Search Results

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.

All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.

MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.

The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).

The design parameters for L-LINK patient-specific abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
• Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
• Maximum angle – 20°

All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.

MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.

The design parameters for PREFIT patient-specific abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
• Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
• Maximum angle – 30°

The provided document is a 510(k) clearance letter for a dental device, specifically dental implant abutments. It details the device's administrative information, predicate devices, indications for use, subject device description, and performance data used to demonstrate substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm. The performance data section refers to non-clinical analyses, such as MR compatibility, sterilization validation, biocompatibility, mechanical properties testing, reverse engineering, and static/dynamic compression-bending testing conforming to ISO 14801. These are standard tests for mechanical dental devices, not AI/ML performance evaluation.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the given text. The device described, "Mist IC," is a physical dental implant abutment, not an artificial intelligence/machine learning (AI/ML) powered medical device.

To directly answer your prompt based on the provided text, the following information is missing or not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical and material performance testing for a physical device, not AI/ML performance metrics like sensitivity, specificity, or AUC against defined acceptance criteria for an AI algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set. The document refers to testing of physical components (OEM implants, abutments, screws, subject device constructs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/ML ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the physical properties and mechanical integrity verified by engineering standards (e.g., ISO 14801).
8. The sample size for the training set: Not applicable. No AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable. No AI/ML training set mentioned.

The document focuses solely on the substantial equivalence of the "Mist IC" dental implant abutments to legally marketed predicate devices based on design, materials, manufacturing, and conventional mechanical/material performance testing.

Ask a specific question about this device

Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant Systems:

All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.

For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.

All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:

(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure

The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.

Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.

Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":

Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.

Regarding the specific questions about an AI/ML context:

1. A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
7. The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.

Ask a specific question about this device

PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject devices are Medentika CAD/CAM Abutments, which primarily expand the options for fabricating patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow". This workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machines, and associated tooling and accessories. The devices include Titanium Base abutments, Titanium base ASC Flex abutments, and PreFace and TI-Form (blanks) abutments.

The abutments are made of titanium alloy (Ti-6Al-4V ELI). Titanium base abutments also include a zirconia superstructure. The specified zirconia materials for milling superstructures are Ivoclar Vivadent IPS e.max ZirCAD Prime, Ivoclar Vivadent IPS e.max ZirCAD Prime Esthetic, Amann Girrbach Zolid Bion, Amann Girrbach Zolid Gen-X, and Institut Straumann AG n!ce Zirkonia HT. The specified cement for bonding superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG.

Key design parameters for CAD/CAM zirconia superstructures (on Titanium base and Titanium base ASC Flex) include: minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm for single unit restorations, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of the final abutment of 30°.

PreFace and TI-Forms abutments (blanks) are used by dental laboratories to fabricate customized abutments from titanium alloy. Their design parameters include: minimum wall thickness of 0.4 mm, minimum cementable post height of 4.0 mm, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of 30°.

Prosthetic-level components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are provided for use with previously cleared Medentika multi-unit abutments and MedentiBASE abutments.

All abutments are provided non-sterile with appropriate abutment screws. The screws attach the abutment to the implant or the prosthesis to the abutment.

The provided 510(k) clearance letter and summary describe a medical device, Medentika CAD/CAM Abutments, and its substantial equivalence to predicate devices based on non-clinical performance data. The document does not contain information about acceptance criteria or performance data for an AI/ML-based device, nor does it detail a clinical study involving human readers or expert consensus for ground truth.

Therefore, for the information requested in your prompt, I can only extract what is presented in the document, which pertains to the non-AI aspects of device acceptance and testing. Many of the points specifically refer to AI/MRMC studies, which are not applicable to this document.

Here's an analysis based on the provided text:

Device Description and Purpose:
The device is "Medentika CAD/CAM Abutments," which are dental implant abutments. The primary purpose of this submission is to expand the fabrication options for patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow" that integrates CAD/CAM software and milling machines. It also adds new sizes and OEM compatibilities.

Study Type:
This is a pre-market notification (510(k)) submission seeking substantial equivalence to existing legally marketed devices. It relies heavily on non-clinical performance data to demonstrate that the new manufacturing workflow and expanded compatibilities do not raise new questions of safety or effectiveness.

Analysis of Requested Information (based on the provided document):

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

The document outlines various performance tests conducted to demonstrate substantial equivalence, but it does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance." Instead, it states that the tests demonstrate sufficient strength or ensure accuracy and reliability.

Here's a summary of the performance tests and their implied purpose:

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

• Sample Size for Test Set: The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., how many abutments were mechanically tested, how many software validation tests were run). It simply states that "testing was conducted" or "validation was performed."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of pre-market non-clinical testing for medical devices, these are typically prospective laboratory tests conducted by the manufacturer or accredited testing facilities. The manufacturer is Medentika® GmbH (Huegelsheim, Germany), suggesting the testing likely occurred in Germany or at internationally recognized labs.

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

This information is not applicable to the provided document. The ground truth for this device is established through engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, not through human expert consensus on diagnostic images.

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

This information is not applicable to the provided document, as it describes non-clinical engineering and manufacturing validation, not a multi-reader clinical study for AI.

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 the provided document. This device is a physical dental abutment and its associated CAD/CAM workflow, not an AI-based diagnostic tool that would require human reader studies. The document explicitly states: "No clinical data were included in this submission."

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

This information is not applicable to the provided document. While the device utilizes CAD/CAM software and milling machines, it is a physical product manufactured through a workflow, not a standalone AI algorithm whose performance needs to be assessed in isolation. The software functions as a design and manufacturing aid, not a diagnostic or decision-making algorithm.

