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Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).

Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.

The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.

Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.

The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.

The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.

The FlexiBase® is a two-piece abutment ultimately composed by three components:

• . FlexiBase® abutment titanium component
• Top-half component (coping and/or crown) .
• . Prosthetic screw

The FlexiBase® abutments will be marketed:

• through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).

The provided text describes a 510(k) premarket notification for "Anthogyr FlexiBase® titanium bases for Axiom® BL". This document focuses on demonstrating substantial equivalence to predicate devices, and therefore, the acceptance criteria and study detailed below relate to the performance of the device in comparison to these predicates, rather than proving a specific diagnostic accuracy or clinical outcome for a novel AI algorithm.

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

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

The document does not detail specific "sample sizes" in the context of a statistical test set using patient data. The performance testing described relates to in-vitro bench testing of the devices themselves.

• Dynamic Fatigue Testing: The document states the test was conducted on the devices, but the specific number of units tested is not provided ("the subject devices").
• Data Provenance: Not applicable in the context of clinical patient data. The testing described is laboratory-based bench testing.

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

This information is not applicable. The device is a physical dental implant component, and the testing described is engineering performance testing (sterilization, biocompatibility, fatigue). There is no "ground truth" to be established by clinical experts in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as this is laboratory bench testing, not a clinical study involving human judgment on a test set.

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. The device is a dental implant base, not an AI, imaging, or diagnostic device that would involve human readers or AI assistance.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. The performance criteria are based on engineering standards and regulatory guidance for device performance and safety (e.g., ability to withstand dynamic loading, biocompatibility, sterility) rather than clinical "ground truth" derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm or a device requiring a training set in that sense.

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

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Performance Testing - Bench" and "Performance Testing 1.1 - Sterilization Validation and Shelf-life", as well as "Biocompatibility Testing" and "Electromagnetic Compatibility".

• Study Design: The studies essentially comprised benchtop engineering tests performed according to recognized international standards and FDA guidance documents. This included:

  • Sterilization Validation: Demonstrated the effectiveness of the recommended moist heat (steam) sterilization method for end-users, aligning with ISO 17665-1, ISO 17665-2, and FDA guidance.
  • Biocompatibility Testing: Conducted biological assessment according to ISO 10993-1 and ISO 10993-5, including cytotoxicity testing. The materials were deemed equivalent to those in predicate devices, implying comparable biocompatibility.
  • Electromagnetic Compatibility (EMC): Assessed by confirming no significant changes in materials and dimensions compared to previously cleared predicate devices, thus inferring MR Conditional status based on prior clearances (e.g., K180564).
  • Dynamic Fatigue Testing: Conducted in accordance with FDA guidance for endosseous dental implants and ISO 14801. This involved cyclic loading tests in saline (2 Hz, 37°C) for:
    • 2 million cycles for permanent restorations (without failure).
    • 200,000 cycles for temporary restorations (without failure).

• Proof of Meeting Acceptance Criteria: The outcome of these tests indicated that the "Anthogyr FlexiBase® titanium bases for Axiom® BL" devices successfully met the performance requirements outlined by the respective standards and guidance documents. The key finding was that the subject devices demonstrated equivalence to the primary predicate and reference devices in all these aspects of performance and safety. This equivalence is the primary basis for the 510(k) clearance.

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The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time.

Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g.

The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.

The cassettes are not intended to be stacked during sterilization process.

Anthoqyr cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

The provided text is a 510(k) Summary for the Anthogyr INTEGRAL Guided Surgery Cassettes. It does not describe a study involving an AI/software device that requires establishing ground truth by experts or evaluating human reader performance. Instead, it focuses on demonstrating substantial equivalence of a medical device (sterilization cassettes) to a predicate device through non-clinical performance testing.

Therefore, many of the requested criteria, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "standalone (i.e. algorithm only) performance" are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance for the non-clinical tests mentioned.

Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" (N/A) for criteria that do not fit the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

• Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
• Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings 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 not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

The provided text describes a 510(k) summary for Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL. This document evaluates the substantial equivalence of new devices to existing legally marketed predicate devices, rather than establishing acceptance criteria and providing direct evidence of device performance against those criteria in a typical clinical study format.

Therefore, the requested information elements related to "acceptance criteria and reported device performance tabletop," "sample size for test set," "data provenance," "number of experts and qualifications," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of this 510(k) submission summary.

This document focuses on demonstrating that the new devices are substantially equivalent to predicate devices through comparisons of technological characteristics and performance testing (e.g., dynamic fatigue, biocompatibility, sterilization validation). The "acceptance criteria" here implicitly refer to demonstrating equivalence to the predicate devices and compliance with relevant standards and FDA guidance.

Here's an overview of the performance testing performed, interpreted as demonstrating compliance/equivalence rather than explicitly stated acceptance criteria with numerical performance targets:

1. Acceptance Criteria and Reported Device Performance:

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

• This information is not provided in the 510(k) summary. The summary refers to "tests were conducted" and "results were substantially equivalent," but actual sample sizes for mechanical, sterilization, or other tests are not detailed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable. This is a medical device, not an AI/software device requiring ground truth established by experts for a test set. The "ground truth" for non-AI devices is typically established through direct physical measurements, chemical analyses, and standardized test methodologies.

4. Adjudication Method for the Test Set:

• Not applicable.

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/imaging device.

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

• Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used:

• For a traditional medical device like a dental implant, "ground truth" refers to established physical, chemical, and biological properties measured through standardized testing. Examples include:
  • Mechanical properties: Measured against international standards (e.g., ISO, ASTM) or FDA guidance for dental implants/abutments (e.g., fatigue strength, fracture resistance).
  • Biocompatibility: In vitro (e.g., cytotoxicity tests under ISO 10993-5) and in vivo tests (if new materials are introduced) against established biological safety profiles.
  • Sterilization efficacy: Measured by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ via methods compliant with ISO 11137-1 (radiation) or ISO 17665-1 (moist heat).
  • Material composition: Chemical analysis to confirm compliance with medical-grade specifications (e.g., Titanium-6Al-4V ELI conforming to ASTM F136).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/software device that uses a "training set."

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

• Not applicable.

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The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization is:

INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,

INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time

The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.

The device dimensions are listed below for Anthogyr Surgical Cassettes:

• INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm

• INMODIGM, INMODIGMV: 76x155x47 mm

The cassettes are not intended to be stacked during sterilization process.

Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment.

To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

The Anthogyr Surgical Cassettes are designed to organize, steam sterilize, and protect dental surgical instruments. They are intended for healthcare providers and must be enclosed in an FDA-cleared steam sterilizable pouch.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants. Implants: Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw. Material: Ti6AI4V-ELI Surface treatment: BCP® Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm Ø5.2, length 6.5, 8, 10, 12 mm Screws: Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI Surface treatment: DLC Dimensions: M1.4, length 5, 7.9 mm

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving a new device meets predefined acceptance criteria in the way a clinical trial for a novel AI device might. The "acceptance criteria" here are largely implied by the need to show equivalence to existing, legally marketed devices and adherence to relevant standards.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a dental implant system (AXIOM® PX), the "acceptance criteria" are primarily established by the performance characteristics of its predicate devices and compliance with relevant industry standards and FDA guidance. The study presented is a non-clinical performance testing suite designed to demonstrate substantial equivalence to these predicates.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact numerical sample sizes for each test (e.g., number of implants tested for fatigue, number of animals for biocompatibility). It generally refers to "representative worst case" scenarios for mechanical testing and indicates tests were performed.
   • Data Provenance: The studies are non-clinical (laboratory/bench testing, and in-vitro/animal biocompatibility). Provenance is likely the testing labs approved by Anthogyr SAS, based in Sallanches, France. It is retrospective, meaning the tests were conducted prior to this submission.

