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The Orthodontic Screw is indicated for use as 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. Screws are intended for single use only.

The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are 1.5mm and 2.0 mm, and total thread lengths is 7.0mm. The minor technological modification for Mico One Orthodontic Screw is designed for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm/0.8mm diameter hole can supply different orthodontic methods for orthodontists.

This document is a 510(k) summary for a medical device called "Mico One Orthodontic Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

This document does NOT describe the acceptance criteria and a study proving a digital device meets acceptance criteria. Instead, it describes acceptance criteria and testing for a physical medical device (an orthodontic screw).

Therefore, many of your requested points, especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and training/test set sizes for digital devices, are not applicable to this submission.

However, I can extract the relevant information for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance values for each criterion. Instead, it refers to industry standards and general performance categories.

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

The document does not specify the sample size for the mechanical performance or biocompatibility testing. It also does not explicitly state the provenance of the data (e.g., country of origin). Since these are bench tests, "retrospective" or "prospective" as typically applied to clinical data don't fully apply, but they would be controlled laboratory studies.

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

This section is not applicable as this is testing for a physical device, not a digital device requiring human expert ground truth for interpretation. Mechanical and biocompatibility tests rely on standardized measurement methods and laboratory analysis.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images or clinical data, which is not relevant to the physical device testing 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

This section is not applicable as this document pertains to a physical orthodontic screw, not an AI or digital device designed to assist human readers.

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

This section is not applicable as this document pertains to a physical orthodontic screw, not an algorithm.

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

For the mechanical performance, the "ground truth" is established by the specifications defined in the ASTM F543 standard. For biocompatibility, the "ground truth" is determined by the Pass/Fail criteria outlined in the ISO 10993 series of standards.

8. The sample size for the training set

This section is not applicable as this document describes testing for a physical device, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications. The screws consist of either three or four components: head, platform, body (thread) or moreover neck.

The provided text describes a 510(k) summary for PSM LOMAS / BENEFIT Screws, a type of orthodontic mini-anchor system. It details the device description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, the document does not provide specific acceptance criteria or details about a study proving the device meets those criteria.

The "Performance data" section only lists the types of tests performed:

• Breakage and Fatigue Tests
• Material Tests
• Validation Tests of sterile barrier system and packaging system
• Sterilization Validation Tests
• Microbiological Test for determination of microorganisms
• Several Clinical Justifications and Studies

It does not provide:

1. A table of acceptance criteria and the reported device performance: The document mentions tests were performed but does not list specific criteria or the results against them.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present, as no specific performance study with a test set is detailed.
4. Adjudication method for the test set: Not applicable as a performance study involving a test set and ground truth is not detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for this type of medical device (physical screw vs. diagnostic AI).
6. If a standalone performance study was done: The document states "Several Clinical Justifications and Studies" were performed but does not describe the methodology or results of any such standalone study.
7. The type of ground truth used: Not applicable as specific performance studies involving ground truth are not detailed.
8. The sample size for the training set: Not applicable as this is not an AI/ML device where a training set would be relevant in the traditional sense. The "training" here would be related to engineering design and material science.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document states that various tests and studies were performed to support substantial equivalence but does not provide the detailed information requested regarding specific acceptance criteria and the evidence proving the device meets them. The filing primarily relies on demonstrating equivalence to predicate devices based on technical characteristics, indications for use, material, target population, performance, safety, effectiveness, and biocompatibility.

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