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Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.

The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.

The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.

The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.

I am sorry, but the provided text does not contain the specific details about the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) summary for Paltop Short Implants, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance in the way you've requested.

The text does mention "Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use," but it does not provide the acceptance criteria for these tests, nor does it present the reported device performance values from these tests. It also states that "static and dynamic testing were not required" because the device is not significantly different from predicate devices.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided document.

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IS-III active Short Implants are 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. The IS-III active Short Implants are indicated for the molar region with delayed loading.

IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with 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 Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.

The provided text describes a 510(k) premarket notification for a medical device (IS-III active Short Implant) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with specific acceptance criteria as you might find for a new diagnostic device or a drug. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to a diagnostic AI/ML device or a drug is not directly applicable in the same way here.

However, we can infer "acceptance criteria" from the performance characteristics and safety evaluations that the FDA requires for substantial equivalence, and "the study" refers to the non-clinical testing performed to meet these requirements.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as the performance and safety benchmarks for substantial equivalence and "study" as the non-clinical testing conducted.

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

Since this is a 510(k) for an endosseous dental implant, the acceptance criteria are primarily focused on mechanical performance, biocompatibility, and sterility, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

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

The document describes non-clinical bench testing. For such tests, the "sample size" refers to the number of physical device samples tested.

• Fatigue Testing: "under the worst-case scenario" implies specific configurations were chosen for testing, but a numerical sample size is not explicitly stated. Typically, multiple samples (e.g., n=5, n=10) would be tested per configuration to ensure statistical robustness.
• Axial Pull-Out Testing: "under the worst-case scenario" implies specific configurations were chosen, but a numerical sample size is not explicitly stated.
• Biocompatibility Testing: The biocompatibility testing was performed on a "reference device, K181138." The sample size for that testing is not specified in this document.
• Sterilization Validation: Tests would involve multiple samples to validate the process to achieve SAL 10^-6, but numerical sample size is not specified.
• Shelf Life Testing: "The worst-case construct was tested," implying specific samples of the device and packaging system were aged and then tested. Numerical sample size is not specified.
• Surface Area Analysis / Comparative Bone to Implant Contact Surface Area Analysis: These are analytical comparisons, likely involving measurements on a set number of devices or designs, but a specific numerical sample size is not given.

Data Provenance: All testing is non-clinical (bench testing), not human data. The data originates from the manufacturer's internal testing and analysis or contracted laboratories, performed to comply with international standards (ISO, ASTM) and FDA guidance documents.

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

This section is not applicable. The evaluations are based on internationally recognized standards (ISO, ASTM) and FDA guidance for medical device performance (mechanical, material, sterility). There isn't a "ground truth" established by human experts in the context of diagnostic interpretation for these types of non-clinical tests. The "truth" is whether the device meets the specified standard (e.g., maximum load before fracture in fatigue testing, or specific material properties).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpreters are evaluating diagnostic images or clinical outcomes, and their interpretations need to be reconciled to establish a consensus ground truth. Here, the "test set" consists of physical devices subjected to mechanical, chemical, and biological tests governed by objective, quantitative standards.

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

This section is not applicable. MRMC studies are specific to diagnostic performance evaluations, particularly when assessing the impact of AI on human reader performance for tasks like image interpretation. This submission is for an endosseous dental implant, which is a physical device, not an AI/ML diagnostic tool.

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

This section is not applicable. There is no AI algorithm being evaluated in this submission. The device is a physical dental implant.

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

As mentioned in point 3, the concept of "ground truth" in the context of diagnostic performance (like pathology or expert consensus) is not directly applicable here. The "truth" or reference for evaluating performance of the dental implant consists of:

• International Standards: e.g., ISO 14801 (dental implant fatigue), ASTM F543-17 A3 (mechanical testing), ISO 10993 series (biocompatibility), ISO 11137-1:2006 (radiation sterilization), ASTM F1980 (accelerated aging/shelf life).
• Manufacturer Specifications: Ensuring the device meets its design specifications (e.g., dimensions, material composition).
• Existing Predicate Device Performance: The primary "ground truth" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by matching or exceeding its established performance in relevant tests.

