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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor.

The provided FDA 510(k) clearance letter and associated summary pertain to a Dental Implant Unit, which is a Class I medical device (a "Dental Handpiece and Accessories"). Class I devices are generally subject to general controls and are considered low-risk.

The documentation does not detail performance testing results for the device against specific, quantitative acceptance criteria for a clinical or software-based performance study as would be expected for a higher-risk Class II or Class III device, particularly those involving AI or diagnostic capabilities.

Instead, the submission focuses on demonstrating substantial equivalence ("SE") to a predicate device (K231845, also a dental implant unit) primarily through:

• Engineering and design comparisons: Showing similar indications for use, fundamental operating principles, and safety features.
• Compliance with recognized electrical safety and biocompatibility standards: This is the primary form of "performance testing" described.

Therefore, the following information will reflect what is discernible from the provided document, highlighting the absence of typical AI/diagnostic device study elements.

Acceptance Criteria and Device Performance (Based on Provided Document)

Study Information (Where applicable, based on provided text)

1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not specified in terms of patient data or typical "test set" for AI/diagnostic algorithms. The "test set" here refers to the device units themselves undergoing engineering and safety tests. The specific number of units tested is not provided, but implies typical engineering validation.
* Data Provenance: Not applicable in the context of patient data. The tests are laboratory/benchtop tests conducted to verify compliance with engineering standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as the "ground truth" for a dental implant unit (a mechanical drive) is established by engineering specifications, calibration, and standardized testing procedures, not by expert human interpretation of medical images or clinical data. Experts involved would be engineers or technicians with relevant expertise in electrical safety, mechanical testing, and quality assurance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable for this type of device and testing. Engineering tests rely on quantitative measurements against defined thresholds—there's no "adjudication" in the sense of resolving conflicting human interpretations.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC study was done. This device is a mechanical drive unit for dental surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "human reader" component or effect size to report.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm or AI system. It is a piece of hardware. While it has software ("Compliance with IEC 62304"), this software controls the mechanical functions of the unit (e.g., motor speed, irrigation), not performs diagnostic or interpretive tasks.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Engineering Specifications and International Standards: The "ground truth" for this device's performance is compliance with established international standards for electrical safety (IEC 60601-1, IEC 60601-1-2), software (IEC 62304), and biocompatibility (ISO 10993-1), as well as verification against its own design specifications (e.g., speed range, output power). There is no "pathology" or "outcomes data" ground truth in this context.

7. The sample size for the training set:
* Not applicable. This is a hardware device; it does not have a "training set" in the machine learning sense. The software it contains likely undergoes traditional software development and validation, but not machine learning training.

8. How the ground truth for the training set was established:
* Not applicable. See point 7.

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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 chewing function of patients with fully or partially edentulous:

• Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models .
• . One stage: OPI and TPI models

The 3.3mm and 3.0mm diameter implants (OPI and TPI. MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

The Two stages and One stage implants are indicated for temporary or long-term use. They are selftapping 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, OPI, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI. and API 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and with appropriate occlusal loading.

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

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

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

This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

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

. An additional implant types:

• MPC (Conical Connection Molecular Precision Implant) o
• O APC (Conical Connection Advanced Precision Implant)
• UPC (Conical Connection Ultimate Precision Implant) O
• CPC (Conical Connection Cylindrical Precision Implant) O

The Conical Connection (CC) implants include a conical connection platform (Morse taper). The intended use, materials, drilling protocol, thread designs and bone interface of the subject Conical Connection implants (MPC, UPC, APC and CPC) are identical to Ditron's cleared Internal Hex connection platform implants (MPI, ULT, API and CPI, respectively). The CC implants include color anodization for aesthetic purposes. The CC compatible Cover and Prosthetic Screws are color anodized as well.

The MPC/APC/CPC/UPC Implants are available in diameters of 3.5mm, 4.2mm, 5.0mm, and 6.0mm, with lengths of 8.0mm, 11.5mm, 12mm, 13mm, 14mm, and 16mm. Additionally, a 6.5mm length is offered for MPC/APC/CPC implants in 4.2mm, 5.0mm, and 6.0mm diameters, and a 7.0mm length is available for UPC implants in 4.2mm, 5.0mm, and 6.0mm diameters.

