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NobelZygoma TiUltra implants

The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Multi-Unite Abutment Xeal Zygoma

The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures.

NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws

The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelZygoma TiUltra Implant system is composed of three device lines: NobelZygoma TiUltra Implants, Multi-unit Abutments Xeal Zygoma and NobelZygoma Multi-unit Abutment Xeal Zygoma Screws.

The NobelZygoma TiUltra Implants are endosseous dental implants surgically placed in the zygomatic bone to provide support for prosthetic devices. They are used with patients with severe bone resorption in the maxilla to provide multi-point support of the dental reconstruction. The NobelZygoma TiUltra Implants are used to support the rehabilitation of a fully or a partially edentulous maxilla. The Subject Devices are only intended for extra-maxillary placement.

The subject Implants are made from unalloyed titanium grade 4 (ASTM F67) and present a two-level anodized surface with a soluble salt (protective) layer. Two variants of the Implants are available based on the collar angulation: the NobelZygoma 0° and the NobelZygoma 45° TiUltra Implants. The NobelZygoma 0° CC TiUltra Implants feature a conical connection platform with an internal hex (size RP). The NobelZygoma 45° Ext Hex TiUltra Implants include an external hexagonal platform (size RP).

The NobelZygoma TiUltra implants are available in lengths ranging from 30 mm to 60 mm, in 2.5 mm increments. They feature a partially threaded design. The neck portion, measuring 3.6 mm from the platform, and the shaft portion which varies depending on the implant length, are unthreaded. For all implant lengths, threading consistently begins at the apex and extends 18 mm coronally.

The NobelZygoma TiUltra Implants are co-packed with an implant mount, which is attached via a pre-assembled implant mount screw to the platform of the implant.

The Multi-unit Abutments Xeal Zygoma are premanufactured prosthetic components intended to be connected to the compatible NobelZygoma TiUltra Implants to support the placement of a dental prosthesis.

The Multi-unit Abutment (MUA) Xeal Zygoma are made from Titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and feature a non-porous oxide layer with a soluble salt (protective) layer. The Multi-unit Abutments Xeal Zygoma are attached to the respective NobelZygoma TiUltra Implants by the compatible NobelZygoma Multi-unit Abutment Xeal Zygoma Screw.

The Multi-unit Abutment Xeal Zygoma are available in four different angulations (straight or 0°, 17°, 45° and 60°) and in different heights ranging from 3 to 9mm (2mm increase). The 45° and 60° angulations are used with the NobelZygoma 0° TiUltra implants, while the Straight (or 0°) and 17° angulations are compatible with the NobelZygoma 45° TiUltra Implants. The 17° MUA is only available in two heights (3 and 5mm).

The Multi-unit Abutments Xeal Zygoma are provided sterile and co-packed with the respective abutment handle and NobelZygoma Multi-Unit Abutments Xeal Zygoma Screw.

The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are dental implant screws designed to fasten dental implant system components to a dental implant or to another component.

The subject screws are made of titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and are partially DLC-coated. They are available in different design and sizes to fit the different Multi-unit Abutments Xeal Zygoma. The Straight NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are available in four sizes to fit the respective Straight Multi-Unit Abutment heights. The screws for the 45°/60° Multi-Unit Abutments and the 17° Multi-Unit Abutment are only available in one size that fits all abutment sizes.

The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are co-packed with the compatible Mult-unit Abutment Xeal Zygoma and are also available separately.

The provided document is a 510(k) Clearance Letter from the FDA for the "NobelZygoma TiUltra Implant system." This type of document primarily focuses on establishing substantial equivalence to previously cleared predicate devices, rather than explicitly detailing acceptance criteria and presenting a single, comprehensive study proving the device meets those criteria.

However, the document does contain information about non-clinical and clinical testing performed to support the substantial equivalence claim. I will extract the relevant information to answer your questions to the best of my ability, acknowledging that not all requested details may be explicitly present in this type of regulatory submission summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list acceptance criteria in a formal table with pass/fail values. Instead, it describes various tests performed and compares the subject device's performance to predicate devices or established standards. The "Reported Device Performance" column reflects the summary of findings from the validation studies described.

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

• Test Set Sample Size: The document does not provide specific sample sizes for the non-clinical tests (fatigue, torque, MR, biocompatibility, packaging, sterilization, endotoxin, surface roughness). These are typically determined by relevant standards.
  • For clinical published literature, the sample sizes varied:
    • Three studies on non-full arch applications involved 176 similar zygomatic implants.
    • Systematic literature review on quad configuration reported data for a mean implant survival rate (implies a larger, unspecified number of cases).
    • Two clinical studies involving Nobel Biocare zygomatic implants: n=15 (minimum 79 months follow-up) and n=302 (mean 7.9 years follow-up).
    • A total of 40 clinical publications were provided to support the established history of safe clinical use (number of implants/patients unspecified in this summary).
    • Seven clinical cases with a total of 16 NobelZygoma TiUltra implants were presented.
    • 36 clinical publications on NobelReplace and TiUltra implant family (number of implants/patients unspecified in this summary).
• Data Provenance:
  • Clinical Studies: Published literature (implies peer-reviewed, multi-center, potentially international data).
  • Real-world evidence (RWE): Post-market surveillance for the Subject Devices from July 2024 to May 2025. This is prospective data specific to the subject device after initial market introduction (likely under a different clearance or within a broader market).
  • Clinical Case Studies: Seven cases presented directly by the submitter.
  • The document implies that data from various regions would be included in "published literature" and "post-market surveillance." No specific countries of origin are mentioned beyond "Nobel Biocare" (Sweden/Switzerland) and "Southern Implants (Pty) Ltd" (implies South Africa). The nature of most clinical data is retrospective (published studies, post-market surveillance).

