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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.

Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.

Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.

The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants

The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.

The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.

1. Table of Acceptance Criteria and Reported Device Performance

• All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved.
• Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding.
• The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge."
• New specific Indications for Use for Ø 3.3 mm implants provide more details.
• The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region.
• For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress. |
  | For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging):
  Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants.
  Demonstrated through systematic literature review or clinical studies. | A systematic literature search identified 5 publications.
• 251 SLActive implants were placed in 237 patients (age range 25-65 years old).
• Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm.
• Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers.
• Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
• References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section). |
  | Sterility:
  Sterilization process validated to SAL of 10^-6.
  Meets pyrogen limit specifications. | - Sterilization via gamma irradiation after final packaging.
• Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method).
• Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1). |
  | Biocompatibility:
  Biological assessment performed according to ISO 10993-1 and FDA Guidance. | - Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed). |
  | Dynamic Fatigue:
  Assessment conducted per FDA guidance and ISO 14801. | - Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801.
• Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed). |
  | Insertion Performance:
  Demonstrated adequate insertion torque in different bone classes. | - Insertion tests performed for the subject implants.
• Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed). |
  | MR Safety:
  Evaluated for MR Conditional status. | - Obtained MR Conditional status per K180540.
• MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted). |

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

The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).

• Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
• Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.

For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."

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

• For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
• For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.

4. Adjudication Method for the Test Set

• For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
• For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.

7. The Type of Ground Truth Used

• For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
• For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.

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

• Not applicable. (See point 8.)

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TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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

• · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
• · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
• · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
• · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
  All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase Screw for fixation to the implant body.
TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes a 510(k) premarket notification for two dental devices, TruAbutment DS and TruBase. The submission asserts substantial equivalence to a predicate device based on material, intended use, and mechanical testing. The document focuses on regulatory compliance and mechanical performance, rather than clinical efficacy measured by expert assessments or comparative effectiveness studies with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental implants and abutments and ensuring mechanical integrity. The reported performance indicates that the devices met these criteria.

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

• Test Set Sample Size: The document does not explicitly state a sample size for the mechanical fatigue testing beyond "worst-case constructs." For other tests (sterilization, biocompatibility, MRI review), specific sample sizes are not provided, though these are typically laboratory-based tests rather than patient-data-based studies.
• Data Provenance: The document does not specify the country of origin for any data or whether the data is retrospective or prospective. The studies mentioned (e.g., fatigue testing, sterilization) are engineering and laboratory tests, not clinical studies involving patient data.

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

This information is not applicable to the provided document. The studies described are non-clinical (mechanical, sterilization, biocompatibility, MRI safety) and rely on testing against established engineering and safety standards, rather than expert interpretation of a 'ground truth' in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical laboratory tests and material/design assessments, not studies involving human judgment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission relates to dental abutments, which are physical medical devices, and does not involve AI or image-based diagnostics requiring human reader performance studies.

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

This information is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical tests is based on:

• Established international and national standards (e.g., ISO 14801, ISO 17665, ISO 10993, ASTM F-136, ANSI/AAMI ST79).
• Engineering specifications and design limits (e.g., minimum thickness, maximum angle for abutments).
• Physical measurements and compatibility assessments (e.g., dimensional analysis and reverse engineering of implant-to-abutment connections).
• Scientific rationale and published literature for MRI safety.

8. The Sample Size for the Training Set

This information is not applicable. The devices are physical dental abutments, not AI models that require training data.

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

This information is not applicable as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of physical medical devices through adherence to established engineering and safety standards, rather than clinical performance based on human reader assessments or AI model evaluations.

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Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.

Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

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.

The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.

The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. 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. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.

The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.

BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.

Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.

This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.

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Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

The subject devices represent a line extension of the previously cleared implants of the Straumann Dental Implant System. The subject devices represent a full line of Straumann implants having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and acid etch surface finish in the same diameters, lengths, emergence profiles and implant-to abutment interfaces as previously cleared implants in the Straumann Dental Implant System.

This document (K150938) describes the Straumann® Dental Implant System - Roxolid® SLA Implants, which are dental endosseous implants. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The key change is the use of a Titanium-13Zirconium alloy (Roxolid®) for the implants, compared to commercially pure Grade 4 Titanium in the predicate devices.

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

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

The document does not explicitly state "acceptance criteria" for specific performance metrics in a tabular format. Instead, it relies on demonstrating that the new material change (Roxolid®) does not negatively impact the performance compared to the predicate devices which used commercially pure Grade 4 Titanium. The performance is assessed through various bench studies.

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

The document explicitly states that the substantial equivalence of the device is addressed via "bench studies" and "dynamic fatigue test data consistent with FDA guidance and ISO 14801." However, it does not provide specific sample sizes (e.g., number of implants tested), the exact test parameters beyond "ISO 14801," or the provenance of the data (country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, which are not included in this summary.

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)

This is a medical device approval based on bench testing and material equivalence, not on clinical performance or interpretation of images by experts. Therefore, the concept of "experts used to establish the ground truth" for a test set (like in a diagnostic AI study) is not applicable here. The "ground truth" for the bench tests would be the results obtained following the specified standards (e.g., force values, cycles to failure).

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

Not applicable. As noted above, this submission relies on bench testing and material characterization, not human interpretation or adjudication of outputs.

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-assisted diagnostic tool. It is a dental implant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance relies on engineering standards and scientific verification of material properties and mechanical performance. This includes:

• Material composition analysis: Verifying the Ti-13Zr alloy (Roxolid®) composition.
• Mechanical testing: Dynamic fatigue testing according to ISO 14801.
• Surface characterization: Analysis of the SLA grit blast and acid etch surface finish characteristics and surface chemistry.
• Sterilization validation: Conformance to ISO 11137-1 and ISO 11137-2 for sterility assurance level (SAL).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device approval process. The device's performance is not learned through data like an AI model; it's designed and verified through engineering principles and testing.

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

Not applicable, as there is no training set for this device.

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