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Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.

Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Sherlock is a dental implant abutment system that includes four (4) abutment designs compatible with three (3) OEM implant systems. The Subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: Titanium blank, multi-unit angled 17°, and multiunit angled 30°. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided nonsterile to the end user. All digitally designed customized Titanium Blank abutments are to an Open Implants-validated milling center for manufacture.

The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness – 0.41 to 1.6 mm (varies by implant line); Minimum post height for single-unit restoration - 4.0 mm; Maximum Correction Angle - 30°; Minimum gingival height - 0.5 mm to 0.8 mm (varies by implant line); Maximum gingival height - 5 mm.

The provided document is a 510(k) summary for a dental implant abutment system named "Sherlock" (K212664). It details the device's technical specifications and compares it to predicate and reference devices to demonstrate substantial equivalence.

However, the document does NOT contain information about an AI/ML-based device or a study proving its performance against acceptance criteria using clinical data, reader studies, ground truth establishment, or sample sizes for AI training/testing. The "Performance Data" section explicitly states: "No animal or clinical data is included in this premarket notification." The tests performed are non-clinical, focusing on biocompatibility, reverse engineering for compatibility, and static compression fatigue.

Therefore, I cannot provide the requested information for an AI/ML device study. The content of the document pertains to the regulatory clearance of a physical medical device (dental abutments) based on substantial equivalence to existing devices, primarily through non-clinical performance data.

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The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
• o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:

• Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
• Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.

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

The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.

• Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
• Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.

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

This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.

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

No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:

• Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
• Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
• Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This section is not applicable for the same reason as above; there is no training set for a physical medical device.

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