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CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm).

The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either.

The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment.

The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm.

The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.

The provided document is an FDA 510(k) clearance letter for the CeraRoot TL Implant System. This type of document is generally a summary for a medical device, specifically a dental implant, and not an AI/ML-enabled device used for diagnostic or screening purposes that would involve image analysis or similar data interpretation.

Therefore, the typical acceptance criteria and study designs described in your request (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, type of ground truth, adjudication methods) are not applicable to this specific device. These criteria are usually for devices that perform a measurement, classification, or diagnostic function, often involving AI/ML.

The "study that proves the device meets the acceptance criteria" in the context of this dental implant is primarily the non-clinical testing (bench testing) and biocompatibility evaluations to demonstrate that the device is substantially equivalent to existing, legally marketed predicate devices.

Here's how to interpret the provided information in the context of the CeraRoot TL Implant System:

1. Table of acceptance criteria and reported device performance:

The acceptance criteria for a dental implant focus on its physical properties, biocompatibility, and mechanical performance rather than diagnostic accuracy.

Regarding the other points of your request:

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

  • For biocompatibility and mechanical testing (e.g., fatigue), specific sample sizes are used as defined by the relevant ISO standards (e.g., ISO 14801). The document does not specify these exact numbers, but indicates that the testing was performed "like the predicate devices" and "according to ISO 14801."
  • Data Provenance: The studies are bench tests (laboratory performance testing) rather than clinical studies with human patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" patient data are not applicable. The data provenance is the testing facility/laboratory where the bench tests were conducted.

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

  • Not applicable. This is a physical device being tested against engineering and biological performance standards, not a diagnostic or AI device requiring expert interpretation of data to establish ground truth.

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

  • Not applicable. Adjudication relates to resolving discrepancies in human expert interpretations, which is not part of dental implant performance testing.

• 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-enabled diagnostic or assistance device.

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

  • Not applicable. There is no algorithm or human-in-the-loop component for this physical medical device.

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

  • The "ground truth" for this device is compliance with established international engineering and biocompatibility standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and demonstrated substantial equivalence to predicate devices. There is no "pathology" or "outcomes data" ground truth directly from this 510(k) summary, as human clinical testing was explicitly stated as "Not applicable."

• 8. The sample size for the training set:

  • Not applicable. There is no "training set" for a physical dental implant. This term applies to machine learning models.

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

  • Not applicable. No training set for this device.

In summary, this 510(k) clearance is for a conventional dental implant, and the requested details about AI/ML device validation are not relevant to the information provided in this document. The "proof" of meeting acceptance criteria for this device rests on rigorous bench testing against established performance standards and a thorough comparison to legally marketed predicate devices to demonstrate substantial equivalence.

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SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.

SDS2.2 dental implants are a two-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS2.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs (standard shoulder and oval shoulder). The implants are provided sterile in sterile packaging and are intended for single use. The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days. SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured. After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations. SDS2.2 standard implant posts are available in different designs. The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided non-sterile.

The document is a 510(k) premarket notification for the SDS2.2 dental implant system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes physical and mechanical properties, material composition, manufacturing processes, and sterilization validation rather than AI/ML algorithm performance.

Therefore, many of the requested bullet points for describing AI/ML device acceptance criteria and study details cannot be directly answered from this document. The document describes a traditional medical device (dental implant) and its non-clinical testing for safety and effectiveness.

Here's an analysis based on the provided document, addressing what can be inferred and stating what cannot:

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

The document doesn't present acceptance criteria in a formal table with values for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses the device meeting "existing requirements and acceptance criteria" based on various regulatory standards and non-clinical tests.

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

• Test Set Sample Size: Not applicable. This document describes testing for a physical medical device (dental implant), not an AI/ML algorithm. The "test set" in this context refers to physical implants subjected to various lab tests (e.g., fatigue testing, material analysis). The sample sizes for these specific physical tests are not provided in this summary document.
• Data Provenance: Not applicable for AI/ML dataset. The "data" refers to the results of bench testing and physical-chemical characterization of the implant. There is no mention of country of origin or retrospective/prospective human data.

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

Not applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used to train and evaluate an algorithm. For a dental implant, "ground truth" is established through engineering and material science standards and confirmed by accredited lab testing, not by expert physicians interpreting images or data for AI.

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

Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers to resolve discrepancies in annotations or diagnoses for AI/ML ground truth. This is not relevant to the physical testing of a dental implant.

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 study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes a physical medical device and its non-clinical performance, not an AI/ML diagnostic aid.

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

No. This concept is specific to AI/ML algorithm testing. The device is a physical implant; its "performance" is inherently "standalone" in mechanical terms, but it's not an algorithm.

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

The "ground truth" for evaluating this device's performance is based on established engineering and material standards for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and the successful outcome of physical bench tests and material analyses. It's not based on clinical imaging, pathology, or outcomes data in the sense used for AI/ML.

8. The sample size for the training set:

Not applicable. There is no AI/ML training set discussed in this document.

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

Not applicable. There is no AI/ML training set discussed in this document.

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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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The ZERAMEX® XT Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The ZERAMEX® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® dental implants are specially indicated for patients with metal allergies/intolerances and chronic illnesses due to metal allergies/ intolerances.

The NobelPearl Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The NobelPearl Dental Implant System can be used for single or multiple unit restorations. NobelPearl Dental Implant System are intended for delayed loading. NobelPearl Dental Implant System are specially indicated for patients with metal allergies/intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® XT Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® XT implants may be restored with screw retained Zeramex® XT abutments. The Zeramex® XT implants are placed using the Zeramex® XT surgical tools.