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

The document does not specify the number of experts used to establish ground truth for the test set (clinical studies). Clinical studies typically rely on diagnoses and assessments made by treating clinicians (dental surgeons, prosthodontists) based on established medical practices and diagnostic criteria, rather than a separate "ground truth" panel for the study itself, unless it's a specific adjudication or consensus study. Such details are usually found within the full study protocols and reports, which are not part of this 510(k) summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify any adjudication methods for the clinical data presented. This information would typically be detailed in the methodology sections of the individual clinical studies or systematic reviews referenced, which are not provided in this summary.

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

The document describes a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with/without AI assistance is not applicable and was not performed.

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

This question is not applicable as the device is a dental implant system, not an algorithm.

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

• Non-Clinical Tests: Ground truth is based on established engineering and materials science principles, international standards (ISO, ASTM), and FDA guidance documents. Performance is evaluated against these benchmarks.
• Clinical Performance Data: Ground truth is primarily based on outcomes data, specifically:
  • Implant survival rate: Directly reported as percentage (e.g., 97.4%, 100%, 89.9%, 99.5%).
  • Reported adverse events and complications: Clinical observations and diagnoses by treating dentists/surgeons. Resolution of these events are considered outcomes.
  • Osseointegration: Inferred from success rates and lack of failure/complaints related to implant stability.
  • Patient esthetics and chewing function: These are indications, and clinical data indirectly supports their achievement through successful implant function.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this is a physical medical device (dental implant system), it primarily relies on engineering design, materials science, and clinical validation. Therefore, a "training set" in the context of an algorithm is not applicable. The development and testing would involve design iterations and validation studies, but not an algorithmic training process with a distinct training set.

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

As noted in point 8, the concept of a "training set" in the context of an AI/ML algorithm is not applicable to this physical device. Therefore, the establishment of ground truth for such a set is also not applicable. The "ground truth" for the device's design and performance validation is derived from established scientific principles, pre-clinical testing, and clinical outcomes for the device itself and its predicates.

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

The NobelProcera Zirconia Implant Bridge (Dental Bridge) is a patient-specific, dental implant supported, screw-retained dental implant bridge which is connected to compatible Nobel Biocare root-form endosseous dental implants (Dental Implants) or Multi-unit Abutments and is intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. The Dental Bridge is made from yttria-stabilized tetragonal zirconia. It is designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. The Dental Bridge is available for use with Nobel Biocare's Dental Implants having Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment connections. One Dental Bridge can feature connections to 2 up to 10 Dental Implants. All Dental Bridges are provided with the required Clinical and/or Prosthetic Screw: The Clinical Screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connects the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the External Hex, Internal Tri-Channel, or Multi-unit Abutment connections. Clinical and Prosthetic Screws are placed from the occlusal side of the restoration. To facilitate access to the connection of the restoration to the implant/abutment a screw channel must be designed into the restoration. The Dental Bridge feature an Angulated Screw Channel (ASC) when connected to a Dental Implant with Internal Conical Connection and has an ASC feature to connect to Multi-unit Abutments. NobelProcera Zirconia Implant Bridges ASC's angulation can be defined by the customer in an angulation (to the implant's or Multi-unit Abutment's axis) between 0° and 25°. The ASC allows access through a screw channel which is not in line with the implant.

The provided text is a 510(k) summary for the NobelProcera Zirconia Implant Bridge. It describes the device, its indications for use, and a comparison to a predicate device.

However, the document states: "Clinical data is not required to establish substantial equivalence for the Subject Device. Non-clinical test data was conducted in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'. This testing involved examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing."

This indicates that a clinical study with acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, or MRMC studies for AI performance was not part of the submission for this particular device. The evaluation relied on non-clinical (bench) testing, specifically fatigue testing, to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the provided text as it pertains to clinical studies or AI performance. The document only mentions "fatigue performance testing" as the evidence for the revised extension length.

