(46 days)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Adolescent TAN is for single use only.
Intramedullary Nail
This submission describes a medical device, the TriGen Adolescent TAN (an intramedullary nail), and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding a test set, ground truth, or training set as typically seen for AI/ML-based devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance (no criteria or performance metrics are mentioned beyond mechanical equivalence).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
- Standalone (algorithm only) performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
Based on the provided text, the device's acceptance is based on its substantial equivalence to predicate devices, supported by a review of mechanical test data.
Here's what can be extracted:
Acceptance Criteria and Device Performance (as inferred from the document):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to currently used clinically devices. | "The TriGen Adolescent TAN is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." |
| Similarities in indications for use, design, operational principles, and material composition to predicate devices. | Stated to be "substantially equivalent" to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942) based on these similarities. |
Study Information:
- Type of Study: Mechanical test data review and comparison to predicate devices. This is not a clinical study involving human patients or an AI/ML algorithm.
- Data Provenance: Not applicable as it's a mechanical test and comparison to predicate devices, not data from a test set of cases.
- Ground Truth: The "ground truth" in this context refers to the established mechanical performance of existing, clinically used devices and the design/material properties of the predicate devices.
- Sample Sizes: Not applicable in the context of clinical test or training sets for AI. The "sample" would be the tested device itself and the predicate devices for comparison.
- Experts: Not explicitly stated as "experts for ground truth," but the evaluation was conducted by the FDA and the manufacturer, implying qualified personnel.
Summary of Device Acceptance:
The TriGen Adolescent TAN received 510(k) clearance based on a finding of substantial equivalence to existing, legally marketed predicate devices. This determination was primarily supported by:
- Mechanical Test Data: A review indicated the device performs equivalently to existing clinical devices and can withstand expected in-vivo loading without failure.
- Comparison to Predicate Devices: The device's indications for use, design features, operational principles, and material composition were found to be similar to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942).
§ 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.