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The LOCATOR® Overdenture Implant System is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

The LOCATOR Overdenture Implant (LODI) was originally cleared under K120198. This submission is to add additional implant sizes to the LODI family that for distinction purposes, will hereinafter be called the Standard Ridge LOCATOR Overdenture Implant (LODI) System. The added implant sizes are listed in Table 1.0 below:

Table 1.0 Subiect Device Sizes

Identical to K120198, the subject LODI Standard Ridge System is designed to retain overdentures of partial dentures in the mandible or maxilla. The System includes a threaded and tapered endosseous dental implant that is made from the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

The provided text describes a 510(k) premarket notification for the "LOCATOR® Overdenture Implant System," specifically to add additional implant sizes to the existing system. The document focuses on demonstrating substantial equivalence to a predicate device (K120198) and a reference device (K192221) rather than presenting a study to prove acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

Therefore, many of the requested fields are not directly applicable to this type of submission which primarily relies on engineering and material testing to confirm equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on engineering design principles, material science, and performance testing for mechanical, biological (biocompatibility, sterilization, cleanability, endotoxin), and shelf-life attributes, rather than a "test set" of clinical data. The acceptance criteria for manufacturing processes (e.g., sterilization, cleanability) are evaluated on representative devices or materials.
• Data Provenance: Not applicable in the context of clinical test data. The data provenance relates to internal manufacturing and testing records (e.g., ISO and USP standards for testing methods).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a clinical study involving expert interpretation for ground truth.

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

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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 a medical device (dental implant) and not an AI-driven diagnostic tool.

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

• Not applicable. This is a medical device (dental implant) and not an AI-driven algorithm.

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

• Not applicable in the sense of clinical ground truth for a diagnostic device. The "ground truth" for this submission are the established engineering standards (e.g., ASTM F136 for material, ISO 11137-2 for sterilization, ISO 10993-1 for biocompatibility, USP for endotoxin) and the performance characteristics of the predicate device.

8. The sample size for the training set:

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

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

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

Summary of the Study/Approach:

The submission K203701 for the LOCATOR® Overdenture Implant System demonstrates substantial equivalence by showing that the new implant sizes are

• Made from the identical material (6Al-4V ELI Titanium conforming to ASTM F136).
• Have the same surface roughening process (Resorbable Blast Media, RBM).
• Maintain the same manufacturing processes and equipment.
• The Indications for Use remain within the scope of the predicate device (K120198).
• Performance testing (mechanical properties, corrosion, biocompatibility, sterilization, cleanability, fatigue, shelf-life, surface treatment, endotoxin) confirmed that adding new implant sizes either did not alter the existing safety and performance profile of the predicate device or, in cases of slight design changes (e.g., dual lead thread, blunted tip), did not create a new worst-case scenario. For instance, the larger cross-sectional area of the new implants was deemed to not introduce a new worst case for fatigue strength, and previous fatigue testing from K120198 was considered applicable. Similarly, the "new worst-case implant" (Standard Ridge LODI 4.9mm) was specifically tested for cleanability to meet acceptance criteria.

Note: "No clinical studies are provided as part of this 510(k) submission" is explicitly stated, reinforcing that this clearance relies on non-clinical (bench and material) testing and established equivalency principles.

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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)

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.

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