To answer your request, here's what can be extracted and what cannot:

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

• Acceptance Criteria: While not explicitly listed as a "table of acceptance criteria" in the format usually requested for clinical studies, the document implies that the device's performance regarding "extension length" was evaluated through fatigue testing. The revised extension length of 16mm (for the subject device) versus 10mm (for the predicate device) suggests an acceptance criterion related to the ability to withstand fatigue at this increased length. The wording "fatigue performance testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness" implies that the device successfully met the fatigue requirements for the 16mm extension.
• Reported Device Performance: The document states that "The revised extension length is supported by the fatigue performance testing provided in the premarket notification." and "fatigue testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness." This indicates that the subject device, with its maximum extension length of 16mm, passed the non-clinical fatigue tests, demonstrating performance equivalent to or better than the predicate device.

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

• Not applicable for a non-clinical fatigue test. The testing involved "examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing." The number of units tested is not specified in this summary. Data provenance is not relevant for bench testing.

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. This was a non-clinical, benchtop fatigue test, not a study requiring expert ground truth for clinical interpretation.

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

• Not applicable. This was a non-clinical, benchtop fatigue 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:

• No. This device is a dental implant bridge, not an AI-powered diagnostic or assistive tool.

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

• No. This device is a physical medical device, not a software algorithm.

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

• Not applicable for non-clinical fatigue testing. The "ground truth" for fatigue testing would be the physical measurement of failure or deformation under specified loading conditions, and comparison against a defined standard or predicate performance.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device and non-clinical testing, not an AI algorithm requiring a training set.

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

• Not applicable. See point 8.

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NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) Premarket Notification letter. This type of document is a submission seeking regulatory clearance, not a standalone study report. As such, it outlines the basis for demonstrating substantial equivalence to a predicate device, which includes non-clinical testing. It does not typically contain detailed acceptance criteria and performance data for a study proving a device meets those criteria in the way a clinical trial report or a comprehensive validation study would.

The document primarily focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. It refers to non-clinical tests that were performed, but does not present the specific acceptance criteria or the numerical results of those tests in a "performance table" format.

Therefore, many of the requested points below cannot be fully extracted from this document, as it's not the type of report that contains that level of detail for acceptance criteria and specific study outcomes. I will highlight what can be inferred or directly stated from the provided text, and what cannot.

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a detailed engineering validation report or a clinical study. Instead, it states that "non-clinical tests demonstrate that the device is substantial equivalent."

The document mentions several tests and standards the device was subjected to:

• Packaging system performance testing: per ASTM D4169. (Specific acceptance criteria and reported performance not detailed.)
• Dynamic loading testing: conducted according to ISO 14801 and FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)). (Specific acceptance criteria and reported performance not detailed.)
• Magnetic Resonance compatibility testing: according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Status: "MR Conditional." (This is a performance outcome, but the specific metrics and acceptance thresholds for each ASTM standard are not detailed.)
• Verification of biocompatibility: in accordance with ISO 10993-1. (The conclusion is that "no new issues regarding biocompatibility were raised," implying acceptance, but specific criteria and test results not detailed.)
• End user cleaning and sterilization validation: in accordance with ISO 17665-1. (Implied acceptance, but specific criteria and results not detailed.)

The "acceptance criteria" here are generally referred to as meeting the requirements of the standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is summarized as favorable results sufficient for substantial equivalence determination.

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

• Sample sizes: Not specified in the provided text for any of the non-clinical tests mentioned (packaging, dynamic loading, MR compatibility, biocompatibility, sterilization validation).
• Data provenance: Not explicitly stated (e.g., country of origin). The testing is non-clinical/bench testing, not patient data. It is implied to be internal testing by the manufacturer, Nobel Biocare AB (Sweden).
• Retrospective or prospective: N/A, as these are non-clinical/bench tests, not clinical studies involving patient data.

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

• Applicability: This question is not directly applicable to the type of non-clinical, bench testing described for the NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for AI/ML device evaluations, particularly in diagnostics. This document refers to physical device testing (mechanical, biocompatibility, etc.).

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

• Applicability: Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses for establishing "ground truth," which is not the nature of the non-clinical tests described here.

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

• Applicability: Not applicable. This device is a dental abutment and screw, not an AI/ML-enabled diagnostic device for image interpretation. Therefore, no MRMC study or AI assistance evaluation would have been performed.

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

• Applicability: Not applicable. See point 5. This is a physical medical device, not a standalone algorithm.

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

• Applicability: The concept of "ground truth" as typically applied in AI/ML validation (e.g., for diagnostic accuracy) does not directly apply to the non-clinical device testing described. For these tests, the "ground truth" is typically defined by the specified parameters and performance requirements of the relevant international standards (e.g., ISO 14801 for dynamic loading, ISO 10993-1 for biocompatibility). The devices are expected to meet the performance criteria defined by these standards.

8. The sample size for the training set

• Applicability: Not applicable. This refers to the training of an AI/ML algorithm. The document describes a physical medical device.

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

• Applicability: Not applicable. See point 8.

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DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions.

It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

It can be used to support guided implant surgery whereby the results can be exported. DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration and bone loss. The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.

DTX Studio™ Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intra/Extra Oral X-Rays, (CB)CT scanners, intraoral and extraoral cameras).

DTX Studio Clinic features an Al-powered Focus Area Detection algorithm which analyzes 2D intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user.