2. 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 not applicable as the studies described are non-clinical performance and biocompatibility tests for a physical medical device (dental implant). The "ground truth" is established by adhering to widely accepted international standards (ISO, ASTM) and FDA guidance, with results interpreted by qualified laboratory personnel, rather than clinical experts establishing a diagnostic ground truth.

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

   • Not applicable for non-clinical bench and biocompatibility testing. The methods are standardized and results are objectively measured per the specified test protocols (e.g., force to failure, chemical composition analysis, cell viability).

4. 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. This is not an AI/Software as a Medical Device (SaMD) submission. It's a traditional physical medical device (dental implant) 510(k).

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

   • No. This is not an AI/SaMD submission.

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

   • The "ground truth" for the non-clinical tests is adherence to established, validated test methodologies and performance criteria outlined in international standards (ISO, ASTM) and FDA guidance documents. For example, for biocompatibility, the ground truth is whether the device elicits a toxic or inflammatory response as defined by the ISO 10993 series. For mechanical testing, it's whether the device meets or exceeds the strength and fatigue limits specified by ISO 14801 or exhibits equivalence to the predicate device.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve machine learning or AI.

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

   • Not applicable, as there is no training set.

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The instrument kits are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization is:

Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time

Anthogyr does not make any lumen claims for the instrument kits.

The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).

The cassettes are not intended to be stacked during sterilization process.

Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.

The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.

The tools included in the kits are class I exempt or already have class II pre-market notification clearance.

The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).

The provided document is a 510(k) premarket notification for "Instrument Kits" by Anthogyr. It details performance testing related to cleaning, sterilization, and material compatibility, but it does not describe a study involving acceptance criteria for device performance in terms of clinical or algorithmic outcomes. Instead, it focuses on the device's ability to be cleaned and sterilized effectively.

Here's an analysis of the information, tailored to the request but acknowledging the different nature of this medical device (sterilization kits vs. a performance-based device like AI):

1. Table of Acceptance Criteria and Reported Device Performance

The device is an instrument kit designed for sterilization of dental tools. The "performance" in this context relates to its ability to be effectively cleaned and sterilized, and its material safety. There are no clinical performance metrics like sensitivity, specificity, or accuracy for this type of device.

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

This is not applicable in the traditional sense for this device. The "test sets" would be the actual instrument kits subjected to cleaning and sterilization validation.

• Test Set Description: The "Axiom range surgery kit" was identified as the "worst case validated load" due to having the highest number of components (34 instruments). This indicates the most challenging configuration for sterilization was tested.
• Sample Size: The document does not specify a numerical sample size (e.g., how many kits were tested, or how many cycles were performed). It states "Sterilization validation was performed [...] on the most complete instrument kit".
• Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies performed by the manufacturer/authorized labs. The manufacturer's location is France (Sallanches, France).

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

This concept is not applicable here as the "ground truth" is based on objective scientific standards for cleaning, sterilization, and material safety, not expert interpretation of outputs. The standards themselves (e.g., ISO 17665, AAMI TIR 30) are established by experts in the field of medical device sterilization.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" is determined by established physical and biological testing standards and results, not by human adjudication of nuanced interpretations.

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 a physical medical device (instrument kit), not an AI algorithm or a diagnostic tool that involves human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The ground truth is based on:

• Scientific Standards: Adherence to recognized national and international standards for cleaning (AAMI TIR 30, AAMI TIR 12), sterilization (ISO 17665), and biocompatibility (ISO 10993-5).
• Biological Endpoints: Sterilization validation typically involves sterility testing (e.g., absence of microbial growth), while cleaning validation may involve residual soil detection.
• Material Properties: Technical data sheets for the materials (Radel) providing evidence of their properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device requiring a "training set."

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

Not applicable.

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ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.
ANTHOGYR dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.