• An additional Abutment type: CC Healing Caps and SRA Healing Caps Abutments The CC Healing Caps are color-anodized for aesthetic purposes. They are used for the maintenance of the soft tissue during the osseointegration phase of Ditron CC implants to be rehabilitated using technique. They are available in diameters of 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5 and 4.5mm.
• An additional Abutment type: CC Cement Retained Abutments the CC Anatomic/Universal . straight/angulated abutments are Cement-Retained Abutments. They are intermediary prosthetic components to be installed onto Ditron's CC implants to support the final prosthesis. They are available as straight (0°) or angulated (15° and 25°) in diameters: 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5 mm.
• . An additional Abutment type: CC Single-Unit and Multi-Unit Abutments - The CC Screw-retained Single Unit Abutment and Multi Unit Abutments are intermediary prosthetic components to be installed onto CC Ditron's implants to support the final prosthesis. They are available as straight (0°) or angulated (17° and 30°) and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.0 mm. The Single Unit abutment height is up to 4.5mm only.
• An additional Abutment type: CC Temporary Titanium Abutments The CC Temporary Titanium Abutments are temporary intermediary prosthetic components to be installed onto the Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are available as straight (0°) in diameters: 3.5 and 4.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5mm.
• An additional Abutment type: CC Temporary PEEK Abutments The CC Temporary PEEK Abutments are temporary intermediary prosthetic components to be installed onto Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium. They are available in diameters of 4.5 and 6.0mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5mm.
• An additional Abutment type: CC Liberator Overdenture Abutment The CC Liberator Overdenture Abutment is similar in design to Ditron's cleared Liberator abutment, except for the addition of Titanium Nitride (TiN) coating on the subject device. It is available in the following gingival heights: 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0mm.
• An additional Abutment type: SRA Titanium Coping Abutments The SRA Titanium Coping . Abutment is suitable for use with the CC Screw-retained single Abutments. It connects to the abutment using one of the designated abutment screws. They are available in short (L4.85mm) and long (L11mm) versions.
• Modification to Cleared Titanium Abutments Addition of Laser Marking for identification as an option for all of the Ditron Dental cleared Titanium Abutments (K140728, K161497, K233231).
• Modification to Cleared Liberator and TPI Overdenture Abutments Addition of TiN coating to . Ditron's cleared Liberator abutment (K161497) and the cleared TPI Liberator Overdenture Abutment (K233231).

The provided text does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a 510(k) summary for Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. It does not mention any AI/ML components or related studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results (effect size).
6. Standalone performance study for an algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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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 and TPI models
  The 3.3 and 3.0mm diameter models for One stage OPI and TPI, 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 and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.

MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.

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

This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

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

. An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.

An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.

• . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
• An additional Abutment type: TPI Titanium Coping Abutments The TPI ● Titanium Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
• An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.

I am sorry, but the provided text focuses on the substantial equivalence of the "Ditron Dental Implants and Abutments" against predicate devices, primarily discussing changes and additions to the product line and the non-clinical testing performed to support their substantial equivalence for FDA clearance.

The document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria for aspects like:

1. A table of acceptance criteria and reported device performance: While there's a substantial equivalence table, it compares features and does not list specific acceptance criteria with reported device performance values for a study.
2. Sample size used for the test set and data provenance: The document mentions non-clinical tests but does not specify sample sizes for test sets (e.g., how many implants were used for fatigue testing, beyond stating "worst case configuration"). It also doesn't discuss data provenance in terms of country of origin or retrospective/prospective for a clinical study.
3. Number of experts used to establish ground truth and their qualifications: This type of information is relevant for studies involving human interpretation (e.g., image analysis devices), which is not the nature of this submission.
4. Adjudication method for the test set: Similarly, this is not applicable here as there isn't a "test set" requiring expert adjudication in the context of device performance in a clinical or reader study.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size: This type of study is for evaluating human performance with and without AI assistance, which is not applicable to dental implants and abutments.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
7. Type of ground truth used: For physical device testing, ground truth refers to validated measurements or established standards (e.g., ISO standards for fatigue). The document states tests were conducted "with accordance to ISO 14801" for fatigue, but doesn't elaborate further on a "ground truth" as might be understood in AI/clinical studies.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document primarily demonstrates that the new dental implant and abutment variations are substantially equivalent to previously cleared devices based on their identical or similar indications for use, technological characteristics (materials, design, sterilization), and non-clinical performance data (biocompatibility, sterilization validation, surface testing, fatigue testing, shelf life, MRI compatibility). The non-clinical tests performed served to ensure the safety and effectiveness of the new devices align with the predicate devices and established standards.

