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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.

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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.

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MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandbular central/lateral incisors only.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from 3 manufacturers, a total of 14 implant-abutment interface compatibilities. The compatible implant body diameters range from 3.25 mm to 6.0 mm and the corresponding implant platform diameters range from 3.4 mm. The subject device prosthetic platform diameters range from 3.8 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K 182246. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate.

Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.

All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.

MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided in straight designs, with engaging and non-engaging connections. The L-LNK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement recommended in the labeling (RelyX RMGIP bonding cement, cleared in K022476).

Design parameters for the L-LINK zirconia superstructure are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height of the coping - 0 mm (all L-LINK bases have minimum gingival height of 0.5 mm) Maximum gingival height – 5.0 mm Maximum angle - 20°

All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.

MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in diameter by 20 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.

Design parameters for the PREFIT patient specific abutment are: Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 5.0 mm Maximum angle - 30°

The provided text describes the regulatory clearance of a dental device, "MIST IC." It outlines the device's intended use and compares it to a predicate device. However, it does not contain explicit information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance.

This document focuses on establishing substantial equivalence for regulatory purposes, relying heavily on non-clinical testing and comparison to an existing predicate device. The information provided is primarily relevant to the safety and mechanical performance of the dental implant abutments, not AI/algorithm performance.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds or performance metrics for an AI algorithm. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to the predicate device and ensure safety and efficacy.

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

This information is not provided in the document. The document refers to "non-clinical testing data" but does not detail the sample sizes for these tests or the provenance of any data beyond indicating it's for dental implant abutment compatibility and mechanical strength. There is no mention of an "AI test set."

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

This information is not provided. The document describes mechanical performance and material compatibility testing, not a study requiring expert-established ground truth for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not provided. As no "test set" for AI or expert review is mentioned, adjudication methods are not applicable here.

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. The document explicitly states: "No clinical data were included in this submission." This type of study typically involves human readers and is clinical in nature.

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

The document describes a physical medical device (dental implant abutments) and its mechanical and material properties. There is no mention of an AI algorithm or standalone algorithm performance.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned, the "ground truth" is established by objective engineering standards and validated testing protocols (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" as ground truth for an AI in this context.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a training set as the document does not concern an AI algorithm.

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

This information is not provided as there is no mention of a training set or AI algorithm in the provided text.

Summary of what the document IS about:

The document is an FDA 510(k) clearance letter for the MIST IC dental abutment. It establishes substantial equivalence to a predicate device (K182246) based on:

• Non-clinical testing: Biocompatibility, sterilization, MR compatibility, reverse engineering for compatibility, and static/dynamic compression-bending.
• Material properties: Both subject and predicate devices are made of Titanium Alloy (ASTM F136), with TiN coating for L-LINK abutments, and use zirconia copings (ISO 13356) and the same bonding cement (RelyX RMGIP).
• Design similarities: Similar CAD-CAM fabrication process, restoration types (single/multi-unit, cement-retained), and design parameters (minimum wall thickness, post height, gingival height, angulation).
• Intended Use: Supports a prosthetic device in partially or completely edentulous patients, compatible with various specified implant systems.

The text does not discuss, describe, or evaluate any AI component of the device.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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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:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

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.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific 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 the 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.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase screw for fixation to the implant body.

TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. The TruBase screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.

The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.

Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.

• Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
• Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.

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 to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.

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

Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.

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. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.

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

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

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

The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.

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Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patient-specific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm.

Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.

The provided document is a 510(k) summary for the Duranext Abutments, a dental device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Therefore, I cannot extract the information required for questions about AI performance, multi-reader multi-case studies, or specific details of ground truth establishment for AI training/testing.

However, I can provide information about the acceptance criteria and the non-clinical study that proves the device meets those criteria, as well as general device information.

Here's what can be extracted based on the document:

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

The document does not explicitly present a table of "acceptance criteria" in the format of a diagnostic test (e.g., sensitivity, specificity). Instead, substantial equivalence is claimed based on performance testing and comparison to predicate devices for mechanical properties, biocompatibility, and sterilization. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant 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)

The document does not mention "test sets" in the context of diagnostic data. The "testing" refers to non-clinical performance testing of the physical abutment blanks. The sample sizes for these specific engineering tests (e.g., number of abutments tested for fatigue) are not provided in this summary. The provenance is implied to be from the manufacturer's testing or a contracted lab.

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, as this is a physical medical device (dental abutment) and the evaluation is based on non-clinical performance testing against engineering standards, not diagnostic interpretation by experts.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, which is not what this document describes.

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 device is a dental abutment, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards and physical measurements. For example:

• Biocompatibility: Established by adherence to ISO 10993 series standards, which involves methods like cytotoxicity testing.
• Mechanical Strength: Established by dynamic fatigue testing according to ISO 14801, which defines acceptable load cycles and failure modes.
• Dimensional Compatibility: Established by reverse engineering and direct measurement against OEM specifications.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no training set in the context of machine learning.

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

Not applicable. As above, there is no training set. The "ground truth" for the device's design and manufacturing parameters is established via engineering specifications, material properties, and adherence to relevant ISO standards, rather than a labeled dataset.

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NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with

NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.

The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).

Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).

The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.

Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.

Acceptance Criteria and Device Performance

This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.

However, based on the performance data listed, we can infer the types of performance evaluated:

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The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.

The Implanter Dental Implant Planning Software is a software aimed to help simplifying dental implant surgery and enhancing its mechanical and esthetic implications in the prosthetic stage. Implanter Dental Implant Planning Software allows dental implant professionals to plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will present the clinician with various reformatted CT/CBCT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. Since the primary purpose of Implanter Dental Implant Planning Software is to aid the planning of implant surgeries, Implanter Dental Implant Planning Software will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy.

