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The Knotilus™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

The Knotilus Anchor System consists of:
• Knotilus Anchor - an implantable anchor preloaded on a disposable inserter to aid with anchor insertion into the bone. The Knotilus Anchor will be offered in outer diameters ranging from 3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm.
• Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema) loop designed for fixation of soft tissue without the need of knot tying. The Knotilus Implant Loop will be offered with a total length of 470 mm and distal loop sizes of 22 mm, 25 mm and 28 mm.
The Knotilus Anchor and Knotilus Implant Loop will be provided separately, sterile for single use only.

The provided text describes a 510(k) summary for the Knotilus Anchor System, which is a medical device for soft tissue to bone fixation. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria.

Based on the provided text, there is no information available regarding specific acceptance criteria, a study proving the device meets those criteria, or details such as sample size, data provenance, expert qualifications, or MRMC studies.

Instead, the submission focuses on:

• Comparison of Technological Characteristics: The document states, "With respect to its indication for use, the Knotilus Anchor System is substantially equivalent to its predicate devices. With respect to technology, the design is similar, as confirmed by comparison, and the performance is the same as verified by design verification."
• Design Verification: This phrase indicates that internal testing was conducted to ensure the device performs as intended and is similar to the predicate. However, no specifics of these "design verification" tests (e.g., test methods, acceptance criteria, results) are provided in this summary.

Therefore, I cannot populate the requested tables and information as the details are not present in this 510(k) summary. The summary focuses on demonstrating equivalence rather than the detailed performance study of the device against specific performance metrics for acceptance criteria that would be found in a clinical trial or a more extensive engineering report.

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