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Straumann® Variobase® Abutments: The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.

Straumann® nice® Zirconia discs: Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.

The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices: Straumann® Variobase® Abutments (NHA) A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), Straumann® n!ce® Zirconia discs (EIH). Straumann® Variobase® Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). Straumann Variobase abutments are available to interface with the following Straumann dental implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586). Straumann® n!ce® Zirconia discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT).

The provided text is a 510(k) summary for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs. It describes the device, its intended use, and compares its technological characteristics and performance to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not describe a study involving a device that uses AI, nor does it discuss acceptance criteria and performance in the way typically expected for an AI/ML medical device submission (e.g., in terms of metrics like sensitivity, specificity, AUC, etc., or human reader performance with and without AI assistance). The "performance testing" section refers to mechanical and material testing (dynamic fatigue, static strength, biocompatibility, sterilization, flexural strength, chemical solubility, CTE, shrinkage factor) to demonstrate that the dental components meet established physical and biological standards.

Therefore, I cannot answer the questions about AI device performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, or training set details as this information is not present in the provided document.

Assuming this question is posed in the context of an AI/ML medical device, and the provided document is a misunderstanding, I will state explicitly that the document does not contain the requested information regarding AI device performance.

If the question implies that the dental devices themselves are the "device" in question and that their "acceptance criteria" pertain to their physical and material properties, then I can extract some relevant information as follows, though it won't perfectly match the structure of AI/ML device performance reporting.

Based on the provided text, the "device" refers to Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs, which are physical dental prosthetics and materials, not an AI/ML medical device. Therefore, the acceptance criteria and study descriptions do not involve AI performance metrics or human reader studies.

The acceptance criteria are primarily related to biocompatibility, mechanical strength, and material properties as per established international standards for dental materials and implants. The "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing of these physical properties.

Here's an interpretation based on the document's content, tailored to the questions where applicable, but noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

For the Straumann® n!ce® Zirconia discs, key mechanical properties are compared to predicate devices, and these represent the performance thresholds that align with ISO 6872 standards. The document implicitly states that the Straumann® Variobase® Abutments also met relevant standards (ISO 14801).

For Straumann® Variobase® Abutments, the document states that "Dynamic fatigue and static strength tests were conducted according to ISO 14801 and the FDA guidance document... and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices." This implies meeting the strength and fatigue requirements of these standards.

Biocompatibility for both devices was confirmed with chemical characterization and in-vitro cytotoxicity testing according to ISO 10993-5, 10993-12, and 10993-18.

Sterilization process for the Abutments was validated according to ISO 17665-1, ISO 17665-2, and applicable FDA guidance.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the mechanical and biological "test sets." It refers to "tests" and "evaluations" that meet ISO standards, which inherently include sample size requirements, but these are not enumerated.
Data provenance is implicitly "non-clinical laboratory testing" by the manufacturer, or a validated testing partner. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these studies is based on objective, standardized physical, chemical, and biological measurements performed in a laboratory, not expert human interpretation (like in imaging studies).

4. Adjudication method for the test set
Not applicable, as ground truth is established by objective measurements against ISO standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth used for these dental devices is based on established international standards (e.g., ISO 6872, ISO 14801, ISO 10993 series) for material properties, mechanical performance, and biocompatibility. This includes objective measurements of flexural strength, chemical composition, thickness, and results from in-vitro cytotoxicity tests.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for physical product testing in this context, as it's not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

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Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

BLX Variobase abutments are two-piece abutments composed of the following components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping or crown), Basal Screw. The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center. The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw. The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw. The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). The BLX Variobase abutments are cleared under K173961. The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).

Here's a breakdown of the acceptance criteria and the study information for the Straumann® BLX Variobase Abutment, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state sample sizes for specific 'test sets' in the way one might expect for a clinical trial or AI model evaluation. However, for the bench testing:

• Dynamic Fatigue Test: The text implies a sufficient number of samples were tested to demonstrate equivalence according to ISO 14801 and the FDA guidance. No specific number is given.
• Data Provenance: The studies were conducted as part of the device manufacturer's (Institut Straumann AG) regulatory submission to the FDA, suggesting a controlled internal testing environment. The country of origin for the data is implied to be related to the manufacturer's R&D facilities. This is a prospective set of tests conducted to support the 510(k) submission.

