Search Results

The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.

The KLS-Martin Ortho Anchorage System includes several different designs of titanium plates.

This document is a 510(k) summary for the KLS-Martin Ortho Anchorage System (Plates), which is a premarket notification to the FDA for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing results as would be found for a novel device or a PMA application.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document primarily focuses on:

• Device Identification: Name, submitter, contact, date, classification, and regulatory class.
• Intended Use: "The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures."
• Predicate Devices: KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565) and Nobel Biocare Onplant Orthodontic System (K980460).
• Technological Characteristics: Discusses similarities (materials, manufacturing process to KLS-Martin Micro Osteosynthesis System) and differences (shape, specific regions of use, fixation method) to the predicate devices.
• Substantial Equivalence Claim: The device is substantially equivalent in application to one predicate and in indications for use to another.

In summary, a study proving device performance against acceptance criteria is not detailed in this 510(k) submission summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than independent clinical performance studies, especially for Class II or III devices where performance is well-understood or can be inferred from predicate devices.

Hence, I cannot populate the table or answer the subsequent questions based on the provided text.

Ask a specific question about this device