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The device is intended to provide a fixed anchorage point for the 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. The screws are intended for single use only.

The Ortho Easy Pin is designed for use in orthodontic treatments as element of anchorage. The screws are made of titanium alloy. The slots in the screw head are cross-shaped. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed to the screw head using an elastic band or steel ligature. A retention groove below the slots serves as the anchor for fixing elements in the slot. The thread of the Pin is self-trapping and self-drilling. The Pin is inserted and screwed into the bone either manually or mechanically. To insert the screw, the hexagon head of the screw is picked up using an instrument. The sleeve between the thread and the functional head serves to protect the soft tissue. These screws are supplied non-sterile. Therefore, the device must be sterilized prior to use. Steam sterilization is recommended. The device is available in different lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags.

The Ortho Easy Pin is a temporary anchorage device used in orthodontics. The device's performance was evaluated through a series of tests to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria against a specific clinical outcome.

Here's a breakdown of the information provided in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on comparison to predicate devices, there aren't explicit numeric "acceptance criteria" defined in the same way one might find for a diagnostic device's sensitivity or specificity. Instead, the acceptance is based on demonstrating comparable performance and characteristics to existing, legally marketed devices.

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

The document does not explicitly state the numerical sample size for the mechanical performance testing (torque, impact on tooth roots, resistance to active forces). It only mentions "our measurements" and "All reports."

The data provenance is from Bernhard Forster GmbH (Germany), the manufacturer. The studies appear to be prospective bench testing conducted specifically for this submission, comparing the Ortho Easy Pin to the two predicate devices under the same parameters. There is no mention of human subject data or clinical trials in this summary.

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

This submission pertains to a medical device's mechanical and material properties, not a diagnostic algorithm. Therefore, there is no "ground truth" in the clinical imaging sense, nor were experts used to establish it for a test set. The validation relies on engineering and material standards (ISO 7405, ASTM F-136) and comparative mechanical testing.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic study requiring human adjudication of findings. Mechanical test results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a mechanical medical device, not an AI-assisted diagnostic tool for imaging interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or validation for this device is based on:

• Material standards: ASTM F-136 for titanium alloy.
• Performance standards: ISO 7405.
• Comparative mechanical testing: Measuring torque, force resistance, and impact characteristics against predicate devices.
• Biocompatibility: Accepted status of ASTM F-136 titanium alloy for endosseous implants.

8. The Sample Size for the Training Set

Not applicable. There is no training set for this type of mechanical device submission, as it does not involve machine learning or AI.

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

Not applicable, as there is no training set.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a comparative mechanical and material testing study. The goal of the study was to demonstrate substantial equivalence to two predicate devices: Tomas PIN (K062733) from Dentaurum and Dual Top Anchor System Screws (K033767) from Jeil Medical Corporation.

The study involved:

• Material Analysis: Confirming the Ortho Easy Pin is made of titanium alloy ASTM F 136, a material already accepted and widely used in similar bone screws and equivalent to the predicate devices.
• Mechanical Performance Testing:
  • Torque Measurements: The Ortho Easy Pin was tested to determine its insertion torque levels, and these were compared to the predicate devices. The study found the torque levels to be comparable and "clearly far from the load limit of 30 Ncm," with no fractures occurring.
  • Force Resistance: Measurements were performed to ensure the pin withstands active forces during orthodontic treatment.
  • Impact on Tooth Roots: Testing was conducted to assess the risk of root damage. This test concluded that the thread peak of the Ortho Easy Pin has a protective function and is not able to cut the tooth, thus not causing unjustified root damage.
• Design and Intended Use Comparison: A detailed table compared the design parameters (dimensions, self-drilling/self-tapping nature), intended use, indications for use, target population, and other characteristics of the Ortho Easy Pin to the predicate devices, showing strong similarities.
• Biocompatibility: The use of ASTM F-136 titanium alloy, an accepted material for endosseous implants, ensured biocompatibility.

Conclusion of the Study:
The overall conclusion from the testing and comparison was that the Ortho Easy Pin is "substantially equivalent in design, material, intended use and function to the products listed as predicate devices." The comparable torque levels led to the estimation that "OrthoEasy® pin will show the same clinical results like the other screws."

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

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. The function and performance of the orthodontic ceramic brackets are equal to the predicate device. The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.

This medical device submission for the Bernhard Forster GmbH Orthodontic Ceramic Brackets is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics.

Therefore, the requested information cannot be fully provided in the format of a typical performance study. Instead, the "study" demonstrating acceptance is the comparison to the predicate device and the material testing conducted.

Here's how the provided information aligns with your request:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device. Performance is primarily assessed through comparison.

Table of Acceptance Criteria and Reported Device Performance (based on substantial equivalence):

Detailed Breakdown of Study Information (as requested):

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

   • See table above. The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the direct comparison point-by-point to the predicate device.

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

   • This is not a traditional "test set" study. The submission relies on material testing data for the device itself and comparison to the predicate device's established performance.
   • Sample Size: Not explicitly stated as a clinical "test set" sample size. The material testing would involve specific numbers of brackets or material samples as per ISO 6474;1994, but these details are not provided in this summary.
   • Data Provenance: The manufacturing company is Bernhard Forster GmbH, based in Pforzheim, Germany. Material testing would typically be conducted by the manufacturer or a certified lab. This would be considered "prospective" data for the new device's material properties, but it's not clinical human data.

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. This is not a study requiring expert readers or "ground truth" establishment in the sense of diagnostic accuracy. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 6474;1994). The "ground truth" for substantial equivalence is the predicate device's established regulatory status and performance.

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

   • Not applicable. No "adjudication method" as this is not a diagnostic performance study involving multiple readers.

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-powered diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This device is a physical medical device, not an algorithm.

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

   • The "ground truth" (or basis of evidence) used for this 510(k) submission is:
     • Predicate Device Equivalence: The legally marketed predicate device (Innovation C, K060837) serves as the primary "ground truth" for safety and effectiveness.
     • Material Standards: Adherence to international material standards (ISO 6474;1994 for Ceramic materials based on High purity alumina) serves as "ground truth" for the material properties and biocompatibility.

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. This is not a machine learning or AI device.

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