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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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