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TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

The purpose of this submission is to obtain marketing clearance for TRI-matrix X-Force implants, a line extension of the TRI-matrix implant line previously cleared in K203660. TRI-matrix X-Force implants are tissue-level endosseous dental implants that are an adaptation of the TRI-matrix Tissue Level implants cleared in K203660, with the same prosthetic interface, but with modified external features. They are intended for use in the mandible or maxilla to restore chewing function. This submission includes only implants, and they are compatible with prosthetic components previously cleared in K203660 as part of the TRI-matrix implant line, including the TRI-matrix Crown Abutment.

TRI-matrix X-Force implants have a tapered body, double-lead threads and self-cutting flutes. A gritblasted and acid-etched surface, named the TRI SBA Surface, is applied to the endosseous portion of the implant. TRI-matrix X-Force implants incorporate a pink anodized, machined, 1.8 mm transgingival collar that is not treated with the TRI SBA Surface. Compared with TRI-matrix implants previously cleared in K203660, TRI-matrix X-Force implants have a modified thread design more suited to immediate placement and restoration, a more tapered apical portion (smaller apical diameter for a given coronal diameter), and more aggressive apical cutting flutes.

TRI-matrix X-Force 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix X-Force 3.7 mm and 4.1 mm diameter implants are available in two (2) platform diameters: 3.7 mm and 4.5 mm. TRI-matrix X-Force 4.7 mm diameter and 5.7 mm diameter implants have a platform diameter of 4.5 mm.

This document describes the marketing clearance for medical devices and does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics or clinical outcomes.

The document discusses the substantial equivalence of the TRI-matrix® X-Force Implants to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. This type of submission (510(k)) generally does not require proof of meeting specific performance acceptance criteria through the kind of studies you've outlined.

Specifically, the "PERFORMANCE DATA" section states:

• "Non-clinical data submitted to demonstrate substantial equivalence included: Referenced from the primary predicate device K203660: sterilization validation according to ISO 17665-1 and ISO 17665-2; . Provided in this submission: biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform. No clinical data were included in this submission."

Therefore, I cannot provide the requested information for the following reasons:

1. Table of acceptance criteria and reported device performance: This document does not specify general "acceptance criteria" for clinical performance or report clinical performance data. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and design comparisons.
2. Sample size used for the test set and data provenance: No clinical test set was used or described. The non-clinical testing involved "worst-case analysis and static and dynamic testing according to ISO 14801," but specific sample sizes for these engineering tests are not detailed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set or ground truth determination by experts is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical studies were included.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device (dental implant), not an AI algorithm.
7. Type of ground truth used: Not applicable, as no clinical data or ground truth determination is described.
8. Sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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

• Sample Size for Test Set: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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

• This is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering standards.

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

• This is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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 dental component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

• "Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

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J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

The document describes the J & P Click Attachments, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to a predicate device, the Zest High Retention Attachment System (K220252), and several reference predicates.

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

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided text is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here are based on comparative attributes for demonstrating substantial equivalence, and "reported device performance" refers to the characteristics of the J & P Click Attachments as compared to the predicate.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests and a comparison to predicate devices, rather than a single "study that proves the device meets acceptance criteria" in the sense of a clinical trial with predefined statistical endpoints. The primary method for demonstrating substantial equivalence is through comparative analysis with predicate devices and non-clinical testing.

Non-Clinical Testing Performed:

• Abutment Steam Sterilization: Done according to ISO 17665-1.
• Cytotoxicity Testing: Conducted according to ISO 10993-5.
• Reverse Engineering Tolerance Analyses: Conducted for all OEM implant systems in the indications for use. These analyses covered OEM implant body models, OEM abutment models, and OEM abutment screw models to ensure compatibility.
• MR Environment Condition (MRI Review): Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to evaluate magnetic compatibility, specifically for magnetically induced displacement force and torque, based on the entire system and material composition (Ti-6AL-4V ELI).

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

• The document does not describe a clinical "test set" with human or animal subjects in the traditional sense of a clinical study.
• The "test set" for the reverse engineering tolerance analyses would be the designs and physical specifications of the OEM implant systems. The number of samples for these analyses is not specified beyond "all OEM implant systems in the indications for use."
• Data provenance: Not explicitly stated, but the submission is for an FDA 510(k), implying compliance with US regulatory standards. Non-clinical tests like cytotoxicity (ISO 10993-5) and sterilization (ISO 17665-1) are international standards.

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

• This information is not provided in the document. The substantial equivalence determination is based on comparative attributes and non-clinical engineering and biological testing, not on expert-adjudicated ground truth from a clinical data set.

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

• This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication in the context of this 510(k) submission.

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 provided and is not applicable to this type of medical device (dental implant attachments). MRMC studies are typically used for imaging diagnostics involving human readers and AI. This device is a mechanical component, not an AI software.

