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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 TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

• · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
• · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
• · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

• (1) For fixing into the endosseous implant
• (2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.

The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.

4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.

7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:

• Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
• Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.

8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.

9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.

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DIO CAD/CAM 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.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: · Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm All digitally designed abutments and/or coping for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format for the device's main function (prosthetic rehabilitation). Instead, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The "performance" is implicitly deemed acceptable if these tests meet the standards and demonstrate equivalence.

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

• Sample Size: Not explicitly stated for specific tests (e.g., how many abutments were fatigued). The document refers to testing "finished assembled implant/abutment systems of the worst-case scenario."
• Data Provenance: The studies are non-clinical (laboratory tests). There is no mention of country of origin for test data beyond the general context of the company (TruAbutment Inc., USA). The studies are inherently "retrospective" in the sense that they are laboratory evaluations, not studies on past patient data.

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

This information is not applicable (N/A) as the study is non-clinical (mechanical, sterilization, biocompatibility testing) and does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense. The "ground truth" is defined by the technical standards (e.g., ISO 14801) themselves.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as point 3. Testing against standards doesn't typically involve adjudication of ground truth by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable (N/A). The TruAbutment DS is a physical medical device (patient-specific CAD/CAM abutment), not an AI/software device that involves human readers or image interpretation.

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

This information is not applicable (N/A). As mentioned above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is established by technical standards and specifications. For example:

• Mechanical performance: Defined by the requirements of ISO 14801:2007 for dental implants.
• Sterilization: Defined by ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility: Defined by ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Dimensional accuracy: Established by engineering specifications and comparison to OEM implant and abutment dimensions.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable (N/A) for the same reasons as point 8.

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