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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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The TRI-matrix® Implant Line is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® Implant Line allows for one and two stage surgical procedures. When a onestage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® Implants are intended for delayed loading only.

The TRI-matrix® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the TRI-matrix® Crown Abutment to the endosseous implant.

The purpose of this submission is to obtain marketing clearance for the TRI-matrix® Implant Line, a series of bone-level and tissue-level root-form endosseous dental implants, corresponding healing components, abutments, and abutment screws intended for use in the mandible or maxilla to restore chewing function. The permanent abutment design in the product line is a patient-specific abutment manufactured using CAD-CAM technology, which also may be manufactured as a direct final direct restoration. The manufacture of these abutments and restorations will be at TRI Dental Implant Int. AG facilities after receipt of the digital design file of the patient-matched components from the dentist or dental lab.

TRI-matrix Bone-Level implants are intended for bone-level placement and are available in three (3) body diameters (3.75, 4.1 and 4.7 mm). The 3.75 mm body diameter is provided in five (5) lengths (8. 10. 11.5, 13, and 16 mm) and the 4.1 and 4.7 mm body diameters are provided in six (6) lengths (6.5, 8, 10, 11.5, 13, and 16 mm). TRI-matrix Bone-Level 3.75 and 4.1 mm diameter implants have a platform diameter of 3.7 mm and TRI-matrix Bone-Level 4.7 mm diameter implants have a platform diameter of 4.5 mm.

TRI-matrix Tissue-Level implants are intended for tissue-level placement and are available in four (4) body diameters (3.3. 3.75. 4.1 and 4.7 mm). The 3.3 mm body diameter is provided in three lengths (10, 11.5, and 13 mm). The 3.75 mm body diameter is provided in four lengths (8, 10, 11.5, and 13 mm). The 4.1 and 4.7 mm body diameters are provided in five lengths (6.5, 8, 10, 11.5, and 13 mm). TRI-matrix Tissue-Level 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix Tissue-Level 3.75 and 4.1 mm diameter implants are available in two platform diameters: 3.7 and 4.5 mm. TRI-matrix Tissue-Level 4.7 mm diameter implants have a platform diameter of 4.5 mm.

Healing components and abutment components for the TRI-matrix Implant Line include Surgical Cover Screw, Healing Collar, Provisional Abutment (Temporary Abutment), and patient-specific Crown Abutment. Abutment screws for the TRI-matrix Implant Line include Replacement Retaining Screw, which are designed to attach the subject device Provisional Abutment, Crown Abutment, or direct final restoration to the implant.

Crown Abutments are patient-specific abutments, fabricated using CAD/CAM technology at a TRI Dental Implants Int. AG manufacturing site. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained prosthesis. The Crown Abutment is different from a normal Titanium Blank abutment because the implant-abutment connection is manufactured at the same time as the patient-specific portion (i.e., there is no stock component). Crown Abutments are fabricated in two platform diameters of 3.7 and 4.5 mm and are attached to the compatible implant with a separate screw. Crown Abutments are available as Zirconia Crown Abutments or Titanium Crown Abutments. The material of Zirconia Crown Abutments will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The material of Titanium Crown Abutments will conform to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

A Crown Abutment also may function as a substructure in zirconia that serves as the single-unit or multiunit final restoration, using the full digital workflow with third-party planning software. For each material there is an associated CAD software file within the full digital workflow that defines the specific screw, interface, and torque used for the direct restoration.

The design parameters for patient-specific Crown Abutments, direct final restorations or direct provisional restorations are:

Abutment diameter range - 4 to 13 mm Maximum abutment height - 15 mm Minimum abutment height above the trans-mucosal collar (post height) for single-unit restorations - 4 mm Maximum gingival height from the implant/abutment interface: 5 mm for a restoration on a bone-level implant, 3 mm for a restoration on a tissue-level implant Minimum gingival height - 0.5 mm Maximum angulation correction - 15°

Zirconia Crown Abutments and Titanium Crown Abutments willed from zirconia blanks and titanium alloy blanks respectively, each conforming to the standards cited above. Design parameters shown above are specified in labeling and are included in the CAD library provided by TRI Dental Implants Int. AG.

The subject device implants, healing components and abutments (except for the Zirconia Crown Abutment), and abutment screws are made of titanium alloy conforming to ASTM F136.

The grit-blasting and acid-etching procedure is applied to the endosseous surface of all subject device dental implants and is identical to the process used to manufacture the dental implants cleared in K151916.

Selected implants and abutments manufactured from titanium alloy (ASTM F136) are anodized using standard electrolytic passivation processing to increase the thickness of the natural oxide layer on the surface and to impart a distinctive surface color; no dyes or coloring additives are used. This anodization process is identical to the anodization process used on abutments cleared in K151916. Titanium allov subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for devices previously cleared in K151916.

The document provided is a 510(k) summary for a medical device (TRI-matrix® Implant Line) seeking substantial equivalence to existing predicate devices. It focuses on the equivalence of the new device's design, materials, and intended use, primarily through non-clinical performance data. It does not describe an acceptance criteria study for a diagnostic AI/ML device.

Therefore, I cannot provide the requested information about acceptance criteria, efficacy studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/ML device. The document is for an endosseous dental implant, which is a physical device, and the "performance data" refers to mechanical, sterilization, and biocompatibility testing, not diagnostic accuracy.

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The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows 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 Dental Implant System 6.5 mm implants are intended for delayed loading only.

The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.

TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw- retained Abutment, Ball Abutment, and applicable abutment fixation screws.

The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws.

Here's a breakdown of the acceptance criteria and study information for the TRI® Dental Implant System, based on the provided text:

Preamble: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It typically describes non-clinical testing performed to show that the new device performs as safely and effectively as predicates, rather than extensive clinical efficacy studies with specific acceptance criteria in the clinical sense. Therefore, the "acceptance criteria" here refer more to the performance standards the device was tested against to prove equivalence, particularly in mechanical and biological compatibility. Clinical outcomes data (e.g., success rates in patients) often come from post-market surveillance or larger clinical trials not detailed in a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information:

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

   • The document does not explicitly state sample sizes for each non-clinical test (e.g., number of implants tested for fatigue). It only mentions that "Non-clinical testing data submitted, referenced, or relied upon" was provided.
   • Data provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's non-clinical lab testing against ISO standards, it would be prospective data generated for the submission.

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

   • Not applicable in this context. The "ground truth" for non-clinical performance data is defined by the technical specifications outlined in the ISO standards themselves (e.g., a specific fatigue load, or a cytotoxicity response in a cell culture). There isn't typically expert consensus to establish a "ground truth" for these types of engineering and biocompatibility tests.

4. Adjudication method for the test set:

   • Not applicable as this is non-clinical testing against ISO standards, not a study involving human readers or clinical adjudication.

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 document describes a dental implant system, not an AI-powered diagnostic device. No MRMC studies were conducted or reported.

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

   • Not applicable. This is a physical medical device (dental implant), not an algorithm.

7. The type of ground truth used:

   • For non-clinical testing: The "ground truth" is defined by the physical, chemical, and biological properties and performance metrics specified in the referenced ISO standards (e.g., mechanical strength requirements, cytotoxicity levels, sterility assurance levels). It's based on established scientific and engineering criteria.
   • For demonstrating equivalence: The ultimate "ground truth" for the 510(k) process is the safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set."

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

   • Not applicable, for the same reason as above.

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