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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients.

Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

INTERNA 3.0 UnicCa® implants with a diameter of 3.3 mm are only intended to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

INTERNA 3.0 UnicCa® implants with a diameter of 3.0 mm are only intended for replacement of maxillary lateral incisors and mandibular incisors, and are only intended for delayed loading.

INTERNA 3.0 UnicCa® implants with a diameter of 2.5 mm are only indicated for missing mandibular central and lateral incisors, and are only intended for delayed loading.

All digitally designed zirconia components for use with Aesthetic Post Abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to add components to the B.T.I. Biotechnology Institute, S.L. product line of endosseous dental implants, abutments, and prosthetic components. Specifically this submission seeks marketing clearance for dental implants with body diameters of 2.5 mm, 3.0 mm, various compatible conventional abutments, and two-piece abutments to be used with a zirconia superstructure fabricated using CAD-CAM technology.

The subject device Interna 3.0 implants have an internal hexolobular connection and a platform diameter of 3.0 mm. The implants are provided in body diameters of 2.5 mm, 3.0 mm. Each body diameter is provided in overall lengths of 8.5 mm, 10 mm, 11.5 mm. The subject implants are manufactured from unalloyed titanium (conforming to ASTM F67 and ISO 5832-2), and the endosseous surface has the UniCa" surface treatment that improves the hydrophilicity of the implant.

The subject device abutments are provided in various designs including Healing Abutments. Healing Screws, Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments (Ti-Bases), Transeptihelial Abutments (Single-unit and Multi-unit, with corresponding screws), and Aesthetic Interfaces for Transepthelial Abutments. The Temporary Titanium Abutments and Definitive Titanium Abutments are provided straight (00) only and are not to be customized to create an angled abutment or to correct for angulation.

The subject Square Abutments are two-piece abutments consisting of titanium bases combined with ceramic superstructures, to be attached directly to the Interna 3.0 implants to support single-unit or multi-unit restorations. The Square Abutments are provided in gingival heights ranging from 0.5 mm to 3 mm, with a titanium base platform diameter ranging from 3.76 mm. The titanium base post height (length above the gingival height) either is 3.5 mm, or in versions with an angled screw access channel, 6.5 mm with a cut-down post height of 2.1 mm, 3 mm, or 3.5 mm. The post of all titanium base versions includes an anti-rotation design to prevent rotation of the superstructure or hybrid crown. The abutments are used with cemented and screw-retained restorations. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952, and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures for use with the Square Abutments will be done at a BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Abutments are:

minimum wall thickness – 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4.0 mm maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Square Abutments have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

Transepithelial Abutments are for supporting single-unit or multi-unit, temporary or definitive, restorations on the Interna 3.0 implants. Transepthelial Abutments are provided to fit implants with a body diameter of 2.5 mm, and to fit body diameters of either 3.0 mm. Transepithelial Abutments are provided in a variety of gingival heights ranging from 0.5 mm. Transepithelial Abutments are used with previously cleared BTI retention screws, temporary cylinders, aesthetic interfaces, and the subject device Interfaces for Transepithelial Abutments.

The subject Aesthetic Interfaces for Transepithelial Abutments are two-piece abutments on titanium bases combined with ceramic superstructures, used to support single or multi-unit definitive prosthetic restorations. Aesthetic Interfaces for Transepithelial Abutments are provided in gingival heights of 0.5 mm to 1.05 mm, titanium base diameters ranging from 3.5 mm, and titanium base post heights (length above the gingival height) ranging from 5.45 mm to 6.5 mm. Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger titanium base platform diameter than the Straight configurations with the same platform diameter. The titanium base platform diameters range from 3.5 mm to 6.5 mm and all designs include anti-rotation indexes to prevent rotation of the superstructure or hybrid crown. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952 and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures will be done at BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelial Abutments are:

minimum wall thickness - 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4 mm

maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Aesthetic Interfaces have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

All subject device abutments are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2, and zirconia confirming to ISO 13356. Selected abutments are provided with a Titanium Nitride (TiN) coating to enhance the aesthetic appearance of the device. Subject device abutments used with screws previously cleared in K211952 and K053355. The screws that are part of the Transepithelial Abutment assemblies are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3. The screws have a diamond-like carbon (DLC) coating that is identical to the DLC coating on screws cleared in K211952.