Implanter is a digital image processing software for Windows that loads images in DICOM format (CT and CBCT images) and rebuilds them in order to get different views that allows the dentist to assess the patient´s anatomy, plan a dental implant surgery, and design a printable surgical guide based on the former.

The software allows the dentist to:

• · use a dental virtual implant gallery to plan a surgery choosing the proper implant size. The IMPLANTER software contains a virtual dental implants library based on the Groovy Implants from Noble Biocare® (FDA cleared under K050258).
• Implanter Dental Planning Software generates 3D models and exports these . models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
• save the surgical planning session of a patient for later analysis. .

The provided text is a 510(k) summary for the IMPLANTER DENTAL PLANNING SOFTWARE. This document indicates that clinical testing was not required for this 510(k) submission. Therefore, a study proving the device meets acceptance criteria via clinical performance data, as typically associated with a medical device approval and the type of information requested about sample sizes, experts, MRMC studies, and ground truth, is not provided or required in this submission.

The section "EFFECTIVENESS AND SAFETY CONSIDERATIONS" states:
Clinical Test: Clinical testing is not required.
Non-clinical Test: The IMPLANTER DENTAL PLANNING SOFTWARE has documented, validated and verified its software system. Performance tests have been conducted to verify equivalent performance to predicate devices. Performance tests include measurement accuracy of 3D and 2D measuring tools, nerve tracing and implant positioning, and implant drilling accuracy. Report generation has also been validated to verify accuracy of the information reported.

Based on the provided document, the assessment for substantial equivalence relies on non-clinical performance tests and a comparison of technical characteristics with predicate devices.

Here's a breakdown of the available information relevant to your request, noting where information is explicitly not provided due to the nature of this 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the format typically used for clinical study outcomes (e.g., sensitivity, specificity, accuracy). Instead, it states that "Performance tests have been conducted to verify equivalent performance to predicate devices."

The non-clinical performance tests mentioned include:

• Measurement accuracy of 3D and 2D measuring tools
• Nerve tracing
• Implant positioning
• Implant drilling accuracy
• Report generation accuracy

No quantitative results from these performance tests are disclosed in the 510(k) summary. The comparison table focuses on features and technical specifications rather than specific performance metrics and their acceptance thresholds.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided due to the absence of a clinical test. The non-clinical performance tests mentioned do not specify sample sizes for test cases or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided due to the absence of a clinical test that would typically involve expert assessment for ground truth.

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

Not applicable/Not provided due to the absence of a clinical test.

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/Not provided. The document explicitly states "Clinical testing is not required." This device is a preplanning software aid, and there's no indication of an MRMC study comparing human reader performance.

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

The device is described as "a software tool which serves as an aid to visualizing and preplanning of dental implant surgery." This inherently implies a human-in-the-loop scenario. The non-clinical performance tests focused on the accuracy of the software's tools (e.g., measurement, positioning) rather than autonomous diagnostic performance. No standalone performance metrics are provided.

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

For the non-clinical performance tests, implicit ground truth would be based on known geometric properties of test objects for measurement accuracy, or perhaps predefined anatomical references for nerve tracing and implant positioning. However, the exact methods for establishing this ground truth are not detailed in the summary.

Type of Ground Truth (for non-clinical tests): Not explicitly stated, but inferred to be based on predefined technical specifications or known values for the performance tests (e.g., actual distances for measurement accuracy tests).

8. The sample size for the training set

Not applicable/Not provided. This device is described as a "software tool" for planning, not an AI/ML device that requires a "training set" in the context of learning algorithms. It processes DICOM images and provides tools for user interaction. The summary does not mention any machine learning components that would necessitate a training set.

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

Not applicable/Not provided, as there is no mention of a training set for a machine learning algorithm.

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Nobel Biocare's Molar Implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The Molar Implants are indicated for single or multiple unit restorations in the molar region. The Molar Implants can be used in splinted or non-splinted applications. The Molar Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare's Molar Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The Molar Implants are similar in design to the NobelSpeedy, Groovy, TiUnite, and NobelActive Internal Connection Implants. Like these implants, the Molar Implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

The provided text describes a 510(k) summary for a dental implant, not a medical device with acceptance criteria for performance against a specific condition or disease, or a study to prove such performance. Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission focuses on establishing substantial equivalence to previously cleared devices based on material, design, and intended use. The "acceptance criteria" in this context would primarily relate to meeting regulatory standards and demonstrating similarity to predicate devices, rather than performance metrics for diagnostic or therapeutic accuracy.

Therefore, I am unable to provide a response to the prompt as medical devices without AI functionality and performance criteria are not included in this document.

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Nobel Biocare's SFB and CFB implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare TiUnite® Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The SFB and CFB implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

Nobel Biocare SFB and CFB implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria. The document is a 510(k) summary for dental implants, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

The document describes:

• Device: SFB & CFB Implants
• Intended Use: Endosseous dental implants to support prosthetic devices.
• Predicate Devices: TiUnite Implants (K050705) and Groovy Implants (K050258).

There is no mention of:

• Specific acceptance criteria.
• Performance metrics (e.g., accuracy, sensitivity, specificity).
• Any study design (e.g., sample size, data provenance, ground truth establishment, expert adjudication).
• MRMC or standalone AI studies.

The letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to the predicate devices for its stated indications for use. This process relies on demonstrating similarity to already legally marketed devices, not necessarily on new performance studies against predefined acceptance criteria for the new device as would be the case for novel AI/ML devices or other complex technologies requiring extensive performance validation.

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