(77 days)
IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.
IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.
The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi 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 back of 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. The 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.
The provided document for the HIOSSEN IS3 device (K180527) does not contain detailed acceptance criteria and a study that proves the device meets these criteria in the typical format of a clinical or performance study for AI/ML-enabled devices.
This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Tellos ISQ Buddy, K143445), not on providing performance metrics against specific, quantitative acceptance criteria for diagnostically or prognostically critical AI/ML-driven tasks. The IS3 device is described as measuring the resonance frequency of an implant pin to determine an "ISQ-value" for implant stability, which is a direct measurement based on a physical principle. It does not appear to involve AI/ML for image analysis, diagnosis, or prediction, which typically require detailed performance studies.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the type of device and submission presented.
However, I can provide information based on the document's content regarding the device's technical performance and comparison to predicate devices, which serves as its "proof" of meeting requirements for substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, AUC, or accuracy, as would be common for AI/ML-powered diagnostic devices. Instead, the "performance" is demonstrated by its functional equivalence and compliance with relevant standards, and it measures an ISQ value from 1-100.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance (from document) |
|---|---|
| Functional Equivalence to Predicate Device | IS3 (Subject Device): |
| Measures stability of dental implants in the oral cavity and maxillofacial region | Indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region. |
| Operates on the same technological principle (resonance frequency measurement) | The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection... The instrument is held towards the Multi 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. (Page 4) The instrument functions the same way as the predicate device regarding the measurement principle and technology used. (Page 5) The IS3 instrument brings a pin attached to a dental implant into vibration and then measures the resonance frequency of the vibrating pin. The resonance frequency is then presented as an "ISQ-value" 1-100. The primary predicate device does the same technological principle and the electronic, software since same circuits are used. (Page 7) |
| Presents measurement output as an ISQ number (1-100) | It presents the resonance frequency of the ISQ peg as an ISQ number, 1-100. (Page 5) |
| Safety and Performance Standards Compliance | IS3 (Subject Device) was found to comply with the following: |
| EMC compatibility | EMC standard IEC 60601-1-2 (Page 7) |
| Software validation | Software validation according to FDA guidance for Software Contained in a Medical Device (Page 7) |
| Sterilization validation (for components like Multi Peg) | Sterilization validation according to ISO 17665-1 and ISO 17665-2 (Page 7) - Note: The Multi Peg is a measurement pin to attach to the implant, implying it contacts the patient and would require sterilization or being disposable. |
| Biocompatibility (for patient-contact materials) | Biocompatibility standard ISO 10993-1 (Page 7) - Note: Instrument tip is PEEK (USP VI), Instrument seal and key are Silicone (USP VI), Multi Peg is Titanium grade 5. While the instrument is not intended for patient contact, potential unintentional contact is noted, and the Multi Peg directly contacts the patient's implant. The biocompatibility standard is relevant for these materials. |
| Electrical safety | Designed to the standard IEC 60601-1 Medical Electrical Equipment (Page 6) |
2. Sample sized used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for validating AI/ML performance. The "testing" mentioned refers to compliance with engineering standards (EMC, software validation, sterilization, biocompatibility, electrical safety) for the device itself, rather than testing its diagnostic accuracy on a clinical dataset. Thus, there is no sample size for a test set of clinical data from this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth for AI/ML performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. The IS3 is a direct measurement device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone instrument for measuring ISQ value. Its performance is inherent in its design and compliance with technical standards, as outlined above. It's not an "algorithm only" in the sense of AI/ML, but a physical measurement system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fundamental measurement principle, the "ground truth" is the physical resonance frequency of the attached pin, which the instrument is designed to accurately measure and convert to an ISQ value. Beyond this, the device's "performance" is assessed by its ability to meet engineering and safety standards, rather than by comparison to clinical ground truth for a diagnostic task.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.