The AXIOM® 2.8 implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The implant-abutment combination can support occlusal charge without risk of damaging the restoration and will not generate hazardous peek of stress at the prosthetic interface level.
The file concerns the implants and abutments.
Implants:
Replacement of a missing root for placement of a dental restoration.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø2.8, length: 10-14 mm
Abutments:
Provide support for a single permanent restoration.
Material: Ti6Al4V
Dimensions: Ø2.8
Angle: 0-23°
Gingival height: 1-5.5 mm
Temporary abutments:
Provide support for a temporary restoration.
Material: PEEK
Dimensions:Ø2.8
Gingival height: 1-5.5 mm

The provided text is a 510(k) Summary for the ANTHOGYR AXIOM® 2.8 endosseous dental implant system. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a fatigue testing," but doesn't specify the number of samples tested.
• Data Provenance: The study was conducted by ANTHOGYR SAS, located in Sallanches, France. It is a non-clinical in vitro test (fatigue testing), not involving human or animal subjects, so terms like "retrospective" or "prospective" are not applicable.

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 section is not applicable. The "ground truth" here refers to the performance of the device against a defined standard (ISO 14801 for mechanical properties). This is an objective measurement based on a standardized test, not a subjective interpretation by experts.

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

This section is not applicable. As stated above, the performance assessment is based on objective, standardized mechanical testing, not a subjective interpretation requiring adjudication.

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

This section is not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to its evaluation.

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

This section is not applicable. This device is a physical medical device (dental implant), not an algorithm or software. Its performance is assessed through physical, mechanical testing.

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

The "ground truth" for the device's performance is established by the ISO 14801 (2007) standard for fatigue testing and the mechanical properties of the legally marketed predicate device. The goal of the study was to demonstrate comparable mechanical properties to the predicate, ensuring the new device performs at least as safely and effectively.

8. The sample size for the training set

This section is not applicable. This is not an AI/ML device, so there is no "training set."

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

This section is not applicable. There is no training set for this type of device.

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Anthogyr AXIOM® REG implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. The Axiom dental system is indicated for one-stage or two-stage surgery.

It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.

The AXIOM® REG Implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the expansion of prosthetic components and surgical instrumentation and also the implants of the AXIOM® REG.

Any abutment can be assembled on any AXIOM® REG implant thanks to its unique prosthetic connection, regardless of the implant diameter chosen.

• Implants
  Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.
  Material: Ti6Al4V
  Surface treatment: BCP®
  Dimensions: Ø3.4 mm, length: 16-18 mm
  Ø 4.0 mm, length: 16-18 mm

• Conical abutments
  Provide support for a permanent restoration, for multiple screw-retained prosthesis and screw-retained bar and brace
  Material: Ti6Al4V
  Dimensions: gingival height: 4.5 mm
  angle: 18-30°
  Rotational and non rotational abutments.

• Aesthetic titanium abutments
  Provide support for a permanent restoration, single and multiple-unit cemented restoration.
  Material: Ti6Al4V
  Dimensions: Ø3.4 mm; gingival height: 2.5-4.5 mm; angle: 7-15°
  Ø4.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23°
  Ø5.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23°
  Ø6.0 mm; gingival height: 1.5-4.5 mm; angle: 0-15°

Standard angulated titanium abutments
Provide support for a permanent restoration
Material: Ti6Al4V
Dimensions: Ø4.0 mm; gingival height: 1.5-3.5 mm; angle 15-23°
Ø5.0 mm; gingival height: 1.5-3.5 m; angle 15-23°

Temporary abutments
Provide support for a temporary restoration
Material: Ti6Al4V
Dimensions: Ø3.4 mm; height: 1.5-4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 1.5-4.5 mm

Healing screws and healing screws flat
Sealing of implant conical connection during bone healing. Prepare gingiva to the permanent restoration shape.
Material: Ti6Al4V
Dimensions: Ø3.4 mm; height: 4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 4.5 mm
Dimensions (flat version): Ø3.4 mm; height: 1.5-4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 1.5-4.5 mm

