(401 days)
Tellos ISQ Buddy is indicated for use in measuring the stability of dental implants in the maxillofacial region.
The Tellos ISQ Buddy measurement system consists of: Tellos ISQ Buddy Instrument (Hand-held instrument), ISQ Peg Driver (Driver to attach the ISQ peg to the implant), Tellos ISQ Buddy Charger (100-240 VAC to 5VDC charger for the instrument batteries), and ISQ Peg (Measurement pin to attach to the implant. Different pins are available to fit different implant types.). The instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "ISQ peg" is attached to the dental implant by a screw-connection, with the Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the ISQ Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second. The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used. The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Produces same ISQ values as predicate device with artificial frequency signal (1,000 to 10,200 Hz). | * Deviation: 0 ISQ (exactly the same) |
| Accepted deviation: +/- 1 ISQ throughout the scale 1-100 ISQ. | * Deviation: 0 ISQ (exactly the same) |
| Produces same ISQ values as predicate device when measuring on an Osstell SmartPeg attached to an implant embedded in artificial bone. | * Deviation: 0 ISQ (exactly the same) |
| Accepted deviation: +/- 1 ISQ (for stability varied from 3 to 85 ISQ). | * Deviation: 0 ISQ (exactly the same) |
| Safety and Compliance: | |
| Compliance with EMC standard IEC 60601-1-2. | * Compliance: Found to comply. |
| Software validation according to FDA guidance for Software Contained in a Medical Device. | * Compliance: Validated. |
| Sterilization validation according to ISO 17665-1 and ISO 17665-2. | * Compliance: Validated. |
| Biocompatibility standard ISO 10993-1. | * Compliance: Complies (indirectly stated by using USP VI materials and successful assessment). |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set 1 (Artificial Frequency Signal): The frequency signal was varied from 1,000 to 10,200 Hz with a resolution of 100 Hz. This implies 93 distinct frequency points were tested ( (10200-1000)/100 + 1 ).
- Test Set 2 (Artificial Bone Model): The stability was varied from 3 to 85 ISQ. The exact number of discrete stability points tested is not specified, but it covers a significant range.
- Data Provenance: The data comes from laboratory testing conducted by the device manufacturer (Tellos Medical AB). It is not patient or human subject data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly. The ground truth for the functional performance tests was established by comparison against a known, controlled input (artificial frequency signal) and against the predicate device (Osstell ISQ) in a controlled laboratory setting. Expert consensus was not used to establish the "ground truth" for the ISQ values themselves in these specific tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are typically used for subjective assessments or when discrepancies arise between human readers/interpreters. In this case, the measurements are objective device outputs compared against objective criteria and the predicate device's output.
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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:
- No. This is a dental implant stability analyzer, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant to this device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for the device's core functionality. The performance testing described (comparison with artificial signals and artificial bone models) represents a standalone assessment of the device's ability to measure ISQ values accurately. The device outputs the ISQ value directly, without an "algorithm only" component separate from the integrated hardware and software. It does not involve human interpretation as part of its primary function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Controlled, known inputs and predicate device output. For the artificial frequency signal test, the ground truth was the known input frequency. For the artificial bone model, the ground truth was essentially the output of the predicate device and the varied stability in the controlled setting.
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The sample size for the training set:
- Not applicable / Not explicitly mentioned. This device does not appear to use machine learning or AI that requires a "training set" in the conventional sense. Its functionality is based on established physical principles (resonance frequency measurement) and signal processing, calibrated and validated against known standards and a predicate device.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.