The following dental findings can be detected by the device:
• Caries
· Discrepancy at marqin of an existing restoration
· Periapical radiolucency

• Root canal filling deficiency
  • Bone loss
  · Calculus

The provided text describes the 510(k) summary for the DTX Studio Clinic (4.0) device, focusing on its substantial equivalence to predicate devices, particularly regarding its AI-powered "Focus Area Detection" functionality. While the document mentions verification and validation activities, it does not provide a detailed breakdown of the acceptance criteria and performance study results as requested by the prompt.

Specifically, it states:

• "A comparative analysis between the output of the focus area detection algorithm of the output of the primary predicate device (K221921) was performed. The test results show that for each intraoral x-ray image, the focus area detection is executed, and the same number of focus areas were detected compared to the predicate device. All detected bounding boxes were identical and the acceptance criteria was met."

This statement indicates that the new device's AI performance for "Focus Area Detection" was evaluated based on its identity to the primary predicate device (K221921), not against independent clinical performance criteria like sensitivity, specificity, or AUC based on a ground truth established by experts. It implies a non-inferiority or equivalence study where the benchmark is the previously cleared AI, rather than a de novo clinical performance evaluation.

Therefore, many of the requested details about the study are not present in this document. I will fill in the table and address the questions based on the information available, highlighting what is not provided.

Acceptance Criteria and Device Performance Study Details for DTX Studio Clinic (4.0) Focus Area Detection

Based on the provided 510(k) summary, the evaluation of the DTX Studio Clinic (4.0)'s AI-powered "Focus Area Detection" functionality was primarily a comparative analysis against its primary predicate device (DTX Studio Clinic 3.0, K221921), rather than a standalone clinical performance study establishing specific diagnostic metrics against a human-expert ground truth. The acceptance criterion appears to be identical output to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "each intraoral x-ray image" without specifying the total number of images used in the comparative analysis.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the use of intraoral x-ray images, but their source, whether retrospective or prospective, or geographical origin, is not detailed.

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

• Not applicable / Not provided. The ground truth for the evaluation appears to be the output of the predicate AI device (K221921), not a human expert consensus. Therefore, no human experts were explicitly stated to establish a direct ground truth for the DTX Studio Clinic (4.0)'s performance itself in this comparative test. The predicate device's original clearance would have been based on such studies.

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

• Not applicable / None specified. Since the comparison was between the subject device's AI output and the predicate AI device's output, there's no mention of human adjudication.

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 described for the DTX Studio Clinic (4.0) for this submission. The evaluation was a technical comparison of the AI output to an existing cleared AI, not a study on human-AI augmented performance.

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

• Yes, in spirit, but not as a de novo clinical performance study. The described test was a standalone comparison of the algorithm's output (DTX Studio Clinic 4.0) against another algorithm's output (predicate K221921) to confirm identical functionality. It was not a performance study measuring the algorithm's diagnostic accuracy (e.g., sensitivity, specificity) against a clinical gold standard. The document emphasizes that "There are no functional or technical differences between the Focus Area detection in DTX Studio Clinic 3.0 (primary predicate - K221921) and the current subject device."

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

• The output of the predicate AI device (K221921). The "ground truth" for verifying the DTX Studio Clinic (4.0)'s "Focus Area Detection" functionality was the identical output of the legally marketed predicate device (K221921), which previously underwent its own validation.

8. The sample size for the training set

• Not provided. The document describes the "Focus Area Detection" as an "AI-powered" algorithm using "supervised machine learning," but it does not specify the sample size of the training set used for this algorithm. This information would typically be part of the original K221921 submission.

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

• Not provided. The document states "supervised machine learning" was used, which implies a labeled training dataset. However, the method for establishing the ground truth (e.g., expert annotations, pathology confirmation) for that training data is not detailed in this 510(k) summary. This information would likely have been part of the K221921 submission when the AI algorithm was first cleared.

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Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.

The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.

All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.

The subject device is available for NP and RP implant platforms.

The subject device is used by dental healthcare professionals in dental offices and dental laboratories.

The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.

It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.

This document is a 510(k) summary for the Titanium Abutment Blank Nobel Biocare N1™ TCC. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" for the overall device. Instead, it details various non-clinical performance tests conducted and indicates that the device met established performance specifications. The "reported device performance" is described through the outcomes of these tests.

However, based on the non-clinical test data section and the comparison table (Table 2), we can infer certain performance aspects that were evaluated against reference points (predicates or standards).

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

The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., number of abutments for fatigue testing, or number of software test cases). It refers to tests being conducted on "the worst-case system" for fatigue testing.

The data provenance is internal testing conducted by the manufacturer, Nobel Biocare AB. The document does not specify a country of origin for the data itself, but the submitter is based in Sweden. These are retrospective tests conducted to support the premarket notification.

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 as the document describes non-clinical engineering and performance testing of a physical and software device, not a diagnostic or AI-driven decision support system requiring expert-established ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

An MRMC study was not done. This device is a component for dental implants and does not involve human readers or AI in the context of comparative effectiveness for diagnostic or interpretive tasks.

