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The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.

The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.

The provided document describes the BIO-RAY A-1 Anchor Screw System, an orthodontic mini-screw, and its substantial equivalence to predicate devices. The document explicitly states that clinical studies were determined to be not required to support substantial equivalence. Therefore, the information regarding acceptance criteria and study design elements related to clinical performance (such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, effect size, and standalone algorithm performance) is not available or applicable in this context.

The acceptance criteria and the study that proves the device meets them are based on non-clinical performance (bench testing, biocompatibility, and sterilization validation).

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical test set was used. The non-clinical tests were conducted on device samples. The provenance of these samples is the manufacturer, Microware Precision Co., Ltd. in Taiwan. The tests are prospective in nature, as they are conducted for regulatory clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth was used. Ground truth for non-clinical tests is established by adhering to the standards (e.g., ASTM, ISO, USP) and the results obtained from standardized testing methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was used.

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 device is a medical implant, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a medical implant, not an AI algorithm.

7. The type of ground truth used:
For non-clinical performance, the "ground truth" is defined by the established industry standards (e.g., ASTM F543 for mechanical properties, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization) and the expected performance thresholds specified within those standards or internal specifications derived from predicate device performance.

8. The sample size for the training set:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable as this is a physical device, not an AI algorithm that requires a 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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