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

This information is not applicable to this type of device submission. The Straumann® BLX Variobase Abutment is a medical device, and its acceptance criteria are based on engineering performance specifications, material science, and regulatory compliance (e.g., sterilization efficacy, biocompatibility, mechanical strength), not on interpretation of images or patient data by experts. Therefore, "ground truth" in the clinical sense (e.g., diagnosis by radiologists) is not relevant here.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involves bench testing and adherence to standards, not human adjudication of a clinical outcome.

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

This is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an endosseous dental implant abutment, which is a prosthetic component.

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

This is not applicable. This device is a physical medical component, not an algorithm. Bench tests evaluate the standalone performance of the physical device under simulated conditions.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

• Established Standards: Adherence to international standards like ISO 14801 (dynamic loading) and ISO 10993-1 (biocompatibility), and ISO 17655-1 (sterilization).
• Regulatory Guidance: Compliance with specific FDA guidance documents for root-form endosseous dental implants and abutments.
• Material Specifications: Properties of the materials used (Ti-6Al-7Nb) meet established strength and biocompatibility profiles.
• Functional Equivalence: Demonstration that the new device performs equivalently to previously cleared predicate devices under defined test conditions.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. It is a physical product, not an AI model requiring data training.

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

This is not applicable for the same reasons as point 8.

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The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.

The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.

CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann PURE Ceramic Implant is a dental implant made out of yttrium-stabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.

The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.

The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.

The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.

The Straumann PURE Ceramic Implant System did not present specific, quantified acceptance criteria with corresponding performance data in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices through various tests.

However, based on the provided "Performance Data 5.7" section and the comparison tables, we can infer the types of acceptance criteria and the nature of the study that proves the device meets those criteria. The acceptance criteria generally revolve around demonstrating equivalence to legally marketed predicate and reference devices in terms of safety and effectiveness, as per FDA guidelines for 510(k) submissions.

Here's an attempt to structure the information based on the request, interpreting "acceptance criteria" as the performance standards expected for demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria were not stated, this table describes the type of performance evaluated and the outcome in relation to the predicate/reference devices.

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

The document describes bench testing for mechanical performance, biocompatibility, and sterilization. It does not refer to a "test set" in the context of clinical data or data from human subjects.

• Sample Size: Not explicitly stated for each test, but typically, mechanical and sterilization validations involve a statistically representative number of units or replicates to demonstrate consistency and meet statistical confidence levels defined in the relevant ISO standards (e.g., ISO 11135, ISO 14801). Biocompatibility is based on material composition equivalency, not a specific sample size.
• Data Provenance: The studies are described as bench tests (laboratory studies), biocompatibility assessments based on material equivalency, and sterilization/reprocessing validations. There is no mention of country of origin of data in the context of test subjects, as these are not human studies for this specific assessment. The data is generated from laboratory testing and analytical comparisons.

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

This information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For this device, which involves material properties and mechanical performance, the "ground truth" is established by adherence to international standards (ISO) and FDA guidance documents, and the expertise lies in the validation engineers and materials scientists performing and interpreting these tests. There is no mention of "experts" in the sense of clinical adjudicators for a "test set" in the provided text.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human interpretation of medical data (e.g., images) requiring adjudication of findings. Performance is evaluated against objective engineering and scientific standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (mechanical, sterilization, biocompatibility) is defined by the International Organization for Standardization (ISO) standards and FDA guidance documents to which these tests were conducted.

• Biocompatibility: ISO 10993-1:2009.
• Sterilization: ISO 11135 and FDA Guidance on "Submission and Review of Sterility Information...".
• Reprocessing: ISO 17665-1:2006 and FDA guidance "Reprocessing Medical Devices in Health Care Settings...".
• Mechanical Testing (Dynamic Fatigue): ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
• Wear and Screw Loosening: Bench tests demonstrating comparable behavior to reference devices, supported by a literature review for screw loosening risk.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a training set.