The NobelPearl Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The NobelPearl Dental Implant System may be restored with screw retained NobelPearl abutments. The NobelPearl Dental Implant System are placed using the NobelPearl surgical tools.

The implants, abutments, and surgical tools for the Zeramex® XT and NobelPearl Dental Implant Systems are exactly the same; two trade names are being used for marketing purposes.

The implants, produced from aluminum toughened zirconia (conforming to ISO 6474-1:2010 Implants for Surgery - Ceramic Materials and ISO 6872:2015 Dentistry - Ceramic Materials), are provided sterile in two (2) diameters (0 4.2 mm (RB), and 5.5 mm (WB)) and three (3) lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also provided in 14 mm. The implants are designed with a "bolt-in tube" internal connection which provide anti-rotational features.

Straight and angular (15°) screw retained abutments, provided non-sterile in two sizes (RB; Ø 5.0 mm and SB, Ø 6.0 mm), are compatible for use with the system implants. The straight and angular abutments are made from the same zirconium materials as the system implants.

The screw retained abutments fit within four (4) retention elements and are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra VICARBO® screw (straight) which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Healing caps and gingivaformers are also provided in the system. These components, provided in two sizes, are manufactured from PEEK and are connected to the implant using a screw. Provisional restoration components may be used to support temporary crowns after the healing period. The provisional restorations and the provisional restoration screws are made of carbon fiber reinforced PEEK.

This document describes a 510(k) premarket notification for the Zeramex® XT Dental Implant System and NobelPearl Dental Implant System. It presents a comparison to predicate devices to demonstrate substantial equivalence, but it does not describe a study that uses acceptance criteria in the context of a diagnostic or AI device and its performance.

The document primarily focuses on demonstrating substantial equivalence for the dental implant systems based on:

• Indications for Use
• Materials of Construction (aluminum toughened zirconia, PEEK)
• Design (two-piece, implant lengths, implant diameters, abutment angulation, screw retained implant/abutment connection, carbon-fiber reinforced PEEK screws)
• Sterilization Methods
• Performance data through fatigue testing and leveraging prior predicate device testing (shelf-life, packaging, transport, cleaning and sterilization validation, biocompatibility, bacterial endotoxin testing, surface composition analysis, surface roughness and contact angle testing).

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance in the context of a diagnostic or AI study as it is not present in the provided text.

The closest relevant information is that fatigue testing was conducted on the subject devices against ISO 14801 standards, and "verification activities... were conducted to written protocols with predefined acceptance criteria." However, the specific acceptance criteria for the fatigue testing or the results are not explicitly detailed in a format that allows for the creation of Table 1. No information regarding test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established is provided, as these are typically associated with diagnostic or AI device evaluations.

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TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

W Zirconia Implants are suitable for one or two stage endosseous form of dental implants. One Piece and Two-Piece implants are available. The abutments are used in conjunction with the endosseous dental implant in order to support in the prosthetic rehabilitation. The implantation procedure can be accomplished, for the One-piece implant in a one stage and for the two piece implant in a one or two stage surgical procedures. TAV Medical's W Zirconia Implants are composed of the following implant models: W One Piece – monotype implant with integrated abutment. W Two Piece –implant for screw retained Abutment. In both implants the endosteal region is provided with a roughness with a Ra value of 2.3 µm. The implants and abutments are tissue level designed and includes a body portion (implant body diameter 4.1 mm with a 4.8 mm platform, and implant body diameter 4.8 mm with a 6.0 mm platform) and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). Each Two piece implant is accompanied with a standard titanium cover screw.

This document, K172668, describes the substantial equivalence determination for TAV Medical's W Zirconia Implants. It is a 510(k) Premarket Notification to the FDA, which means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device. This is not a de novo application or a PMA, and therefore, the study information described below primarily focuses on non-clinical testing to demonstrate equivalence, rather than extensive clinical efficacy studies to establish new performance criteria.

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

Since this is a 510(k) submission, the "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices. The "reported device performance" demonstrates that the new device meets those equivalent characteristics through non-clinical testing. The document highlights various aspects, but direct quantifiable acceptance criteria with a single reported value for "reported device performance" are not presented in a concise table format in the provided text for all features.

However, based on the non-clinical testing section (5.19.3 Performance Testing) and the substantial equivalence tables (5.18), we can infer some key comparisons.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for the non-clinical bench testing (e.g., number of implants tested for fatigue). It generally states that "testing and evaluation" were performed and "validation results have demonstrated" adherence to standards.
• Data Provenance: All testing appears to be non-clinical bench testing performed by or for TAV Medical Ltd. The country of origin of the data is not explicitly stated beyond TAV Medical Ltd. being located in Israel. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

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

• Not Applicable. Since no clinical studies were performed (Section 5.21), there was no "ground truth" established by human experts in a clinical setting for the performance of the device on patients. The "ground truth" for the non-clinical tests is established by the specified ISO/ASTM standards and the performance of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. As there were no clinical studies involving human readers or expert consensus, no adjudication method was employed.

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

• No, an MRMC comparative effectiveness study was not done. The submission states: "No clinical studies were performed" (Section 5.21) and "No Animal studies were performed" (Section 5.20).

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

• Not Applicable. This device is a physical medical implant (dental implant), not a software algorithm or AI device. Therefore, the concept of "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

• Standards-Based and Predicate Device Equivalence: The primary "ground truth" or reference for evaluating the W Zirconia Implants is compliance with recognized international and national standards (e.g., ISO 14801 for dynamic fatigue, ISO 10993-1 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices through comparable material properties, design features, and validated non-clinical performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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