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BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.

However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.

Here's the summary based on the provided document:

Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)

The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
• Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.

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

• This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical submission for a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical dental implant system, not an AI/ML device, so no MRMC study was performed.

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

• Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for establishing device performance in this context is derived from:
  • Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
  • Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
  • Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable.

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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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent Implant System - Temporary Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Temporary Abutment for provisional restoration employed for up to 6 months;
• Intended for single use;
• Provided sterile via ethylene oxide gas;
• Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
• Coronal geometry has grooves to facilitate bonding of acrylic material;
• Abutment is screw-retained;
• Coronal geometry contains channels to facilitate reduction of abutment height;
• Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
• Provided in multiple gingival heights;
• Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it refers to performance data used to demonstrate substantial equivalence to a predicate device. The performance data is therefore related to demonstrating features or durability comparable to established standards and the predicate.

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

The document does not specify the exact sample sizes for each of the tests (dynamic fatigue, torsion, sterility, aging, biocompatibility). It only states that the tests were performed.

The data provenance is from JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) located in Curitiba, Parana, Brazil. The studies are prospective in nature, as they involve performing tests and gathering data specifically for this submission.

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

This information is not applicable as the studies described are performance tests (mechanical, sterilization, aging, biocompatibility) of a medical device, not diagnostic studies that require expert interpretation of results to establish ground truth (e.g., image interpretation by radiologists). The "ground truth" here is defined by objective physical and chemical standards (e.g., ISO and ASTM standards).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of studies presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation of data is involved and discrepancies need to be resolved. The described studies are objective laboratory/engineering tests.

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 performed. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) to assess the impact of AI on human reader performance. The device described (Temporary Abutments) is a physical implant component, not a diagnostic AI tool.

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

This question is not applicable as the device is a physical medical device (temporary abutment), not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance studies conducted (fatigue, torsion, sterility, etc.) are inherently "standalone" in that they test the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance studies is established by objective technical standards and regulatory guidelines. This includes:

• ISO 14801 for dynamic fatigue.
• ISO 1135 for sterilization validation.
• ISO 10993-7 for ethylene oxide residuals.
• ASTM F1980 for accelerated and real-time aging.
• ISO 10993-1, 10993-5, 10993-18, 10993-12 for biocompatibility.
• FDA Guidance documents for specific test methodologies.

The "ground truth" is adherence to and performance within the limits or specifications set by these recognized standards to ensure safety and effectiveness comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI model or algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as above; there is no "training set" for physical device performance.

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URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

URIS OMNI System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:

Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (L).

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.

The provided text is a 510(k) Summary for the URIS OMNI System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data for mechanical properties and biocompatibility.

Crucially, this document explicitly states: "No clinical data were included in this submission."

Therefore, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance with or without AI, multi-reader multi-case studies, standalone algorithm performance, or ground truth derived from expert consensus, pathology, or outcomes data, cannot be found in this document.

The acceptance criteria mentioned in this 510(k) summary are for non-clinical tests to demonstrate the device's physical and biological properties.

Here's the relevant information that can be extracted, interpreting "acceptance criteria" in the context of this regulatory submission:

Acceptance Criteria and Device Performance (Non-Clinical)

The "acceptance criteria" for this submission are not expressed as performance metrics for an AI/CADe device, but rather as meeting established standards for dental implants and abutments. The "reported device performance" is a statement that the device met these criteria.

Since "No clinical data were included in this submission," the following requested information cannot be provided from this document:

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to device performance in a clinical context.
8. The sample size for the training set: Not applicable (refers to AI/machine learning data, not present here).
9. How the ground truth for the training set was established: Not applicable.

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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 Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.

The Stern AC Dental Implant System is only intended for use with straight abutments.

The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.

The provided document is a 510(k) Premarket Notification for the Stern AC Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or quantifiable performance metrics for the Stern AC Dental Implant System. Instead, the "performance" demonstrated is that the device is "substantially equivalent" to predicate devices and "performs appropriately for the proposed indications for use." The performance testing mentioned is primarily non-clinical, focusing on material and design characteristics.

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

• Test Set Sample Size: Not applicable in the context of this document. The submission is based on demonstrating substantial equivalence through comparison of design, materials, and non-clinical performance to existing cleared devices, not on a clinical "test set" of patients or a defined dataset with ground truth for algorithm evaluation.
• Data Provenance: The data provided primarily stems from the manufacturer's internal design specifications, material characterization, manufacturing process descriptions, and comparisons to predicate devices. It is entirely retrospective in the sense that it relies on existing knowledge and data for predicate devices and internal validation of the manufacturing processes and material properties of the new device. There is no mention of patient data, clinical trials, or external datasets.

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

• Not applicable. There is no "test set" in the sense of a dataset requiring expert ground truth establishment for algorithm evaluation. The "ground truth" for this submission is FDA's existing clearances for predicate devices and established standards for dental implant materials and design.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" 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:

• Not applicable. This document describes a traditional medical device (dental implant) submission, not an AI/software as a medical device (SaMD) submission. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is established by:
  • Regulatory Precedent: The FDA's previous clearance of the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
  • Industry Standards: Adherence to guidance documents like "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
  • Material Science Principles: The properties of CP Titanium grade 4 and the known performance of specific surface treatments (blasted with aluminum oxide particles and acid etched).
  • Engineering Design Principles: The design features like self-tapping threads, flared neck, and internal connections are evaluated against known engineering principles for dental implants.
  • Laboratory Testing: SEM photographs for blasting residue removal and sterilization validation results.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. There is no "training set" or ground truth for such a set.

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The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.

The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.

"The provided text does not contain information about studies related to AI/ML device performance or acceptance criteria in the typical sense for such devices. The document is a 510(k) summary for a dental implant system (Stern IC Dental Implant System).

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This document
   focuses on substantial equivalence to predicate devices, not performance criteria
   against a defined benchmark.
2. Sample size used for the test set and the data provenance: Not applicable as
   there is no discussion of a test set for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the
   qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was
   done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data,
   etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details the substantial equivalence of the Stern IC Dental Implant
System to predicate devices based on material, design, surface treatment, and intended
use. The study described is a non-clinical testing to demonstrate appropriate
performance for the proposed indications for use, following "Guidance for Industry and
FDA Staff - Class 11 Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments."

Specifically, the non-clinical testing involved:

• SEM photographs: To show removal of all residue of the blasting material from the surface.
• Surface chemical analysis: To confirm no contaminants are left on the surface (conducted on the final device).

It states that fatigue testing was not required because design and technological features are substantially equivalent to predicate devices. The conclusion is based on an analysis of intended use, material, design, and performance being substantially equivalent to the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Straumann ITI Dental Implant System (K012757))."

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