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The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below:

• Root Form Implants:
  • Ø 3.5/ 8, 10, 12, and 14 mm
  • Ø 4.0/ 8, 10, 12, and 14 mm
  • Ø 4.5/ 8, 10, 12, and 14 mm
  • Ø 5.0/ 8, 10, 12, and 14 mm
  • Ø 5.5/ 8, 10, 12, and 14 mm
• Wide Form Implants:
  • Ø 4.1/ 8, 10, 12, and 14 mm
  • Ø 4.5/ 8, 10, 12, and 14 mm
  • Ø 5.5/ 8, 10, and 12 mm
  • Ø 6.5/ 8 and 10 mm

Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472).

The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics.

This document is a 510(k) summary for OsteoCentric Dental Implants, a Class II medical device. The primary purpose of this type of submission is to demonstrate substantial equivalence to an already legally marketed predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the same way one might for a novel device or a software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria, specific study designs (like MRMC), expert ground truthing, and training/test set details for AI/ML-based devices is not present in this document. This submission focuses on comparing the new device's design, materials, and mechanical performance (fatigue testing) to a predicate device, along with leveraging existing data for biocompatibility, sterility, shelf-life, etc.

Here's an attempt to answer your questions based on what is available in the document, and where applicable, explaining why the information is not present:

Analysis of the Provided Document for Acceptance Criteria and Device Performance Study Information:

The provided document is a 510(k) summary for OsteoCentric Dental Implants. This is a traditional medical device (dental implants), not a software or AI/ML-based device that would typically involve a test set, expert ground truth, multi-reader studies, or large training sets. The "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device, focusing on material, design, and mechanical performance, rather than clinical performance metrics in the way your questions are framed for AI/ML.

Here's a breakdown based on your questions:

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

• Acceptance Criteria: For this type of device, the acceptance criteria are not clinical performance metrics in the sense of sensitivity/specificity, but rather engineering and safety benchmarks to demonstrate substantial equivalence to the predicate. The key "acceptance criterion" mentioned is fatigue testing per ISO 14801.
• Reported Device Performance: The document states: "As noted in the table above, the subject and predicate devices are identical with respect to design, materials of construction, method of stabilization, implant size offerings, surface treatment, and sterility status. A gripping feature was introduced to the implant to eliminate the need for a carrier; however, as demonstrated by fatigue testing, the introduction of this feature does not impact substantial equivalence."
  • This implies that the device met the fatigue testing requirements of ISO 14801, demonstrating that the design change (the gripping feature) did not negatively impact its mechanical performance compared to the predicate. Specific numerical results of the fatigue testing are not provided in this summary document, only the statement that it was performed and met the criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable in the context of this 510(k) summary. This is a mechanical device, not an AI/ML system. The "test set" would refer to the mechanical samples used for fatigue testing. The document does not specify the number of samples tested for fatigue, only that "Fatigue testing per ISO 14801" was performed.
• Data provenance for mechanical testing is typically in-house or third-party lab testing, not patient data in the sense of retrospective/prospective clinical studies.

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 relates to AI/ML ground truthing, which is not part of this device's submission. Ground truth for mechanical testing is established by engineering standards (e.g., ISO 14801 thresholds for failure) and laboratory measurements.

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

• Not applicable. This relates to human expert review for AI/ML validation.

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 hardware device, not an AI assistance tool.

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

• Not applicable. There is no algorithm.

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

• For the mechanical aspects, the "ground truth" implicitly refers to the failure criteria defined by ISO 14801 and the material properties and design specifications. For biocompatibility, sterilization, etc., the "ground truth" is adherence to relevant ISO standards and regulatory guidelines, which was demonstrated by leveraging data from the predicate device.

8. The sample size for the training set

• Not applicable. This is a hardware dental implant, not an AI/ML system that requires a "training set."

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

• Not applicable. As above, no training set for this type of device.

In summary, the provided document is a 510(k) submission for a non-AI/ML dental implant. The "acceptance criteria" and "study" are primarily focused on demonstrating engineering and safety equivalence to a predicate device via standardized mechanical testing (like fatigue) and compliance with general device regulations (biocompatibility, sterilization, etc.), often by leveraging existing data from the predicate. The detailed breakdown of AI/ML validation (test sets, ground truth experts, MRMC studies) is not relevant to this type of traditional medical device submission.

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