(49 days)
Repair of long bone fractures due to trauma or reconstruction
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy
The Metagen Activelock™ Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. The fundamental components of the system are a 4.5 mm wide x 250 mm long metal band, a titanium sleeve which slides onto the band, and a Nitinol clamp which secures the band. There are two metal band designs in the system; a .30 mm thick Ti 6Al-4V band, and a .Smin thick Nitinol band. Both bands in this system are secured with the same Nitinol clamp. The sleeve is a low profile titanium block with slots to accept the band and sharp tines which project into the bony surface. The Nitinol clamp component provides a positive method of securing the band. When viewed from the top the clamp is an open. rectangular block. A side view shows the through slot that accepts and ultimately secures the band. Because of the super-elastic properties of the Niinol material, the clamp component can be physically stretched along its with a cerclage applicator instrument . The cerclage applicator instrument device by design limits the elongation of the slot well within the clamp's elastic range. The clamp is in no danger of undergoing permanent (plastic) deformation.
When the slot is elongated, the band fits easily through the slot. Upon release of the stretching force, the clamp retracts toward its resting position and engages the hand with sufficient force to lock the band securely in place. Mechanical testing of the assembled device comparing the band in both titanium and Nitinol to 18 and 16 gage twisted monofilament wire assemblies shows that the Activelock ™ system exceeds the strength of the twisted wire assemblies.
The provided submission is a 510(k) summary for the Metagen Activelock™ Cerclage System, seeking to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through a dedicated study with specific acceptance criteria that would typically generate the detailed performance data requested. Therefore, many of the requested data points (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, ground truth details, and training set information) are not applicable or provided in this type of submission.
However, based on the "Mechanical Testing" section, we can infer a primary acceptance criterion and its reported performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from "Mechanical Testing") | Reported Device Performance |
|---|---|
| Tensile strength equal to or greater than clinically accepted 16 and 18 gage stainless steel cerclage wire. | "The data support the hypothesis that the Metagen band/NiTi clamp design provides tensile strength equal to or greater than that of clinically accepted 16 and 18 gage stainless steel cerclage wire." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "static tensile tests were performed" comparing the Metagen system (both maximum material condition (MMC) and least material condition (LMC) clamps and bands) against "both 16 gage and 18 gage AISI Type 316L stainless steel cerclage wires." While not a specific number, it indicates a comparative mechanical test rather than a clinical trial with human subjects.
- Data Provenance: The data is generated from in vitro mechanical testing. There's no information on country of origin, and it's by definition a prospective test (not retrospective human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical engineering test comparing tensile strength of physical devices, not a study requiring expert clinical assessment or ground truth establishment in the traditional sense. The "ground truth" here is the measured tensile strength of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was a mechanical test, not a subjective clinical assessment that would require adjudication.
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 device is a physical cerclage system, not an AI or imaging diagnostic algorithm. There were no human readers or AI in this context.
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 comparison was the measured tensile strength of "clinically accepted 16 and 18 gage stainless steel cerclage wire." This is an objective, quantitative measurement from mechanical testing of existing, predicate devices.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable for the reason above.
§ 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.