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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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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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Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.

Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.

The acceptance criteria and device performance for the Nobel Biocare N1™ Esthetic Abutments are described based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test. However, it mentions that dynamic loading (fatigue) testing was conducted in saline at 37 °C. The data provenance is from non-clinical testing, therefore not involving human subjects or data from a specific country of origin in the context of clinical studies. The testing was performed in a laboratory setting.

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

Not applicable. The reported performance data for this device (dental abutments) is based on non-clinical, laboratory-based testing (mechanical, MRI compatibility, biocompatibility, cleaning/sterilization), rather than expert assessment of clinical data or images to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As the testing mentioned is non-clinical and laboratory-based, an adjudication method in the context of human assessment is not relevant.

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 device is a physical dental abutment, not a diagnostic or AI-assisted interpretation system.

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

Not applicable. This device is a physical dental abutment, not an algorithm or software. The performance evaluations are of the physical product's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is established by adherence to recognized international and FDA standards for medical device testing. For example:

• Mechanical strength: Conformance to force/stress limits defined by ISO 14801.
• MRI compatibility: Conformance to safety and performance specifications outlined in ASTM F2052, F2213, F2119, F2182.
• Biocompatibility: Conformance to safety requirements defined by ISO 10993-1.

8. The Sample Size for the Training Set

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

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.

Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.

Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.

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