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The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.

The Piezolmplant System consists of endosseous dental implants, surgical instruments and restorative components in a variety of dimensions to accommodate differing patient anatomy. The Rex TL endosseous implants are blade-form having a wedge shape and an endosseous resorbable blast media (RBM) surface. The REX TL 1.8 implant series has a buccolingual thickness of 1.8mm, a mesiodistal width of 5mm and an external hex connection platform. The REX TL 2.9 implant series has a buccolingual thickness of 2.9mm, a mesiodistal width of 5mm and an internal hex connection platform. The endosseous lengths for both implant series range from 9mm to 15mm and all lengths are offered for both series. Cover screws provide protection to the threads of the abutment connection during endosseous and gingival healing. Retention screws fasten the implant and abutment. A variety of Piezolmplant abutments are offered including Healing, Angled, Straight, Provisional Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to the abutments.

The provided text describes a 510(k) premarket notification for the Rex Implants, Inc. PiezoImplant System. This submission is for a dental implant system, and most of the document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical testing. The document also includes information about two clinical studies to support the special controls for blade-form endosseous dental implants.

It's important to note that this is NOT a study that "proves the device meets the acceptance criteria" in the typical sense of a clinical trial proving efficacy against pre-defined endpoints for a drug or novel device. Instead, it's a demonstration of substantial equivalence, where the device needs to show similar performance to legally marketed predicate devices, especially regarding safety and effectiveness, to gain market clearance. The acceptance criteria in this context are for substantial equivalence, often demonstrated through comparison to predicates and meeting special controls, which include mechanical testing and, in this case, clinical experience.

Here's a breakdown of the requested information based on the provided text, focusing on the clinical data section which is most relevant to "device performance" in a functional sense:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for the clinical performance in a structured table. Instead, it refers to fulfilling "special controls" and showing "equivalent performance" to the predicate. The "acceptance criteria" presented below are derived from industry standards and the performance metrics mentioned in the clinical studies.

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

• Study 1 (Case Series Review):

  • Initial Patient Sample: 56 patients (20 male, 35 female, ages 24 to 81, mean age 59.7 years).
  • Implants: 111 implants.
  • Patients meeting ≥12 months post-loading criterion: 37 patients (79 implants).
  • Patients with follow-up radiographs: 23 patients (43 implants).
  • Patients with time of implantation radiographs: 20 patients (37 implants) for bone level measurements.
  • Data Provenance: The text states "Clinical data from five OUS clinical centers was acquired," indicating data from Outside the U.S. and is retrospective.

• Study 2 (Prospective Cohort Study):

  • Initial Patient Sample: 44 patients (15 male, 29 female, mean age 59.5 ± 12 years, age range 35 to 88 years).
  • Implants: 59 REX TL implants implanted. One implant was lost, leaving 58 implants (from 43 patients) for analysis.
  • Data Provenance: "44 patients... were prospectively enrolled in an International Piezosurgery Academy Study at six OUS clinical centers," indicating data from Outside the U.S. and is prospective.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for either clinical study.

• For Study 1, it mentions "Bone level measurements were made on each radiographic image using ImageJ." It doesn't state who performed these measurements or if multiple experts were involved in defining the baseline or changes.
• For Study 2, clinical outcomes like discomfort, pain, and marginal bone loss were recorded, but the involvement of independent experts for ground truth establishment beyond the reporting clinicians is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or ground truth establishment in either study. The results appear to be reported based on direct collection and measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. The studies described are clinical outcome studies for the device itself, not studies comparing human reader performance with and without AI assistance for interpretation. The device itself is a physical implant, not an AI diagnostic tool.

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

Not applicable. The device is a physical dental implant system, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this device. The clinical studies assess the physical implant's performance in human patients.