Subject device components provided sterile by gamma irradiation include the Interna 3.0 Implants, Healing Abutments, Healing Screws, and Transepithelial Abutments. Components provided non-sterile for end-user moist heat sterilization include the Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments, Aesthetic Interfaces for Transepithelial Abutments, and retention screws.

This document, K240262, is a 510(k) premarket notification for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The non-clinical data submitted or referenced in this document are for a traditional dental implant system and include:

• Worst-case MRI review.
• Measurements of surface area comparisons with predicate implants.
• Moist heat sterilization validation.
• Gamma sterilization validation.
• Sterile barrier shelf life data.
• Biocompatibility data for device materials.

Therefore, I cannot extract the requested information in the format of acceptance criteria and a study proving the device meets the acceptance criteria for an AI/ML device from the provided text. The document explicitly states: "No clinical data were included in this submission." and the device is a dental implant system, not an AI/ML device used for diagnostic or screening purposes that would require such performance studies.

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The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

This document describes a 510(k) premarket notification for a dental implant system called S-Mono. The provided text, however, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or performance study involving human subjects or AI algorithm performance metrics.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving the device meets certain performance metrics through standalone testing, the manufacturer compares the new device (S-Mono) to existing, legally marketed devices (predicates) and argues that it is as safe and effective because of similar intended use, materials, and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details because this information is not present in the provided text.

The "Non-Clinical Testing" section describes several tests performed on the S-Mono, but these are primarily material, sterilization, shelf-life, and biocompatibility tests, not performance studies that would typically define "acceptance criteria" through clinical outcomes or diagnostic accuracy.

Non-Clinical Testing Information Provided:

• Sterilization validation testing: Performed according to ISO 11137 (gamma sterilization) and ISO 11737, ISO 17665-1, ISO 17665-2 (steam sterilization).
• Shelf-life testing: Performed according to ASTM F1980, ASTM F1929, and ISO 11737-2.
• Fixture surface characteristics evaluation: EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness Analysis were performed after RBM treatment.
• Biocompatibility tests: Performed according to ISO 10993-1, 3, 5, 6, 10, 11, 12, and 33.
• MR Conditional labeling: A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (Woods, Terry O., et al., 2019). Titanium alloy (Ti-6A1-4V, ELI) properties were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

In summary, the provided text describes the regulatory filing for a dental implant and focuses on demonstrating substantial equivalence, not on providing the results of a performance study with acceptance criteria.

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The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

The BoneTrust® Mini Implant System is a two-piece dental implant system including various sizes of threaded root-form dental implants and abutments to provide temporary support of prosthetic restorations in edentulous or partially edentulous patients during the healing phase of permanent endosseous dental implant(s). The maximum duration of intraoral use of all members of the BoneTrust® Mini Implant System is 180 days.

The provided text describes a 510(k) premarket notification for the BoneTrust® Mini Implant System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a new device meets specific performance acceptance criteria through the types of studies typically conducted for novel AI/ML-driven medical devices.

Therefore, the requested information about acceptance criteria tables, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not present in this document. This document primarily relies on a comparative analysis of:

• Indications for Use: The BoneTrust® Mini Implant System's intended use is compared to that of primary and reference predicate devices (EM Provisional, Sterngold 2.2mm Angled Micro ERA Dental Implant System, BoneTrust® Implant Systems, MIS LOCKIT Abutments System, Nobel Biocare AB, OSSTEM Implant Co. Ltd.). The conclusion is that the indications are "Similar to primary predicate device" or "Substantially Equivalent." The additional limitation of implant duration (max 180 days) is noted as not changing the intended use.

• Technological Characteristics: Detailed comparisons are made regarding:

  • Implant Material: Titanium Grade 4 ASTM F67, identical to reference device K182313.
  • Implant Type and Design: Screw-type, straight body/tapered body, self-tapping, with thread, two-piece design. Largely identical or similar to predicate/reference devices.
  • Implant-Abutment Connection: External Torx Implant/Abutment fixture. Differences from some predicates (one-piece design or different connection types) are stated not to raise concerns regarding safety and effectiveness.
  • Implant Dimensions: The proposed device's sizes (diameters and lengths) are stated to be "within range of primary predicate device."
  • Surface Treatment: Machined / Microstructured blasted etched surface passivated, stated as identical to K191751 and K182313.
  • Sterilization: Beta Radiation, identical to K182313.
  • Abutment Material, Surface, Size, Connection, Angulation, and Sterility: Comparisons are made to various predicate/reference abutments, with conclusions of "Identical" or minor differences not raising safety/effectiveness concerns.
  • Ball Attachment Material, Surface, Size, Connection, Angulation, and Sterility: Similar comparisons are made, concluding "Identical" or differences not impacting safety/effectiveness.