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

This concept is primarily relevant for AI/ML-enabled diagnostic or decision-support software. While the device utilizes CAD/CAM software, the "standalone performance" in this context refers to the software's ability to accurately design and a milling machine's ability to accurately produce the customized abutment according to the design parameters and restrictions. The "Software verification and End-to-end workflow validation" addresses this by demonstrating that the software ensures applicable restrictions are in place and cannot be modified by the user, and that damage to the connection geometry is avoided during milling. It implicitly assesses the algorithm's performance within the manufacturing workflow.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Cleaning and Sterilization: The "ground truth" is adherence to established FDA guidance and validated protocols.
• Biocompatibility: The "ground truth" is compliance with ISO 10993 standards.
• Fatigue Testing: The "ground truth" is compliance with FDA guidance for dental implants and abutments and demonstrated substantial equivalence to the mechanical properties of predicate devices. This involves mechanical testing to failure or for a specified number of cycles under defined loads.
• Software Verification and End-to-end Workflow Validation: The "ground truth" is the established design parameters, manufacturing specifications, and the functionality requirements for the software (e.g., locking restriction zones, avoiding damage to connection geometry). It's based on engineering specifications.
• MRI Compatibility: The "ground truth" is the established MR Conditional specifications from the referenced K212125 clearance.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device manufactured using a CAD/CAM workflow, not an AI/ML system that requires a "training set" in the conventional sense. The CAD/CAM software would have been developed and validated through its own software lifecycle, but that is distinct from an AI model training set.

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

This information is not applicable for the same reason as point 8.

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DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.

The DTX Studio Clinic CADe functionality is indicated for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.

DTX Studio Clinic features an AI-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. The following dental findings can be detected by the device: Caries, Discrepancy at margin of an existing restoration, Periapical radiolucency, Root canal filling deficiency, Bone loss, Calculus.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the DTX Studio Clinic 3.0.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents the performance results from the standalone (algorithm only) and clinical (human-in-the-loop) studies. The acceptance is implicitly based on these results demonstrating clinical benefit and safety.

Standalone Performance (Algorithm-Only)

Clinical Performance (Human-in-the-Loop)

2. Sample Size and Data Provenance

• Test Set (Standalone Performance):

  • Sample Size: 452 adult intraoral radiograph (IOR) images (bitewings and periapical radiographs).
  • Data Provenance: Not explicitly stated, but implicitly retrospective as they were "assembled" and "ground-truthed" for the study.

• Test Set (Clinical Performance Assessment - MRMC Study):

  • Sample Size: 216 periapical and bitewing IOR images.
  • Data Provenance: Acquired in US-based dental offices by either sensor or photostimulable phosphor plates. This suggests retrospective collection from real-world clinical settings in the US.

3. Number of Experts and Qualifications for Ground Truth

• Test Set (Standalone Performance):

  • Number of Experts: A group of 10 dental practitioners followed by an additional expert review.
  • Qualifications: "Dental practitioners" and "expert review" (no further details on experience or specialized qualifications are provided for this set).

• Test Set (Clinical Performance Assessment - MRMC Study):

  • Number of Experts: 4 ground truthers.
  • Qualifications: All ground truthers have "at least 20 years of experience in reading of dental x-rays."

4. Adjudication Method for the Test Set

• Test Set (Standalone Performance): "ground-truthed by a group of 10 dental practitioners followed by an additional expert review." - The specific consensus method (e.g., majority vote) is not explicitly stated.

• Test Set (Clinical Performance Assessment - MRMC Study): Ground truth was defined by 4 ground truthers with a 3 out of 4 consensus. This is an explicit 3+1 (or simply 3 out of 4) adjudication method.

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

• Yes, a MRMC comparative effectiveness study was done.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
  • The primary endpoint, overall Area Under the Curve (AUC), showed a statistically significant increase of 8.7% (CI [6.5, 10.9], p

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DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

This document is a 510(k) Premarket Notification for the DTX Studio Clinic 3.0. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study report with specific acceptance criteria and performance metrics for novel functionalities.

Therefore, the requested information regarding detailed acceptance criteria, specific performance data (e.g., accuracy metrics), sample sizes for test sets, data provenance, expert qualifications, and ground truth establishment for the automatic annotation of mandibular canals is not explicitly detailed in the provided text.

The document states that "Automatic annotation of the mandibular canals" is a new feature in DTX Studio Clinic 3.0, and it is compared to the reference device InVivoDental (K123519) which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature." However, it does not provide the specific study details for validating this new feature within DTX Studio Clinic 3.0. It only broadly states that "Software verification and validation testing was conducted on the subject device."

Based on the provided text, I cannot fulfill most of the requested information directly because it is not present. The document's purpose is to establish substantial equivalence based on the overall device function and safety, not to detail the rigorous validation of a specific AI/ML component with numerical acceptance criteria.

