Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

ANTHOGYR Dental Implant System implant AXIOM is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

AXIOM dental implant system is designed to enhance the functional and aesthetic integration of implant supported restorations. AXIOM implants are made of grade V titanium and present a single connection (2.7 mm) common to all implant forms in the range. AXIOM implants are available in 4 diameters (3.4, 4.0, 4.6 and 5.2 mm) and various heights from 8 to 14 mm. AXIOM dental implant system includes all required prosthetic components and surgical instrumentation.

The provided text details the 510(k) summary for the ANTHOGYR DENTAL IMPLANT SYSTEMS: AXIOM, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with acceptance criteria for an AI/ML-driven device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC study, standalone performance, ground truth establishment, and training set details for an AI/ML device) is not present in the provided 510(k) summary.

This document primarily covers:

• Device Description: What the AXIOM implant system is, its materials, sizes, and components.
• Intended Use: The medical conditions and applications for which the device is designed.
• Performance Data (Non-clinical): Mentions fatigue testing, implant-to-abutment compatibility, corrosion testing, and modified surfaces information.
• Clinical Data: Explicitly states "None included."
• Substantial Equivalence: Compares the AXIOM system to its predicate device (PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM - K051614) based on intended use, material, design, mechanical properties, and function.
• Regulatory Information: Product codes, classifications, and panel.
• FDA Communication: The letter from the FDA affirming the substantial equivalence determination and outlining regulatory responsibilities.

Since the device is a dental implant system and not an AI/ML-driven diagnostic or therapeutic tool, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, reader studies, etc.) are not applicable to this document. The "performance data" referred to here are engineering and material performance tests, not clinical performance or AI algorithm performance.

Ask a specific question about this device