(17 days)
The T2 Proximal Humeral Nail 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 calotte, or Humeral Fractures according to Neer-Classification.
This Special 510(k) submission is a line extension to the T2 Nailing System to add a new style of Proximal Humeral Nail. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nail is intended for single use only.
The provided text describes a Special 510(k) submission for a line extension to the T2 Nailing System, adding a new style of Proximal Humeral Nail. The submission focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices. Instead, it relies on demonstrating comparable mechanical properties to a predicate device for a physical medical device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Properties | "FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device." |
| Material Composition | "The material used to manufacture the line extension to the T2 Nail System is identical to that of the predicate." |
| Intended Use | The intended use for the T2 Proximal Humeral Nail is consistent with the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not describe a test set or data provenance in the context of an AI/software device. The evaluation method mentioned is "FEA analysis and mechanical testing," which refers to engineering simulations and physical tests on the device itself, not data from patients or a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this submission. The "ground truth" here relates to the mechanical properties of the physical device, established through engineering standards and testing, not expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this submission as there is no human-interpreted test set requiring 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
This is not applicable. This submission is for a physical orthopedic implant (an intramedullary nail), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established mechanical properties and material composition of the predicate device, which are used as a benchmark for comparison. This is based on engineering specifications and prior performance of approved devices.
8. The sample size for the training set
This is not applicable. There is no training set mentioned or implied for this physical device submission.
9. How the ground truth for the training set was established
This is not applicable as there is no training set involved.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study described is an engineering and materials-based assessment rather than a clinical or AI performance study.
- Study Type: Mechanical testing and Finite Element Analysis (FEA).
- Objective: To demonstrate that the new T2 Proximal Humeral Nail line extension has "comparable mechanical properties" to its predicate device and is made of "identical" material.
- Methodology:
- Material Comparison: Stated that the material used for the new device is "identical" to that of the predicate.
- Mechanical Property Comparison: Performed "FEA analysis and mechanical testing." While specific tests (e.g., bending, torsion, fatigue) are not detailed, these are standard methods for evaluating the structural integrity and performance of orthopedic implants.
- Results: The FEA analysis and mechanical testing "demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device."
- Conclusion: The device meets the acceptance criteria by demonstrating substantial equivalence in material and mechanical performance to a legally marketed predicate device. This approach is typical for line extensions of physical medical devices where the changes are limited and do not alter the fundamental scientific technology or intended use.
§ 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.