(192 days)
The Cable-Ready® Pin System is indicated for use in olecranon fractures, proximal humerus fractures, greater tuberosity humerus fractures, and medial malleolus tibial fractures may not be securely held by either a bone screw, bone pin, cable, or cerclage cable alone.
The Cable-Ready® Needle System is indicated for securing fractures of the olecranon, patella, humerus, shoulder and ankle, reducing and securing acromioclavicular dislocations as well as sternotomy surgery.
Zimmer is requesting clearance for modifications to the Cable-Ready Cable Grip System: Cable-Ready Pin System and Cable-Ready Needle System. The subject devices are similar in that they are both 1.3mm cables used in reconstructive and trauma surgery, securing bone fractures. The stainless steel Cable-Ready Pin System has a partially threaded 4.0mm cancellous lag screw (pin), available in differing lengths, attached to the cable which is implanted into the bone. The Cable-Ready Needle System has a curved stainless steel surgical needle attached to either a stainless steel or titanium leader and cable that is passed through the bone. The needle is cut off once the fracture is secure. Both systems' cables utilize the same instruments to secure the crimp and trim off excess.
The provided document is a 510(k) summary for the Zimmer Cable-Ready Cable Grip System, which consists of the Cable-Ready Pin System and the Cable-Ready Needle System. It primarily outlines the regulatory process for receiving FDA clearance based on substantial equivalence to predicate devices, rather than detailing a study focused on specific acceptance criteria and performance metrics in the way one would for a novel AI/software medical device.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI algorithm performance, ground truth, expert adjudication, MRMC studies, and training/test set details) are not applicable to this document.
However, I can extract the information relevant to the performance data presented:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of specific acceptance criteria with numerical targets for device performance. Instead, it describes types of non-clinical performance evaluations and their conclusions regarding safety, effectiveness, and substantial equivalence to predicate devices.
| Performance Evaluation Type | Conclusion on Device Performance |
|---|---|
| Shelf Life | Accelerated aging testing shows a shelf life of 10 years. |
| Biocompatibility | Testing conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed. |
| Performance Evaluation (Cable Pin) | Static, fatigue, torque, and pullout testing demonstrate the device is safe, effective, and substantially equivalent to predicate devices. |
| Performance Evaluation (Cable Needle) | Engineering analyses demonstrate the device is safe, effective, and substantially equivalent to predicate devices. |
| Overall Conclusion | The data demonstrates that the subject devices are substantially equivalent to their respective predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of devices tested for each evaluation.
- Data Provenance: Not specified (e.g., country of origin). The testing was non-clinical (laboratory-based physical/mechanical testing) rather than clinical with patient data.
- Retrospective/Prospective: Not applicable, as this refers to clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these non-clinical tests would be the measured physical properties or successful completion of a test standard, not an expert assessment of clinical findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This typically refers to resolving disagreements among human readers or experts, which is not relevant for non-clinical device testing.
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. No MRMC study was conducted, as this device is a physical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical performance evaluation types were engineering standards, test methods, and material properties. For example, successful completion of ISO 10993-1 for biocompatibility, or meeting predefined mechanical performance benchmarks for static, fatigue, torque, and pullout testing.
8. The sample size for the training set:
Not applicable. This refers to AI algorithms.
9. How the ground truth for the training set was established:
Not applicable. This refers to AI algorithms.
Summary from the document:
The regulatory clearance for the Cable-Ready Cable Grip System was based on demonstrating substantial equivalence to existing predicate devices. This was achieved through a combination of non-clinical performance evaluations, including:
- Shelf-life testing: Accelerated aging to support a 10-year shelf life.
- Biocompatibility testing: Conducted according to ISO 10993-1 and 21 CFR 58 (Good Laboratory Practices). All tests passed.
- Mechanical performance testing: Static, fatigue, torque, and pullout testing for the Cable-Ready Pin System.
- Engineering analyses: For the Cable-Ready Needle System.
The conclusion drawn from these non-clinical studies was that the subject devices are safe, effective, and substantially equivalent to the predicate devices. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."
§ 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.