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The Fin-S Orthodontic/Dental Microimplant is 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. This device is intended for single use only.

The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths. Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.

The provided text describes a 510(k) submission for the Fin-S Orthodontic/Dental Microimplant. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and product comparison, rather than an AI-driven device requiring extensive performance studies against acceptance criteria in the manner of diagnostic algorithms.

Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission.

However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serve as the "acceptance criteria" for substantial equivalence in this context.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fin-S Orthodontic/Dental Microimplant are primarily based on demonstrating substantial equivalence to predicate devices, and non-clinical testing to ensure biocompatibility and sterility.

Study Information (as applicable to a 510(k) for a physical device)

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

   • Cytotoxicity Test: "An established cell line was obtained from a recognized cell repository." The specific number of cell cultures or replicates is not stated. Data provenance is not specified beyond "recognized cell repository."
   • Sterilization Test: "Bacillus atrophaeus and Geobacillus Stearothermophilus spore strips and inoculated microimplants." The specific number of strips or microimplants tested is not stated. Data provenance is not specified.
   • Note: For a physical device like a microimplant, "test set" and "data provenance" typically refer to samples used in laboratory testing (biocompatibility, sterility, material characterization), not clinical data or imaging data.

2. 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):

   • Not Applicable. The ground truth for biocompatibility (cytotoxicity) is determined by observing cell cultures under a microscope against predefined criteria, not by human expert consensus on images. The ground truth for sterility is determined by microbiological assay results (killing of specified spore organisms). For material composition and dimensions, it's objective measurement/testing.

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

   • Not Applicable. As described above, the assessments are objective laboratory tests, not subjective interpretations requiring adjudication.

4. 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 an AI-driven device or an imaging diagnostic device.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Biocompatibility: Microscopic examination of cell cultures for visual clues of cytotoxicity against a control culture.
   • Sterilization: Microbiological testing (e.g., absence of growth from spore strips or inoculated microimplants post-sterilization).
   • Material Composition & Dimensions: Laboratory analytical techniques and metrology.
   • Substantial Equivalence: Comparison of device characteristics (materials, dimensions, intended use) against legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set.

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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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