• Non-Clinical Testing Summary:

  • Clinical Studies: None were performed.
  • Biocompatibility: Relied on previous clearance of BoneTrust® Implant System (K182313) due to identical manufacturing process and materials. Periodic bacterial endotoxin testing (USP ) is performed, with historical data showing acceptable levels.
  • Fatigue Testing: Not deemed necessary as per FDA Guidance Document for Class II Special Controls, because the system does not contain angulated abutments.
  • Sterilization: Beta-radiation sterilized (SAL 10⁻⁶) according to ISO 11137-1:2006 and 11137-2:2013. Efficacy reliant on K182313 due to identical process. Unsterile prosthetic components are intended for end-user sterilization, with methods identical to K182313.
  • Shelf Life: 5 years, reliant on K182313 due to identical packaging system.
  • Implant Surface Analysis: Energy Dispersive X-ray Spectroscopy (EDX) and SEM analysis were conducted, and results support substantial equivalence to legally marketed predicate devices.

In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the manner requested, because the submission focuses on demonstrating substantial equivalence to existing devices through comparative analysis and non-clinical testing rather than de novo clinical or performance studies with defined acceptance criteria for a novel AI/ML device.

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The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.

The provided text is a 510(k) summary for the "S-mini active Fixture," an endosseous dental implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. This is because the device in question is a dental implant, a physical medical device, not a software or AI-based diagnostic tool.

Therefore, many of the requested points in your prompt are not applicable to the information contained within this document. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device based on material, design, sterilization, and non-clinical bench testing.

Here's how the provided information relates to your request, with an emphasis on what's not applicable:

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

The acceptance criteria for a 510(k) for a physical device like a dental implant are primarily centered around demonstrating "substantial equivalence" to a predicate device, as opposed to performance metrics like sensitivity or specificity for a diagnostic algorithm.

The document states:

• "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
• "Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance."

Acceptance Criteria (Implicit from Non-Clinical Testing):
The device must meet the criteria of the following standards and tests, demonstrating bio-compatibility, structural integrity, and durability:

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the number of physical devices tested in the non-clinical bench studies (e.g., how many implants were used for fatigue testing), which is not specified.
• Data Provenance: The tests are non-clinical, meaning they are laboratory/bench tests, not studies on human patients. The manufacture is located in South Korea.

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

• Not Applicable. This document describes a physical medical device (dental implant), not an AI or diagnostic software. Therefore, there is no "ground truth" in the diagnostic sense, nor experts interpreting images or data for a test set. The "truth" is established through engineering and biological testing against predefined standards.

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

• Not Applicable. See point 3.

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

• Not Applicable. This is a physical device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical device.

7. The type of ground truth used:

• Not Applicable in the context of diagnostic AI. For this physical device, "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, ANSI, USP) and the physical properties and performance characteristics demonstrated by the predicate devices. For instance, the "ground truth" for biocompatibility is defined by meeting the criteria of the ISO 10993 series.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" and thus no "ground truth" establishment process for one.

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The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

This product is orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment.
It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily and is removed after orthodontic treatment has been completed.
Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures.
The Orthodontic Screw is a dental device made of titanium alloy metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
It is 1.2, 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length.
It is made of Titanium alloy (Ti-6Al-4V ELI).
There are two types of surface treatment one is non-treated (Machineed) another one is Acid etching

The provided text describes the regulatory submission for an Orthodontic Screw, which is a medical device, and includes a summary of nonclinical testing. It does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study involving an AI device or human readers. Therefore, I cannot fulfill the request as it pertains to AI/ML device performance.

However, I can extract information regarding the nonclinical testing performed for this Orthodontic Screw:

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

The document mentions three types of performance tests conducted. It states "We conducted performance test due to addition of smaller diameter Ø1.2mm Fracture load Test, Rotational fracture torque test, Axial pull-out strength test." However, the specific acceptance criteria (e.g., minimum fracture load, torque, or pull-out strength) and the reported device performance values are not provided in the document. The document only lists the types of tests performed.

