(264 days)
The Tornier 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 Humeral Nail and Tornier Long Humeral Nail include intramedullary nails and screws. The Tornier Humeral Nail is a straight, cannulated intramedullary nail available in 9mm proximal diameter with a tapered 7mm distal diameter with nail lengths of 210mm, 230mm, 250mm, and 270mm long and a tapered 8mm distal diameter with nail lengths of 130mm, 210mm. 230mm. 250mm, and 270mm long. Both distal diameter sizes are available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm 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 130mm nails incorporate two or three screw holes for distal stabilization using 4.3mm screws. The nails and screws are manufactured from anodized titanium alloy. The polyethylene insert is manufactured from ultrahigh molecular weight polyethylene (UHMWPE).
This document is a 510(k) premarket notification for the Tornier Humeral Nail and Tornier Long Humeral Nail. It seeks to establish substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device evaluations. The submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing for MR compatibility.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set for an AI/ML component is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no AI/ML component requiring ground truth establishment is described.
4. Adjudication method for the test set:
Not applicable, as no AI/ML component requiring a test set or adjudication is described.
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, as this submission does not involve an AI assist feature for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this submission does not involve a standalone algorithm for performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no ground truth is required for the evaluation presented in this document.
8. The sample size for the training set:
Not applicable, as this submission does not involve an AI/ML component with a training set.
9. How the ground truth for the training set was established:
Not applicable, as this submission does not involve an AI/ML component requiring ground truth for a training set.
Summary of Device Evaluation:
The Tornier Humeral Nail and Tornier Long Humeral Nail were evaluated for Magnetic Resonance (MR) compatibility through non-clinical testing. The submission explicitly states:
- "The Tornier Humeral Nail and Tornier Long Humeral Nail has been evaluated in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff', dated October 10, 2023."
- "This testing was conducted to characterize the compatibility of the Tornier Humeral Nail System in the MR environment."
- "No clinical studies were performed."
The conclusion is that "The Tornier Humeral Nail System does not raise different questions of safety or effectiveness. Based upon a comparison of the intended use, materials, summary of technological characteristics, and non-clinical evaluation, the subject Tornier Humeral Nail and Tornier Long Humeral Nail is considered substantially equivalent to the current Tornier Humeral Nail and Tornier Humeral Long Nail (cleared as Aequalis Humeral Nail System on K133376)."
This document focuses on regulatory clearance for a medical device (intramedullary fixation rod) by demonstrating substantial equivalence to a predicate device, specifically addressing MR compatibility. It does not involve the evaluation of an AI/ML component or associated criteria like performance metrics for an AI system.
§ 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.