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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
• . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
• ZiLock prosthetic interface with internal indexer;
• Apically tapered implant with trapezoidal thread profile;
• Implant provided with sand-blasted, acid etched surface finish;
• . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
• . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.

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Neodent prosthetic abutments are indicated to be used on Neodent implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The subject device is a temporary abutment composed of PEEK with a titanium alloy fixation screw. The subject device is compatible with Neodent zirconia implant bodies with Zilock connection platform (K201491).

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard;
• . ZiLock prosthetic interface with internal indexer;
• . Cylindrical format with a passing hole to fixate the screw.

I apologize, but the provided text is an FDA 510(k) Pre-market Notification letter and a 510(k) Summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence of a new device (Neodent Implant System - Zirconia Implant System) to existing predicate devices.

This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

• The device's trade name, regulation number, and product code.
• Indications for Use.
• Comparison of technological characteristics between the subject device and predicate devices (e.g., intended use, design, materials, sterilization).
• Bench testing (biocompatibility, MRI compatibility) and sterilization validation, largely leveraged from predicate devices.

It does not describe an AI/ML-based device, nor does it provide the type of study details requested (e.g., expert ground truth, sample sizes for AI model testing/training, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, as this information is not present.

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• HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
• Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
• Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
• Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
• CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
• GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
• GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
• . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

• Titamax WS implants, abutments and copings (originally cleared per K123022)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Titamax WS implants are indicated for a delayed loading protocol.

• Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

• Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
  The Zygomatic implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.

• CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
• o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

• CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
• CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
  The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

• . The Neodent Graft Screw (originally cleared per K103084)
  The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA regarding the MRI compatibility of various Neodent Implant System devices. It primarily focuses on defining the indications for use for different components of the implant system and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/Medical Device.

The document is a regulatory approval letter and descriptive indications for use, not a study report or technical performance assessment. Therefore, I cannot extract the requested information from this text.

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The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the "test set" in terms of number of devices for biocompatibility, mechanical, or sterilization testing. It mentions "samples" were submitted for testing.

The data provenance is from laboratory testing performed by or for JJGC Indústria e Comércio de Materiais Dentários SA, a company based in Curitiba, Parana, BRAZIL. The clinical data was not submitted or relied upon, so the testing is likely retrospective in the sense that it's laboratory data, not data gathered from human trials.

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

This information is not applicable as the studies conducted are laboratory-based performance tests (biocompatibility, mechanical, sterilization validation) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way it's typically understood for AI/diagnostic devices. The acceptance criteria are based on established international standards (ISO, ASTM) and FDA guidance documents.

4. Adjudication Method for the Test Set

This is not applicable for the type of laboratory performance studies described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical outcomes, which did not occur here.

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

No, an MRMC comparative effectiveness study was not done. The study involved laboratory performance testing of the device itself, not a comparison of human readers with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (dental abutment), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests consists of:

• Compliance with international standards: ISO 10993 series for biocompatibility, ISO 14801 and FDA Guidance for Mechanical Strength, ISO 11135 and ISO 10993-7 for Sterilization, and ASTM F1980, ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M for Shelf Life.
• Predicate device characteristics: The subject device's performance is compared against the established performance and characteristics of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for a physical device.

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Indications for Use for GM implants and conventional abutments:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, 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.

Indications for Use for GM Titanium Base abutments:

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for GM Pro Peek Abutments:

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line.

The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows:

The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment:

NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface.

Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface.

GM Titamax implants: cylindrical shape with double threads of pyramidal profile, rounded apex.

GM Helix implants: conical shape, double threads with trapezoidal profile, a rounded apex.

GM Drive implants: conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex.

The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible.

GM Cover Screws: devices for temporary use during the implant healing phase.

GM Healings: devices for temporary use for maintenance of the soft tissue during the osseointegration phase.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Click Universal Abutments (straight and angled): intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Titanium Base abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration.

GM Pro PEEK Abutment: temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months.

Protection Cylinders: prosthetic components with a tapered shape intended to be placed on abutments to protect them during the fabrication of the prosthesis and/or healing of the peri-implant tissues.

Coping Screws: prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment.

This document is a 510(k) Premarket Notification from the FDA regarding the "Neodent Implant System - GM Line." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in a clinical or performance study context.

Therefore, the information requested in your prompt (Acceptance Criteria, Study Design for proving performance, Sample Sizes, Expert consensus, MRMC studies, etc.) is not present in this document. This document details the comparison of the new device with existing ones based on:

1. Indications for Use: The new device's indications align with or are subsumed by those of the predicates.
2. Technological Characteristics: Materials, design features, sterilization methods, and compatibility are compared.
3. Performance Data (Mechanical Testing and Biocompatibility): This section confirms that the materials meet established standards (ASTM, ISO) and that the device components (implants, abutments) have undergone mechanical fatigue testing according to ISO 14801 and FDA guidance. Biocompatibility has been assessed for the materials used. However, it does not provide specific acceptance criteria or detailed results of these tests, simply stating that the performance is "equivalent" to predicate devices.