However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Study for DTX Studio Clinic 3.0's Automatic Mandibular Canal Annotation (Information extracted from the document):

Given the provided text, the specific, quantitative acceptance criteria and detailed study proving the device meets these criteria for the automatic annotation of the mandibular canal are not explicitly described. The document focuses on a broader claim of substantial equivalence and general software validation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for the automatic mandibular canal annotation feature. The document states "Software verification and validation testing was conducted on the subject device," but provides no numbers.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or detailed. The document primarily makes a substantial equivalence claim based on the device's overall functionality and features, not a comparative effectiveness study involving human readers.

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

• Standalone Performance: Not explicitly detailed. The document describes the automatic segmentation functionality and mentions that the user can manually adjust, implying a human-in-the-loop scenario. No standalone performance metrics are provided.

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

• Type of Ground Truth: Not specified for the automatic mandibular canal annotation. Given the context of a dental/maxillofacial imaging device, it would likely involve expert annotations on CBCT scans, but this is not confirmed in the text.

8. The sample size for the training set:

• Training Set Sample Size: Not specified. This document is a 510(k) submission, which focuses on validation, not the development or training process.

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

• Ground Truth Establishment for Training Set: Not specified.

Summary of what can be inferred/not inferred from the document regarding the mandibular canal annotation:

• New Feature: Automatic annotation of mandibular canals is a new feature in DTX Studio Clinic 3.0 that was not present in the primary predicate (DTX Studio Clinic 2.0).
• Comparison to Reference Device: This new feature's "functionality is similar as in the reference device InVivoDental (K123519)", which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature."
• Human Oversight: The user has the ability to "manually indicate or adjust the mandibular canal," suggesting that the automatic annotation is an aid to the diagnostic process, not a definitive, unreviewable output. This is typical for AI/ML features in medical imaging devices that are intended to support, not replace, clinical judgment.
• Validation Claim: The submission states that "Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." This implies that the validation was performed in accordance with regulatory guidelines, but the specific details of that validation for this particular feature are not disclosed in this public summary.

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

NobelProcera Zirconia Implant Bridges (Dental Bridges) are patient-specific, dental implant supported, screw-retained dental implant bridges which are connected to compatible Nobel Biocare root-form endosseous dental implants or Multi-unit abutments and are intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing.

NobelProcera Zirconia Implant Bridges are made from 'Nacera Pean' (yttriastabilized tetragonal zirconia), Reference Device #1, K143071. The Dental Bridges are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo-approved dental scanner.

The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing.

NobelProcera Zirconia Implant Bridges are available for use with Nobel Biocare's root-form endosseous dental implants (Dental Implants) havinq Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment Connections (for MUA and MUA Plus). One Dental Bridge can feature connections to 2 to 10 Dental Implants.

All NobelProcera Zirconia Implant Bridges are provided with the required clinical and/or Prosthetic Screw: The clinical screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connect the Dental Bridge with a Multi-unit Abutment.

Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the external hex, internal tri-channel, or Multi-unit abutment connections.

The provided text is a 510(k) Summary for a medical device (NobelProcera Zirconia Implant Bridge) seeking substantial equivalence to a predicate device. It describes performance testing but does not present the specific acceptance criteria or the reported device performance in a table, nor does it detail a study designed to directly prove the device meets pre-defined acceptance criteria in the manner requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and performance data. The performance data mentioned are from fatigue testing and biocompatibility evaluation, suggesting these are the key areas where the device's performance needs to be comparable to or better than the predicate.

Here's an analysis of the available information in the context of your request:

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

The document does not provide a table explicitly outlining acceptance criteria and reported device performance. It only states that "The results of the testing were used to address questions related to substantial equivalence based on difference in design between the Subject and Predicate Devices." and that "The performance testing results provided in this submission supports that the Subject Device performs as well as the Predicate Devices for its intended use."

The closest to "acceptance criteria" are the standards used for testing:

• Fatigue Performance: Modified version of ISO 14801 (in saline solution) to reflect clinical loading. The specific acceptance criteria (e.g., minimum fatigue limit, number of cycles) are not detailed. It only states that the fatigue limit was determined.
• Biocompatibility: ISO 10993-1:2018. Acceptance is implied by the statement "The results demonstrated that biocompatibility testing... is appropriate to assess the biological safety of the subject device." and "The results demonstrate the biocompatibility of the subject device."
• Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12. Acceptance is implied by "Validation for the cleaning and sterilization... was conducted."

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

• Sample Size for Test Set: Not explicitly stated for performance testing.
• Data Provenance: Not specified. It's likely from testing conducted by the manufacturer, Nobel Biocare AB (Sweden), or a contracted lab. The document does not specify if the data is retrospective or prospective.

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 as the evaluation did not involve human interpretation or a "ground truth" derived from expert consensus in the sense of image analysis or diagnostic accuracy. The performance testing is engineering/laboratory-based.

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

This information is not applicable for the type of performance testing described. Adjudication methods are typically used in clinical studies or expert reviews.

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 as the device is a dental implant bridge, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm.

