(117 days)
The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Sports Medicine Sternal Closure System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in a quantitative format. Instead, it relies on a comparative statement against predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent cyclic fatigue strength to predicate devices. | "The test results indicate that the Biomet Sports Medicine Sternal Closure System provide equivalent cyclic fatigue strength to the predicate devices and would be functional within their intended use." |
| Functional within intended use. | "The test results indicate that the Biomet Sports Medicine Sternal Closure System provide equivalent cyclic fatigue strength to the predicate devices and would be functional within their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing was performed" and "The efficacy of the Biomet Sports Medicine Sternal Closure System was compared to that of the Ethicon Surgical Stainless Steel Sutures," implying a test set was used, but the number of devices or iterations tested is not provided.
- Data Provenance: The testing was "Non-clinical laboratory testing," suggesting an in-vitro or bench-top study. The location or specific laboratory where this testing occurred is not detailed. The data is retrospective in the sense that it's a submission after the tests were conducted, but it's not clinical retrospective data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical laboratory study involving mechanical testing, not a clinical study requiring expert assessment of images or patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as this was a non-clinical mechanical test, not a study requiring human adjudication of results.
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. The provided document concerns a medical device (Sternal Closure System), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI-powered device. The "standalone" performance refers to the device's mechanical properties without human interaction during its function (i.e., its ability to provide equivalent cyclic fatigue strength).
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study was the mechanical performance (cyclic fatigue strength) of the predicate devices. The Biomet system's performance was measured against the established performance of these legally marketed devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would be the design and engineering process of the device, informed by existing knowledge of sternal closure mechanics and predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning device, there is no "training set." The understanding that informed the device's design would stem from engineering principles, material science, and the known performance characteristics of existing sternal closure systems (predicate devices), rather than a specific "ground truth" derived for a training set.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.