Therefore, I cannot extract the specific information you requested from the provided text for a "study that proves the device meets the acceptance criteria" in the format you outlined.

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C-Sailor Pro: This device is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-PUMA MASTER: The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth. This device is designed for use by a trained professional in the filed of general dentistry.

The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.

The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.

The provided text describes a 510(k) premarket notification for "Dental Implantation Systems, Dental Electrical Motors." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and comparison of technical specifications.

It's crucial to understand that this document does not describe a study involving an AI/ML algorithm or its performance criteria. The device in question is a dental electromechanical system, not a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the types of acceptance criteria and performance studies detailed in the prompt's request.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this submission.

However, I can extract information related to the closest concept of "acceptance criteria" and "study" as presented for this type of medical device submission.

Acceptance Criteria and Device Performance (as inferred from a 510(k) for an electromechanical device)

For this type of device, "acceptance criteria" are typically the standards compliance and functional equivalence to the predicate device. The "study" proving this involves non-clinical bench testing to demonstrate adherence to specific performance and safety standards, and a comparison of key technical specifications with the predicate device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases, as no clinical study was conducted. For non-clinical bench testing, the "sample size" would refer to the number of devices or components tested. This is typically determined by the testing standard requirements but is not explicitly stated here (e.g., "1 device tested for electrical safety," etc.).
• Data Provenance: The data comes from non-clinical bench testing performed by the manufacturer (Foshan COXO Medical Instrument Co., Ltd.) in China. The testing validates compliance with international standards (e.g., ANSI, IEC, ISO). The tests were conducted to verify that the device "met all design specifications" and was "Substantially Equivalent (SE) to the predicate device." It is retrospective in the sense that it's a report of completed tests, not prospective patient enrollment.

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

• Not Applicable. For this type of electromechanical device and 510(k) submission, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" in this context is the compliance with engineering and safety standards, verified through objective laboratory measurements and tests, and the functional specifications of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert readings for diagnostic accuracy studies. This submission relies on objective engineering and performance conformity with standards and the predicate device.

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

• No. No clinical study, and therefore no MRMC study, was conducted or submitted. The document explicitly states: "No clinical study is included in this submission."

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

• Not Applicable. This is an electromechanical dental device, not an algorithm. Therefore, "standalone algorithm performance" is not a concept relevant to this submission.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on:
  • Compliance with recognized international standards (e.g., ANSI, IEC, ISO) for medical device safety, electrical performance, EMC, biocompatibility, and specific dental equipment requirements.
  • Technical specifications and performance data of the legally marketed predicate device (NAKANISHI INC.'s Surgic Pro, Surgic Pro+ K173905).
  • Bench test results demonstrating the proposed device's adherence to its design specifications and functional equivalence.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm. This is an electromechanical device.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for one.

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The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Bone Level Tapered Design are an addition to the currently distributed Dental Implant System® OKTAGON Bone Level. The implants can be used for immediate or early implantation after loss or extraction of natural teeth. The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

This document is a 510(k) Pre-Market Notification for a medical device, specifically Dental Implants OKTAGON® Bone Level Tapered Design. It does not describe an AI medical device or the results of a study proving a device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence to predicate implant devices based on material composition, design, intended use, and mechanical performance (fatigue and breakage tests for physical implants, not AI performance).

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The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.

