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Indications for Use for iPhysio® Profile Designer:

iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months.

Compatible Implant Systems:

Indications for Use for iPhysio® PEEK Temporary Abutment:

The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.

The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio® Profile Designers) be screwed into the implant using compatible anodized titanium screws during the 1st or the 2nd surgical intervention. The iPhysio® Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile Designers are available in multiples anatomical shapes and gingival heights, and are compatible with Nobel BioCare (NobelActive®, NobelReplace®, NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile Designers are straight (0°). Supporting screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with its corresponding height. The iPhysio® Profile Designer healing abutment screw is for placing the iPhysio® Profile Designer in the implant in the patient's mouth.

The iPhysio® Profile Designer remains in place throughout the bone and gingival healing process as well as during the taking of a digital or conventional impression, preserving the emergence profile during the impression. The abutment is only removed once to place and finally screw in the final abutment. Anatomical healing, implant impression, and placement of the temporary crown may all be done without removing the iPhysio® Profile Designer.

A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile Designer to which a non-load bearing temporary crown may be then placed for improved aesthetics during healing. To use the PEEK temporary abutment, the iPhysio® Profile Designer healing abutment screw is replaced with a compatible temporary abutment screw. The temporary crown is placed over the PEEK temporary abutment following modification of the abutment to the appropriate shape. The PEEK temporary abutment is connected onto the iPhysio® Profile Designer by a combination of friction and cement. All iPhysio® temporary abutments are manufactured from PEEK per ASTM F2026.

This document is part of a 510(k) summary for a medical device called "iPhysio® System." It details the comparison of the subject device to predicate devices to establish substantial equivalence, which is a key requirement for FDA clearance. The document focuses on non-clinical performance testing rather than studies involving human data or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document as it pertains to clinical performance and AI algorithm validation, which are not the primary focus of this 510(k) submission for this specific type of dental device.

However, I can extract the information related to acceptance criteria for the non-clinical performance testing and the reported results:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Note: The document explicitly states "Device met all predetermined acceptance criteria" or "Coating met all predetermined acceptance criteria" for several tests, which implies the acceptance criteria were established prior to testing and the device successfully met them. The specific numerical or qualitative thresholds for these criteria are not detailed in this summary for each test but are generally understood to align with relevant international standards (e.g., ISO 14801 for fatigue).

The following points cannot be answered from the provided text, as this is a 510(k) summary for a dental implant accessory, primarily relying on non-clinical (bench) testing and substantial equivalence arguments, rather than clinical trials or AI/image analysis studies.

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

• Not applicable / Not provided. The "tests" referred to are non-clinical bench tests (e.g., mechanical fatigue, material characterization), not clinical studies with human patient data. Sample sizes would refer to the number of physical device units tested for each non-clinical performance test. Data provenance in this context would be the lab where the bench tests were performed, which is not specified.

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

• Not applicable / Not provided. Ground truth, in the context of diagnostic AI or clinical studies, refers to disease labels or interpretations. For non-clinical bench testing, the "ground truth" is adherence to established engineering standards and material properties, validated by testing methodologies. No human experts are establishing "ground truth" in the clinical sense for these types of tests.

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

• Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations in clinical or imaging studies. This document describes bench testing, where outcomes are determined by physical measurements and adherence to engineering standards.

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

• No. This document explicitly states: "No clinical data was included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed as part of this submission. The device (dental healing abutment) does not involve AI.

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

• No. As noted above, this device is a physical dental implant component, not an AI algorithm.

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

• Not applicable / Not provided. For this submission, which relies on non-clinical testing, the "ground truth" is adherence to established engineering specifications, material standards (e.g., ISO 5832-3 for titanium alloy, ASTM F2026 for PEEK), and performance test methods (e.g., ISO 14801 for fatigue testing).

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. This device does not involve machine learning or a "training set."

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The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Prima Plus™ Conical Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The purpose of this submission is for the marketing clearance for Prima Plus Conical Implants, an endosseous root-form dental implant. The overall system is designed to be used with compatible components and are indicated for single-unit, multi-unit and overdenture restorations. No new prosthetic components were designed as part of this submission, with these implants designed to be compatible with previously cleared prosthetic components.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Prima Plus Conical Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Prima Plus Conical Includes previously marketed abutments with fifteen (1 5) designs: Healing Abutments, Straight (with and without TiPink), Angled (with and without TiPink), Straight Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder (with and without TiPink), Titanium Temporary Immediate (with and without TiPink), Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

lmplants are fabricated from a Titanium 4 Vanadium ELI titanium alloy which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications (UNS R56401). They have a Sandblasted, Large grit and Acid-etched (SLA) surface treatment.

