(135 days)
The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla.
The LOCATOR® Overdenture Implant (LODI) System comprises a narrow diameter endosseous dental implant (2.4mm or 2.9mm in diameter and 10, 12, 14, or 16 mm in length) and a screw-retained abutment (2.9mm platform with cuff heights of 2 or 4mm). The collar of the 2.4mm diameter implant is flared to a 2.9mm platform to accommodate the 2.9mm abutment. The implant is made of Ti 6Al-4V ELI conforming to ASTM F136 and the abutment is made of Ti 6AI-4V ELI conforming to ASTM B348.
The provided document describes a medical device submission, K120198, for the LOCATOR® Overdenture Implant System. However, this submission is for a traditional 510(k) premarket notification for a dental implant system, which is a physical device, and not an AI/ML-enabled medical device.
Therefore, most of the requested information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) is not applicable to this type of device submission.
The primary method of demonstrating substantial equivalence for this physical device is through nonclinical mechanical testing and comparison to a legally marketed predicate device.
Here's a breakdown of the relevant information from the provided text:
Acceptance Criteria and Reported Device Performance (Table)
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Static Compression Test | Subject device found substantially equivalent to predicate |
| Dynamic Compression (Fatigue) Test | Subject device found substantially equivalent to predicate |
Explanation Regarding Non-Applicable Sections:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" for this device refers to the physical samples used in mechanical testing, not a dataset of patient information.
- 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. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ISO 14801), not expert medical interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations, not objective mechanical test results.
- 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 for AI/ML-enabled devices.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI/ML-enabled devices.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" is adherence to established mechanical performance standards (ISO 14801) and equivalence to the predicate device under those conditions. It is not based on clinical pathology or outcomes data for this type of submission.
- The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML algorithm that requires a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a nonclinical mechanical testing based on ISO 14801. The tests performed were:
- Static Compression Test
- Dynamic Compression (Fatigue) Test
The purpose of these tests was to demonstrate substantial equivalence to the predicate device, the Ace Surgical Supply Co., Inc., Ace Surgical Secure-Mini™ LOCATOR® Implant System (K092594). The document explicitly states: "The subject device was found to be substantially equivalent to the predicate device when tested side-by-side." This means that the LOCATOR® Overdenture Implant System performed comparably to its predicate device under the standardized mechanical stress conditions outlined in ISO 14801.
§ 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.