Pacific system
Ensure passive fit between the conical abutment and the framework. Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments.
Materials: Ti6Al4V, PMMA

Temporary cap and protecting cap
Give the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration

Here's a breakdown of the acceptance criteria and study information for the AXIOM® REG device, 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

• Sample Size for Test Set: Not specified in the provided text. The text only mentions "fatigue testing" according to a standard, but does not detail the number of units tested.
• Data Provenance: Not explicitly stated as prospective or retrospective. The testing was "performed for added devices," suggesting it was conducted specifically for this submission (likely prospective in the context of this regulatory filing). The country of origin for the testing is not mentioned, but the submitter is based in France.

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

This information is not applicable and not provided in the document. The study described is a non-clinical, mechanical fatigue test, not a clinical study involving human expert assessment or ground truth establishment based on clinical observations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, this was a mechanical test, not a study requiring adjudication of clinical data.

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

This information is not applicable and not provided. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. This device is a physical dental implant system and prefabricated components, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance testing was the established pass/fail criteria and performance characteristics defined by the NF EN ISO 14801 (2007) standard for fatigue testing of endosseous dental implants, against which the predicate devices presumably also complied. The objective was to demonstrate "comparable mechanical properties" to the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

This information is not applicable and not provided. As above, there is no training set for this type of device.

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Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications : - MontBlanc Surgical contra-angle handpiece : for e.g. hemisection, wisdom tooth extraction. - MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.

The device consists of MontBlanc Surgical contra-angle handpieces and straight handpieces with different reduction/multiplication rates, color codes, weights, light options (NO, OPTIC FIBER, LED), motor connection standards (ISO 3964, ISO 3964 (type Intra-Matic Lux), ISO 3964 (type Intra-Matic Lux with anthogyr connexion system)), maximum motor speed, tool types according to NF EN ISO 1797-1, diameter of tools according to NF EN ISO 1797-1, maximum length recommended by Anthogyr, maximum diameter of the active part of the tool recommended by Anthogyr, and water spray output according to ISO 7785-2.

This is not an AI/ML device - hence the information for acceptance criteria and study data does not follow the expected format.
The MontBlanc Surgical Contra-angle and Straight Handpiece is a conventional dental handpiece, and its clearance focuses on demonstrating substantial equivalence to previously marketed devices and conformity to recognized consensus standards rather than AI/ML specific performance metrics.

Here is a summary of the information provided, tailored to the context of this traditional medical device:

Acceptance Criteria and Device Performance

The device demonstrates performance by conforming to several FDA-recognized consensus standards and other relevant standards. "Acceptance criteria" in this context refers to meeting the specifications and requirements outlined in these standards.

• Reduction/multiplication rate: 1:3 (Contra-angle), 1:1 (Straight handpiece)
• Weight: 98g (Contra-angle), 125g (Straight handpiece)
• Light: NO, OPTIC FIBER, LED options
• Motor connection standard: ISO 3964
• Maximum motor speed: 40,000 rpm (Contra-angle)
• Tool type according to NF EN ISO 1797-1: Type 3 (Contra-angle), Type 1 or 2 (Straight handpiece)
• Water spray output according to ISO 7785-2: > 50 ml/min (Contra-angle) |
  | ISO 3964 (1982): Dental Handpieces - Coupling dimensions (Recognition List Number: 003) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This ensures the device's compatibility with standard dental motor connections. |
  | ISO 7405 (2008-12-15): Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Recognition List Number: 022) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This indicates that the materials used in the device have been evaluated for biocompatibility, minimizing adverse reactions when in contact with tissues. |
  | ISO 14971 (2007): Medical devices - Application of risk management to medical devices (Recognition number: 5-40) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This means a risk management process was applied during the device's development to identify, analyze, evaluate, control, and monitor risks associated with its use. |
  | ISO 13485 (1996): Medical devices - Particular requirements for the application of the ISO 9001 | This standard, though not FDA-recognized in the list provided, is also stated as one the device conforms to. It signifies that the manufacturer operates under a quality management system specifically for medical devices. |
  | NF EN ISO 1797-1 (1995): Dental rotatory instruments - Shanks - Part 1: Shanks made of metal | This standard specifies requirements for the shanks of dental rotary instruments. The device explicitly references this standard for "Tool type" and "Diameter of tools." |
  | NF EN ISO 17664 (2004): Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices | This standard ensures that the manufacturer provides adequate instructions for the sterilization of the device, which is crucial for reusable surgical instruments. |

