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The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

The ACE Tru-FIX™ Implant System is a set of machined surgical grade titanium alloy (Ti-OAL-AV ELI) screws, intended to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects. The implants are supplied sterile in 3.0 mm and 15 mm, in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in the screw raw materials and characteristics to that cleared under K951392. These screws are supplied in ACE Surgical TRU-Fix™ trays. The ACE Surgical TRU-Fix™ Implant System is a comprehensive system retaining prosthetic components, if applicable, of the ACE Surgical Orthodontic Miniboneplate system.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the ACE Tru-FIX™ Implant System, which focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating performance against defined acceptance criteria through a clinical study.

The core of this submission is a comparison of technological characteristics and intended use to predicate devices, using:

1. Device description
2. Indications for use
3. Bench test results
4. Materials
5. Labeling

It explicitly states: "In particular, the bench testing the ACE andidn's for use, 3) benefit test results, 17 materials, and by is effectiveness between the ACE Cal TRU-Fix™ Implant System and the specified predicate devices." This indicates that bench testing was performed, but details about specific acceptance criteria, methodology, sample sizes, and outcomes are not provided in this summary.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, ground truth, or expert involvement because this information is not present in the provided text.

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The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

The ACE Surgical Orthodontic Screw System is a is a set of machined surgical grade titanium alloy (Ti-6AI-4V ELI) screws, intended for orthodontic use, constructed with a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. This head design also permits the use of the screw with the orthodontic appliances (bracket, wire, elastic head, etc.) The tip of the screw is designed available to self drilling and self-tapping, supplied in 1.2/1.5mm and 1.5/1.8mm tapered thread, both with a 3.0mm diameter head and in lengths of 6,8,10mm. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics that cleared under K951392. These screws are supplied sterile in standard Tyvek™ mylar packaging.

The ACE Surgical Orthodontic Bone Screw System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The provided text describes a 510(k) submission for the ACE Surgical Orthodontic Bone Screw System. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical or algorithmic study in the way a diagnostic AI device might.

Therefore, many of the requested categories for AI device evaluation (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence): The primary acceptance criterion for this 510(k) notification is to demonstrate that the ACE Surgical Orthodontic Bone Screw System is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:
The submission states the following to support substantial equivalence:

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This submission relies on bench testing, material specifications, and comparison to predicate devices, not a clinical "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
• Data Provenance: Not applicable. The "data" here refers to design specifications, material standards (ASTM F136), and results from bench tests conducted by the manufacturer, rather than clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The evaluation is based on engineering principles, material science, and comparison to existing devices.

4. Adjudication method for the test set

• Not applicable. No clinical test set or adjudication process for diagnostic performance is described.

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

• Not applicable. This is not a study assessing human reader performance or AI assistance.

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

• Not applicable. This device is a physical orthodontic screw, not an algorithm, and therefore doesn't have "standalone" algorithmic performance in the sense of AI.

7. The type of ground truth used

• Ground Truth: For the purpose of a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is effectively derived from established engineering standards, material specifications, and the historical safety and effectiveness records of the legally marketed predicate devices. The bench test results serve to confirm the new device meets performance characteristics equivalent to those established standards and predicates.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

• Not applicable.

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