(267 days)
The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Leone TADs are miniscrews made of titanium for surgical use (ISO 5832-3/ASTM F136). These orthodontic miniscrews are self-drilling with right-hand thread and they are available in an 8mm length. These devices are supplied sterile and sterilized by gamma irradiation.
The provided FDA 510(k) clearance letter and its associated 510(k) summary pertain to a Leone Orthodontic Implant TAD (Temporary Anchorage Device), which is a physical medical device (an endosseous dental implant). The documentation does not describe an AI/ML-driven device or a study involving a test set, ground truth experts, or MRMC studies.
Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria for an AI/ML system based on this document. The document describes non-clinical performance testing for a physical implant.
However, I can extract the acceptance criteria and study information that was used to demonstrate substantial equivalence for this physical medical device.
Acceptance Criteria and Study for Leone Orthodontic Implant TAD (Physical Device)
The "acceptance criteria" for this physical device are implicitly defined by the demonstration of substantial equivalence to a predicate device (PSM LOMAS/BENEFIT Screws, K110392) through a series of non-clinical performance tests and material comparisons. The acceptance is based on the results of these tests showing comparability to, and no significant differences from, the legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (as demonstrated by comparison to Predicate)
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Meeting Criteria) |
|---|---|
| Indications for Use: Provide fixed anchorage point for orthodontic appliances to facilitate orthodontic movement of teeth in adolescents > 12 years and adults. Temporary use, single-use screws. | Identical to predicate device. |
| Material: Titanium Alloy (ISO 5832-3/ASTM F136) | Identical to predicate device. |
| Anatomical Site: Maxillary and mandibular bone. | Identical to predicate device. |
| Design: Self-drilling with right-hand thread. | Identical to predicate device. |
| Length (mm): Within range of predicate (7-15mm). | 8mm, which is within the predicate's range. Minor difference deemed not to affect overall performance. |
| Body Diameter: Comparable to predicate (e.g., Ø1.5mm, Ø2.0mm, Ø2.3mm). | Ø2.0mm, which is the same as some predicate variants. |
| Sterilization: Provided sterile by irradiation. | Identical to predicate device. Validated to SAL of 10⁻⁶ (ISO 11137 series). |
| Packaging: Primary sterile package inside a protective box. | Identical (or very similar) to predicate device. |
| Single Use/Reuse: Single use only. | Identical to predicate device. |
| Biocompatibility: Biocompatible per ISO 10993-1. | Biocompatible, manufacturing process and materials same as previously cleared device (K070483). Additional testing per ISO 10993-5 and ISO 10993-12 performed. |
| Mechanical Performance (comparable to predicate): |
- Insertion capacity
- Failure Torque
- Pull-out retention
- Bending strength
- Screw accessory torsion resistance | Non-clinical tests performed (ASTM F543, ISO 19023, ISO 5832-3).
"The results of the analysis demonstrate that the subject device and the legally marketed predicate device performances are substantially equivalent for the assessed endpoints, because the outcomes of the test are comparable between the proposed and the predicate device." |
| Surface Analysis: Acceptable residual contamination. | SEM Surface Analysis performed to assess residual contamination. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices tested for each non-clinical test. The document refers to "the results of the analysis" and "outcomes of the test" for performance tests without giving specific N values. For biocompatibility, it leverages prior clearance (K070483) and adherence to ISO standards, which would imply a specific number of samples for in vitro and in vivo tests, but these numbers are not detailed here.
- Data Provenance: The tests are described as non-clinical laboratory tests, implying data generated from controlled experimental conditions, not patient data. The origin (e.g., specific country of test lab) is not specified. It is inherently "prospective" in the sense that the tests were performed specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This section is not applicable as the device is a physical implant, not an AI/ML system requiring human expert interpretation or ground truth establishment from patient data for performance validation. The "ground truth" for non-clinical testing refers to established engineering specifications and standard test methods.
4. Adjudication Method for the Test Set:
This section is not applicable for a physical device's non-clinical testing. Adjudication methods like 2+1 or 3+1 typically apply to human reader studies for AI/ML performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
This section is not applicable. No clinical studies, and therefore no MRMC studies, were performed or required for this 510(k) submission, as explicitly stated: "No clinical performance data were provided to demonstrate substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
For the performance testing of this physical medical device, the "ground truth" is established by:
- Engineering Standards: Established international and national standards (ASTM F543, ISO 19023, ISO 5832-3, ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 11137 series). These standards define the test methodologies and acceptable performance ranges or comparative metrics.
- Predicate Device Performance: The performance of the legally marketed predicate device (K110392) serves as the benchmark against which the subject device's performance is compared for substantial equivalence.
8. The Sample Size for the Training Set:
This section is not applicable. This is a physical device; there is no "training set" for an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.