All implants are one-time use devices All Subject device components are provided sterilized by gamma irradiation.

The provided text is a 510(k) summary for a medical device (Keystone Dental Inc.'s Prima Plus Conical Implant System). It describes the device, its intended use, and how it is substantially equivalent to previously marketed devices based on non-clinical performance testing.

However, the document does not contain information typically found in a study proving device performance against acceptance criteria for AI/ML-enabled devices, especially regarding clinical performance, human-in-the-loop studies, or the establishment of ground truth by experts.

The key phrases from your request which are not addressed in the provided text are:

• "Acceptance criteria and the study that proves the device meets the acceptance criteria."
• "Table of acceptance criteria and the reported device performance." (beyond static mechanical testing)
• "Sample sized used for the test set and the data provenance." (There's no clinical test set described)
• "Number of experts used to establish the ground truth for the test set and the qualifications of those experts."
• "Adjudication method for the test set."
• "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."
• "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
• "The type of ground truth used (expert consensus, pathology, outcomes data, etc)."
• "The sample size for the training set."
• "How the ground truth for the training set was established."

The document explicitly states: "No clinical data were included in this submission." This means there are no studies involving human patients or complex data analysis that would require features like AI models, human readers, or ground truth establishment by medical experts.

The "acceptance criteria" and "device performance" mentioned are limited to:

• Non-Clinical Performance Testing:
  • Fatigue testing per ISO 14801:2016 (Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants). This is a mechanical test.
  • Biological Evaluation per ISO 10993-1.
  • Sterilization information leverage (from a reference device, K220200).
  • MRI review (non-clinical, using scientific rationale and published literature).

The "study" that proves the device meets the acceptance criteria is primarily benchtop mechanical performance testing (ISO 14801) on "worst-case constructs" to demonstrate "suitability for intended use."

Therefore, I cannot provide a table or details on the ground truth, expert involvement, or clinical study design as requested for an AI/ML device, because this 510(k) filing for a dental implant does not involve such elements. It is a physical medical device, and its equivalency is based on material properties, design comparisons, and mechanical durability.

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

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

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

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

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

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

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

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

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

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

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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).

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Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure.

The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm.

The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.

All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3.

All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base 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 Multi-Unit DAS System are:

Minimum wall thickness - 0.25 mm

Minimum post height for single-unit restorations - 4.0 mm

Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants

Minimum gingival height - 0.5 mm (in the Ti-Base)

Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants

The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.

Here's a breakdown of the acceptance criteria and study information for the Multi-Unit DAS System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing (ISO 14801) & Sterilization Validation: The document does not explicitly state the sample sizes used for these tests. For ISO 14801, typically a statistically significant number of samples are tested to demonstrate fatigue resistance, but the exact number isn't provided. For sterilization, typically multiple runs with biological indicators are performed.
• Data Provenance: The document does not specify the country of origin for the data for specific tests, but the manufacturer, Talladium España, SL, is located in Lleida, Spain. The data is non-clinical.

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 (N/A) as the submission details non-clinical data (mechanical testing, material specifications, biocompatibility, sterilization, MR safety analysis) rather than studies involving human expert assessment of images or clinical outcomes.

4. Adjudication method for the test set

• N/A, as no expert adjudication for medical diagnoses/interpretations was conducted due to the non-clinical nature of the 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

• No MRMC comparative effectiveness study was done. This is a medical device for dental implants, not an AI software intended for diagnostic assistance. 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

• No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

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

• Mechanical Testing: Ground truth is defined by the ISO 14801 standard and the manufacturer's performance specifications.
• Biocompatibility: Ground truth is established by the cellular responses and lack of toxicity as defined by ISO 10993-5.
• Material Composition: Ground truth is defined by the ASTM F136 and ISO 5832-3 standards.
• Sterilization: Ground truth is defined by the Sterility Assurance Level (SAL) of 10^-5, validated against microbiological indicators as per ANSI/AAMI/ISO 17665.
• MR Safety: Ground truth is established by scientific rationale and published literature, determining the device's behavior in an MR environment.
• Compatibility with OEM Implants: Ground truth is established by the precise measurements and design characteristics obtained through reverse engineering analysis of the OEM implants and their components.

