(36 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 510(k) submission is a line extension to the T2 Nailing System to add new types of Proximal Humeral Nails. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nails are intended for single use only.
The provided 510(k) summary (K042396) for the T2 Proximal Humeral Nail Line Extension is for a medical device (intramedullary nail) and not a diagnostic or AI-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) is not applicable here.
Instead, for a medical device like an intramedullary nail, "acceptance criteria" would typically relate to mechanical performance (e.g., strength, fatigue resistance), biocompatibility, manufacturing quality, and substantial equivalence to a predicate device. The "study" proving these criteria would be mechanical testing, biocompatibility testing, and comparison to a predicate device.
Based on the provided document, here's an attempt to extract the relevant information, aligning it as much as possible with your requested categories, even though they are largely designed for diagnostic devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (or how it was met) |
|---|---|---|
| Substantial Equivalence | Similar design concepts to predicate devices. | "The T2 Proximal Humeral Nail also has the same basic design concepts as the predicate devices." |
| Mechanical Properties | Comparable mechanical properties to predicate device. | "FEA Analysis demonstrated comparable mechanical properties to the predicate device." |
| Indications for Use | Alignment with the intended use of predicate devices. | The stated Indications for Use are consistent with those typically found for intramedullary nails for humeral fractures, implying alignment with predicate devices. |
| Biocompatibility | (Not explicitly stated in the provided text, but implied for all implantable devices) | (Not explicitly stated in the provided text, but would have been demonstrated as part of the overall submission for the T2 Nailing System). |
| Sterility | (Not explicitly stated, but implied for single-use surgical implants) | (Not explicitly stated, but would have been demonstrated as part of the overall submission for the T2 Nailing System). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable for a mechanical device submission. There is no "test set" in the context of patient data or readings for diagnostic accuracy. The "test set" would be physical nails subjected to mechanical testing. The document does not specify the number of nails tested in the FEA analysis. Data provenance relates to patient data, which is not relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" for a mechanical device is established through engineering specifications, material science, and mechanical testing standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this device.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" as this is not a diagnostic interpretation task.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and its goal is to assess the impact of AI assistance on reading performance. This device is a surgical implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "standalone" performance for a mechanical device would be its direct mechanical properties, which were assessed via FEA.
7. The Type of Ground Truth Used
For this device, the "ground truth" for mechanical properties would be:
- Engineering standards: e.g., ASTM standards for mechanical testing of orthopedic implants.
- Predicate device performance data: The mechanical performance of the legally marketed predicate device (to which the T2 Proximal Humeral Nail is claiming substantial equivalence) serves as the benchmark or "ground truth" for comparison.
- Material properties: Established properties of the implant materials.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and material selection based on established engineering principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI/ML sense. The analogous "ground truth" for the development of such a device is based on long-standing biomechanical principles, clinical experience with similar devices, and engineering design specifications.
In summary, the 510(k) for the T2 Proximal Humeral Nail Line Extension relies on demonstrating "substantial equivalence" to a predicate device, primarily through comparable design concepts and mechanical properties (verified by FEA Analysis), rather than through diagnostic performance 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.