(68 days)
T2 Proximal Humeral Nail: The T2 Proximal Humeral Nail is intended to be used for various types of proximal and/or diaphyseal fractures of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The T2 Proximal Humeral Nail is intended for single use only. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type BFractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.
T2 Humeral Nail: The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
This 510(k) submission is a line extension to the T2 Nailing System to add a new Proximal Humeral Nail with accessories, additional sizes of the T2 Humeral Nail, additional End Caps for various T2 nails and additional lengths of T2 Locking Screws. The T2 Nailing System also has the same basic design concepts as the predicate devices.
The provided text is a 510(k) Premarket Notification for the T2 Humeral Nail System Line Extension, which is a medical device for bone fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through human studies with specific acceptance criteria and ground truth.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
Here's why and what can be extracted:
- Acceptance Criteria & Reported Performance (Table): Not applicable for this type of submission. This device is a mechanical implant, not a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, etc. The "performance" is mechanical equivalence.
- Sample Size (Test/Training) & Data Provenance: Not applicable. There's no "test set" or "training set" in the context of typical AI/diagnostic device studies. The "study" mentioned is an FEA (Finite Element Analysis).
- Number of Experts & Qualifications / Adjudication Method / Ground Truth Type: Not applicable. These relate to studies involving human interpretation or clinical outcomes, which are not detailed here. The "ground truth" for a mechanical device is typically its physical properties and intended mechanical behavior.
- MRMC Comparative Effectiveness Study: Not applicable. There's no AI component or human reader interaction tested against the device itself.
- Standalone Performance: Not applicable in the context of AI algorithms. The device performs its function as a mechanical implant.
What the document does provide regarding "performance" and "study":
The document states:
- "The T2 Nailing System also has the same basic design concepts as the predicate devices."
- "FEA Analysis demonstrated comparable mechanical properties to the predicate device."
This indicates that the "study" was a Finite Element Analysis (FEA), and the "acceptance criterion" was demonstrating comparable mechanical properties to the predicate device. This is how mechanical equivalence is established for such devices. However, specific numerical acceptance criteria (e.g., "flexural strength must be within 5% of predicate") and the precise results are not detailed in this summary.
In summary, the provided document is a regulatory submission for a mechanical medical device, not a diagnostic or AI device. Hence, most of the requested information pertinent to AI/diagnostic study design is not present.
§ 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.