(128 days)
The Synthes Sternal ZipFix™ System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes Sternal ZipFix™ System consists of polyetheretherketone (PEEK Optima LT-3) cable ties with detachable, stainless steel needle. The ZipFix are placed in peristernal fashion through the intercostal space, with the help of the detachable needle. Once inserted, the needle is removed and the ZipFix™ are tightened and secured in place to provide stable fixation of the sternum. The ZipFix™ can be cut and removed for emergent, and long-term, re-entry through the sternum.
Here's an analysis of the provided text regarding the Synthes Sternal ZipFix™ System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Single Implant Static | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for static loading strength and stiffness compared to stainless steel surgical wire. |
| Single Implant Dynamic | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for fatigue strength compared to stainless steel surgical wire. |
| Cut-through Resistance | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for resistance to cut-through compared to stainless steel surgical wire. |
| Construct Strength | Equivalent or better than predicate (worst case construct) | Sternal ZipFix™ had equivalent or better performance for construct strength compared to the predicate (stainless steel surgical wire). |
| Needle Pull-out Force | Specific force threshold (not detailed, but implied) | The Sternal ZipFix™ passed the mechanical test acceptance criteria for needle pull out. |
| Creep Testing | Specific deformation limit under constant load (implied) | The Sternal ZipFix™ passed the mechanical test acceptance criteria for creep testing. |
| Tensioning Performance | Functional performance (implied) | The ZipFix™ application instrument passed the mechanical testing acceptance criteria for tensioning performance. |
| Life Cycle Testing | Functional performance over expected lifespan (implied) | The ZipFix™ application instrument passed the mechanical testing acceptance criteria for life cycle testing. |
| Biocompatibility | Meet biocompatibility requirements | Biocompatibility requirements have been met. |
| Cytotoxicity | Non-cytotoxic | The finished product was determined to be non-cytotoxic after sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the mechanical testing, nor does it specify the country of origin of testing (though "Synthes (USA)" suggests the testing was likely conducted in the US or under US regulations). The studies were non-clinical (mechanical testing), so the concept of "retrospective or prospective" data provenance for patient data does not apply here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device underwent non-clinical (mechanical) testing, not clinical studies requiring expert consensus on patient data. The "ground truth" for these tests would be the established engineering and material science standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As this was non-clinical mechanical testing, there was no expert adjudication in the sense of reviewing clinical cases. Test results against pre-defined engineering criteria and comparison to a predicate device served as the evaluation method.
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
No. The document explicitly states: "No clinical testing was performed to support this submission." Furthermore, this is a medical device for physical sternal fixation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical mechanical testing was based on:
- Established engineering measurement standards and methodologies for static loading strength, stiffness, fatigue strength, resistance to cut-through, needle pull-out force, creep, tensioning performance, and life cycle.
- The performance of a predicate device (Ethicon Stainless Steel Suture Wire), which served as a comparative benchmark for several key performance indicators.
- Biocompatibility and cytotoxicity standards for medical device materials.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" as understood in machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical medical device.
§ 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.