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Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.

The proposed device, the Young INFINITY Cordless Handpiece System, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing of tooth surfaces and fillings. The Young INFINITY Cordless Handpiece System is comprised of a cordless, battery-powered handpiece, a removable nosecone, a cradle for the cordless handpiece, a direct current (DC) power supply and charging cord, and a wireless foot controller. Accessories to the Young INFINITY Cordless Handpiece System include a single-use doriot style Disposable Prophy Angle (DPA), which can be purchased from any DPA manufacturer. Additionally, the Young Infinity Cordless Handpiece System must be used with a disposable barrier (cleared as Class II, Product Classification Code PEM, under premarket notification K151123 in 03/03/2016 as Cover-It™ Barrier Film). The handpiece features a removable nosecone that is to be cleaned and steam sterilized prior to first use and after each patient use. The handpiece utilizes an on-board user control for on/off and an LED indicator to communicate handpiece battery life, handpiece battery charging, foot control low power level, excessive pressure being applied, and wireless pairing status, The handpiece can only be operated by the appropriately paired wireless foot controller. The Young INFINITY Cordless Handpiece System is operated by using a wireless foot controller, where the amount of vertical actuation on the wireless foot controller correlates to the speed of the handpiece supplied to the DPA. The corresponding variable speed range of the DPA is between 500RPM and 3000RPM. The wireless foot controller operates using a Bluetooth low energy (BLE) communication protocol. When the handpiece has been turned ON, engaging the wireless foot controller activates the (BLE) mode of both the cordless handpiece and the wireless foot controller. The wireless foot controller features LEDs to indicate when the BLE mode on the foot controller has been activated, battery charging and adequate battery power level.

The provided text is a 510(k) summary for the Young INFINITY Cordless Handpiece System, which is a dental handpiece. It aims to demonstrate substantial equivalence to a predicate device.

The document describes performance data for the device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to artificial intelligence, machine learning, or complex algorithmic performance involving human-in-the-loop interaction, ground truth establishment by experts, or large-scale data sets for training/testing.

The performance data mentioned relates to standard medical device testing for safety, functionality, and biocompatibility, such as:

• Sterilization/Cleaning validation: Per ISO 17665-1 and ISO 17665-2, and FDA Guidance Document.
• Electrical Safety and Electromagnetic Compatibility: Per IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility validation: Per FDA Guidance Document for Use of ISO 10993-1, and ISO 10993-5 cytotoxicity testing.
• Risk Analysis: Per ISO 14971 (hardware and software).
• Software documentation: For software of moderate level of concern per FDA Guidance Document Software Contained in Medical Devices.
• Hardware Performance/Safety Verification/Validation: Including conformance to ISO 14457 Dentistry -- Handpieces and motors.
• Verification of component specifications, speed and torque control, connectivity, battery life, noise testing, chemical compatibility, fluid ingress, weight, and dimensions.

Given the nature of the device (a cordless dental handpiece) and the type of performance data presented, the questions about AI/ML specific study design elements (human readers, effect size, standalone algorithm performance, expert adjudication, training/test set sample sizes for algorithms, ground truth for AI) are not applicable to this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The document describes a traditional medical device premarket notification demonstrating substantial equivalence based on engineering, safety, and performance characteristics, not AI/ML performance.

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