8. The sample size for the training set

This section is not applicable. There is no AI/ML model for which a "training set" would be used.

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

This section is not applicable, as there is no AI/ML model or corresponding training set.

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UniFit Dental Implant System is intended for surgical placement in the maxillary and or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Adin's UniFit Dental Implant System is a new model that provides an additional connection platform to Adin's legally marketed Dental Implant Systems, indicated for use in surgical and restorative applications for placement in the maxillary and/or mandibular arch to provide support for prosthetic devices such as crowns, bridges, or overdentures in order to restore masticatory function.

This new UniFit model is identical to Adin's cleared Touareg™ CloseFit (RP- Regular Platform, and WP- Wide Platform) and Adin's Touareg™-S implant systems (cleared under K112585 and K081751, respectively) except for the "Star" (Torx) connection and new 6mm length for specific diameters.

The UniFit Dental Implant System includes dental implants, screws and prosthetic components for CAD/CAM restorations.

The UniFit dental implants are tapered core implants with a spiral tap, and a dome apex and double lead thread design.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the UniFit Dental Implant System.

Please Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict numerical acceptance criteria against a pre-defined performance target. The studies described are primarily to ensure safety, functionality, and equivalence to already cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission focused on substantial equivalence to predicate devices rather than meeting a specific performance target for AI, the "acceptance criteria" here refer to meeting the established performance standards of the predicate devices and general safety/performance testing for the type of medical device. The document does not provide a traditional table of AI-specific acceptance criteria (e.g., sensitivity, specificity, AUC) or corresponding numerical performance for the device's AI component. Instead, it describes a series of engineering and biocompatibility tests to ensure the new device is as safe and effective as previously cleared devices.

The "device performance" reported is that the device successfully meets the internal protocols and relevant ISO/ASTM standards, indicating it performs comparably to the predicate devices and is safe for its intended use.

No AI is mentioned in the provided text for the UniFit Dental Implant System. The document describes a physical dental implant system and components, not a software or AI-driven medical device. Therefore, the subsequent questions regarding AI-specific criteria (sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable based on this document.

