Search Results

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, intended to be placed into dental implants to provide support for dental prosthetic restorations.

Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.

IPD Dental Implant Abutments includes the following categories of dental abutment designs:

• Titanium base (Interface) abutments (INC3D);
• Multi-Unit abutments (MUA);
• Overdenture Abutments (PSD);
• Temporary Abutments (PP);
• Healing Abutments (TC).

The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:

• Ti Screw (TT): Used during restoration fabrication.
• TiN Screw (TTN): Used in finished restorations, with TiN coating.
• TPA Screw (TPA): Used in finished angulated restorations, with TiN coating.

The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implant for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

The purpose of this submission is to expand IPD Dental Implant Abutments offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)

Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment and cemented to the zirconia superstructure.

The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory.

The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials:
Scanner: 3D Scanner D850.
Design Software: 3Shape Abutment Designer Software, K151455.
Zirconia Material: DD Bio Z, K142987.
Milling machine/Brand: Dental Concept System Model: DC1 Milling System.
Cement: Multilink® Automix, K123397.

Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows:
Minimum gingival height: 1.5 mm
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm (1)
Maximum gingival height: 6.0 mm
Maximum angulation of the final abutment 30° (2)

The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

The provided FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.

The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
• Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
• Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
  • Sterilization validation (ISO 17665-1)
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
  • Reverse engineering and dimensional analysis for compatibility
  • Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
  • Static and dynamic fatigue testing (ISO 14801)
  • Modified Surfaces Information
  • MRI safety review

Conclusion:

The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this text.

Ask a specific question about this device

S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. dental implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22 or 24mm may be tilted up to 30º. When used in the mandible or maxilla with implants with lengths of 18, 20, 22 or 24 mm at an angulation of 30º, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22 or 24 mm at angulations between 0º and less than 30º, the S.I.N. Dental Implant System implants are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes various endosseous implants with 16° Morse tapers interface connection. This submission adds to the S.I.N. Dental Implants System, the Versalis S implants line.

The Versalis S implant line has the Versalis S and Versalis S Plus implants, and both have a Morse taper connection with an internal 16° cone taper. The Versalis S implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment. The Versalis S Plus implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment plus hydroxyapatite surface coating.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), Grade 4. The material used to manufacture the dental implants in this submission (conforming to ASTM F67) is identical to the material used to manufacture the device implants cleared in primary predicate K170392 and in additional predicate K222231.

The provided text is a 510(k) clearance letter for a dental implant system. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The "Performance Data" section discusses non-clinical testing for the dental implant itself, such as sterilization validation, shelf-life testing, and biocompatibility, as well as fatigue testing and MRI environment compatibility. This is for a physical medical device, not a software device that relies on AI/ML.

Therefore, I cannot provide the requested information as it is not present in the given document.

To reiterate, the document is about a physical dental implant system and the performance data pertains to its physical properties, sterility, and biocompatibility, not to the performance of an AI/ML algorithm.

Ask a specific question about this device

DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate.

DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by Terrats Medical SL.

DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior region of the mouth.

DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

This submission includes dental implants that are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by the sponsor of this submission, Terrats Medical SL, and cleared under K212628, K222288, K233316, K240208, and K242340. No claims of compatibility between the subject device implants and abutments from any OEM other than DESS® Dental Smart Solutions will be made. This submission also includes DESSLoc abutments that are compatible with eight (8) dental implant lines from five (5) OEM manufacturers. Also included in this submission is one (1) Pre-Milled Blank abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH.

This submission includes one implant line, the Dental Implant NEO GM, a series of self-tapping, threaded, root-form dental implants to be placed at bone level. The subject device implants are provided in body diameters of 3.55 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. The subject device implant body diameters will be labeled as 3.5 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. Implant with body diameters ranging from 3.55 mm to 5.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, 11.4 mm, 12.9 mm, 15.9 mm, and 17.9 mm. Implants with body diameters 6.0 mm and 7.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, and 11.4 mm. The subject device implant lengths will be labeled as 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm, and 18 mm. All subject device implants, regardless of body diameter, have an internal Morse taper connection with a 16° included angle and 2.99 mm diameter opening at the top of the implant. This NEO GM connection is identical to the connection for abutments cleared previously in K242340.

All subject device implants are made of unalloyed titanium conforming ASTM F67 and ISO 5832-2. The entire endosseous surface, except for a small coronal bevel, features a grit blasted and double acid etched (SLA) surface, which is identical to the surface treatment for DESS® implants that were cleared in K212538.

