(86 days)
The T2™ Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients. Specific indications include: - Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and . fibula in pediatric and small-statured patients. - Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm . fractures in all patients.
The T2™ Flexible Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design that can be cut to size intraoperatively. The nail is available in eight diameters and two lengths. The nails will be available sterile and non-sterile in titanium alloy and stainless steel.
This document is a 510(k) summary for a medical device called the T2™ Flexible Nail, an intramedullary nail for bone fracture stabilization. It is not an AI/ML device, therefore the typical acceptance criteria and study information for such devices are not applicable.
The document discusses the device's substantial equivalence to predicate devices, which is the basis for its clearance by the FDA, rather than performance against pre-defined acceptance criteria or a clinical study in the context of AI/ML performance metrics.
Therefore, I cannot provide the requested information in the format of AI/ML device performance and study details, as this device does not fall into that category.
Here's a breakdown of why the requested information cannot be generated based on the provided text, related to the typical requirements for AI/ML medical devices:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics (like sensitivity, specificity, accuracy, etc.) or acceptance criteria for the T2™ Flexible Nail in the way an AI/ML device would. Instead, it relies on demonstrating substantial equivalence to existing devices.
- Sample sized used for the test set and the data provenance: Not applicable. There is no AI model being tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI model, and thus no "ground truth" to establish through expert consensus for a test set. The efficacy of this device is assessed through clinical use of similar devices and potentially mechanical testing, not through expert interpretation of data for model validation.
- Adjudication method: Not applicable for the same reasons as above.
- 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 a physical medical device, not an AI diagnostic or aid.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical medical device often comes from clinical outcomes, long-term follow-up, and mechanical testing results, not from expert consensus on interpretations of data for AI model training or testing.
- The sample size for the training set: Not applicable. There is no training set for an AI model.
- How the ground truth for the training set was established: Not applicable.
The provided document describes a traditional medical device (an intramedullary nail) seeking 510(k) clearance based on substantial equivalence, which is a different regulatory pathway compared to AI/ML devices that often require evidence of performance against specific metrics.
§ 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.