(51 days)
Repair of long bone fractures due to trauma or reconstruction o
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement の arthroplasty, or other procedures involving trochanteric osteotomy
Sternotomy closure の
Sublaminar and intrafacet wiring of the spinal column 0
The Metagen ActiveLock™ Wire Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. There are two versions of the device disclosed in this submission. The fundamental components of each device are a straight, annealed CoCr alloy wire and a novel Clamp device to secure the wire is 16.5 gage (.048 inch) fully annealed CoCr alloy. (ASTM F-799). A Clamp is provided to secure the wire after tensioning. The Clamp is offered in a "Single" configuration, which secures opposing ends of a single wire, and a "Double" configuration, which secures the free ends of two adjacent wires.
The provided 510(k) summary for the Metagen ActiveLock™ Wire Cerclage System does not contain information about a study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device submission. This document is from 1998 for a mechanical medical device, not an AI/ML device, and therefore the structure and content of the submission are vastly different.
Here's an attempt to extract and reframe the information based on your requested categories, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of this submission.
Acceptance Criteria and Device Performance for Metagen ActiveLock™ Wire Cerclage System
This submission pertains to a mechanical wire cerclage system, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "reported device performance" typically associated with diagnostic AI algorithms (e.g., sensitivity, specificity, AUC) is not directly applicable. Instead, the submission focuses on mechanical testing to demonstrate performance against established benchmarks of predicate devices or existing standards. The primary criterion is demonstrating substantial equivalence in mechanical properties, particularly tensile strength, to already accepted devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Explicit) | Reported Device Performance (Metagen ActiveLock™ Wire Cerclage System) |
|---|---|---|
| Tensile Strength | Equal to or greater than clinically accepted 16 gauge stainless steel wire. | Data demonstrate that the Metagen wire/Clamp design provides tensile strength equal to or greater than that of clinically accepted 16 gage stainless steel wire. |
| Intended Use | Must align with predicate devices for: |
- Repair of long bone fractures
- Reattachment of greater trochanter
- Sternotomy closure
- Sublaminar/intrafacet wiring of spinal column | YES - Intended uses are the same as predicate devices. |
| Design Principles | Fundamentally the same as Metagen ActiveLock™ Cerclage Band system and comparable to pre-amendment stainless steel suture wire and cerclage cable systems. | System features a novel locking Clamp (similar to ActiveLock™ Band). Manual tightening instrument used for reduction/consolidation (similar to ActiveLock™ Band). Clamping methods similar to predicate cable systems (e.g., crimp, swage, sleeve). |
| Material Composition | Wire: CoCr alloy (ASTM F-799) Clamp: Nitinol (superelastic effect utilized) | Wire: CoCr alloy conforming to ASTM F-799.
Clamp: Nitinol, utilizing its superelastic effect for clamping force. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The submission mentions "Mechanical Testing" was performed and "data demonstrate" equivalence, but the number of samples tested is not quantified in this summary.
- Data Provenance: Not explicitly stated, but it would be from in-vitro mechanical testing conducted by the manufacturer, Metagen, LLC. It is prospective testing designed to characterize the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is a mechanical device, not an AI/ML diagnostic. Ground truth would be based on engineering measurements and material science standards (e.g., ASTM F-799) rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Mechanical tests typically involve direct measurement against defined standards, not human adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI/ML device, so a MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone Performance Study (Algorithm Only)
- Not applicable. This is a mechanical device. The "standalone performance" is its mechanical properties (tensile strength), which were evaluated through direct testing without any human-in-the-loop component in the assessment itself.
7. Type of Ground Truth Used
- Engineering Standards and Benchmarks: The "ground truth" for this device's performance is based on established engineering standards for materials (e.g., ASTM F-799 for CoCr alloy) and the performance characteristics (e.g., tensile strength) of predicate devices (like 16 gauge stainless steel wire, DePuy Control Cable System, Howmedica Dall-Miles Stainless Steel Cable) that are already clinically accepted. The "ground truth" is therefore comparative performance against accepted mechanical properties.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is designed and manufactured based on established engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.