• Pyrogenic Material-Mediated and chemical extractions conducted.
• Biocompatibility tests were conducted in accordance with referenced standards. |
  | Connection Design Effectiveness | Stable connection and all measurements within component's specification, following tolerance analysis. | All tested specimens showed stable connection and all measurements were found to be within each component's specification. |
  | Maximal Applicable Torque Resistance (Implant) | Withstand maximal insertion torque as predefined in implant specification, considering safety margins and device design. | Test conducted in accordance with internal protocol; implies meeting criteria (no explicit numerical value reported as metric). |
  | Tool to Implant Connection Lifetime Performance | Maximal applied torque and deformation test met predefined acceptance criteria; no mechanical or visual damages observed at end of reusable tool's recommended lifetime. | Met predefined acceptance criteria; no mechanical or visual damages observed. |
  | Implant-Abutment Connection Degree of Rotation | Predefined acceptance criterion for degree of free rotation after applying closure torque. | All tested specimens met the predefined acceptance criterion. |
  | Abutment Screw Performance - Maximum Applicable Torque | Torque resistance of connecting screw such that breakage occurs above acceptance criteria and at the desired location (under the screw head/groove). | All tested screws failed in values above the acceptance criteria and at the desired location. |
  | Screw Loosening and Abutment Extraction by Retrieval Tool | Ability to screw and loosen with no deformation or fracture; abutment easily retrieved from implant under lateral pressure; screw retrieval torque withstands predefined torque. | All tested screws and abutments were successfully unscrewed and retrieved; screw retrieval torque withstood predefined torque. |
  | Regular Platform Dynamic Loading (Fatigue) | Meet requirements of ISO 14801:2016 for fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and prosthetic components. | All of the success criteria were met. |
  | Torsion Testing | Meet acceptance criteria for torsional performance as per YY0315:2016 for torsional yield strength and maximum torque of worst-case implant/connecting part joints. | All tested specimens met acceptance criteria for UniFit implant system torsional performance per YY0315:2016. |
  | 6.00mm Implants Pull-Out Test | Axial pull-out strength comparable to or better than predicate devices (MIS short implants K103089), per ASTM F543. | The test met its acceptance criteria (comparison with legally marketed device). |
  | Comparative Surface Area Analysis (before treatment) | UniFit Short Implant's actual surface area (before surface treatment) greater than or equivalent to legally marketed reference item (MIS short implants K103089) at worst-case implant variation. | The total surface area measurements of the tested items were greater than the legally marketed reference item, the acceptance criteria was met. |
  | Comparative Bone to Implant Contact (BIC) Surface Area Analysis | Test article (Adin's UniFit short implant, 6.0 mm) BIC volume and surface area comparable to or exceeding reference item (MIS SEVEN MF7-06420) for Hard Bone (Type I) and Soft Bone (Type IV) conditions. | Test article, at both conditions of the bone, exceeded the MIS reference item in terms of B.I.C. volume and surface area. |
  | Single TMA Fatigue Rationale | Fatigue limit of Single TMA abutments assembled to designated Dental Implants (including compatible screw) conforms to ISO 14801:2016, and does not present new worst-case compared to existing and approved TMA system. | The Single TMA and designated superstructures do not present any new worst-case when compared to the existing and approved TMA system (Rationale provided). |
  | Fatigue testing of TiBase Abutments | Worst-case combination of subject device implants, TiBase abutments, and zirconia superstructure is strong enough for clinical application per ISO 14801. | Tested according to ISO 14801; implies meeting strength requirements (no explicit numerical value reported as metric). |
  | Gamma Irradiation Sterilization | Assurance of SAL (Sterility Assurance Level) of 10^-6 using VDmax 20kGy according to ISO 11137-2:2013 and ISO/TS 13004. | Sterilization validated in accordance with ISO 11137-2:2013, assuring SAL of 10^-6. |
  | Cleaning and Steam Sterilization (End-User) | Assurance of SAL of 10^-6 for steam sterilization (for non-sterile components) using full cycle approach as detailed in Annex D4 of ISO 17665-1:2006, in accordance with ISO 17665-1:2006 and ISO 17665-2:2009. | Steam sterilization validated in accordance with ISO 17665-1:2006 and ISO 17665-2:2009, assuring SAL of 10^-6. |
  | Disinfection (End-User) | Disinfection process validated in accordance with ISO 17664-1:2021 and AAMI TIR12:2020. | Disinfection process validation conducted with accordance with ISO 17664-1:2021 and AAMI TIR12:2020. |
  | Shelf-Life, Packaging and Transportation | Ensure 5 years shelf life under accelerated and real-time aging, and confirmed sterility throughout shelf life and after packaging/transportation per ISO 11607-1. | Shelf-life tests conducted to ensure 5 years shelf life, confirming sterility after packaging and transportation. |

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

As no AI component is described, this question is not directly applicable. The performance data section describes various engineering tests.

