(230 days)
The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.
The applicant is seeking 510(k) clearance for the KATOR Suture Anchor, a device designed to attach soft tissues to bone. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics comparison and nonclinical testing.
Here's an analysis of the provided information, structured to address your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Insertion | Meets criteria |
| Pullout Strength | Meets criteria |
| Cyclic Displacement Testing | Meets criteria |
| Pyrogenicity (BET Test) | Meets pyrogen limit specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual nonclinical tests (Insertion, Pullout Strength, Cyclic Displacement, Pyrogenicity). It only mentions that "All testing was performed on test units representative of finished devices."
Data provenance is not explicitly stated as retrospective or prospective, but considering it's nonclinical testing of a device, it would inherently be prospective testing performed in a controlled laboratory environment. There's no mention of country of origin for the data, but the manufacturer is based in Logan, Utah, USA, suggesting the testing was likely conducted in the US or by a US-affiliated lab.
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 this submission. The KATOR Suture Anchor is a physical medical device, and its performance is evaluated through mechanical and biocompatibility testing, not through interpretations requiring expert consensus or ground truth derived from expert opinions (as would be the case for AI/software devices or diagnostic tools). The "ground truth" here is defined by engineering and biological standards.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons above. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts when establishing ground truth, typically in the context of diagnostic or interpretive tasks. The nonclinical tests here have objective pass/fail criteria based on predefined specifications.
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
An MRMC study was not applicable and therefore not performed. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is a key component. The KATOR Suture Anchor is a physically implanted medical device, and its safety and effectiveness are determined by objective mechanical and biocompatibility tests, not by human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The KATOR Suture Anchor is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm performance" to evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical tests conducted:
- Mechanical Tests (Insertion, Pullout Strength, Cyclic Displacement Testing): The ground truth is established by engineering specifications and industry standards. The device is subjected to forces and movements, and its response is measured against predefined thresholds for strength, displacement, and ease of insertion.
- Pyrogenicity (BET Test): The ground truth is established by biological safety standards for pyrogen limits. The test measures the presence of pyrogens, and the result is compared against a specified limit to determine if the device meets safety requirements.
8. The Sample Size for the Training Set
This question is not applicable. The KATOR Suture Anchor is a physical medical device, and its development and testing do not involve "training sets" in the context of machine learning. The design and manufacturing processes are based on engineering principles and material science, not data training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as #8. There is no training set for a physical medical 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.