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This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.

Orthodontic Ceramic bracket, VENUS and ROSE Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire.

VENUS Bracket no hook type and ROSE bracket have consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

VENUS Bracket with hook type consist five parts: the slot for the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth.

These devices are designed for orthodontic use only. The devices intended use for single use only.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for orthodontic brackets (VENUS Bracket and ROSE Bracket), establishing their substantial equivalence to a predicate device (ROSA Bracket).

The document details the device's description, indications for use, comparison with a predicate device, and non-clinical performance data (biocompatibility and mechanical properties) to support its safety and effectiveness. It explicitly states that "No clinical performance testing was performed on VENUS and ROSE brackets," which means there would be no study to prove acceptance criteria based on clinical outcomes.

Therefore, I cannot provide the requested table and information as it is not present in the provided text.

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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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This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

This document is a 510(k) summary for a medical device called "ROSA Bracket," an orthodontic ceramic bracket. It states that no clinical performance testing was performed on ROSA brackets. Therefore, it is not possible to describe acceptance criteria and a study proving the device meets those criteria, as no such study was conducted according to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Speed Dental Co., Ltd's Orthodontics Bracket, K150141) through non-clinical performance data and biocompatibility testing.

Here's a breakdown of the information that is available, addressing the elements requested where applicable, and explicitly stating where information is not present:

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

This document does not contain a table of acceptance criteria or reported device performance for a clinical study, as no clinical study was performed. Instead, it provides a "Substantial equivalence comparison" table comparing the ROSA Bracket to its predicate device based on material, design, and dimensions, aiming to demonstrate that the differences are not expected to affect overall performance.

Table 1: Substantial equivalence comparison (from the document)

The document concludes that the "Rosa Bracket has the same device characteristics as the predicate device... We conclude that Rosa Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K150141)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• No clinical test set was used.
• Non-clinical performance data: The document mentions that "design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015, Dentistry -Testing of adhesion to tooth structure." It does not specify the sample size for these non-clinical tests or the data provenance.
• Biocompatibility testing: Was completed according to ISO 10993 series. No sample sizes are provided.

3. 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, as no clinical test set requiring expert ground truth was performed.

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

Not applicable, as no clinical test set or adjudication was performed.

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 an orthodontic bracket, not an AI or imaging diagnostic tool, and no MRMC study was performed.

6. 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.

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

Not applicable for a clinical study, as none was performed. For the non-clinical tests, the "ground truth" would be established by the standards and methodologies outlined in ISO 27020:2010 and ISO 11405:2015 for physical and mechanical properties.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable.

In summary, the ROSA Bracket received 510(k) clearance based on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical performance testing (adherence to ISO standards for material, design, and mechanical properties) and biocompatibility testing, rather than through a clinical study with acceptance criteria and direct performance measurement in a patient population.

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