• Test Set Description: The "test set" for the engineering evaluations consists of physical samples of the UniFit Dental Implant System.
• Sample Sizes:
  • For most tests (connection design effectiveness, torque resistance, tool life, rotation, screw performance, screw loosening/extraction, torsion testing, fatigue testing of TiBase abutments), the document states "All tested specimens" or "All tested screws," implying all manufactured or a representative sample of components tested met the criteria. It does not provide specific numerical counts for these "specimens" or "screws."
  • For the UniFit 6.00mm Implants Pull-Out test, comparison was made to "proposed predicate devices MIS short implants (K103089)." The sample size for UniFit is not explicitly stated but implies sufficient numbers for comparison.
  • For Comparative Surface Area Analysis and Comparative Bone to Implant Contact Surface Area Analysis, comparison was made against "legally marketed devices (MIS short implants cleared under 510(k) K103089) at worst case implant variation" and "MIS's SEVEN MF7-06420." Again, specific sample sizes for the UniFit components are not given, but "tested items" is used.
• Data Provenance: The data comes from internal testing conducted by Adin Dental Implant Systems Ltd. (implied by "Adin internal protocol") and potentially external accredited labs for biocompatibility and sterilization (e.g., "Tests have been conducted at MDT Medical Device Testing GmbH"). The tests are in accordance with international standards (ISO, ASTM, YY) and FDA guidance. The implants are compared to predicate devices already marketed in the US.

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

This question is not applicable as the document does not describe the use of experts to establish a "ground truth" for an AI algorithm's performance on a test set. The validation is through engineering, materials, and biocompatibility testing against established standards and comparisons to predicate devices, which generally do not involve human "experts" establishing ground truth in the AI sense.

4. Adjudication Method for the Test Set

Not applicable, as there is no AI component or subjective human interpretation of results requiring adjudication for ground truth.

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 no AI component is described.

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

Not applicable, as no AI component is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established through:

• Compliance with International Standards: Adherence to ISO and ASTM standards for material properties, mechanical performance, fatigue, sterility, and biocompatibility.
• Comparison to Predicate Devices: Performance characteristics (e.g., implant design, connection types, material, dimensions, sterilization methods, clinical indications) are compared against several legally marketed predicate and reference devices (e.g., Adin's Touareg™ CloseFit Dental Implant System, MIS C1 implants, Straumann BLX System, etc.). The "ground truth" implicitly aligns with the documented safety and effectiveness of these predicate devices.
• Internal Protocols: Performance data is generated and evaluated against Adin's internal protocols and specifications.

8. The Sample Size for the Training Set

Not applicable, as no AI component or machine learning model is described that would require a training set.

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

Not applicable, as no AI component or machine learning model is described that would require a training set with established ground truth.

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Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.

Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for a medical device, Adin Short Implants. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device and its performance metrics.

The document details the substantial equivalence of the Adin Short Implants to predicate dental implants through a comparison of their technological characteristics and non-clinical performance data. This includes:

• Device Description: The physical characteristics of the Adin Short Implants (self-tapping, root-form, two-piece screw type, made of Titanium 6AL-4V-ELI Alloy, specific lengths and diameters, surface treatments).
• Intended Use: Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients to restore chewing function, with immediate loading possible under certain conditions.
• Substantial Equivalence: A detailed comparison table (pages 8-9) of the subject device with several predicate devices, highlighting similarities in classification, indications for use, patient population, sterility, body contact, prescription status, single use, operation principle, placement method, self-tapping, implant material, biocompatibility, shape, connection (with some variations), surface treatment, implanted length, outer diameter, abutment angulation, packaging, and shelf-life.
• Non-Clinical Performance Data (Page 6-7):
  • Pull-Out Testing: Measured axial pull-out strength compared to predicate devices, according to ASTM F543.
  • Comparative Bone to Implant Contact Surface Area Analysis: Compared to predicate devices.
  • Comparative Surface Analysis Before Surface Treatment: Compared to predicate devices.
  • Biocompatibility: Tests conducted according to FDA Guidance for ISO 10993-1, ISO 10993-5, ISO 10993-11, and ISO 10993-18.
  • Surface Analysis After Surface Treatment: Using SEM/EDS.
  • Gamma Sterilization Validation: According to ISO 11137-2 and ISO/TS 13004.
  • Shelf-life validation: According to ISO 11607-1.
  • MR Environment Condition: Non-clinical worst-case MRI review based on scientific rationale and published literature.

