(79 days)
The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK Tissue Anchors are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio- clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis, patellar tendon repair Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.
The provided text describes a 510(k) Premarket Notification for medical devices, specifically suture and tissue anchors. It details the device, its intended use, and states that non-clinical testing was performed. However, it does not contain information about formal acceptance criteria, a specific study proving those criteria were met, or any of the detailed aspects typically associated with clinical or performance studies for AI/software devices.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material biocompatibility and non-clinical engineering tests.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct study proving specified performance metrics against such criteria in a clinical context. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and functional performance requirements are satisfied. | "Non-clinical test data (deployment, static pull-out, and cyclic suture retention testing) 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." |
| Substantial equivalence to predicate device. | "The documentation provided demonstrates that the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The study mentioned is "non-clinical test data (deployment, static pull-out, and cyclic suture retention testing)." These tests are typically conducted on a sample of devices, but the exact number is not provided.
- Data Provenance: Not specified, but given it's non-clinical testing, it would likely be laboratory-generated data rather than patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable: The study described is non-clinical (mechanical testing), not involving ground truth derived from expert review of medical images or patient outcomes.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable: No adjudication method mentioned as it's non-clinical mechanical testing, not a clinical study involving human judgment.
-
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 medical device (suture/tissue anchors), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant, and no AI component is involved.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: See point 4. This is a physical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering specifications/measurements: For the non-clinical tests (deployment, static pull-out, cyclic suture retention), the "ground truth" would be the measured physical properties and performance characteristics against predefined engineering standards or comparison to the predicate device's performance.
-
The sample size for the training set:
- Not applicable: There is no mention of a training set as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable: See point 7.
§ 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.