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iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.

iCTmotor (WL-1) is a software based driving engine that controls the speed of a specific dental micromotor. This device is optimized for dental implant procedures and user programmable parameters operate and control a dental handpiece for dental implant surgery. iCTmotor (WL-1) consists of a main controller unit, a charger, a foot controller, micro motor, cable, a water holder, tube holder, and micro motor holder. The main control unit operates the speed and torque of a dental micromotor that drives dental handpiece to cut tissues in the mouth and to screw dental implants. The main control unit is operated via a wireless foot pedal. The holders are used for placement of a water bag, a micro motor and a handpiece. The power cord delivers electric power to the main control unit.

The provided text is a 510(k) summary for the iCTmotor (WL-1), a dental device. It does not describe an AI/ML-based medical device or a study involving human readers or AI assistance. Therefore, it's not possible to provide acceptance criteria or a study description related to AI/ML device performance from this document.

The document focuses on demonstrating substantial equivalence to a predicate device (MASTERsurg / EXPERTsurg) through non-clinical performance testing. It highlights the device's intended use in dental surgery and implantology, specifically controlling a dental micromotor for cutting tissues and screwing dental implants.

The non-clinical tests performed are related to the physical and electrical characteristics of the device, as well as software validation for its control functions.

Key points from the document relevant to non-clinical performance testing (not AI/ML):

• Acceptance Criteria & Performance: The document states that "Performance testing was conducted according to ISO 14457:2012 to show that the device meets its design requirements and performs as intended." The specifications for the following parameters were met:

  • Rotating speed of micromotor
  • Torque of micromotor
  • Stop of micromotor
  • Rotating direction of micromotor
  • Irrigation amount

  The exact numerical acceptance criteria and the reported numerical performance for these parameters are not explicitly detailed in a table format within this summary, but the general claim is that they were "met." For example, under "Electrical Specification Motor (Speed)," the iCTmotor (WL-1) has a speed of "400- 40,000rpm," and the predicate has "300 - 40,000 rpm." While these are performance specs, the document doesn't present them as formal "acceptance criteria" vs. "reported performance" in a dedicated test. Instead, it asserts compliance with ISO 14457:2012.

• Sample Size and Data Provenance: Not applicable for an AI/ML context. For the non-clinical tests, the sample size would refer to the number of units tested, which is not specified but is typically a small engineering sample or a representative batch. The data provenance is from the manufacturer's internal testing.

• Experts and Ground Truth: Not applicable in the context of AI/ML interpretation. The "ground truth" for these performance tests is the engineering specification for each parameter (e.g., a specific RPM range, torque value).

• Adjudication Method: Not applicable. Performance testing of physical devices is typically a direct measurement against a specification.

• MRMC Comparative Effectiveness Study: Not applicable. This study focuses on a hardware device, not an AI/ML algorithm.

• Standalone Performance: The "performance testing" described (rotating speed, torque, etc.) represents the standalone performance of the device's control system and motor.

• Type of Ground Truth: The ground truth for this device's performance testing is based on engineering specifications and established international standards (ISO 14457:2012) for dental handpieces/micromotors.

• Training Set Sample Size: Not applicable. This is a hardware device with software control, not an AI/ML model that requires training data. The software was subjected to verification and validation as per FDA guidance for software in medical devices, but this is distinct from AI/ML model training.

• Ground Truth for Training Set: Not applicable, as there is no AI/ML training set in this context. Software "ground truth" for verification and validation typically means that the software functions as designed according to its requirements specification.

In summary, this document is a 510(k) premarket notification for a traditional medical device (iCTmotor (WL-1)) and does not contain information about AI/ML acceptance criteria or a study proving an AI/ML device meets such criteria.

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