(57 days)
The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.
The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.
Here's an analysis of the provided text regarding the Sonoma Fibula Repair System, outlining the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or provide detailed performance data from a study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, and material composition.
However, based on the context of a 510(k) submission, the implicit "acceptance criteria" revolve around demonstrating comparable safety and effectiveness to legally marketed predicate devices. The "reported device performance" in this context refers to the similarities identified.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The new device's intended use is substantially the same as predicate devices. | The intended use of the subject device (Sonoma Fibula Repair System) is stated to be the same as the Acumed predicate devices (Acumed Small Bone Locking Rod System II). Both are for the fixation of fibula fractures and osteotomies. |
| Indications for Use Equivalence: The new device's indications for use are substantially similar, or a subset of, predicate devices. | The indications for use for the subject device are "the fixation of fibula fractures and osteotomies." This is described as limited to the fibula compared to additional anatomical locations for the Acumed predicate devices, indicating it is a subset. There were "no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945)." This implies that the previous K142945 submission already established equivalence for the fibula. |
| Technological Characteristics Equivalence: The new device's technological characteristics do not raise new questions of safety or effectiveness. | The implants are composed of "316 stainless steel per ASTM F138," a common and well-understood material in medical devices. The system utilizes "Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws," which is a design feature of the device. The assertion of "no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945)" further supports technological equivalence for this specific system. |
| Performance Testing (if required): Device meets relevant performance standards or demonstrates comparable performance to predicate(s). | The document explicitly states: "No performance testing was performed associated with the additional indication of osteotomies for the Sonoma Fibular Rod System." This suggests that previous performance testing (for K142945) was deemed sufficient for "fractures," and the "osteotomies" indication was considered equivalent without new testing based on design similarity. |
| Material Equivalence: The materials used are equivalent to predicate devices or well-established for medical use. | Implants are made of "316 stainless steel per ASTM F138." This is a standard medical grade material for orthopedic implants. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe an independent test set with efficacy data. The submission is a 510(k) for "substantial equivalence" to existing predicate devices, rather than a de novo submission requiring extensive clinical trial data.
The "data provenance" primarily consists of referencing existing FDA clearances (K142945, K071944, K031438) for the predicate devices. This indicates a reliance on the previously established safety and effectiveness of those devices, rather than new, primary data from a study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no independent test set with efficacy data is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. No independent test set is described.
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
Not applicable. This is not an AI-based device. It is a physical orthopedic implant system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI-based device.
7. The Type of Ground Truth Used
Not applicable. For a substantial equivalence claim for a physical implant, "ground truth" in the clinical efficacy sense (e.g., pathology, outcomes data) is typically established through a combination of:
- Engineering and Biomechanical Testing: (Though not explicitly detailed in this summary, would have been part of previous submissions for K142945).
- Clinical Experience with Predicate Devices: The long history of successful use of the predicate devices.
- Material Standards Compliance: Adherence to established ASTM standards for medical-grade materials.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-based device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI-based device.
§ 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.