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The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

The LL Implant System consists of a one-piece implant and temporary cap. The LL Mini Onebody Implant is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: submerged type, tapered body, sided cutting edge. The LL Temporary Cap is made Polyoxymethylene (ASTM F1855) without any surface treatment.

The provided text does not contain detailed acceptance criteria and a study that proves the device meets them in the format requested. The document discusses the substantial equivalence of the "LL Implant System" to predicate devices, primarily focusing on materials, design, and general non-clinical testing performed according to ISO standards and FDA guidance.

Here's an analysis based on the information available and what is missing regarding your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

• Information Available: The document mentions that several non-clinical tests were performed (Fatigue Testing, Sterilization Validation, Shelf-Life Testing, Biocompatibility, Bacterial Endotoxin Testing, Surface Modification, and MR Safety). For some tests, it states that "the results have met the acceptance criteria" or "demonstrated equivalence to the predicate device."
• Missing Information: Specific numerical acceptance criteria for each test and the corresponding quantitative results/performance from the LL Implant System are not provided. For example, for "Fatigue Testing," it says it was done "according to ISO 14801:2016" and "expected to function properly," but it doesn't state the specific load cycles, force applied, and the device's measured endurance limits to compare against predefined acceptance thresholds. Similarly for "Bacterial Endotoxin Testing," it says "met the acceptance criteria," but the criteria itself and the measured endotoxin levels are absent.

2. Sample Size Used for the Test Set and Data Provenance

• Missing Information: The document does not specify the sample sizes used for any of the non-clinical tests. It refers to "worst-case scenario" for several tests but doesn't quantify how many samples were included in these scenarios. Additionally, there's no mention of the data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical lab tests and not human subject studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This question is relevant for studies involving human data and expert review for ground truth establishment (e.g., diagnostic AI models). The studies described here are non-clinical, laboratory-based tests on a physical medical device (dental implant). Thus, there's no "ground truth" to be established by human experts in this context.

4. Adjudication Method for the Test Set

• Not Applicable: Similar to point 3, adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in ground truth labeling. This is not pertinent to the non-clinical device testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Performed: The document does not mention any MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance. The device is a physical dental implant, not an AI software.

6. Standalone (Algorithm Only) Performance Study

• Not Performed: This question is referring to AI algorithm performance. The device is a physical dental implant, not an AI algorithm.

7. Type of Ground Truth Used

• Not Applicable (for clinical ground truth): As these are non-clinical, laboratory tests, the "ground truth" aligns with established scientific and engineering principles, international standards (e.g., ISO 14801 for fatigue, ISO 11137 for sterilization), and FDA guidance documents. The "truth" is whether the device physically performs according to these standards, not an expert consensus or pathology on a biological sample.

8. Sample Size for the Training Set

• Not Applicable: This question typically relates to AI/ML models. The LL Implant System is a physical device, and therefore, there is no "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set for an AI model, this question is not relevant.

Summary of what is available (and implied in relation to "acceptance criteria" and "proof"):

• Acceptance Criteria (Implied): The acceptance criteria are largely implied by compliance with specific ISO standards (e.g., ISO 14801:2016 for fatigue, ISO 11137-1 for sterilization, ISO 10993-1 for biocompatibility) and FDA guidance documents. The document states that the test results "met the acceptance criteria" or "demonstrated substantial equivalence" to predicate devices, indicating that the predefined thresholds within these standards were achieved.
• Study That Proves the Device Meets Criteria: Various non-clinical studies were conducted:
  • Fatigue Testing: Performed on the subject device according to ISO 14801:2016 and FDA guidance.
  • Sterilization Validation: Gamma sterilization (implants) validated per ISO 11137 series; End-user sterilization (caps) validated per ISO 17665 series and FDA guidance. These were leveraged from previous submissions (K223924, K231079).
  • Shelf-Life Test: Performed per ASTM F1980 (leveraged from K223924).
  • Biocompatibility Testing: Performed per ISO 10993-1 and FDA guidance, including Cytotoxicity per ISO 10993-5 (leveraged from K223924, K231079).
  • Bacterial Endotoxin Testing: Performed per USP and and FDA guidance.
  • Surface Modification Information: Evaluation per FDA guidance, including surface roughness, composition analysis, SEM, and ICP analysis.
  • MR Safety: Worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.

In short, the document confirms that required non-clinical tests were conducted according to recognized standards and guidance, and the results were deemed to meet acceptance criteria, thereby demonstrating substantial equivalence to predicate devices. However, it does not provide the specific quantitative details of these acceptance criteria or the measured performance results for each test.

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