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

The "ground truth" for the performance testing is based on:

• Engineering standards: ISO 14801 for fatigue.
• Biocompatibility standards: ISO 10993-1.
• Sterilization standards: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
• The performance is compared to a predicate device rather than an absolute clinical "ground truth."

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as the device is a physical medical device.

Summary of what is available regarding the study:

The study described is a performance testing study aimed at demonstrating that the NobelProcera Zirconia Implant Bridge is substantially equivalent to a predicate device.

• Objective: To show that new technological characteristics (material Nacera Pearl, MUA Plus connection, DLC coating on prosthetic screw, maximum of 10 implants instead of 14) do not raise new concerns and that its performance is comparable to the predicate.
• Key Tests Conducted:
  • Fatigue testing: Using a modified version of ISO 14801 (in saline solution) to reflect clinical loading. "Worst-case assessment" was followed.
  • Biocompatibility evaluation: According to ISO 10993-1:2018, specifically cytotoxicity and chemical characterization using GC-MS analysis.
  • Sterilization validation: According to ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
• Comparison Basis: The subject device and predicate device were tested under identical conditions. The results "support that the Subject Device performs as well as the Predicate Devices for its intended use."
• Clinical Data: "No clinical data was used to support the decision of Substantial Equivalence."

In conclusion, the document provides evidence of engineering and biological performance testing against relevant standards and in comparison to a predicate device, rather than a study with explicit acceptance criteria for diagnostic accuracy or human performance improvement.

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DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intraoral and extraoral X-rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

Here's a breakdown of the acceptance criteria and study information for the DTX Studio Clinic device, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some information requested (like specific sample sizes for test sets, the number and qualifications of experts for ground truth, adjudication methods, MRMC study effect sizes, and detailed information about training sets) is not explicitly stated in this document. The focus here is on software validation and verification.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format of a table with specific metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance is based on demonstrating that the DTX Studio Clinic software performs its intended functions reliably and safely, analogous to the predicate and reference devices, as verified through software validation and engineering testing.

The "reported device performance" is primarily described through the software's functionality and its successful verification and validation.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Not explicitly stated in the provided text. The document mentions "verification testing" and "validation testing" but does not detail the specific sample sizes of images or patient cases used for these tests.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It focuses on the software's functionality and its comparison to predicate devices, rather than the performance on specific clinical datasets.

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

   • Not explicitly stated in the provided text. The 510(k) summary primarily addresses software functionality verification and validation, not a diagnostic accuracy study involving expert ground truth.

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

   • Not explicitly stated in the provided text.

4. 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 or reported. The document explicitly states: "No clinical data was used to support the decision of substantial equivalence." This type of study would involve clinical data and human readers.

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

   • Yes, in spirit. The software validation and verification described are for the algorithm and software functionalities operating independently. While the device does not make autonomous diagnoses (it "supports the diagnostic process and treatment planning"), its individual features (like airway segmentation, image sorting, virtual tooth setup) are tested in a standalone manner in terms of their computational correctness and adherence to specifications. However, this is distinct from standalone clinical performance (e.g., an AI algorithm making a diagnosis without human input). The document focuses on the technical performance of the software.

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

   • For the software verification and validation, the implicit "ground truth" would be the software's functional specifications and requirements. For features like measurements or segmentation, this would likely involve mathematical correctness checks or comparison to pre-defined anatomical models or manually delineated reference segmentations. It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense, as no clinical data was used for substantial equivalence.

7. The sample size for the training set:

   • Not explicitly stated in the provided text. The document describes a medical device software for image management and analysis, not a machine learning model that typically requires a large 'training set' in the deep learning sense. If any features (like the automatic image sorting or virtual tooth setup) utilize machine learning, the details of their training (including sample size) are not provided in this 510(k) summary.

8. How the ground truth for the training set was established:

   • Not explicitly stated in the provided text. As mentioned above, details about training sets are absent. If machine learning is involved in certain features, the ground truth would typically be established by expert annotation or curated datasets, but this is not detailed here.

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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.

Nobel Active TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.

NobelReplace CC TiUltra

NobelReplace CC Tilltra 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 or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with

The TiUltra implants and Xeal abutments are endosseous dental implants and abutments with an internal conical connection (CC) with hex interface. The TiUltra implants are comprised of three implant lines with various body shapes, range of diameters (3.0 - 5.5mm), and lengths (6.5 -18mm). The Xeal abutments are comprised of specific abutment types (i.e., straight, angled, and base). Both the TiUltra implants and Xeal abutments are made of titanium and feature a surface treatment that preserves the hydrophilicity of the device.

Here's a breakdown of the acceptance criteria and the studies performed for the Nobel Biocare AB TiUltra Implants and Xeal Abutments, as described in the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore section 2, 3, 4, 5, 6, 8, 9 are not applicable in this case.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the acceptance criteria are primarily focused on demonstrating substantial equivalence to predicate devices through various performance tests and material characterizations. Direct numerical "acceptance criteria" for specific clinical outcomes (like sensitivity/specificity for diagnostic AI) are not explicitly stated in this format. Instead, the "acceptance criteria" are implied to be meeting established performance specifications and not raising new questions of safety or effectiveness compared to the predicate devices. The reported performance is the result of demonstrating these equivalences through testing.

