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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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The Zeramex® P6 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® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.

The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm, 4.1 mm, and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.

Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN; 4.0mm) and regular neck (RN, 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.

The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.

The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.

The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).

The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) VICARBO screws (made of PEEK-Optima™ Ultra (Endolign)), which are provided as straight and angular screws in SN and RN sizes.

Healing caps and gingivaformers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingivaformers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

A closure screw (Ø3.5 mm) may be used in lieu of the healing cap to allow the gingiva to cover the platform during the healing period. This component is manufactured from PEEK.

This document is a 510(k) summary from the FDA for a dental implant system. As such, it does not contain the detailed information required to describe acceptance criteria and associated study results for a medical device's performance.

Specifically, the document states under "VII. Performance Data": "New performance data is not required in support of this submission. The sterilization validation, shelf-life studies, biocompatibility studies, mechanical testing, and clinical studies from K152385 are applicable to this submission." This indicates that the current submission (K163043) is relying on previously submitted data for its predicate device (K152385) and does not present new performance studies. The changes made in this 510(k) (addition of a closure screw, administrative updates, additional contraindications, and a minor word revision in the Indications for Use) were deemed not to require new performance data.

Therefore, I cannot provide the information requested in your prompt because the provided document does not contain new performance study data, acceptance criteria, sample sizes, expert qualifications, or adjudication methods for the Zeramex® P6 Dental Implant System related to this specific 510(k) submission (K163043). The document is a regulatory approval notice based on substantial equivalence, not a detailed report of a new performance study.

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The Zeramex® P6 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® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.

The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.

Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.

The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.

The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.

The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).

The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).

Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zeramex® P6 Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., a specific percentage for success rates or a certain threshold for complications). Instead, it describes a retrospective clinical study and non-clinical tests whose positive results support the substantial equivalence claim.

However, based on the non-clinical and clinical study outcomes, we can infer the implied acceptance criteria from the reported success:

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

• Sample Size (Clinical Test Set): 19 patients, receiving a total of 35 screw-retained abutments. Follow-up data was obtained on 15 of those patients (representing 27 screw-retained abutments). Specific follow-up numbers are:

  • 6 months follow-up: 8 patients

  • 1 year follow-up: 3 patients

• Data Provenance: Retrospective clinical data. The country of origin is not explicitly stated in the provided text.

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

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the retrospective clinical test set. The data appears to rely on clinical observations and professional documentation from the treatment of the 19 patients. It's implied that the treating clinicians (dentists/surgeons) made the assessments of complications and adverse events.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set data. Given it's retrospective clinical data, it's highly likely that the outcomes were recorded as part of routine patient care, without a formalized independent adjudication process mentioned for the purpose of this 510(k) submission. Therefore, the adjudication method is effectively "none" in the context of this regulatory submission.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the safety and performance of the device itself, not on comparing differences in human reader performance with or without AI assistance, as the device is a dental implant system, not an AI diagnostic tool.

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

This question is not applicable. The Zeramex® P6 Dental Implant System is a physical medical device (dental implant and associated components), not an algorithm or software-as-a-medical-device (SaMD). Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was based on clinical observations and outcomes data from real patients. This includes:

• Absence of complications (e.g., infection, pain, fracture).
• Absence of adverse events.
• Stability and function of the implant and abutment over time.

For the non-clinical studies, the "ground truth" was established by adherence to recognized international and national standards (e.g., ISO, ASTM) for material properties testing, biocompatibility, sterilization validation, and fatigue strength.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional medical device submission, not an AI/ML device. Therefore, this question is not applicable.

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

As there is no training set mentioned or implied for an AI/ML device, this question is not applicable.

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The Zeramex® T 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® T Dental Implant System can be used for single or multiple unit restorations.

Zeramex® T implants are intended for delayed loading.

The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies.

The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

The Zeramex® T System is an endosseous dental implant/abutment system. The Zeramex® T implants are placed using the Zeramex® T surgical tools. The implants are provided in three diameters (Ø 3.5 mm, 4.2 mm, and 5.5 mm) and three lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also offered in a 14 mm length. Dentalpoint AG offers several compatible abutments and other accessories including straight and angular (15°) abutments in small, regular/wide, and wide sizes, healing caps, and gingiva formers. The abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex system: Panavia (K032455) and 3M ESPE RelyX (K111185).

Class I, 510(k) exempt accessories are provided in the Zeramex® T tray and include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication or dental prosthetics, and trial abutments. The surgical tools are intended to be reprocessed (cleaned, disinfected, and sterilized) after each procedure.

Here's an analysis of the acceptance criteria and study information for the Zeramex® T Dental Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical study endpoints. However, it does report the device performance for key safety and effectiveness measures. The "acceptance criteria" listed below are inferred as the performance observed in the study.

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

• Sample Size (Clinical Study): 49 implants
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is Dentalpoint AG, located in Zurich, Switzerland. The clinical study was a "single-center" study.
  • Retrospective or Prospective: Prospective

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical study. The "ground truth" for the clinical study would likely be the direct clinical observation and measurements by the treating clinicians and study staff.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set (clinical study). Outcomes were presumably assessed by the clinical site directly.

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

No, an MRMC comparative effectiveness study was not done. The clinical study described is a single-arm study evaluating the device's performance, not comparing it against human readers or other devices.

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

This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device (dental implant), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the clinical study, the ground truth was based on:

• Outcomes data: Specifically, implant survival rates, and reported complication rates (soft-tissue, technical, bone loss, aesthetic). These are direct measures from the patients and their clinical follow-ups.

8. The Sample Size for the Training Set

This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device involves engineering design, material science, and manufacturing processes, supported by pre-clinical testing, rather than data-driven machine learning.

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

This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. The development of the device involves pre-clinical testing:

• Fatigue testing in accordance with ISO 14801
• Surface chemical analysis
• Validation of cleaning, disinfection, and sterilization processes
• Packaging and transport validation

The "ground truth" for these pre-clinical tests would be the established scientific standards, protocols, and measurable outcomes (e.g., meeting specific force thresholds in fatigue testing, chemical composition analysis results, sterility assurance levels).

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