Study Information (Not Applicable for this type of device)

For a traditional medical device like a dental handpiece, the "study" for 510(k) clearance typically involves demonstrating compliance with recognized standards and substantial equivalence to predicate devices, rather than a clinical study with patients or a separate performance study with a test set of data. Therefore, many of the requested attributes related to AI/ML device studies are not applicable.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. Performance is demonstrated through engineering tests and compliance with standards, not a data-driven test set.
2. 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): Not applicable. Ground truth as understood in AI/ML is not relevant here. Device performance is measured against engineering specifications.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Device performance is verified against established engineering and safety standards.
7. The sample size for the training set: Not applicable. This is not an AI device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Substantial Equivalence: The primary "study" for this device's clearance is the demonstration of substantial equivalence to legally marketed predicate devices:

• ANTHOGYR Contra-angle and Handpiece (K040674)
• ANTHOGYR MontBlanc Contra-angle (K090676)
• WH Surgical contra-angle Handpieces (K011061)
• WH Surgical contra-angle and straight handpiece (K080939)

The manufacturer states that the new MontBlanc handpieces "have the same fundamental scientific technology, operating principle and intended use as predicate devices." This comparison forms the basis of their "performance data" for regulatory submission.

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ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.

ANTHOGYR has developed "IMPLANTEO" implantology and dental surgery motor unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit consist of design improvement of non essential characteristics of the device. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR implantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angle (K970953) or W&H implantMED (K052741) with contra-angle (K080939).

Here's a breakdown of the acceptance criteria and study information for the "IMPLANTEO" Implantology and Dental surgery motor unit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily established by conformity to recognized industry standards for dental handpieces and medical electrical equipment. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to predicate devices. The document does not provide specific quantitative performance metrics like accuracy, sensitivity, or specificity, as it's a hardware device designed for mechanical tasks.

Note: This is a 510(k) submission for a Class I mechanical device, so the "study" is primarily focused on demonstrating conformance to established safety and performance standards and substantial equivalence to existing devices, rather than a clinical trial with statistical performance metrics like those for diagnostic AI devices.

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

This document does not describe a "test set" or "data provenance" in the way one would for an AI/software device. The performance data presented refers to conformity with technical standards for the physical device and its components. Therefore, there isn't a sample size of patient data or clinical images mentioned. The "test set" would implicitly be the manufactured device units themselves undergoing testing against the listed standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a mechanical device being validated against engineering standards, "experts" in a clinical sense (e.g., radiologists) are not used to establish a "ground truth." The ground truth is defined by the requirements outlined in the engineering and safety standards themselves.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as would be used for subjective data in diagnostic evaluation. Conformity to standards is typically assessed through objective measurements and verification processes.

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 type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers are involved. This submission is for a mechanical dental surgery motor unit.

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

Not applicable. This device is a mechanical motor unit, not an algorithm or AI. Its operation inherently requires a human operator.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is defined by:

• Engineering and Safety Standards: The technical specifications and requirements outlined in the explicitly listed ISO, IEC, and NF EN standards (e.g., electrical safety, mechanical dimensions, electromagnetic compatibility).
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices to which this device claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical motor unit, not an AI or machine learning model that requires a training set of data.

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

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

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