(127 days)
The N8TIVE™ ACL Anatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during anterior cruciate ligament reconstruction surgeries of the knee.
The N8TIVE ACL Reconstruction System is designed for ACL repair and consists of the N8TIVE ACL Femoral and Tibial Implants, as well as various Class I ancillary devices, all of which may be marketed or used individually or in conjunction with one another. The N8TIVE ACL System provides fixation of a soft-tissue graft within the femoral and tibial tunnels to reconstruct the anterior cruciate ligament and is designed to create femoral and tibial tunnels that are "figure-eight" or oval shaped.
The N8TIVE ACL Femoral Implant consists of a polyether etherketone (PEEK) spacer, an ultra-high molecular weight polyethylene (UHMWPE) graft suspension loop, UHMWPE suture tape, and a titanium cortical button. The suspension loop is threaded through the titanium cortical button and the PEEK spacer and forms a symmetrical graft suspension construct. The suspension loop is tightened by pulling each "tail" of the suture to remove the slack and adjust the construct to match the tunnel length. The UHMWPE suture tape is provided to secure the graft to the spacer so that it remains seated during insertion into the bone tunnel.
The N8TIVE ACL Tibial Implant consists of a PEEK screw, a PEEK sheath, and an UHMWPE tether suture pre-threaded through the screw and through an optional titanium cortical button. The Tibial Implant is available in two sizes in order to accommodate specific patient anatomy: a 29 mm length screw with a 33 mm length sheath for smaller tibial anatomy and a 36 mm screw with a 40 mm sheath for larger tibial anatomy.
Both N8TIVE ACL Implants are supplied preloaded onto an inserter handle and are provided sterile. for single patient use only.
The N8TIVE ACL Implants may be marketed and/or used in conjunction with various Class I ancillary instruments. These instruments include both sterile/reusable instrumentation for use in the ACL reconstruction procedure.
The provided text describes a 510(k) summary for the ArthroCare® Corporation N8TIVE™ ACL Anatomic Reconstruction System. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (bench) testing, rather than device performance against specific acceptance criteria the way a clinical study would.
Here’s a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for device performance. Instead, it relies on comparative testing to predicate devices and conformance to design and performance specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Magnetic Resonance Imaging compatibility | Testing conducted; results confirm compatibility. |
| Mechanical performance (cyclic and static loading) comparable to predicate devices | Comparative testing conducted in a simulated human bone substrate; "All test results confirm that the N8TIVE ACL Reconstruction System is substantially equivalent to the predicate devices." |
| Insertion strength in dense bone model | Insertion strength testing conducted in a dense bone model; results confirm that the device meets its design, performance, and safety specifications. |
| Cyclic evaluation of the interface between UHMWPE suture tape and graft analog | Cyclic evaluation conducted; results confirm that the device meets its design, performance, and safety specifications. |
| Conformance to design and performance specifications | Design Verification testing conducted; "All test results confirm that the N8TIVE ACL Reconstruction System is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, specimens) used for each bench test. It indicates that "bench testing was conducted."
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified but implicitly would be related to the submitter, ArthroCare Corporation, located in Austin, TX, USA. The data is not retrospective or prospective in a clinical sense, as it’s bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" for this submission is based on engineering specifications, material science, and comparison to legally marketed predicate devices, not on expert clinical interpretation of data from a test set.
4. Adjudication Method for the Test Set
This question is not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
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
This question is not applicable. This 510(k) submission is for a medical device (ACL reconstruction system), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission refers to:
- Established material properties and standards for medical implants.
- The performance characteristics of the predicate devices.
- Engineering design and performance specifications.
The testing conducted aims to demonstrate that the N8TIVE ACL System meets these engineering and comparative standards.
8. The Sample Size for the Training Set
This question is not applicable. This is a medical device, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. As noted above, this is not a machine learning algorithm.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.