8. The sample size for the training set

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Genesis ACTIVE Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

The purpose of this submission is for the marketing clearance for the Genesis ACTIVE Implant System which comprises endosseous root-form dental implants, mating compatible abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Genesis ACTIVE Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Genesis ACTIVE Implant System includes eleven (11) compatible implant abutment designs: Healing Abutments, Straight, Angled Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder, Titanium Temporary Immediate, Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, ANGLEBase®, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device Multi-Unit abutments. The overdenture bar is a dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial or totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology by a Keystone Dental Group company and is used to facilitate the attachment of both fixed and removable prostheses.

Subject device implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium and ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700). They are anodized pink (AnaTite™) to provide a pink color and have the BioSpark™ surface treatment which results in a hydrophilic surface enriched with calcium and phosphorous ions.

All titanium Subject device abutments, accessories and screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R5640). Except for the Titanium Blank abutment design, all titanium Subject device abutments are anodized pink. Post surfaces of select abutments receive a media blasting treatment referred to as AnaTite™ or TiPink.

Subject device PEEK temporary abutments are fabricated from PEEK (PolyEther Ether Ketone) material.

All implants and prosthetic components are one-time use devices. All Subject device components are provided sterile and sterilized by gamma irradiation, except for Titanium Blank abutments and the KDG-Osteon Precision Milled Suprastructure which are provided non-sterile. Devices provided non-sterile or modified are sterilized by steam.

The provided text describes the 510(k) summary for the Keystone Dental Inc. "Genesis ACTIVE Implant System." It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The document explicitly states that no clinical data were included in this submission, which means there was no study proving the device meets acceptance criteria related to human performance or clinical outcomes.

Therefore, many of the requested information points, particularly those pertaining to acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert involvement in ground truth establishment for such studies, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document primarily discusses bench testing and material/design comparisons to establish equivalence, rather than clinical performance acceptance criteria or studies involving human readers or AI.

Here's what can be extracted from the provided text:

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

The document focuses on non-clinical performance testing (bench testing) and material/design specifications for establishing substantial equivalence, rather than specific performance metrics or acceptance criteria typically seen for AI/diagnostic devices in clinical settings. The acceptance is based on demonstrating the new device performs similarly and is as safe and effective as the predicate device through these non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it relies on non-clinical data (bench testing) rather than a clinical test set. The number of samples for each bench test is not specified in this summary document.
• Data Provenance: Not applicable for clinical data. For non-clinical (bench) testing, the tests were conducted according to recognized international standards (e.g., 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. No clinical test set or ground truth established by experts is described, as the submission focuses on non-clinical data.

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

• Not applicable. No test set requiring adjudication in a human reader study 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:

• No MRMC study was done. 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:

• Not applicable. This device is a physical dental implant system, not an AI algorithm. Its "performance" is mechanical and biological, not diagnostic or algorithmic.

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

• Not applicable for clinical ground truth. The "ground truth" for this submission are the standards and specifications (e.g., ISO 14801 for mechanical fatigue, ISO 10993 for biocompatibility) against which the device's physical and material properties are tested in a lab setting.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires training data.

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

• Not applicable. This is not an AI/machine learning device.

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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 Bases or Blanks 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 abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.

Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.

The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.

Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance (for non-AI device):

The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.

Regarding the AI-specific questions (2-9), the document provides no relevant information.

• 2. Sample sized used for the test set and the data provenance: Not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
• 4. Adjudication method for the test set: Not an AI device.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
• 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
• 8. The sample size for the training set: Not an AI device.
• 9. How the ground truth for the training set was established: Not an AI device.

Summary of Device and its "Study":

The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:

• Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
• Biocompatibility testing: Referenced from previous 510(k) submissions.
• Sterilization validation: Referenced from previous 510(k) submissions.
• MR environment compatibility analysis: Based on scientific rationale and published literature.
• Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.

This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.

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KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B.

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.

Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.

The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.

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