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

The "ground truth" in this context refers to established engineering and material standards:

• Standards Compliance: Adherence to ISO standards (e.g., ISO 14801 for mechanical strength, ISO 10993 for biocompatibility, ISO 17665 for sterilization).
• Dimensional Accuracy: Verification against established design parameters and compatibility specifications for dental implants (e.g., OEM implant body and abutment dimensions).
• Material Specifications: Conformance to ASTM F136 for titanium alloy and specifications for zirconia and cement.
• Software Design Parameters: The "ground truth" for the CAD software validation is the pre-defined maximum and minimum design parameters that the software must enforce.

8. The sample size for the training set:

This information is not applicable to the provided document. The "device" in question is a physical dental abutment and its manufacturing workflow, not an AI/ML model that requires a training set. The CAD/CAM software itself is validated, not "trained" on a dataset in the AI sense.

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

This information is not applicable to the provided document for the same reasons as point 8.

Ask a specific question about this device

The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.

The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.

The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.

Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:

Description of the Device

The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.

• Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.

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

This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.

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

A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.

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

The "ground truth" for the non-clinical performance evaluations relies on:

• Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
• Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
• Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.

8. The Sample Size for the Training Set

This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.

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

This information is not applicable for the same reason as above (not a machine learning model).

Ask a specific question about this device

Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.

Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).

Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.

Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.

Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.

Abutment Screws: Connects and fixes the abutment and implant body.

This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.

The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.

However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.

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

Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:

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

The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.

• Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.

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 type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.

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

This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.

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 is not applicable. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a machine learning model.

Ask a specific question about this device

The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.

The provided FDA 510(k) summary for the "LOCATOR Angled Abutment" does not describe a study involving an AI/Machine Learning (ML) device or any specific performance metrics for such a device like sensitivity, specificity, or AUC, or a comparative effectiveness study involving human readers.

This submission is for a medical device (dental implant abutment) and focuses on demonstrating substantial equivalence to a predicate device through physical and mechanical testing, material compatibility, and intended use.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the information required (acceptance criteria for an AI/ML device, details of an AI/ML study, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present.

In summary, the document does not contain the information needed to answer your questions regarding acceptance criteria and performance of an AI/ML device.

Ask a specific question about this device

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 Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.

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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

Ask a specific question about this device

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.

They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:

BLC implants:

• L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
  TLC implants:
• L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
• L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
• L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height)

and presented with WT (Wide TorcFit) prosthetic platform.

The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.

This is a 510(k) summary for a medical device that is cleared based on substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria in the same way an AI/ML device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

Device Type: This document is for an Endosseous Dental Implant, not a software or AI/ML device. The acceptance criteria and performance study described are focused on hardware aspects (sterilization, biocompatibility, mechanical performance) rather than algorithmic performance.

Applicable Information from the document:

Since this is a dental implant and not an AI/ML device, concepts like "test set," "training set," "experts to establish ground truth," and "MRMC study" are not relevant in the context of the device's technical clearance. The document focuses on showing the new implants are substantially equivalent to previously cleared implants.

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

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

• Sterilization Validation: The document mentions "worst-case test articles representative of the BLC and TLC implant systems" for X-ray sterilization validation. It does not provide a specific sample size. The methods (VDmax25) are standard for radiation sterilization validation.
• Biocompatibility Testing: The document refers to "assessed devices" and "conducted tests" (e.g., at T0, T3, T5 for X-ray sterilization impact). Specific sample sizes are not provided, but the testing followed ISO 10993-1.
• Mechanical Testing (Insertion Torque): "Insertion tests were performed for the subject implants." No specific sample size is given.
• Data Provenance: The studies appear to be internal validation studies conducted by the manufacturer, not patient data from specific countries. They are prospective in the sense of being planned validation tests for the device changes.

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

• This concept is not applicable as the studies described are bench and lab validations against industry standards (ISO, FDA guidance), not expert-interpreted clinical data. The "ground truth" is defined by the technical specifications and performance against those standards.

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

• Not applicable for these types of technical validation studies. Adjudication methods are typically used in clinical trials or studies involving human interpretation of medical images or data.

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

• Not applicable. This is not an AI/ML device, nor does it involve human readers interpreting data assisted by the device.

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

• Not applicable. This is a physical medical device (dental implant).

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

• The "ground truth" in this context is defined by established international standards (e.g., ISO 11137 for sterilization, ISO 10993-1 for biocompatibility, FDA guidance for MR Conditional status) and the engineering specifications/performance achieved by the device. It's essentially performance against predefined engineering and safety standards.

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

Conclusion based on the document:

The device is an extension of existing dental implants, and its clearance relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the need to conform to generally recognized standards and to demonstrate that the new sizes and sterilization method do not introduce new safety or effectiveness concerns compared to the predicates. The studies performed are primarily bench testing and validation studies to confirm the physical and biological characteristics of the implants meet these standards.

Ask a specific question about this device

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.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.

Ask a specific question about this device

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.

The BLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
• L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
• L 6 mm to L 16 mm for diameter Ø 5.5 mm
• L 6 mm to 14 mm for diameter Ø 6.5 mm.

The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.

The TLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
• L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
• L 6 mm to L 12 mm for diameter Ø 5.5 mm
• L 6 mm to 10 mm for diameter Ø 6.5 mm.

The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. The document is an FDA 510(k) summary for Straumann® BLC and TLC Implants, which are endosseous dental implants, not an AI/ML device.

Therefore, I cannot provide the requested information.

Ask a specific question about this device