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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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Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth.

It is used temporarily and is removed after orthodontic treatment has been completed.

OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length.

• Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) .
• Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) .

There are three types of OBS Anchorage Screw.

• . Square collar mushroom head none hole
• . Square collar mushroom head round hole
• Square collar mushroom head slot hole .

OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.

The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated.

Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.

The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.

The provided text describes a 510(k) premarket notification for the "OBS Anchorage Screw," a temporary orthodontic anchorage device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data, not on the performance of a standalone AI-powered device or comparative effectiveness with human readers.

Therefore, many of the requested elements, such as those related to AI performance, sample sizes for test sets in the context of AI, ground truth establishment for AI, expert involvement for AI adjudication, and MRMC studies, are not applicable to this document. The document describes a medical device, not an AI device.

However, I can extract information related to the acceptance criteria and supporting studies for the physical medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI algorithm. The performance data refers to physical testing of the device for biocompatibility, sterilization, and mechanical properties. The sample sizes for these tests are not explicitly stated in the provided text.
Data provenance: N/A, as this refers to physical device testing, not data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI device where experts would establish ground truth for a test set.

4. Adjudication method for the test set
Not applicable.

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 an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used
For the physical device:

• Biocompatibility: In vitro and in vivo biological responses to the device material, evaluated against established ISO standards.
• Sterilization Validation: Microbiological testing and adherence to established sterilization efficacy standards (ISO and AAMI/ANSI).
• Mechanical Performance: Physical and mechanical properties of the screw (e.g., strength, torque) compared against the performance of legally marketed predicate devices and ASTM F543 standards.

8. The sample size for the training set
Not applicable. This is not an AI device with a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI device.

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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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