This submission also includes DESSLoc Abutments designed for overdenture retention. The subject device DESSLoc Abutments are straight, non-engaging abutments that attach directly to the implant and are compatible with eight (8) dental implant lines from five (5) OEM manufacturers.

The subject device DESSLoc Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The subject device DESSLoc abutments have a zirconium nitride (ZrN) coating produced by a physical vapor deposition (PVD) process. The ZrN coating is applied to increase the surface hardness and reduce wear of the abutment surface. The ZrN coating for the subject device DESSLoc Abutments is identical to the ZrN coating applied to DESSLoc Abutments cleared in K242340, K240208, K222288, K191986, and K170588.

This submission also includes one (1) Pre-Milled Blank Abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH, including Implant Active Konus, Implant Classic Konus, and Implant Active Bio, cleared in cleared in K210499. Reverse engineering compatibility analysis of the Alpha Dent implants, abutments, and abutment screws and Terrats Medical SL abutments and abutment screws was provided in the prior Terrats Medical SL submission K243212.

The Pre-Milled Blank Abutment has a maximum (before milling) diameter of 10 mm and a solid cylindrical design and an engaging implant connection. The Pre-Milled Blank Abutment is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All patient-specific custom abutment fabrication for the Pre-Milled Blank Abutment is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum post height for single-unit restoration – 4.0 mm (post height measured above the gingival height of the final patient-matched design)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

The abutment screw for use with the Pre-Milled Blank Abutment and the Alpha Dent implants was cleared previously in K243212.

All subject device implants are provided sterile, and all subject device abutments are provided non-sterile. The Pre-Milled Blank Abutment is supplied with the previously-cleared non-sterile abutment screw for attachment to the corresponding compatible implant. All subject device components are provided in single-unit packages for single-patient, single-use only.

The provided FDA 510(k) Clearance Letter for DESS® Dental Implants (K251280) does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML device performance.

The document is a clearance letter for a dental implant system, which is a physical medical device, not an AI/ML-driven diagnostic or treatment planning software. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth) are not applicable to the content provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use and Indications for Use
• Technological Characteristics (design, materials, surface treatment, sterilization methods, dimensions)
• Performance Data (non-clinical data such as MRI review, sterilization validation, bacterial endotoxin testing, shelf life, biocompatibility, and mechanical testing according to ISO 14801).

Since the request specifically asks for AI/ML-related performance evaluation, and the provided document is not for an AI/ML device, I cannot fulfill the request as stated with the given input.

However, I can extract the non-clinical performance data and the comparison to predicate devices, which serve as the "study" and "acceptance criteria" for this type of physical medical device in the context of a 510(k) submission.

Non-Clinical Performance Data (Serving as "Study" for Substantial Equivalence):

1. Worst-Case MRI Review:

   • Method: Scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation Volume 49, No. 2 (March/April 2021): 783–795).
   • Scope: Evaluated all compatible implant bodies, abutments, and fixation screws and their material composition.
   • Parameters: Magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
   • Outcome: Rationale addressed parameters; device components found suitable for the MR environment.

2. Gamma Irradiation Sterilization Validation (for implants):

   • Method: Selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2.
   • Acceptance Criteria: Sterility Assurance Level (SAL) of $10^{-6}$.
   • Outcome: Analysis showed the subject device implants met the SAL and did not create a new worst case compared to predicate device K212538.

3. Bacterial Endotoxin Testing:

   • Method: Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72.
   • Acceptance Criteria: Limit of

Ask a specific question about this device

The Bioline Dental Implant System 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 patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 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 3.3 implants adjacent to one another.

The Bioline Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).

Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.

Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.

Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.

Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.

Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.

Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.

Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.

Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.

Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

The provided FDA 510(k) clearance letter and 510(k) Summary for the Bioline Dental Implant System describe the device and its equivalence to a predicate device. However, this documentation does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based performance, human-in-the-loop studies, ground truth establishment, or training set details.

The document primarily focuses on:

• Mechanical and Biocompatibility Testing: Dynamic fatigue testing (ISO 14801), cytotoxicity (ISO 10993), skin sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), sterilization validation (ISO 17665-1, ANSI/AAMI ST72:2019, USP , ISO 11137-2), package testing (ASTM D999-08, ASTM F3039-13, ASTM D5276-98(2009), ASTM F1929-12, ASTM F1980-07), and surface cleanliness.
• Substantial Equivalence: Comparing the Bioline system to the TOV Dental Implant System (K240837) based on indications for use, materials, design, and fatigue performance.
• MR Environment Conditions: A non-clinical review addressing magnetically induced displacement force and torque based on scientific rationale and published literature.

