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The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion. Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.

The provided document is a 510(k) premarket notification for a medical device called "Anchor plate." This type of document is generally used by manufacturers to demonstrate that their device is substantially equivalent to a predicate device already legally marketed in the U.S. It primarily focuses on comparing the new device against existing predicates based on technological characteristics, intended use, and performance data to establish safety and effectiveness.

This document does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the format requested in the prompt.

Specifically, it lacks:

• A table of acceptance criteria with reported device performance against those criteria.
• Details on sample size used for a "test set" (as this is not a diagnostic device, there isn't a traditional test set of clinical cases).
• Information on data provenance for a clinical test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (pathology, outcomes data, etc.) for clinical evaluation.
• Training set size or how ground truth for a training set was established (again, not a diagnostic AI device).

Instead, the document focuses on non-clinical performance data and a comparison to predicate devices, which is typical for a 510(k) submission for a mechanical implantable device.

Here's an extraction of the relevant performance data and comparisons that are available in the document:

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

The document mentions comparative performance testing but does not present a formal table of acceptance criteria. Instead, it compares the proposed device's mechanical properties to those of the primary predicate device. The "acceptance criteria" are implicitly that the proposed device performs comparably or better than the predicate device.

Note: The document states "the results showed that the properties considered were similar when used for intended use" despite the numerical differences in bending strength and tensile force, suggesting that the observed differences were deemed clinically acceptable.

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

• Test Set Sample Size: Not explicitly stated for performance testing. Mechanical tests typically involve a certain number of units, but the specific quantity is not reported. This is a non-clinical device; there isn't a "test set" of clinical data.
• Data Provenance: The tests were conducted by the manufacturer, BioMaterials Korea, Inc., (South Korea). It is preclinical (bench and biocompatibility) data, not clinical patient data. The tests are non-clinical (bench testing and biocompatibility).

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 a pre-clinical (bench) study for a mechanical device, not a diagnostic or clinical study requiring expert ground truth for imaging or clinical outcomes.

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

• Not applicable. This is a pre-clinical (bench) study.

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-enabled device requiring MRMC studies.

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

• Not applicable. This is not an algorithm or AI device.

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

• For mechanical properties: The "ground truth" is measured physical properties against established standards (e.g., ISO 9585 for bending strength) or internal validated test methods.
• For biocompatibility: The "ground truth" is established by adherence to recognized standards like ISO 10993.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

• Not applicable.

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The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.

The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization.

Screw Anchors
The screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor.

The screw anchors are manufactured from titanium alloy (Ti-6Al-7Nb).

Plate Anchors
The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed) to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs

The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6Al-7Nb)

The provided text describes a 510(k) premarket notification for the Synthes Orthodontic Bone Anchor System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) cannot be extracted from this document as this type of information is generally not required or provided in a 510(k) summary for mechanical devices like bone anchors.

The document primarily states:

• Non-Clinical Testing Data: "The Synthes Orthodontic Bone Anchor System was tested for resistance to pullout under clinical loads by means of axial, shear, and cantilever loading. Screws were also tested for insertion torque, removal torque, and yield and failure torque."
• Substantial Equivalence: "The proposed devices are similar to the predicate devices identified above in terms of indications, principles of operation (provide fixed anchorage for orthodontic movement of teeth), device design/geometry, and materials. Information presented supports substantial equivalence."

This indicates that mechanical testing was performed, but specific acceptance criteria and the quantitative results validating against them are not detailed in the provided summary. The focus is on demonstrating that the new device performs similarly to existing, legally marketed devices.

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