. | "Based on risk analysis and acceptable results from testing, the Tornier Aequalis Humeral Nail System was found to be substantially equivalent to the predicate device." (This is the overarching conclusion rather than a specific performance metric, but it indicates meeting regulatory acceptance.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The studies conducted are non-clinical (engineering tests), not clinical studies involving patient data or test sets in the context of AI/software performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. "Ground truth" in the context of this device would refer to material properties and mechanical integrity, which are established through standardized engineering tests, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are relevant for human interpretation or AI output, not for the direct measurement of mechanical properties in non-clinical tests.
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
This information is not applicable. The device is an intramedullary nail, not an AI-based diagnostic or assistive software. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For this medical device, the "ground truth" used for evaluation would be:
- Measured Material Properties: Standards for the Ti-6Al-4V alloy regarding its strength, biocompatibility, etc.
- Mechanical Test Results: Direct measurements of bending strength, torque resistance, and other mechanical properties obtained through laboratory testing. These measurements are compared against pre-defined engineering specifications and performance of the predicate device.
- Design Specifications: The documented design requirements and specifications for the nail's dimensions, features, and intended function.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The development and testing of this physical device do not involve "training sets" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As explained above, there is no "training set" in the machine learning sense for this device. The development relies on engineering principles, materials science, and testing against established performance benchmarks for similar devices.
§ 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.