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The KLS Martin Drill-Free MMF Screw is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The KLS Martin Drill-Free MMF Screw are bone-borne, self-drilling screws for maxillomandibular fixation (MMF). The screws are intended to provide stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoneralive bone fixation. These screws may be applied prior to or after exposure of the Drill Free MMF Screw is manufactured from stainless steel (ASTM F138) with a head designed with a hole to allow passing and securing ligature wire during the procedure and is available in threaded lengths of 2.0 x 8.0 mm - 2.0 x 12.0mm. Implants are available both sterile and non-sterile.

This document is a 510(k) Premarket Notification summary from the FDA for a medical device called the "KLS Martin Drill-Free MMF Screw". It is specifically a clearance letter and a summary of the device and its equivalence to a predicate device.

Based on the provided text, the device is a mechanical implant (a screw for bone fixation), not a software-based AI/ML medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, training data, MRMC studies, and effect sizes are not applicable to this documentation.

The document describes the non-clinical performance data used to demonstrate substantial equivalence for this mechanical device.

Here's an analysis of the provided information, focusing on the mechanical device's testing:

1. A table of acceptance criteria and the reported device performance.

The document states that comparisons were made to a primary predicate device (KLS Martin Drill Free MMF Screw (K083432)) and reference devices. It describes the type of tests performed, but does not provide specific numerical acceptance criteria or the reported device performance metrics in a tabular format within this summary.

Types of Tests Mentioned:

• Comparative head-to-head static and dynamic bench testing: Conducted on the subject device and the primary predicate device to determine equivalent performance.
• Comparative screw testing: Performed to evaluate:
  • Torsional strength
  • Drive torque
  • Pullout strength
• Biological safety risk assessments: In compliance with ISO 10993-1:2018.
• LAL endotoxin testing: To address the presence of bacterial endotoxins and meet pyrogen limit specifications in accordance with ANSI/AAMI ST72:2019.
• Gamma sterilization process validation: In accordance with ISO 11137-1:2015 and ISO 11137-2:2015 using the VDmax25 method, and also ISO 11737-1:2018 and ISO 11737-2:2019.
• Packaging validations: Performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1 and ASTM D7386.

Reported Device Performance (General Statement):
"Mechanical test results demonstrate that KLS Martin MMF Screw's performance is substantially equivalent to the primary predicate device."
"Biological safety risk assessments... concluded the devices are biocompatible and appropriate for their intended use."
"LAL endotoxin testing... meet pyrogen limit specifications."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).

The document does not specify the sample sizes used for the bench testing (e.g., number of screws tested for torsional strength, number of packaging units for validation). The provenance is "Non-Clinical Performance Data," implying lab testing rather than patient data. Country of origin for data is not mentioned, but the applicant and correspondent are KLS-Martin L.P. in Jacksonville, Florida, United States. These are bench tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).

This question is not applicable. Ground truth for mechanical performance is established through physical measurements and adherence to engineering standards (e.g., ASTM, ISO). There are no "experts" in the sense of clinicians establishing ground truth from medical images for this type of device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.

This question is not applicable as this is a mechanical device, not an AI/ML system requiring human annotation adjudication.

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.

This question is not applicable. This is a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

This question is not applicable. This is a mechanical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc).

For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., force, torque, material properties) as defined by ASTM and ISO standards, and comparison to the predicate device's measured performance. Biosafety is determined by established biological test methods (e.g., LAL, biocompatibility assays).

8. The sample size for the training set.

This question is not applicable. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established.

This question is not applicable. As above, there is no AI training set for this device.

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The KLS Martin Drill Free® MMF Screws is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

The KLS-Martin Drill Free® MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KLS Martin Drill Free® MMF Screw.

Unfortunately, the provided text does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary and the FDA's clearance letter for the KLS Martin Drill Free® MMF Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot populate most of the requested sections. Here's what I can extract from the provided text based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable as no specific study data or ground truth establishment is described in the provided document.

4. Adjudication Method for the Test Set

• Not applicable as no specific study data or adjudication is described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, there is no mention of an MRMC study.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this is a medical screw, not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No, there is no mention of a standalone performance study. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable as no specific study data or ground truth is described in the provided document.

8. Sample Size for the Training Set

• Not applicable as no "training set" is relevant for this type of medical device submission.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as no "training set" is relevant for this type of medical device submission.

Summary of Document's Content:

The provided documents describe the submission of a 510(k) premarket notification for the KLS Martin Drill Free® MMF Screw. The core of the submission is to demonstrate substantial equivalence to existing predicate devices based on:

• Identical intended use: For maxillomandibular fixation to stabilize fractures of the maxilla, mandible, or both.
• Similar application: Compared to other drill-free and anchorage systems.
• Key difference: The new device is "drill-free" (self-tapping), while its primary predicate required a pilot hole.

The FDA's clearance letter confirms their determination of substantial equivalence, allowing the device to be marketed. This type of submission relies on comparisons to already cleared devices rather than a de novo study with acceptance criteria for a novel device.

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