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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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Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post-operative sensitivity. 1mL of varnish contains 50 mg of sodium fluoride, equivalent to 22.6 mg fluoride ion. Varnish is sweetened with sucralose and Xylitol, and flavored. Varnish and applicator are packaged together in a molded opaque acclar tray, and sealed with a metallized foil.

Here's an analysis based on the provided document, addressing your questions about acceptance criteria and the supporting study:

The provided document (K153334) is a 510(k) premarket notification for the Oral-B 5% Sodium Fluoride Varnish. It's important to understand that this document describes a submission seeking substantial equivalence to a predicate device, not necessarily a study proving a device meets specific pre-defined acceptance criteria for efficacy or safety in a new, standalone clinical trial. The focus here is on demonstrating that the new device is as safe and effective as an already legally marketed predicate device.

Therefore, many of your questions, particularly those related to a clinical study with detailed performance metrics, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding performance data and the comparison to the predicate device.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission seeking substantial equivalence to a predicate, the "acceptance criteria" are generally that the new device performs as expected and is comparable to the predicate device in relevant quantifiable aspects, and is safe and effective for its intended use. Specific quantitative performance "acceptance criteria" and direct numerical "reported device performance" are not explicitly listed in the format you might see for a de novo or PMA submission. Instead, the document focuses on demonstrating comparability.

2. Sample size used for the test set and the data provenance

The document mentions "Performance - Comparative bench testing with the predicate was carried out by independent laboratories." However, it does not specify the sample size for these bench tests.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "independent laboratories" performed the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. For bench testing related to fluoride release and tubule occlusion, the "ground truth" would be established by the measurement methods themselves, adhering to scientific standards, rather than expert interpretation of results in the way ground truth is established for diagnostic devices (e.g., by radiologists).

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for diagnostic outputs where multiple experts interpret data. The tests described here are bench tests for physical/chemical properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done and is not mentioned. The document states, "Clinical data were not needed for these devices to show substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical product (fluoride varnish), not a software algorithm.

7. The type of ground truth used

For the nonclinical performance data mentioned:

• Fluoride Release and Dentin Tubule Occlusion: The "ground truth" is derived from objective laboratory measurements based on established scientific protocols and methods. This is not "expert consensus," "pathology," or "outcomes data" in the usual sense.
• Biocompatibility: The "ground truth" is established by adherence to international standards (ISO 10993-5 and ISO 10993-10) and the specific biological responses observed in the tests.

8. The sample size for the training set

This is not applicable/not provided. The device is a physical product, and the testing described does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this type of device and submission.

Summary of the Study:

The "study" described in the 510(k) summary is primarily a non-clinical bench testing comparison of the Oral-B 5% Sodium Fluoride Varnish against a legally marketed predicate device (VarnishAmerica 5% Sodium Fluoride Varnish).

• Objective: To demonstrate substantial equivalence of the new device to the predicate device.
• Methods: Comparative bench testing was performed by independent laboratories for:
  • Fluoride release
  • Dentin tubule occlusion
  • Biocompatibility (cytotoxicity, irritation, sensitization) per ISO 10993 standards.
  • Shelf-life determination.
• Findings: The Oral-B varnish's fluoride release and tubule occlusion characteristics were found to be "as expected and comparable to the predicate." Biocompatibility testing yielded "equivalent results" for cytotoxicity and provided "evidence of biocompatibility" for irritation and sensitization. A 24-month shelf life was established.
• Conclusion: The non-clinical performance data, along with composition and indications for use, established that Oral-B varnish is substantially equivalent to the predicate device. Clinical data were deemed unnecessary for this demonstration.

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