The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

Subject to this submission are the following implant variations:

BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm

TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm

TL RP Conical Ø4.1 mm, L 10 mm

The provided text is a 510(k) summary for a medical device (Dental Implants OKTAGON® Tissue Level and Bone Level). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of algorithm performance for an AI/ML powered device. The "performance tests" mentioned refer to fatigue tests against ISO 14801 for mechanical properties of dental implants, not AI/ML algorithm evaluation.

Therefore, I cannot extract the requested information as it does not exist within the provided document.

To be explicit, the following information is not present in the document:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (for an AI/ML algorithm).
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI/ML-powered medical device.

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Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implant System OKTAGON® Bone Level is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients.

The devices covered in this submission are angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

This document is a 510(k) Summary for the Endosseous Dental Implant Abutments OKTAGON® Bone Level. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study sizes, expert involvement, and ground truth types for AI/ML device studies is not applicable or not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

Since this is a submission for substantial equivalence based on predicate devices, explicit "acceptance criteria" for novel device performance are not listed in a quantifiable table as they would be for a new technology with specific performance claims. Instead, the "acceptance criteria" are implied by adherence to recognized standards and similarity to predicate devices.

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

• Sample Size for Test Set: Specific sample sizes for the mechanical and biocompatibility tests are not disclosed in this summary. The document states that "performance tests (breakage and fatigue tests) have been conducted," but does not provide the number of units tested.
• Data Provenance: Not specified. The manufacturer is Hager & Meisinger GmbH, located in Neuss, Germany. Testing was likely conducted in Germany or by certified labs.
• Retrospective or Prospective: Not specified, but typically, these types of laboratory tests for medical devices are conducted prospectively under controlled conditions.

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 to this type of device submission. The device is a physical dental implant abutment, and its performance is evaluated through standardized material and mechanical testing, not through expert review of data like an AI/ML diagnostic device.

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

• This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating clinical data or outputs of AI/ML systems where subjective interpretation might be involved. The testing here involves objective measurements against engineering 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 information is not applicable to this type of device submission. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation enhanced by AI. This device is a physical implant component.

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

• This information is not applicable to this type of device submission. This device does not involve an algorithm.

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

• The "ground truth" for this device's performance is based on established engineering and medical device standards. For example:
  • Mechanical Integrity: ISO 14801 (Fatigue Testing) and the FDA's Class II Special Controls Guidance document for dental implants.
  • Biocompatibility: ISO 10993-1, ISO 7405, ISO 10993-5.
  • Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST 79.
  • Materials: ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3.
  • The "ground truth" is adherence to these normative standards and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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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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Aria Bio's Dental Implant System is 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of indications for use and technological characteristics with predicate devices.
• Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.

The document states:

• "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
• "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."

This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.

Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.

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

The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.

The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.

Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.

Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.

The provided text is a 510(k) premarket notification for a Medical Device, specifically a "Dental Implant System." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study of device performance against pre-defined acceptance criteria in the context of clinical or AI-based performance metrics.

Therefore, the document does not contain the information requested for acceptance criteria and a study that proves the device meets those criteria, especially in relation to AI/algorithm performance. It is a regulatory submission demonstrating mechanical, material, and safety equivalence.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/Algorithm Component: There is no mention of any AI, machine learning, or algorithm being part of this "Dental Implant System." The device is a physical dental implant.
• Focus on Substantial Equivalence: The entire document is geared towards proving that the proposed device is "substantially equivalent" to a legally marketed predicate device (STRAUMANN DENTAL IMPLANT SYSTEM). This is a regulatory pathway, not a clinical trial to demonstrate new performance metrics against acceptance criteria for a novel AI.
• No Clinical Study: Section 7 explicitly states: "No clinical study is included in this submission." This means there is no data from human subjects or a clinical setting to evaluate performance.
• Non-Clinical Test Conclusion: Section 6 details non-clinical tests. These tests are primarily for material properties, sterility, biocompatibility, and mechanical durability (e.g., dynamic fatigue test). These are engineering and material science tests, not performance studies for a diagnostic or AI-driven medical device.

Therefore, it is impossible to complete the requested table or answer the specific questions about acceptance criteria, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this 510(k) submission for a physical dental implant.

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