(59 days)
The AperFix AM Femoral Implant is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
The AperFix AM Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment. Modifications to the device that are the subject of this submission are confined solely to limited to a line extension consisting of a 24 mm (shortened) version of the original 29 mm implant to enable greater flexibility in tendon graft placement within the femur when clinical conditions (i.e. anatomy and/or deformity) preclude use of the original 29 mm device. The body wedge and wings of the modified 24 mm device differ from those of the original 29 mm device in that the wings are one piece (as opposed to using an assembly of a wedge, two arms, and two pins). In both the 24 mm and 29 mm versions of the AperFix device, the advancing head of the central screw causes lateral deflection of the body as the implant is secured in position. In the subject 24 mm device, the wings engage the wall of the femoral tunnel upon tightening the central screw. In the predicate 29 mm device the arms engage the wall of the femoral tunnel upon tightening the central screw and wedge.
Here's a breakdown of the acceptance criteria and study information for the AperFix® AM Femoral Implant with Inserter, based on the provided 510(k) summary:
The provided document is a 510(k) Summary for a device modification, specifically a line extension (a shortened version of an existing implant). The primary focus of this type of submission is to demonstrate substantial equivalence to a predicate device, rather than proving initial safety and efficacy for a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described herein relate to demonstrating equivalence for the modification, not necessarily proving full clinical utility from scratch.
Here is the requested information:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Pull-out strength comparable to predicate device "It was shown that pull-out strength is comparable to the predicate device." Product dimensional analysis met component and product specifications "Product dimensional analysis met the components and product specifications." -
Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Mechanical testing was performed" and "Dimensional analysis was performed," but does not provide specific sample quantities for these tests.
- Data Provenance: The document does not specify country of origin for the data or whether the tests were retrospective or prospective. Given the nature of mechanical and dimensional testing, these are typically prospective laboratory tests conducted by the manufacturer.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth for mechanical and dimensional testing is established by technical specifications, engineering standards, and direct measurement, not by human expert interpretation.
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Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or image-based studies. Mechanical and dimensional tests have objective pass/fail criteria based on predefined specifications.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. This submission is for an orthopedic implant.
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If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
- Not applicable. This is an orthopedic implant, not an algorithm or software device. Performance is based on mechanical properties and dimensions, not algorithmic output.
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The Type of Ground Truth Used
- Engineering Specifications and Standards: For mechanical testing (pull-out strength), the ground truth would be defined by established engineering principles for fixation strength in bone, relevant ASTM standards (if applicable), and the performance characteristics of the predicate device. For dimensional analysis, the ground truth is the engineering design specifications and drawings for the implant components.
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The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of mechanical and dimensional testing for a physical implant. The device's design is validated against specifications, not trained on data.
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How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no training set, there's no ground truth for it. The "ground truth" for the device's design and performance validation (as mentioned in point 7) is established through engineering design, material science principles, and comparison to the predicate device.
§ 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.