(29 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. Trochanteric Antegrade Nail is for single use only.
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The provided text describes a 510(k) premarket notification for the "TriGen Trochanteric Antegrade Nail." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a
new device.
Here's an analysis based on your requirements and the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Test Data: Withstand expected in vivo loading without failure. | Review of mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure. |
| Substantial Equivalence: Similarities in indications for use, design features, operational principles, and material composition to predicate devices. | The substantial equivalence is based on its similarities to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942) in indications for use, design features, operational principles, and material composition. |
| Clinical Equivalence: (Implicitly, that clinical outcomes are comparable to predicate devices). | Not explicitly stated as a separate clinical study with new data. Equivalence is inferred from mechanical data and substantial equivalence to existing devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document describes a 510(k) submission based on mechanical testing and substantial equivalence to predicate devices, not a clinical study with a "test set" of patients.
- Data Provenance: Not applicable. The data primarily comes from mechanical test data and comparisons to existing predicate devices. No patient-specific data is mentioned, thus no country of origin or retrospective/prospective nature is indicated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. As there was no clinical test set for this 510(k) submission, no ground truth was established by experts in this context. The "ground truth" for the submission is the regulatory determination of substantial equivalence based on engineering and design comparisons.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set or human interpretation was involved in the data presented in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. This is a premarket notification for a medical device (intramedullary nail), which typically relies on mechanical testing and substantial equivalence to existing devices rather than reader studies.
- Effect Size of AI Improvement: Not applicable, as no AI component or reader study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical implant (intramedullary nail), not an algorithm or software.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" in this context is the mechanical equivalence to established devices, as determined by engineering tests, and the regulatory determination of substantial equivalence by the FDA based on design, materials, and intended use as compared to predicate devices. It is not pathology, outcomes data, or expert consensus from a clinical trial.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable. No training set was used.
§ 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.