The document concludes that the Adin Short Implants are substantially equivalent to the predicate devices and do not introduce new risks.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets the acceptance criteria with respect to AI/ML device performance metrics because the provided text is for a mechanical dental implant and does not involve AI/ML.

If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

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MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations.

It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments.

Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software.

MIS Ti-base abutments are intended for use with the following MIS implants:

C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system.

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base.

The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment.

lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS conical connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

Here's a breakdown of the requested information based on the provided FDA 510(k) document for the MIS Ti-base Abutment.

Important Note: This document describes a dental abutment, not an AI/ML device. Therefore, many of the requested fields regarding AI/ML-specific study aspects (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of medical device submission. The FDA 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

Device Name: MIS Ti-base Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML medical devices like this, "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device, often through mechanical and material testing against established standards. The performance is assessed against these standards and comparative data from the predicate.

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

• Sample Size for Test Set:
  • For Fatigue Testing (ISO 14801:2016), samples were tested. While a specific number isn't explicitly stated on the provided pages, ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to achieve statistically meaningful results for fatigue curves. The document refers to testing "worst case abutments" from both narrow and standard platforms.
  • For Sterilization Testing, an unspecified number of representative samples would have been used for validation.
  • For Software Verification & Validation, the "test set" would be various design scenarios and inputs used to confirm software functionality and adherence to design constraints. The specific "sample size" of test cases is not quantified here.
• Data Provenance: The studies were non-clinical performance tests conducted by MIS Implants Technologies (manufacturer). The location of testing is not specified, but the manufacturer (Dentsply Sirona / MIS Implants Technologies Ltd.) is located in the USA (York, Pennsylvania) and Israel, respectively. These are prospective tests performed specifically for this 510(k) submission.

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

• N/A (Not Applicable for this device type). Ground truth based on expert consensus is typically relevant for AI/ML diagnostic or prognostic devices. For a dental implant abutment, "ground truth" is established by adherence to engineering standards, material specifications, and mechanical performance limits. The "experts" involved would be engineers and quality control personnel responsible for developing and conducting the tests, interpreting standard requirements, and designing robust products. Their qualifications would be in relevant engineering, materials science, and quality assurance fields.

4. Adjudication Method for the Test Set

• N/A (Not Applicable for this device type). Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for AI/ML devices, where human readers (often physicians) independently evaluate medical images or data, and a tie-breaking or consensus process is needed. For mechanical and software performance testing, adjudication is based on objective measurements and established pass/fail criteria from international standards.

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 is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is mechanical and procedural, not algorithmic. The software component (CEREC SW) is for design and manufacturing, not for automatic diagnosis or interpretation.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established by:
  • Engineering Standards: Adherence to established international voluntary consensus standards (e.g., ISO 14801:2016 for fatigue, ANSI/AAMI/ISO 17665 for sterilization).
  • Material Specifications: Compliance with material standards (e.g., ASTM F136 for TI-6Al-4V ELI).
  • Validated Design & Manufacturing Parameters: Verification that the CAD/CAM software maintains design limitations and that the manufacturing process yields correct physical properties.
  • Predicate Device Performance: Comparative performance data against the legally marketed predicate devices serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no "training set." The development process relies on engineering design, material science, and established manufacturing practices, not machine learning.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.

The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation.

MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex.

The MIS M4 Implants are available in the following diameters, platforms and lengths:

• Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
• Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm
• . Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
• Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm
• . Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm

MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths:

• Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
• Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
• Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm
• Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
• . Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm
• The implants are designed for both two-stage procedures, with one internal thread for screwed abutment.

The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.

Components:
The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments.

Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of TI 6AL 4V ELI, and supplied sterile to the user, for single use.

Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.

CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. They are supplied non sterilized by the user according to the labeling, and intended for single use.

Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is burned out for casting with precious metals.. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non sterilized by the user according to the labeling, and intended for single use.

Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of TI 6AL 4V ELI. The overdenture is connected to the multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use.

OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.

Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation. They are straight abutments. They are available in TI 6AL 4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from TI 6AL 4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration, as directed in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.

There are two types of emergence profiles among the abutments, concave or straight emergence profile.

This document is a 510(k) Summary for the MIS Internal Hex Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to legally marketed predicate devices through non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

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

The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific acceptance criteria with quantifiable metrics for each device performance aspect. Instead, it states that the device's performance is "at least equivalent" to the predicates. The primary performance metric mentioned is fatigue testing.

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

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., number of implants/abutments tested for fatigue). It mentions "worst case implants and abutments chosen for the tests" but no specific numbers.

• Sample Size: Not specified (implied to be sufficient for engineering testing validation).
• Data Provenance: The tests were conducted by MIS Implants Technologies Ltd. (Israel) or an "independent testing laboratory" for shelf life. No country of origin is explicitly stated for each test, but the submitter is based in Israel and the US Agent in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The study involves non-clinical engineering and laboratory testing (mechanical, sterilization, biocompatibility, shelf-life, risk analysis) of a dental implant system, not a diagnostic or AI-driven device requiring expert-established ground truth.

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

This section is not applicable for the same reasons as 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

No MRMC or human-in-the-loop study was conducted. This device is a dental implant system, not an AI or diagnostic tool.

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

This section is not applicable. This device is a physical dental implant system, not a standalone algorithm.

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

For the non-clinical tests conducted, the "ground truth" refers to established engineering and regulatory standards:

• Fatigue: ISO 14801:2016 standard.
• Sterilization: ANSI/AAMI/ISO 11137-1, -2; ANSI/AAMI/ISO 17665-1, -2.
• Endotoxin: USP 85, USP 161, ANSI/AAMI/ ST72.
• Disinfection: ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.
• Shelf Life: ISO 11607-1.
• Risk Analysis: ISO 14971.

8. The sample size for the training set

This section is not applicable. There is no training set as no AI/machine learning component is involved.

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

This section is not applicable for the same reason as point 8.

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The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.

ATLANTIS® products are compatible with the implants shown in the table below.

The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).

The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.

The provided text is a 510(k) Pre-Market Notification for the ATLANTIS® Abutment for MIS Implant. It does not describe an AI/ML powered medical device, but rather a dental implant abutment which is a physical device. Therefore, the questions related to AI/ML device acceptance criteria and study design are not applicable.

However, I can provide the acceptance criteria and the study that proves the physical device meets its acceptance criteria based on the information provided in the document.

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

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

The document does not explicitly state the sample sizes used for the mechanical testing or geometric analyses. It also does not specify the country of origin or whether the data was retrospective or prospective. These details are typically found in the full test reports referenced in the 510(k) submission, not in the summary document.

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 is a physical device, not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be established by engineering specifications, materials science standards, and established regulatory test methodologies.

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

Not applicable. This is a physical device, not an AI/ML device that requires expert adjudication for diagnostic outputs. The performance is assessed through standardized engineering 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 device, not an AI/ML device.

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 AI/ML device.

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

The "ground truth" for this medical device would be defined by engineering standards, material properties, and regulatory performance requirements. For example:

• Mechanical Testing: Ground truth is defined by the requirements of ISO 14801, which sets pass/fail criteria for fatigue strength, and by the established strength and durability of the predicate device.
• Dimensional Compatibility: Ground truth is defined by the precise geometric specifications and tolerances of the MIS implant interface, ensuring a proper fit.
• Sterilization: Ground truth is defined by the validation criteria outlined in ISO 17665-1 and ISO 20857, ensuring a sterile product.
• Biocompatibility: Ground truth is established by the accepted biocompatibility of the identical materials used in the predicate device.

8. The sample size for the training set

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

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

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

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The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.

Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.

SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.

Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.

