(178 days)
The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
The Osstell IDx is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell IDx is a portable, handheld/tabletop instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg. The Osstell IDx can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.
Here's a breakdown of the acceptance criteria and study information for the Osstell IDx, as provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Non-clinical evaluation method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISQ correlation evaluation | The average difference could be up to +/-5 ISQ. | Approved. The average difference was -1 ISQ and 3.17 ISQ. |
| Torque correlation evaluation | The average variance due to tightening torque is checked so that it stays within 3 ISQ between 4 and 6 Ncm. | Approved. The highest variance due to tightening torque were measured to 1.33 ISQ. Most of the measured variances were 0 or below 1 ISQ. |
| Nonclinical Biocompatibility evaluation of the new probe material | Approved Biocompatibility evaluation according to ISO 10993. | Mediprene 500M has passed cytotoxicity test according to ISO 10993-5 and biocompatibility tests according to USP Class VI. Due to very low degree of skin contact and that the ingoing materials are well known. The individual materials have passed the biocompatibility evaluation and the combination into a steam autoclavable product is judged not to change the risk spectrum. Based on the low degree and duration of skin contact, the biocompatibility tests performed is the biocompatibility evaluation approved for the IDx Probe. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for the ISQ correlation and torque correlation evaluations. It refers to two different evaluations being performed, but details on the number of individual tests or cases are not provided.
Data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the non-clinical evaluations. These tests appear to be technical performance comparisons against defined metrics rather than assessments requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable as expert adjudication was not mentioned for these non-clinical evaluations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device, Osstell IDx, is a measurement instrument for implant stability, not an AI diagnostic tool requiring human reader comparison.
6. Standalone (Algorithm Only) Performance Study
The studies described are standalone performance tests of the device itself (ISQ and torque correlation, and biocompatibility), comparing it to its predicate device (Osstell ISQ) or established standards. There is no mention of an "algorithm only" study, as the device's function is centered on physical measurement and conversion to an ISQ value.
7. Type of Ground Truth Used
For the ISQ correlation evaluation and Torque correlation evaluation, the "ground truth" implicitly refers to the performance of the predicate device (Osstell ISQ) and the established acceptance criteria (tolerance ranges for ISQ differences and torque variances). Essentially, the new device's measurements are compared to those of a known, previously cleared device or expected physical behavior.
For the Biocompatibility evaluation, the ground truth is established by adherence to recognized international standards: ISO 10993-5 (cytotoxicity) and USP Class VI (biocompatibility).
8. Sample Size for the Training Set
Not applicable. This is a medical device for measuring implant stability, not a machine learning or AI-based device that typically requires a training set. The descriptions of the tests are for verification and validation of the device's physical and functional performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this type of device and evaluation.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.