The questions you've asked are typical for the clinical validation of AI/ML-based medical devices, particularly those involving image analysis, diagnostics, or predictive capabilities where "performance" is measured by metrics like sensitivity, specificity, AUC, or reader agreement. The Bioline Dental Implant System, as described, is a physical medical device (dental implants and associated components), not a software or AI-driven diagnostic tool. Therefore, the concepts of a "test set," "ground truth," "expert readers," "MRMC study," and "training set" as they relate to AI/ML device validation are not applicable here.

Based on the provided document, I cannot fulfill your request for the tables and study details related to AI/ML device validation because the Bioline Dental Implant System is a physical medical device, and the clearance documentation focuses on its mechanical, material, and biological performance, not software performance.

If the intent was to ask about the physical performance of the device (e.g., fatigue strength), then the "acceptance criteria" would be compliance with standards like ISO 14801, and the "study that proves the device meets the acceptance criteria" would be the engineering tests described.

Here's how I would interpret the "acceptance criteria" and "study" if applied to the mechanical properties mentioned in the document:

Reinterpretation for Physical Device Performance (as per document)

Since the device is a physical dental implant system, the "performance" here refers to its mechanical integrity, biocompatibility, and sterilization effectiveness, not diagnostic or AI-driven capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions (2-9), these are entirely relevant for software/AI device validation and are not applicable to the physical dental implant system described in this 510(k) summary.

Summary of non-applicability for the requested AI/ML specific information:

2. Sample sizes for test set and data provenance: Not applicable to a physical device. Testing is mechanical/biological, not data-driven.
3. Number/qualifications of experts for ground truth: Not applicable. Ground truth for mechanical/biological testing is compliance with engineering standards and laboratory results.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as no human-AI interaction is involved.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm.
7. Type of ground truth used: For physical/biological testing, ground truth is defined by established engineering and biological standards (e.g., ISO, ASTM, USP).
8. Sample size for training set: Not applicable, as there is no training set for a physical device.
9. How ground truth for training set was established: Not applicable.

Ask a specific question about this device

The OsseOne Dental Implant System 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 patient's esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast.

OsseoMax Hex implants are tapered internal hex implants with evenly spaced large threads the length of the implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293.

Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Height above the platform is 7.58mm. Tapered Multipurpose Indexed Hex Abutments are to be used with internal hex implant designs cleared in K182293 and are not to be used with OsseoMax Hex.

OsseoCone implants are slightly tapered conical implants with evenly spaced sharp edge threads with microthreads in between them as well as microgrooves in the collar. OsseoCone comes in NP (3.5mm), and RP (4.3, 5.0, and 5.5mm) in lengths of 8.5, 10, 11.5, 13 and 15mm.

OsseoCone Plus implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. OsseoCone Plus comes in 3.5 (NP), 4.3 (RP), 5.0 (RP) and, 5.5 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16 mm (no 5.5 x 16mm).

OsseoMax Conical implants tapered conical implants with evenly spaced large threads the length of the implant. OsseoMax Conical comes in 4.6 and 5.4 RP diameter with lengths of 8, 10mm. OsseoMax Conical are only restored using Conical ball attachments or Conical Denture Lock.

Conical healing caps come in NP and RP (3.75 and 4.5 mm diameter) with cuff heights (also height above gingiva) of 2,3,4,5 mm. Total heights are 7.32, 8.32, 9.32, 20.32 mm and 7.47, 8.47, 9.47, 10.47mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm.

Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm.

Multipurpose Indexed Conical abutment comes in NP, RP, and RP Wide with platform diameters of 4.2, 4.2 and 4.7 mm Total heights are 11.69, 11.33 and 11.33 mm. Height above platform is 8.29, 7.93, 7.93mm. Multipurpose Indexed Conical abutments are to be used with the conical implants listed above but are not to be used with OsseoMax Conical Implants.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical Denture Lock attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. The Denture Lock attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm.

Conical NP and RP Angled Multi-Units are 4.8mm in diameter and come in 17° and 30° with cuff heights of 1, or 2 mm. Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm.

Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.

The provided FDA 510(k) clearance letter and summary for the "OsseOne Dental Implant System" does not contain information typically found in an AI/software as a medical device (SaMD) submission regarding acceptance criteria, study design, and performance metrics for an AI-powered diagnostic device.

