(279 days)
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.
| Performance Metric | Acceptance Criteria (Implied "Similar to Predicate") | Reported Device Performance (Anchor Plate) | Reported Predicate Performance (K091051) |
|---|---|---|---|
| Bending strength (Avg.) | Comparable to K091051 (97.125 N·mm) | 102.428 N·mm | 97.125 N·mm |
| Tensile force (Avg.) | Comparable to K091051 (176.782 N) | 301.814 N | 176.782 N |
| Biocompatibility | Compliance with ISO 10993-1 | Compliant per ISO 10993-1 | Compliant per ISO 10993-1 |
| Sterilization Efficacy | Needs autoclave prior to use (specific temp/time) | Autoclave at 121°C for 30 min exposure, 15 min dry | Gamma Radiation (ISO 11137-1) |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.