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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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