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

The document does not provide details on the sample size used for these performance tests, nor the data provenance (country of origin, retrospective/prospective).

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 information is not applicable as the tests described are mechanical performance tests of a physical device, not an AI/ML system requiring expert ground truth for imaging or diagnostic tasks.

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

Not applicable for mechanical performance tests.

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

Not applicable. This is a physical medical device, not an AI system that assists human readers.

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

Not applicable. This is a physical medical device.

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

For the three performance tests (Fracture load Test, Rotational fracture torque test, Axial pull-out strength test), the "ground truth" would be the experimentally measured physical properties of the Orthodontic Screw under specific load conditions. These measurements are typically derived from standardized testing procedures, not from expert consensus, pathology, or outcomes data in the context of device performance claims.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML system.

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

Not applicable. This is a physical device.

Additional Information from the Document:

• Biocompatibility: Demonstrated by reference to K122171.
• Sterilization Validation: Demonstrated by reference to K072896 (gamma irradiation process).
• Surface Treatment Characterization: Demonstrated by reference to K122171.
• Clinical Studies: "No clinical studies are submitted."
• Substantial Equivalence: The claim of substantial equivalence is based on the device having the same principles of operation, material (Titanium alloy Ti-6Al-4V ELI, ASTM F 136), indication for use, and similar design to predicate devices. The performance tests were conducted due to the addition of a smaller diameter (Ø1.2mm) and new head types (Small Head, Bracket Head) and a change in surface treatment (Acid etching).

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The ETIII SA Fixture System (03.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The ETIII SA Fixture System (Ø3.2) is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

This document is a 510(k) premarket notification for the ETIII SA Fixture System (Ø3.2mm) to the FDA. It declares substantial equivalence to existing predicate devices, rather than presenting a study to prove a device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be found in this document.

Here's an analysis of the provided text in relation to your request:

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

• Not Applicable. This document does not present specific acceptance criteria or performance metrics for the ETIII SA Fixture System (Ø3.2mm) in the way one would expect for a new diagnostic or AI-driven device. Instead, it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. The "performance" is implicitly deemed equivalent to these predicates.
• The document does list various tests conducted, such as biocompatibility tests (Subchronic Toxicity, Bacterial reverse mutation, Chromosome aberration, Cytotoxicity, Skin sensitization, Oral Mucosa Irritation, Acute Systemic Toxicity, Pyrogen tests), sterility tests, and mechanical tests (adaptation accuracy, static and dynamic fatigue). However, it does not provide specific numerical outcomes or acceptance thresholds for these tests that could be presented in a performance table. It merely states that "All tests were conducted in accordance with relative standards without any discrepancies."

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

• Not Applicable. This document describes a medical device (dental implant), not a software or AI device that would typically have a "test set" in the context of data analysis. The testing involved material properties, biocompatibility, and mechanical performance, not a clinical data set for algorithm validation.
• Therefore, there is no information on sample size for a "test set" as would be relevant for an AI study, nor data provenance (country of origin, retrospective/prospective).

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

• Not Applicable. As this is a physical medical device (dental implant) and not an AI or diagnostic software, there is no "ground truth" established by experts in the context of data labeling or diagnosis for a test set. The validation relies on standard engineering, material, and biological safety testing.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method as typically defined for AI or diagnostic studies is mentioned.

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

• No. This document pertains to a physical dental implant, not an AI or diagnostic tool, so an MRMC study is not relevant and was not conducted.

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

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

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

• Not Applicable. For the physical properties and safety of a dental implant, the "ground truth" is established through adherence to recognized international standards (e.g., ISO, ASTM, USP) for material science, biocompatibility, and mechanical testing. There isn't a "ground truth" in the sense of clinical diagnosis or outcomes data detailed here for a study to prove acceptance criteria.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not applicable.

Summary based on the document:

The document describes the ETIII SA Fixture System (Ø3.2mm) dental implant and seeks FDA clearance based on substantial equivalence to predicate devices. It references various non-clinical tests performed in accordance with international standards (ISO, USP) to demonstrate safety and performance, but does not provide the specific results or acceptance criteria values for these tests. It explicitly states, "No clinical studies are submitted." The focus is on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety and effectiveness as legally marketed predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel technology.

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