(23 days)
The KFx APPIANFx PEEK Femoral 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.
KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
The provided 510(k) summary describes a medical device, the KFx APPIANFx PEEK Femoral Implant with Inserter, and its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance testing rather than clinical studies involving patient data and ground truth established by experts.
Therefore, many of the requested categories related to clinical study design, expert evaluation, and ground truth are not applicable in this context.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | The materials used are biocompatible and identical to the materials used in the predicate device. The same materials are used in a myriad of legally marketed orthopedic devices. |
| Functional Performance | Non-clinical test data, which includes cycle testing and pullout strength, indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness. |
| Sterility | Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6. |
| Substantial Equivalence | Concluded to be substantially equivalent to the currently marketed predicate device (KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle) based on similar design, materials, and mode of operation. |
| Intended Use | Intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during ACL, PCL, MCL, LCL, and MPFL reconstruction. Performance data supports safe and effective use as indicated. |
| Device Dimensions | Available in 8 and 9 mm diameters and are 27 mm long pre-deployment. (This is a specification rather than a performance criterion, but it's a key physical characteristic that would be tested). |
| Single Use | Each device is intended for single use. (An acceptance criterion would involve verifying it's designed for and performs as a single-use device). |
| Pre-loaded | Device is pre-loaded on a sterile inserter. (An acceptance criterion would verify proper pre-loading). |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "non-clinical test data, which includes cycle testing and pullout strength." It does not specify the sample size for these engineering tests.
- Data provenance is not applicable as this refers to non-clinical laboratory testing, not human-derived data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on engineering testing and comparison to a predicate device, not clinical ground truth established by medical experts for patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This applies to expert review of clinical data, which was not part of this submission.
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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:
- Not applicable. This is a medical device (implant) and not an AI/imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (implant) and not an AI/imaging diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is established through engineering specifications and non-clinical mechanical testing results (e.g., strength measurements meeting defined thresholds, sterility levels, material composition verification), and comparison to the predicate device's known performance.
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The sample size for the training set:
- Not applicable. This refers to non-clinical engineering tests, not machine learning model training.
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How the ground truth for the training set was established:
- Not applicable. This refers to non-clinical engineering tests, not machine learning model training.
§ 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.