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The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.

This looks like a 510(k) summary for a medical device that has achieved substantial equivalence, not a study evaluating whether a device meets specific acceptance criteria through performance.

The provided text, K080694, describes the OsteoMed Modular Locking Fixation System, indicated for fracture fixation in cranio-maxillofacial trauma, mandibular reconstruction, and orthognathic reconstruction. However, it is a document seeking clearance for a medical device by demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with acceptance criteria and reported device performance metrics.

Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because this document is not a performance study in that sense.

Here's a breakdown based on the provided text, Highlighting why certain information is not available from this type of document:

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 applicable. This document does not describe a performance study with a test set.
• Data Provenance: Not applicable. This document relies on comparisons to predicate devices and their established safety and effectiveness.

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

• Not applicable. No test set or ground truth establishment by experts is described in this document.

4. Adjudication Method for the Test Set

• Not applicable. No test set adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. This submission uses a substantial equivalence pathway.

6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device (plates, screws, instrumentation), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable. No ground truth is established or used in this submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning that the device is shown to be as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of physical, non-AI medical device submission.

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

• Not applicable. (See #8)

Summary Explanation:

The document provided (K080694) is a 510(k) premarket notification. The primary goal of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device (or devices). This means the device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

This clearance pathway typically involves:

• Comparison to Predicate Devices: Identifying existing devices with similar indications for use, materials, and design.
• Performance Testing (Non-Clinical): Often involves bench testing (e.g., mechanical strength, fatigue, biocompatibility) to ensure the device meets specified engineering standards and performs comparably to the predicates. These tests are usually against internal company specifications or recognized standards, not necessarily "acceptance criteria" for a clinical performance study.
• Material Equivalence: Demonstrating that materials used are equivalent to those in predicate devices or have established safe use.

The text explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448), and Lorenz (K063052)." and "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues."

Therefore, this document does not contain the information requested about a clinical study involving acceptance criteria, test sets, expert adjudication, or AI performance metrics because it is a regulatory clearance document based on substantial equivalence, not a clinical trial report.

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