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

Not applicable. This device is not an AI/machine learning model.

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Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

There are three components to the Straumann® SC Variobase® Abutments:

• Straumann® SC Variobase® Abutments (Ti-base)
• Prosthetic restoration (coping and/or crown)
• Basal Screw
  The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
  The prosthetic restoration (the second component of the two-piece abutment) is digitally designed using CAD software and sent to Straumann for manufacture at a validated milling center.
  The purpose of this submission is to add the following materials to the previously cleared list of top-half materials for use on the previously cleared Straumann® SC Variobase® Abutments:
• Digital materials:
  • zerion ML
  • zerion UTML

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental implant abutment, discussing its equivalence to predicate devices, indications for use, and a summary of performance testing related to sterilization, biocompatibility, and bench testing (dynamic fatigue and static strength).

It does not describe the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/ML medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML device (e.g., sensitivity, specificity, AUC).
• Sample sizes for AI/ML test sets, data provenance, ground truth establishment methods, or details about expert reviewers.
• Information regarding MRMC studies or human reader improvement with AI assistance.
• Details on standalone algorithm performance.
• Sample sizes or ground truth establishment for an AI/ML training set.

Therefore, I cannot fulfill your request based on the provided input.

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The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).

There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.

The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.

There are three components to the Straumann® Variobase® for Crown AS:

• . Straumann® Variobase® for Crown AS (Ti-base)
• o Prosthetic restoration (coping and/or crown)
• o Basal Screw

Here's an analysis of the provided text regarding the Straumann® Variobase® for Crown AS, focusing on acceptance criteria and the study proving it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "device must perform at X% accuracy"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests and material comparisons. The "acceptance criteria" can be inferred as successful completion of the listed tests and demonstrating comparable performance or safety profiles to the predicates.

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

The document does not provide details on the specific sample sizes for the test sets (e.g., number of units tested for fatigue, number of software test cases). It broadly states that "bench studies" were conducted.

• Sample Size: Not explicitly stated for performance tests.
• Data Provenance: The studies were internal "bench studies" conducted by Institut Straumann AG. The country of origin of the data is not specified, but the applicant is Institut Straumann AG (Switzerland), with a US contact address. The studies appear to be prospective as they were conducted to support the 510(k) submission.

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

This information is not applicable in this context. The device is a physical dental implant component, not an AI/software device requiring expert interpretation for "ground truth" establishment of medical images or patient data. The "ground truth" for performance is based on established engineering standards (ISO, FDA guidance) and validated testing methods.

4. Adjudication Method for the Test Set

This is not applicable. As a physical device undergoing performance and material testing, there is no need for an adjudication method as would be relevant for clinical studies or AI diagnostic tools involving human interpretation.

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

No, an MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. An MRMC study is typically used for diagnostic devices (e.g., AI in radiology) where the performance of human readers with and without AI assistance is being evaluated. This device is a dental implant abutment, not a diagnostic tool.

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

No, a standalone algorithm performance study was not conducted and is not applicable. This is a physical medical device, not a standalone algorithm. Its function is to be physically implanted and support dental restorations. While it supports digitally designed copings, the device itself is not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, material science properties, and validated test methods. Specifically:

• Dynamic fatigue testing: Conformance to ISO 14801 and FDA guidance. This standard dictates how fatigue life is measured and evaluated.
• Software validation: Conformance to IEC 62304 for medical device software lifecycle processes.
• Sterilization validation: Conformance to ISO 17665-1 and ISO/TS 17665-2.
• Biocompatibility: Likely conformance to ISO 10993 series.
• Material specifications: Ti-6Al-7Nb alloy properties.

These standards and specifications define the "truth" against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical component. It does not employ machine learning or AI that requires a "training set" of data in the conventional sense. The "training" for this device involves its design, engineering, and manufacturing process based on established dental implant principles.

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

This is not applicable for the same reasons as #8. There is no training set or ground truth in the context of machine learning for this device. The design and validation are based on engineering principles and regulatory standards.

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