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The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.

The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is an orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily, removed after orthodontic treatment has been completed. Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. Orthodontic Fixation Screw [Smart Anchor Miniscrew] is made of Titanium Alloy (T)-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is through hole head type. The head of the Orthodontic Fixation Screw [Smart Anchor Miniscrew] is designed to apply various orthodontic tools. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, the design accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.). The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is available in in diameters of 1.2, 1.4, 1.6, 1.8, and 2.0mm and lengths of 8 and 10mm. The Orthodontic Fixation Screws with a diameter of 1.4mm and greater are also available in a 6mm length version.

The provided text is a 510(k) summary for the "Orthodontic Fixation Screw [Smart Anchor Miniscrew]". This document describes the device and its equivalence to predicate devices, focusing on bench testing rather than clinical studies or AI-based performance.

Therefore, the requested details regarding acceptance criteria for AI/ML performance, study types (MRMC, standalone), ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this document. The document confirms that no clinical performance testing was necessary for the demonstration of substantial equivalence.

The acceptance criteria provided in this document are primarily for the physical and mechanical properties of the orthodontic screw, demonstrating substantial equivalence to a predicate device.

Here's what can be extracted from the provided text regarding acceptance criteria and the study:

Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)

Study Details:

The document describes non-clinical performance testing to demonstrate substantial equivalence, not a study involving AI/ML performance, human readers, or clinical outcomes.

1. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. For bench testing, samples of the device were used. No information on the number of devices tested is explicitly provided. The provenance of the data is from in-house bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility tests is established by physical measurements and laboratory analyses against established standards (ASTM, ISO).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical performance testing was necessary for the demonstration of substantial equivalence."
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an orthodontic screw, not an algorithm.
6. The type of ground truth used:
   • For biocompatibility: Laboratory test results against ISO 10993 standards.
   • For mechanical tests: Physical measurements (e.g., force, torque) against ASTM 543-13 and manufacturer's specifications, compared to predicate device performance.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device (an orthodontic screw) and its demonstration of substantial equivalence through non-clinical (bench) testing, not through clinical or AI/ML performance studies. Therefore, many of the requested data points related to AI/ML device validation are not relevant to this document.

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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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