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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:

Compatibility Table

Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm.

The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws.

The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.

All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.

The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are:

• Minimum Zirconia Wall Thickness – 0.5 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia)
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician.

The overall design parameters for the Titanium Blank customized abutments are:

• Minimum Wall Thickness – 0.75 mm
• Minimum Post Height for single-unit abutment* – 4.0 mm
• Minimum Overall Gingival Height – 0.8 mm
• Maximum Overall Gingival Height – 5 mm
• Maximum Correction Angle – 30°

All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations.

Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration.

All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The provided FDA 510(k) Clearance Letter for Sherlock Dental Implant Abutment does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical data reviewed by the FDA for clearance. However, it does not detail specific acceptance criteria or an associated study demonstrating compliance with those criteria.

The "Performance Data" section lists several types of non-clinical data submitted, such as static and fatigue testing according to ISO 14801, a reverse engineering study, biocompatibility testing, cleaning and sterilization validation, and an MRI review. These are the studies performed to support the substantial equivalence claim, but the FDA letter does not specify quantitative acceptance criteria for these tests nor does it report specific performance outcomes that directly address such criteria.

Therefore, I cannot populate the requested table or provide details for points 1-9 based solely on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study against predefined acceptance criteria.

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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 is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile.

In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center.

All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.

All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.

The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are:

Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30°

The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.

This document is an FDA 510(k) clearance letter for the Sherlock dental implant abutment system. It outlines the device's intended use, technological characteristics, and a comparison to predicate and reference devices to demonstrate substantial equivalence.

Based on the provided text, the "device" in question is a dental implant abutment. The approval is based on a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical study proving new performance claims. Therefore, the typical structure of acceptance criteria and a study proving those criteria for a novel device, especially an AI/ML system, is not directly applicable here.

However, I can extract information related to the non-clinical performance data used to support the substantial equivalence claim, which serves as a form of "acceptance criteria" for this type of submission.

Here's a breakdown of the information requested, adapted to what is available in the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the "acceptance criteria" are implied by the regulatory requirements for demonstrating substantial equivalence for dental implant abutments, primarily relying on non-clinical testing and comparison to predicate devices, rather than specific performance metrics from a human-in-the-loop or standalone AI study.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not applicable in the context of human data for an AI/ML system. The "test set" here refers to physical devices and materials subjected to non-clinical testing. The text refers to "worst-case constructs" for mechanical testing, but does not provide specific sample numbers for these tests.
• Data Provenance: The data provenance for this submission is primarily non-clinical bench testing (static and fatigue testing, biocompatibility, cleaning, sterilization, MRI review) and comparison to previously approved devices (leveraging data from K193335 and K212664). No human clinical data was included in this premarket notification. The tests are general, and therefore, "country of origin" of data or "retrospective/prospective" does not directly apply to the non-clinical tests themselves, although the regulatory submission is for the U.S. market.

3. Number of Experts for Ground Truth and Qualifications:

• Not applicable. This submission does not involve an AI/ML system that requires expert human annotation for ground truth establishment for a diagnostic or similar task. The ground truth for the device's performance is established through established engineering standards (ISO, AAMI) and material science principles, confirmed via laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human reading or diagnostic task involved that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements from bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This device is a physical dental implant abutment, not an AI/ML software for data interpretation or diagnosis. Therefore, no MRMC study was performed or required.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Engineering Standards and Bench Test Results: The "ground truth" for this device's safety and effectiveness is based on compliance with established international standards (e.g., ISO 14801, ISO 10993-5, ISO 13356, ISO 14937, AAMI TIR30) demonstrated through physical and chemical testing. "Reverse engineering studies" are also mentioned, implying a comparison against the physical characteristics of existing OEM implant systems.

8. Sample Size for the Training Set:

• Not applicable. There is no AI/ML system involved that would require a "training set." The CAD/CAM customizations refer to design parameters for manufacturing, not a machine learning training process.

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

• Not applicable. As no AI/ML training set is used, this question is not relevant.

In summary: This FDA 510(k) clearance is for a physical medical device (dental implant abutment) and relies on demonstration of substantial equivalence through non-clinical bench testing and comparison to existing predicate devices. It does not involve AI/ML technology, human readers, or clinical data that would necessitate the types of "acceptance criteria" and "study proofs" typically associated with AI/ML-driven diagnostic devices.

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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.

Ask a specific question about this device

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:

Compatibility Table

                        | 4.3, 5.0                   | 3.9 (RP)

Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP).

The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user.

Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment.

The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture.

The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.

The provided document describes a 510(k) premarket notification for a dental implant abutment called "Sherlock." It does not contain information about a study with acceptance criteria and device performance in the context of a diagnostic AI device or a comparative effectiveness study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.

Therefore, many of the requested items related to acceptance criteria for a study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of FDA submission.

However, I can extract the information available from the document that relates to the device's characteristics and the non-clinical performance data used to support its substantial equivalence.

Here's a summary based on the provided text, addressing the points where information is available and indicating where it is not:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria for a study in terms of metrics like sensitivity, specificity, or accuracy, nor does it report device performance against such criteria. Instead, it discusses "performance testing" to validate differences in design parameters for demonstrating substantial equivalence. The specific acceptance criteria for these non-clinical tests (e.g., fatigue testing, biocompatibility) are not explicitly detailed in a table format with corresponding results, beyond stating that they were performed according to specific ISO standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document focuses on non-clinical performance data, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes non-clinical performance testing and substantial equivalence, not a study requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of an adjudication process as no clinical test set requiring ground truth adjudication is described.

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

Not applicable. This is a 510(k) submission for a dental implant abutment, not an AI or diagnostic device that would typically undergo an MRMC study.

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

Not applicable. The device is a physical dental abutment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical performance data, the "ground truth" would be the engineering specifications, material properties, and performance limits defined by the relevant ISO standards (e.g., successful sterilization, biocompatible materials, passing fatigue tests).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device.

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