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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.

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

The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point.

This document is a 510(k) summary for the KLS-Martin Ortho Anchorage System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. Here's a breakdown of what is present and what is missing:

What is present:

• Device Description: The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point.
• Intended Use: Surgically placed in the mouth for use as an anchor for orthodontic procedures.
• Predicate Devices:
  • Centre-Drive Drill Free Screw (K971297) - used for plate fixation across fractures or osteotomies.
  • Nobel Biocare Onplant Orthodontic System (K980460) - also an orthodontic anchorage system.
• Substantial Equivalence Argument:
  • Similar in application and function to the KLS Martin Centre-Drive Drill Free Screw (K971297).
  • Substantially equivalent in intended use to the Nobel Biocare Onplant Orthodontic System (K980460).
  • Technological characteristics: Screws are similar to KLS-Martin Centre-Drive Drill Free Screw and are made of CP titanium or Ti-6Al-4V Titanium Alloy.

What is missing (which would be required to answer your specific questions):

• Acceptance Criteria: There are no explicit acceptance criteria mentioned for any performance metrics of the device.
• Reported Device Performance: No performance data (e.g., strength, durability, biocompatibility, clinical success rates, failure rates, etc.) is provided from any study.
• Study Details:
  • No mention of any specific study (clinical, non-clinical, bench) that assesses the device's performance against criteria.
  • Therefore, all related questions about sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, or training set details are not applicable as no such study is described.

In summary, this 510(k) summary is a regulatory filing asserting equivalence to existing devices, not a scientific report detailing performance testing against acceptance criteria. To find the information you requested, you would need to look for a different type of document, such as a design validation report, a clinical study report, or a comprehensive PMA application (if it were a Class III device requiring one, which it is, but this document is a 510(k) for an implant).

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