The SpiralTech Dental Implant System's acceptance criteria and studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical performance metrics against a defined standard. Therefore, the device performance is reported in terms of equivalence to established devices and compliance with relevant standards.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is derived from the "Non-Clinical Testing" and "Substantial Equivalence" sections, as well as the comparison tables. The acceptance criteria essentially reflect conformance to established standards and similarity to predicate devices.

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

The document describes non-clinical laboratory testing, not clinical studies involving patient data. Therefore, there isn't a "test set" in the sense of patient data.

• Sample Size for Testing: The specific sample sizes for fatigue testing, sterilization validation, SEM/EDS analysis, and biocompatibility testing are not explicitly stated in the provided text. They are implied to be sufficient for compliance with the referenced ISO and ASTM standards.
• Data Provenance: The studies are non-clinical, laboratory-based tests conducted following international standards (ISO, ASTM, USP). There is no country of origin for "data" in the context of patient information, nor is it retrospective or prospective. The data originates from the manufacturer's testing or contracted laboratories.

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

Not applicable. This device's approval is based on substantial equivalence through non-clinical testing and comparison to predicate devices, not on interpretation of patient data by a panel of human experts.

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

Not applicable, as there is no "test set" requiring expert 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 pertains to a dental implant system, which is a physical medical device, not an AI-powered diagnostic or decision support system.

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

Not applicable, as this is not an algorithm-based device.

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

The "ground truth" in this context is the established performance and safety requirements outlined in international standards (ISO, ASTM, USP) for dental implants and materials, as well as the documented characteristics of the predicate and reference devices. For example:

• Sterility: Demonstrated by meeting specified sterility assurance levels (SAL) according to ISO standards.
• Mechanical Strength: Demonstrated by meeting fatigue resistance criteria according to ISO 14801.
• Biocompatibility: Demonstrated by passing cytotoxicity tests (MEM elution) and material characterization (SEM, EDS) in accordance with relevant standards.
• Design & Materials: Comparison to the known, established designs and materials of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

Ask a specific question about this device

Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

• · Two stage: MPI, ULT, API and CPI models
• One stage: OPI model

The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.

MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.

The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall be used within 32 degrees of parallelism for a splinted restoration.

This submission covers the changes related to Ditron's dental implants and abutments. The addition of more products' variations is to offer dental surgeons additional implant options for patient treatment.

The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:

. Modification to the MPI Model -
The MPI features an expanding tapered implant body with double-thread selftapping design to gradually condense the bone.

The MPI model remained the same as cleared under K140727 except for the following modifications:

Length: 6mm (only with diameter of 4.2mm, 5.0mm and 6.0mm), Diameters: 3.3 (with lengths 8.0mm, 10mm, 11.5mm, 13mm and 16mm). The 'groove' between thread leads which is part of the MPI design in all dimension variations, was removed only at the OD 3.3mm design.

All MPI dimensions are detailed in section 7 of this 510(k) summary.

An additional implant type: ULT (Ultimate) -.
The ULT design is based on Ditron's cleared MPI model. The ULT features an expanding tapered implant body and a truncated-cone profile provides root-form morphology of the tooth root.

The implant has a self-tapping design and micro threads at the top of the implant. All ULT implant dimensions are detailed in section 7 of this 510(k) summary.

• An additional implant type: API (Advanced Precision Implants) -●
  The API design is based on Ditron's cleared MPI model. The API features an expanding tapered implant body with double-thread self-tapping implant body and apex design. The design is intended for subcrestal placement.

The implant beveled collar shifts the implant-abutment junction inward, in order to achieve platform-switching configuration. Only the 6mm API model includes a 'groove' while the others do not. All API implant dimensions are detailed in section 7 of this 510(k) summary.

● An additional Abutment type: Milled Abutment -
The Milled Abutment design is based on Ditron's cleared Straight Abutments. The Milled Abutment allows the dentist to produce customized abutments (no additional angular correction).

No CAD/CAM design and fabrication is allowed for the Milled Abutment models. Only hand-milling or casting may be used for abutment modification.