This document describes a dental implant system, which is a physical device used in surgery, not a software or AI-driven diagnostic tool. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment for AI models, and training/test set sizes for AI are not applicable to this submission.

The "Testing Summary" section primarily discusses non-clinical physical performance and biocompatibility testing for the dental implant components.

Here's a breakdown of the relevant information found in the document, framed as closely as possible to your request for acceptance criteria and study details, acknowledging the nature of the device:

OsseOne Dental Implant System - Acceptance Criteria and Study Overview

This FDA 510(k) clearance pertains to a physical medical device, the OsseOne Dental Implant System, and not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and study details focus on the mechanical and biological aspects of the implant system rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a quantitative performance table typical for AI/diagnostic devices. Instead, it states that the device was tested to demonstrate safety and effectiveness for its intended use, primarily through non-clinical laboratory testing. The reported performance is summarized qualitatively.

2. Sample Size for Test Set and Data Provenance

For this physical device, there isn't a "test set" of patient data in the way an AI diagnostic device would have. The "samples" refer to the physical implant components tested in various laboratory conditions.

• Sample Size for Testing: Not explicitly stated as a number of implants/abutments for each test. The summary mentions "Dynamic fatigue testing according to ISO 14801 was conducted," "Biocompatibility testing...was done," "Steam sterilization validation was conducted," etc. ISO standards typically prescribe minimum sample sizes for such tests.
• Data Provenance: Not applicable in terms of retrospective/prospective patient data or country of origin for patients. The data provenance is from laboratory testing performed by the manufacturer or contract labs.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. "Ground truth" in the context of an FDA 510(k) for a physical device like a dental implant is established through adherence to recognized international standards (e.g., ISO, ASTM), material specifications, and validated engineering principles. There are no "experts establishing ground truth" on a test set of cases in the diagnostic sense. The experts are the engineers, material scientists, and microbiologists who perform and interpret the laboratory tests according to established protocols.

4. Adjudication Method for Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for physical device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is specific to evaluating the clinical effectiveness of AI-assisted diagnostic tools by comparing human reader performance with and without AI assistance. The OsseOne Dental Implant System is a physical implant, not a diagnostic aid.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. The system is a physical dental implant.

7. Type of Ground Truth Used

For this physical medical device, the "ground truth" is established through:

• Engineering Standards: Conformance to mechanical test standards (e.g., ISO 14801 for fatigue).
• Biocompatibility Standards: Conformance to biological safety standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation).
• Material Specifications: Verification that components meet specified material requirements (e.g., ASTM F136 Ti-6AL-4V ELI).
• Sterilization Validation: Demonstrated effectiveness of sterilization processes (e.g., ISO 17665-1, ISO 11137-2).

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device. The design and manufacturing processes are validated through engineering and biological testing, not through training on data.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The DAND Dental Implant System 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 patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 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 3.3 implants adjacent to one another.

The DAND Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).

Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.

Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.

Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.

Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.

Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.

Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.

Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.

Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.

Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

Based on the provided FDA 510(k) clearance letter for the DAND Dental Implant System, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a set of performance tests and comparisons to the predicate, rather than a clinical trial or an AI-based study with ground truth establishment as would be seen for a diagnostic AI device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DAND Dental Implant System are implicitly defined by its substantial equivalence to the TOV Dental Implant System (K240837). The device must meet the performance and safety characteristics of the predicate. The "study" here is a series of non-clinical tests demonstrating that DAND devices perform comparably to the predicate and are safe for their intended use.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Performance Testing & Benchmarking)

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of implants tested for fatigue). It generally states that "Dynamic fatigue testing according to ISO 14801 was conducted," "Cytotoxicity testing according to ISO 10993 was done," etc. For general device clearances like this, the sample sizes would be determined by the relevant ISO/ASTM standards for each test (e.g., a specific number of samples for fatigue testing, specific biological samples for biocompatibility).
• Data Provenance: The tests are explicitly described as "non-clinical" and "in vitro" (e.g., fatigue testing, biocompatibility, sterilization validation, packaging). There is no mention of human clinical data or geographical origin of such data.

