(89 days)
The AperFix® Tibial Implant with Inserter 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 Cayenne Medical AperFix® Tibial Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a screw and a twopart screw sheath. AperFix Tibial Implants are available in diameters of 8, 9, 10 and 11 mm with a standard length of 30 mm. Each device is intended for single use and is provided with a sterile inserter.
The provided 510(k) summary for the AperFix® Tibial Implant with Inserter (K083607) focuses on establishing substantial equivalence to predicate devices through mechanical testing. It does not contain information about clinical studies with human participants, expert review, or detailed ground truth establishment as would be typical for AI-based medical devices or diagnostic tools.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to human reader interaction or AI standalone performance) are not applicable or not present in this document.
Here's a breakdown of the available information based on the prompt's categories:
Acceptance Criteria and Reported Device Performance
The document states: "Mechanical testing was performed on the AperFix Tibial Implant. It was shown that pull-out strength is significantly higher than that of a predicate device."
This implies that the acceptance criterion for the mechanical testing was likely a demonstration of superior or at least equivalent (non-inferior) pull-out strength compared to a predicate device. The device "met" this criterion by showing significantly higher strength.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstration of superior or equivalent pull-out strength compared to a predicate device | Pull-out strength is significantly higher than that of a predicate device. |
Study Details (Limitations due to document content)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document only mentions "Mechanical testing was performed" but does not specify the number of samples tested or the origin of any data (as it's mechanical testing, 'country of origin' isn't really applicable in the same way clinical data would be).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. For mechanical testing, the "ground truth" is typically established by the physical testing methodology itself and validated against engineering standards, not by human expert assessment in the way clinical diagnostic accuracy is.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for human expert assessments of clinical data, not for mechanical testing of device properties.
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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
- No. This is a physical implant device, not a diagnostic or AI-assisted interpretation product. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an algorithm component.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing would be the measured physical properties (pull-out strength) under controlled laboratory conditions, validated against established engineering principles and possibly compared to a predicate device's known performance. It's not based on expert consensus, pathology, or outcomes data.
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The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI-driven device.
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How the ground truth for the training set was established
- Not applicable / Not provided. As there's no training set, this question is not relevant.
In summary, the 510(k) provided focuses on demonstrating substantial equivalence through a comparison of a key mechanical property (pull-out strength) with a predicate device. It does not involve AI, clinical studies, or expert review in the manner described by the prompt's more granular questions.
§ 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.