Search Results

LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Compatible Implant: LW Implant, LW Narrow Implant
Implant Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant)
Platform Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant)

LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.

The LW Pre-milled Abutment is made of Ti-6AI-4V-ELI (ASTM F136), and it is provided non-sterile, which is required to be sterilized by the end-user before use. The subject abutment is indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations.

To produce patient-specific abutments, the cylindrical section of LW Pre-milled Abutment is customized by machining it using CAD/CAM technology. Each patient-specific abutment is custom-prescribed by the clinician.

Abutment Name: LW Pre-milled Abutment, LW Narrow Pre-milled Abutment
Uses: The Abutment is used as a support of prosthesis to restore the patient's chewing function.
Surface Treatment: N/A
Fixture Connection: Hex 2.48 / Non-Hex (LW Pre-milled Abutment), Hex 2.08 / Non-Hex (LW Narrow Pre-milled Abutment)

LW Pre-milled Abutment is compatible with following Implant System.

1. LW Pre-milled Abutment
   Proprietary Name: LW Implant System
   Pre-market Submission Number: K223924
   Compatible Implant Device Name: LW Implant
   Implant Interface Connection Type/Size (mm): Internal Connection Type/2.5
   Type of Implant-Abutment Connection: Hex/Non-Hex

LW Pre-milled Abutment is used with an LW Abutment Screw in LW Implant System(K223924).

2. LW Narrow Pre-milled Abutment
   Proprietary Name: LW Narrow Implant System
   Pre-market Submission Number: K233808
   Compatible Implant Device Name: LW Narrow Implant
   Implant Interface Connection Type/Size (mm): Internal Connection Type/2.1
   Type of Implant-Abutment Connection: Hex/Non-Hex

LW Narrow Pre-milled Abutment is used with an LW Narrow Abutment Screw in LW Narrow Implant System(K233808).

The design envelope for Patient-Specific Abutment are as follows:
Diameter: 4.5-7.0 mm (LW Pre-milled Abutment), 4.0, 4.5 mm (LW Narrow Pre-milled Abutment)
Length: Straight: 7.9 - 16.9 mm, Angled: 12.9, 14.9 mm (LW Pre-milled Abutment)
Minimum gingival height: 1.0 mm (LW Pre-milled Abutment)
Maximum gingival height: 7.0 mm (LW Pre-milled Abutment)
Minimum wall thickness: 0.4 mm (LW Pre-milled Abutment)
Minimum post height for single-unit restorations (length above the abutment collar / gingival height): 4.0 mm (LW Pre-milled Abutment)
Maximum angulation: 30° (LW Pre-milled Abutment)

This FDA 510(k) summary does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria from an AI/machine learning perspective.

The document describes a dental implant abutment, which is a physical medical device (LW Pre-milled Abutment). The "tests" mentioned are traditional hardware tests for physical devices, not assessments of AI algorithmic performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance (for AI): Not applicable. The "device" here is a physical abutment, not an AI model.
2. Sample size used for the test set and the data provenance: Not applicable. There is no AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no AI test set with ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (algorithm only) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details non-clinical tests performed on the physical dental abutment, which include:

• End User Sterilization Validation Test (according to ISO 17665-1,-2)
• Fatigue Testing (according to ISO 14801:2016)
• Biocompatibility Testing (according to ISO 10993-1)
• MRI Safety review

These tests are standard for physical medical devices to demonstrate safety and performance under specific conditions, and they are not related to artificial intelligence performance.

Ask a specific question about this device

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

The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use.

The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.

The provided text is an FDA 510(k) clearance letter for a dental implant abutment system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, AI-driven or novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria for a device's performance, a study proving it meets those criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The "Non-Clinical Test Data" section lists various engineering and material tests (surface modification, sterilization, biocompatibility, fatigue, MRI safety) that were performed to demonstrate the device's safety and effectiveness in comparison to the predicate devices, but these are not performance metrics that would be evaluated against specific acceptance criteria for a new and complex medical device with an AI component or a diagnostic function.

In summary, none of the requested information to describe acceptance criteria and the study proving the device meets those criteria is present in this FDA 510(k) document because it's for a dental implant abutment, not a device with the type of performance metrics implied by your query.

Ask a specific question about this device

The LW UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW UCLA Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924. The Abutment is used as a support of prosthesis to restore the patient's chewing function. It is made of Co-Cr-Mo alloy (ASTM F1537) in the main body and POM (ASTM F1855) in the plastic sleeve, and it is provided non-sterile, which are required to be sterilized by the enduser before use. The dimensions are O 4.5 (D) x 10.0 mm (P/H, when the main body and plastic sleeve are connected.).

The provided document is a 510(k) summary for a medical device called "LW UCLA Abutment," which is an endosseous dental implant abutment. It describes the device's indications for use, technological characteristics, and non-clinical test data to demonstrate substantial equivalence to a predicate device.

However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for demonstrating the device meets performance criteria in the context of an AI/ML powered device.

The non-clinical tests mentioned are:

• End User Sterilization Validation: Conducted according to ISO 17665-1 and ISO 17665-2 to ensure the device can be properly sterilized by the end-user.
• Biocompatibility Tests: Performed according to ISO 10993-1:2009 and FDA guidance to demonstrate the biocompatibility of the materials used.

The conclusion states that "The non-clinical testing results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device." However, the specific acceptance criteria values for these tests are not provided in the document, nor are the detailed study results that prove these criteria are met (only that they "met the acceptance criteria").

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or the other detailed study information, as it is not present in the provided text. The document focuses on establishing substantial equivalence based on material, design, and non-clinical safety aspects for a dental implant abutment, not on the performance evaluation of an AI-powered diagnostic or predictive device.

Ask a specific question about this device

The LW Retaction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW Retraction Cap is a component of the LW Implant System (K223924), and it is used with the LW Solid Abutment and LW Vis Abutment of the LW Implant System.
Used to protect the LW Solid Abutment and LW Vis Abutment in the oral cavity.
The LW Retraction Cap is made of POM(Polyoxymethylene(ASTM F1855)) and provided non-sterile, which is required to be sterilized by the end-user before use.
The dimensions of subject device are as following: Ø 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 mm (D) x 5.5, 7.0, 8.5 mm (L).

The provided text describes the regulatory clearance of a medical device and does not contain information about an AI/ML diagnostic or prognostic device's acceptance criteria or a study proving its performance. The document is a 510(k) premarket notification for a dental device called "LW Retraction Cap," which is an endosseous dental implant abutment.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: The LW Retraction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Material: POM (Polyoxymethylene) (ASTM F1855)
• Design Features: Dimensions (various diameters and lengths)
• Sterilization: Provided non-sterile, intended for end-user sterilization.
• Non-Clinical Tests:
  • End User Sterilization Validation: Performed according to ISO 17665-1 and ISO 17665-2.
  • Biocompatibility Tests: Cytotoxicity Testing performed according to ISO 10993-5 and FDA Guidance.
  • Performance Tests: Tests for appearance and dimensions to ensure fit and function.

The conclusion is that the LW Retraction Cap is substantially equivalent to the predicate device because it has the same indication for use, material, design feature, surface treatment, and sterilization. Differences in diameter do not raise serious safety or performance issues as it is used temporarily and fits its compatible abutment.

Ask a specific question about this device