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

• None applicable for this type of device and submission. This medical device is a Class II dental implant, cleared via 510(k) demonstrating substantial equivalence to an existing device. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM) for materials, design, biocompatibility, and mechanical performance, and by direct comparison to the predicate device’s characteristics. This is not an AI/diagnostic device where expert radiologists would establish ground truth for image interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. As this is not an AI/diagnostic study involving human readers or subjective interpretations, there is no expert adjudication process described. Test results are quantitative measurements against established 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:

• Not applicable. This submission is for a physical medical device (dental implant system), not an AI software or a diagnostic imaging device. Therefore, no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm. The performance evaluation is for the physical implant system's mechanical, material, and biological properties.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on engineering and performance standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility) and direct comparison to the established characteristics of the legally marketed predicate device. The device demonstrates equivalence in its physical and mechanical properties, as well as its intended use. There is no biological or clinical "ground truth" established from patient outcomes or pathology reports in this 510(k) summary.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in this context.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

Ask a specific question about this device

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.

Ask a specific question about this device

The Surcam 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 C Type 3.3mm diameter implants are indicated for use with only straight abutments.

Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.

The document discusses:

• Device Name: Surcam Dental Implant System
• Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
• Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
• Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
• MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
• Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.

Ask a specific question about this device

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.

All digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture

The MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.

The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.

Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.

Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.

Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.

Example for Healing Abutment:

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

• Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
• Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).

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

Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes is described.

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

Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Comparison to legally marketed predicate devices (their established safety and effectiveness).
• Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
• Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This pertains to AI algorithms.

Ask a specific question about this device

Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.

The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Superior Active and Active Bio Plus are a conical-shaped implant with a helical aggressive thread. It is used under one- or two-steps procedure in all bone types. The implant has a platform with an inner cone and a hexagon for positioning.

Superior Active and Active Bio Plus consist of the implant itself and a cover screw, which are packed in a titanium cuff filled with isotonic sodium chloride solution and a plastic flask.

The implant surface treatment method, known as Sandblasted, Large Grit, Acid-Etched (SLA), is a technique designed to roughen the surface of dental implants. The SLA process consists of two key steps: sandblasting with large grit particles to create a roughened texture, followed by acid etching to refine the surface.

The implant WET packaging process involves placing the implant in a protective titanium sleeve within a vial filled with NaCl 0.9% solution. The vial is sealed with a lid and placed inside a blister package. Both the plastic vial and the blister package serve as sterile barriers.

Additional abutments to the already submitted abutments in K210499: The abutments are anodized. Healing caps for implants with conical connection and Anatomical Titanium Shoulder Abutments and Healing caps for Multi-Unit System are also described.

This document pertains to a 510(k) submission for the Alpha Dent Implants Dental Implants System (K240435). It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data. It explicitly states: "No clinical studies were performed." Therefore, there is no information about a "study that proves the device meets acceptance criteria" in terms of clinical performance, sample sizes for test sets in clinical trials, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these typically relate to clinical efficacy/effectiveness or AI/software performance, neither of which are the primary focus of this specific 510(k) for a dental implant system.

The "acceptance criteria" discussed below are related to the non-clinical performance testing conducted to support the substantial equivalence claim.

Acceptance Criteria and Device Performance (Non-Clinical)

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact number of units tested for each non-clinical test (e.g., how many implants were tested for mechanical strength, how many samples for SEM/EDX, etc.). It states that "worst-case scenario" samples were tested for mechanical strength (e.g., "Implant Active Bio Plus (IABP)3.3x13 and Implant Superior Active(ISPA)3.5x13, along with Angulated Titanium Abutment 25 ° angulation").

The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Alpha Dent Implants GmbH, based in Germany) or outsourced laboratories, as part of the 510(k) submission process. This is retrospective in the sense that the testing was performed before the submission for premarket review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this 510(k) submission. "Ground truth" established by experts in this context would typically refer to clinical or diagnostic evaluation (e.g., radiologist reads for AI models), which are explicitly stated as "No clinical studies were performed." The "ground truth" for the non-clinical tests are objective measurements based on established engineering and materials science standards (e.g., forces measured, chemical analysis).

4. Adjudication Method for the Test Set:
Not applicable, as this refers to clinical evaluation or expert consensus, not non-clinical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states "No clinical studies were performed." Therefore, no MRMC study was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental implant system, not a software algorithm or AI.

7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing is based on objective measurements from laboratory tests against established industry standards (e.g., ISO, ASTM, USP). For example, mechanical strength is measured against the failure loads defined by ISO 14801, surface properties are observed and measured via SEM/EDX and contact angle, and biocompatibility is assessed by established protocols like ISO 10993.

8. The Sample Size for the Training Set:
Not applicable. This is 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 not an AI/ML device.

Ask a specific question about this device