● An additional Abutment type: Liberator Abutment -
The Liberator Abutment is an overdenture retention abutment. Its design is based on Ditron's cleared Ball Attachments. The Liberator abutments are used for tissue and implant support of overdentures. Typically with two or more relatively parallel implants. Liberator overdenture retention abutments provide firm retention and stabilization to the overdenture.

The Liberator Abutment is available is several length dimensions of 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0mm.

● Straight Multi-Unit Abutment -
Additional two lengths were added to Ditron's cleared Straight Multi-Unit abutments. These length dimensions are: 4.0mm and 5.0mm. All dimensions' variations of the straight Multi-Unit abutments are detailed in section 7 of this 510(k) summary.

All above described implants and abutments are made of biocompatible 6A1-4V-ELI Titanium grade.

The provided document is a 510(k) summary for Ditron's Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study for a novel device. As such, it primarily details non-clinical performance data and uses comparison to established predicate devices as its "proof".

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported numerical performance values in the way one might expect for a diagnostic AI device. Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of specific tests, and "performance" is stated as meeting these requirements.

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

The document describes non-clinical performance data for dental implants and abutments. Therefore, the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical studies with human participants does not apply directly. The "samples" used were the physical dental implant and abutment devices and their components which underwent various engineering and laboratory tests.

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

This question is not applicable to the provided document. The "ground truth" for non-clinical engineering tests (like fatigue, sterilization, biocompatibility) is defined by established international standards (e.g., ISO, AAMI) and regulatory guidance documents (e.g., FDA Guidance). The experts involved would be engineers, material scientists, and microbiologists conducting the tests and interpreting results against these standards, rather than medical experts establishing a "ground truth" for patient data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of medical images or patient outcomes. The non-clinical tests described here are objective laboratory measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This question is not applicable. The document concerns dental implants and abutments, which are physical medical devices, not AI-powered diagnostic tools. Therefore, an MRMC study related to AI assistance for human readers does not apply.

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

This question is not applicable, as the device is a physical dental implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on international standards and regulatory guidance documents (e.g., ISO 14801 for fatigue, ISO 11137-2 for gamma sterilization, ISO 10993-1 for biocompatibility). These standards define acceptable limits and methodologies for demonstrating the safety and effectiveness of medical devices.

8. The Sample Size for the Training Set

This question is not applicable. The document describes pre-market notification (510(k)) for physical medical devices and their non-clinical testing, not an AI or machine learning model that requires a training set.

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

This question is not applicable, as there is no "training set" in the context of this 510(k) submission for dental implants and abutments.

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Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.

The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.

The submission includes:

• Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
• Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2

The provided text describes a 510(k) summary for the Biodenta Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in this context, as the submission relies on non-clinical testing and comparison to predicate devices, not on a clinical performance study with acceptance criteria.

However, I can extract the non-clinical testing data that was used to support the safety and effectiveness for equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The device should have sufficient mechanical strength for the intended clinical application and its surface area/bone to implant contact area should be sufficient compared to predicate devices.
• Reported Device Performance:
  • Dynamic Fatigue Testing: The subject device (Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm) was found to be "identical" to the predicate device (Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm, K123512) and thus has "sufficient mechanical strength for the intended clinical application."
  • Surface Area and Bone to Implant Contact Area: The Biodenta implant's surface area and bone to implant contact area were calculated to be "larger than the predicate device's surface area and bone to implant contact area." Therefore, the surface area and bone to implant contact area are "considered to be sufficient."

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical (dynamic fatigue, CT scan modeling).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on established engineering standards (e.g., ISO 14801:2007) and calculations.

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. This is not an AI/medical imaging 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): For the non-clinical tests:
* Dynamic fatigue testing: Conformance with ISO 14801:2007 standard.
* Surface area and bone to implant contact area: Calculated from 3D models generated from CT scans, compared against predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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