Summary of missing information based on your prompt:

• Table of acceptance criteria and reported device performance: Not provided in a quantifiable manner for clinical performance. Only mentions "equivalent" mechanical performance based on ISO standards.
• Sample sizes for test set and data provenance: No clinical test set involving human subjects is described. Mechanical tests likely involved specific numbers of devices, but these are not disclosed.
• Number of experts and qualifications for ground truth: Not applicable as no clinical ground truth assessment is detailed.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not conducted or reported. This submission relies on substantial equivalence to existing devices, not a comparative clinical trial with human readers/outcomes.
• Standalone performance (algorithm only): Not applicable as this is a physical medical device (dental implant system), not an AI algorithm.
• Type of ground truth used: For regulatory purposes, the "ground truth" for this submission is established through comparison to legally marketed predicate devices and adherence to relevant industry standards (ISO, ASTM) and FDA guidance for mechanical and biocompatibility testing. No clinical "ground truth" derived from patient outcomes or expert consensus on images is mentioned regarding the device's function.
• Sample size for training set: Not applicable as this is not an AI/ML device.
• How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates regulatory compliance and substantial equivalence through a comparison of device characteristics and a statement of meeting mechanical and biocompatibility standards, rather than presenting a detailed study proving the device meets specific, quantifiable clinical acceptance criteria.

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The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.

The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature:

• cylindrical shape
• hexagonal indexing at the apical end of the Morse taper connection
• indexing guide in the cementable portion for coping fitting

The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.

The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.

The Titanium Base for CEREC is compatible with the following devices:

Dental implants
All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.

Raw material blanks

• -InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
• -IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.

Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.

Instruments

• -Neodent screwdrivers (class I - exempt devices)
• Sirona scanbodies (class I exempt devices)

The provided text is a 510(k) premarket notification for the "Neodent Implant System - Titanium Bases For Cerec" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving device performance through a standalone study with a test set, expert ground truth, or MRMC studies.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), and details on training set ground truth cannot be directly extracted from this document, as it outlines a comparison and testing against existing standards and predicate devices.

However, I can extract information about the types of performance data used to support substantial equivalence, which acts as a proxy for meeting certain "acceptance criteria" related to safety and effectiveness by demonstrating similarity to already cleared devices.

Here's a breakdown of what can be inferred:

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

The document does not present explicit acceptance criteria with numerical targets in the traditional sense, as it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. The "reported device performance" is framed as meeting these standards or being comparable to predicate devices.

2. Sample sized 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 as a separate "test set" for performance evaluation in the typical sense.

  • Biocompatibility: No new testing was performed; reliance on prior clearance of the material.
  • Mechanical Testing: Not specified for this submission, but it refers to tests presented in K153624 (a reference predicate). For fatigue testing per ISO 14801, a specific number of samples (typically 5, 8, or 10, depending on the method) would be tested. The number isn't provided here.
  • Software Verification & Validation: The document states the "Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow." This implies testing against the workflow, but specific sample sizes (e.g., number of test cases, scenarios) are not provided.
  • Sterilization Validation: Sterilization validation studies typically involve a defined number of biological indicators (BIs) or process challenge devices (PCDs) per run, over multiple runs. Specific numbers are not provided, only the standards used (ISO 11135, ISO 17665-1).

• Data Provenance: Not explicitly stated. Given Neodent's location in Brazil (JJGC Indústria e Comércio de Materiais Dentários SA, Curtiba, Parana, BRAZIL), it's reasonable to infer that any original data generation would have been conducted in either Brazil or relevant testing laboratories supporting their operations, or by the manufacturers of the predicate devices. The study type (retrospective/prospective) is not detailed.

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)

Not applicable. This device is a dental implant component, not an AI or diagnostic imaging device that requires expert adjudication for ground truth. Its performance is evaluated through material properties, mechanical testing, and software validation.

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

Not applicable, as this is not an AI or diagnostic imaging device for which such adjudication methods would be relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device. Software verification was performed, but not as a "standalone algorithm" in the typical sense of AI performance evaluation.

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

The "ground truth" for this device's performance is established by:

• Material Specifications: Adherence to ASTM F136 for titanium alloy.
• Mechanical Performance: Demonstrating strength and fatigue resistance according to ISO 14801.
• Sterilization Efficacy: Achieving performance per ISO 11135 and ISO 17665-1 standards.
• Software Functionality: Verification and validation against predefined functional requirements within the Sirona validated workflow.
• Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that the device is as safe and effective as its legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm trained on data sets. The "training set" concept is not relevant here.

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

Not applicable, for the same reason as point 8.

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