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

• This information is not provided and is not applicable. This device is a physical dental component and does not involve an algorithm or AI.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1.
  • Cytotoxicity: Ground truth is defined by the requirements and endpoints of ISO 10993-5.
  • Reverse Engineering Tolerance Analyses: Ground truth is the design specifications and tolerances of the referenced OEM implant systems.
  • MRI Environment Review: Ground truth is established by scientific rationale and published literature referenced (e.g., relating to magnetic properties of materials).
• For substantial equivalence: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices, as documented in their 510(k) clearances and product specifications.

8. The sample size for the training set

• This information is not provided and is not applicable. The device is a physical medical device, not an AI or software device that undergoes a training phase.

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

• This information is not provided and is not applicable (see point 8).

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AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• · Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
• · Implant Direct Legacy2(K192221) 3.0
• · Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
• · Nobelactive Wide Platform (Wp) (K133731) WP 5.5
• · TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• · Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Study Details

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

   • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
   • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

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

   • Not applicable. This is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

   • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

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

   • Not applicable. This is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

   • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

   • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

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

   • Not applicable for the same reason as above.

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DESS Multi-Unit 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 add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.

This appears to be a 510(k) Summary for a medical device (dental abutments) rather than a study report with acceptance criteria for an AI/ML powered device. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance data (mechanical testing, biocompatibility, sterilization validation, MRI compatibility). It explicitly states: "No clinical data were included in this submission."

Therefore, I cannot extract acceptance criteria or information about a study that proves the device meets those criteria in the context of an AI/ML device, as the provided text doesn't describe such a device or study.

If the request was based on a misunderstanding of the document's content, please clarify. If you're looking for general information on what would be included in such a study for an AI/ML device, I can provide a theoretical outline.

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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.

Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.

The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

Not Found

The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.

Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.

To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.

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The LOCATOR® Overdenture Implant System is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

The LOCATOR Overdenture Implant (LODI) was originally cleared under K120198. This submission is to add additional implant sizes to the LODI family that for distinction purposes, will hereinafter be called the Standard Ridge LOCATOR Overdenture Implant (LODI) System. The added implant sizes are listed in Table 1.0 below:

Table 1.0 Subiect Device Sizes

Identical to K120198, the subject LODI Standard Ridge System is designed to retain overdentures of partial dentures in the mandible or maxilla. The System includes a threaded and tapered endosseous dental implant that is made from the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

The provided text describes a 510(k) premarket notification for the "LOCATOR® Overdenture Implant System," specifically to add additional implant sizes to the existing system. The document focuses on demonstrating substantial equivalence to a predicate device (K120198) and a reference device (K192221) rather than presenting a study to prove acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

Therefore, many of the requested fields are not directly applicable to this type of submission which primarily relies on engineering and material testing to confirm equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on engineering design principles, material science, and performance testing for mechanical, biological (biocompatibility, sterilization, cleanability, endotoxin), and shelf-life attributes, rather than a "test set" of clinical data. The acceptance criteria for manufacturing processes (e.g., sterilization, cleanability) are evaluated on representative devices or materials.
• Data Provenance: Not applicable in the context of clinical test data. The data provenance relates to internal manufacturing and testing records (e.g., ISO and USP standards for testing methods).

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

• Not applicable. This is not a clinical study involving expert interpretation for ground truth.

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

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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

• Not applicable. This is a medical device (dental implant) and not an AI-driven diagnostic tool.

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

• Not applicable. This is a medical device (dental implant) and not an AI-driven algorithm.

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

• Not applicable in the sense of clinical ground truth for a diagnostic device. The "ground truth" for this submission are the established engineering standards (e.g., ASTM F136 for material, ISO 11137-2 for sterilization, ISO 10993-1 for biocompatibility, USP for endotoxin) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device.

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

• Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study/Approach:

The submission K203701 for the LOCATOR® Overdenture Implant System demonstrates substantial equivalence by showing that the new implant sizes are

• Made from the identical material (6Al-4V ELI Titanium conforming to ASTM F136).
• Have the same surface roughening process (Resorbable Blast Media, RBM).
• Maintain the same manufacturing processes and equipment.
• The Indications for Use remain within the scope of the predicate device (K120198).
• Performance testing (mechanical properties, corrosion, biocompatibility, sterilization, cleanability, fatigue, shelf-life, surface treatment, endotoxin) confirmed that adding new implant sizes either did not alter the existing safety and performance profile of the predicate device or, in cases of slight design changes (e.g., dual lead thread, blunted tip), did not create a new worst-case scenario. For instance, the larger cross-sectional area of the new implants was deemed to not introduce a new worst case for fatigue strength, and previous fatigue testing from K120198 was considered applicable. Similarly, the "new worst-case implant" (Standard Ridge LODI 4.9mm) was specifically tested for cleanability to meet acceptance criteria.

Note: "No clinical studies are provided as part of this 510(k) submission" is explicitly stated, reinforcing that this clearance relies on non-clinical (bench and material) testing and established equivalency principles.

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