Search Results

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.

Ask a specific question about this device

Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.

The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The system offers the following components. - Comfort Cap

This document describes a 510(k) premarket notification for the "Advanced Intermezzo Implant System," an endosseous dental implant. The purpose of the 510(k) summary is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for a typical performance study of a diagnostic device. Instead, the focus is on demonstrating "substantial equivalence" to predicate devices through various tests.

The primary method for demonstrating substantial equivalence related to performance was a comparative fatigue test.

While specific numerical acceptance criteria (e.g., minimum force for fatigue failure) are not provided, the reported device performance is that the subject device met the performance of the predicate device.

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

• Sample Size for Fatigue Testing: The document does not specify the exact sample size used for the comparative fatigue test per ISO 14801. It only states that the test was "conducted on the subject device and primary predicate."
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the test data. However, the submitting company, MegaGen Implant Co., Ltd., is located in the Republic of Korea.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as this submission is for a medical device (dental implant) and its physical properties (e.g., fatigue strength), not for an AI/diagnostic software where expert ground truth would be established. The "ground truth" here is the physical performance of the device under mechanical stress.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical image interpretation or diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for the physical performance of a dental implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through physical testing and engineering standards. Specifically, comparative fatigue testing per ISO 14801 was used. This standard defines methods for dynamic fatigue testing of endosseous dental implants.

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device, not an AI model requiring a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device