7. The Type of Ground Truth Used

• Study 1 (Case Series):
  • Implant Success: Based on the ICOI Health Scale. While this is a clinical scale, it's applied to the clinical observations and outcomes of the implants.
  • Bone Level Changes: Radiographic measurements using ImageJ, with the implant shoulder as a reference. This is a form of radiological ground truth based on quantifiable measurements.
• Study 2 (Prospective Cohort):
  • Intraoperative Discomfort: Patient-reported (via VRS - likely Verbal Rating Scale). This is patient-reported outcome data.
  • Postoperative Pain: Patient-reported (via VAS - Visual Analog Scale). This is patient-reported outcome data.
  • Marginal Bone Loss: Radiographic measurements. This is a form of radiological ground truth.
  • Implant Satisfaction: Clinical assessment based on the study protocol, leading to the conclusion that "All of the 58 implants were satisfactory." This is likely clinical outcome data based on defined criteria.

8. The Sample Size for the Training Set

Not applicable. The PiezoImplant System is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training set" for the development of such a device would involve engineering design, material science research, and mechanical testing, not a dataset in the AI sense.

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

Not applicable. As explained above, there is no "training set" for this physical device in the AI sense. Ground truth for the development of the device would involve established scientific and engineering principles, material standards (e.g., ASTM F136 for titanium alloy), and mechanical testing methodologies (e.g., ISO 14801). The "ground truth" for the clinical studies mentioned above is established through clinical observation, patient reports, and radiographic measurements as detailed in point 7.

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The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
• Data Provenance:
  • Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
  • Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.

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

Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" was established through:

• Physiochemical surface analyses: Laboratory measurements of surface properties.
• Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.

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

Not applicable. As above, this is not an AI/ML device.

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The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.

The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched. This surface has been modified for faster osseointegration and secondary stability. The dental implants are composed of Grade 4 titanium, cold worked. The neck of the implant is a smooth machined surface to allow for the attachment of epithelial tissue. Straumann implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths. No changes to overall implant design or dimensions were made.

The provided text is a 510(k) summary for the ITI Dental Implant System, specifically focusing on a modified surface (SLActive). The core of the submission is to demonstrate substantial equivalence to previously marketed ITI dental implants, primarily based on animal studies showing faster osseointegration and earlier secondary stability with the new surface.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for either test or training sets.

The document details the device description, intended use, and the basis for substantial equivalence, which revolves around animal studies comparing the SLActive surface to the SLA surface in terms of osseointegration and secondary stability. It states:

• "Increased bone to implant contact and earlier secondary stability with the modified surface compared to the SLA surface was demonstrated at early healing periods of 2-4 weeks in animal studies."

This means the study that 'proves' the device meets criteria (faster osseointegration and earlier stability) is an animal study. The acceptance criteria are implicitly those metrics related to bone-to-implant contact and stability measured in the animal study.

Therefore, for your specific request, I can only provide what is explicitly mentioned in the text.

Here's a summary of the information you requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Animal studies. The type of animal is not specified, nor is the country of origin. The studies are prospective in nature, comparing different implant surfaces.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not specified. The ground truth would likely be established through histological analysis and biomechanical testing from the animal studies, performed by veterinary pathologists or researchers. The text does not elaborate on this.

4. Adjudication Method for the Test Set

• Not specified.

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

• No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret medical images. This submission is for a dental implant, and the evidence presented is from animal studies on osseointegration, not human interpretation.

6. Standalone (Algorithm Only) Performance Study

• No. This is not a software algorithm; it is a physical medical device (dental implant).

7. Type of Ground Truth Used

• Based on the description of "increased bone to implant contact and earlier secondary stability in animal studies," the ground truth likely involved:
  • Histology: Directly measuring bone-to-implant contact (BIC) from tissue sections.
  • Biomechanical testing: Measuring implant stability (e.g., resonance frequency analysis or push-out/torque removal tests).
  • Outcomes Data: In an animal model context, the "outcome" is the measured biological response of bone healing and implant integration.

8. Sample Size for the Training Set

• Not applicable as this is an animal study for a physical device, not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence based on pre-clinical (animal) studies of a physical device, not on clinical performance metrics or AI algorithm validation.

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