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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.

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