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The Bio-TackS Orthodontic Mini Implant 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.

Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.

The provided text describes the Bio-TackS Orthodontic Mini Implant and its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility. It explicitly states that clinical testing was not required (Section 9, page 8). Therefore, the information requested about acceptance criteria and studies proving device performance with human data (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, ground truth type for test/training sets) is not available within this document.

The document primarily focuses on demonstrating substantial equivalence through bench testing (non-clinical performance tests) and biocompatibility testing.

Here's the available information relevant to the acceptance criteria and the study that proves the device meets them, based on non-clinical data:

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

The document doesn't explicitly state quantitative acceptance criteria for the "performance tests" in a table format. Instead, it describes performing tests according to a standard (ASTM F543) and comparing the subject device's results to the predicate device, concluding "similar performance."

Reported Device Performance (from Section 8, page 6-7):

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

• Bench Tests (Performance Tests): For each specific test (Insertion-Removal torque, Rotational fracture torque, Axial pull-out), the document mentions testing specific models of the Bio-TackS and Osstem implants (e.g., BSH1810S, OSSH1810 for insertion-removal torque). It does not specify the exact number of samples tested for each condition but implies at least one sample of the "worst-case" or specific diameter/length combinations.
• Biocompatibility Tests: Sample sizes are not explicitly stated for these tests (e.g., number of cells for cytotoxicity, number of animals for toxicity/reactivity tests).
• Data Provenance: The tests are explicitly non-clinical bench and laboratory tests. No country of origin for the data is specified, but the applicant (BIO CETEC CO., LTD.) is from the Republic of Korea.

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

This is not applicable as no clinical test set requiring human expert ground truth was conducted. The "ground truth" for the non-clinical tests is based on objective measurements against established standards (e.g., ASTM F543, ISO 11137, ISO 10993 series).

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

Not applicable, as no clinical test set requiring adjudication was conducted.

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, as no clinical study (MRMC or otherwise) involving human readers or AI assistance was conducted.

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

Not applicable, as this device (an orthodontic mini implant) is a physical medical device, not an algorithm or AI.

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

For the non-clinical performance tests, the "ground truth" is measured physical and mechanical properties against established engineering and material science standards (ASTM F543), and for biocompatibility, it is biological response as assessed by ISO 10993 standards and laboratory assays.

8. The sample size for the training set:

Not applicable. This is a physical device, and the evaluation did not involve machine learning or AI models with training sets.

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

Not applicable (as above).

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S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.

The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance:

Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.

7. Type of Ground Truth Used:

The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.

8. Sample Size for the Training Set:

This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above.

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