Implied Acceptance Criteria for Substantial Equivalence and Reported Device Performance:

Studies Proving Acceptance Criteria are Met:

The submission relies on a combination of non-clinical (bench, material characterization, animal) and real-world evidence (clinical) studies to demonstrate substantial equivalence.

Non-Clinical Testing:

• Sterilization Validation: Conducted according to ISO 11137-1:2006 and ISO 11137-2:2013 to establish and validate a SAL of $10^{-6}$ for Gamma Radiation.
• Endotoxin Testing: Performed per USP 42-NF37:2019 and ANSI/AAMI ST72:2011/(R)2016.
• Packaging Performance Testing: Conducted according to ISO 11607-1:2019.
• Biocompatibility Testing: Comprehensive assessment following ISO 10993-1:2018 for permanent implant devices with tissue/bone contact. This included:
  • Expert toxicity assessment.
  • Dissolution kinetics of the soluble salt (protective) layer.
  • Chemical characterization of leachables (ISO 10993-18:2009).
  • Cytotoxicity assessment (ISO 10993-5:2009).
  • Sensitization testing (ISO 10993-10:2010).
  • Irritation testing (ISO 10993-10:2010).
  • Material mediated pyrogenicity testing (ISO 10993-11:2017).
  • Acute systemic toxicity testing (ISO 10993-11:2017).
  • Local effects after implantation testing (ISO 10993-6:2016).
• Mechanical Testing: Performed according to ISO 14801:2016 ("Dentistry - Implants — Dynamic loading test for endosseous dental implants") and the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). An assessment of implant-to-abutment connection wear was also conducted.
• Surface Treatment Characterization: Modified surface treatment was characterized per the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutment" (May 12, 2004). Additionally, specific tests for hydrophilic surface properties (contact angle measurements and conductivity/salt amount testing) were done.
• Animal Study: A comparative study in a Yucatan mini-pig model, assessing clinical observations, clinical pathology, macroscopic observations, micro-CT for osseointegration, histomorphometry for osseointegration and soft tissue attachment, and histopathology for inflammatory response at 3, 6, and 13 weeks.

Clinical Testing (Real-World Evidence):

• Sponsor-Investigator Study: A prospective, single-arm study.
• Real World Evidence: Interim 18-month post-market surveillance data from CE mark recognizing countries and five case studies with 3-5 month follow-ups were also provided.

2. Sample Size for the Test Set and Data Provenance

• Sponsor-Investigator Study (Clinical Test Set):
  • Sample Size: 61 patients.
  • Data Provenance: Prospective, single-arm, sponsor-investigator study conducted in Italy.
• Animal Study (Pre-clinical Test Set):
  • Sample Size: Not explicitly stated as a number of animals, but refers to a "Yucatan mini-pig model" and "its predicates," indicating multiple animals used for comparison.
  • Data Provenance: Not specified, but likely a controlled laboratory setting.

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

• Not Applicable (N/A): This is a 510(k) submission for a medical device (dental implants/abutments), not an AI/ML diagnostic tool. Therefore, "ground truth" as established by human experts for an AI test set is not relevant in this context. The "truth" for device performance is established through physical, chemical, and biological testing, and clinical observation against established medical criteria. For the animal study, veterinarians and pathologists would have established observations. For the human clinical study, dentists/oral surgeons and clinical researchers would have established the outcomes. The qualifications of these individuals are not specified in the 510(k) summary provided.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): This device is not an AI/ML diagnostic device requiring adjudication of expert readings. Clinical outcomes in the human study would be based on direct observation and measurement by investigators, and the animal study observations would be made by scientific personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: An MRMC comparative effectiveness study, typically used for evaluating the impact of AI on human reader performance for diagnostic tasks, was not conducted. This is not applicable to a device like a dental implant.

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

• Not Applicable (N/A): This is a medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing:
  • Measurement Standards: Adherence to international standards (e.g., ISO, ASTM), physical and chemical characterization (e.g., surface roughness, material composition), and biological endpoints (e.g., cell viability, immune response).
  • Pre-clinical (Animal Study): Histology/Histomorphometry, Micro-CT findings, clinical observations, and pathology assessments.
• For Clinical Testing (Real-World Evidence):
  • Clinical Outcomes: Implant survival, soft tissue parameters, occurrence of adverse events, and demonstration of stable bone levels via radiography. These are direct patient outcomes and clinical assessments made by medical professionals.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This device does not involve a "training set" in the context of AI/ML or statistical modeling. Its design and manufacturing are based on established engineering principles, material science, and prior predicate device designs for which extensive clinical experience exists.

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

• Not Applicable (N/A): As there is no "training set" in the AI/ML sense, "ground truth establishment" for a training set is not applicable. The design and validation are based on scientific principles, regulatory standards, and comparative data to predicate devices.

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