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The Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic treatment to dental patients in a clinical environment.

The Forest Dental Unit serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The controls are contained in a Doctor's Unit, Assistant's Instrumentation Unit, Duo Unit (both Doctor's and Assistant's Control) and Cuspidor and are configured in a variety of mounts. Additional accessory items include a pneumatic unit foot control, utility center (aka junction box) that houses a power supply and air/water regulators, hoses, trays, and mounting assemblies. The dental unit is supplied air and water from the utility connections through air/water regulators via the umbilical chase. The dental unit is supplied SELV-24VAC from the output of the power supply, also routed through the umbilical chase and terminated on an internal terminal strip.

This document is a 510(k) Premarket Notification for the "Forest Dental Unit," a Class I device. The submission aims to demonstrate substantial equivalence to a predicate device, the "SPIRIT – K143696" dental delivery unit manufactured by Pelton & Crane.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal, explicit table of "acceptance criteria" in the traditional sense of measurable performance metrics with pass/fail thresholds. Instead, it relies on demonstrating equivalence to a predicate device and compliance with various standards. The "reported device performance" is largely communicated through declarations of compliance with these standards and the successful outcome of testing.

However, we can infer some "acceptance criteria" from the comparative table (Table 5.2) and the descriptions of testing performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of patient data or a specific number of devices tested in a clinical trial setting. The evaluation is primarily based on:

• Engineering and Performance Testing: This involves testing physical devices (Forest Dental Unit models) against established standards (e.g., electrical safety, mechanical, biocompatibility, sterilization, cleaning, waterline disinfection). The number of individual units subjected to each specific test is not detailed, but it's implied that representative samples were tested to demonstrate compliance.
• Predicate Comparison: The comparison is made against the specifications and known performance of the Pelton & Crane Spirit 1500 (K143696) dental operative unit.

Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to a patient-based test set is not applicable here as no clinical study with human subjects or patient data is described. The data provenance is from laboratory and engineering testing of the device components and systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable. The "ground truth" for this type of submission is established by engineering standards, regulatory requirements, and the characteristics of the predicate device. There is no mention of experts being used to establish ground truth for a clinical test set, as no such clinical test set is described. The compliance with standards and the demonstration of substantial equivalence are likely evaluated by internal qualified personnel (engineers, quality assurance) and potentially third-party testing labs.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no clinical test set with human subjects and associated interpretations that would require an adjudication method. The evaluation method relies on objective measurements against engineering standards and a direct comparison to the predicate device's specifications.

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

This information is not applicable. The Forest Dental Unit is a physical dental care delivery system, not an AI-powered diagnostic or therapeutic device that would involve "human readers" or AI assistance.

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

This information is not applicable, as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is multi-faceted and derived from:

• Engineering Standards: Compliance with recognized international and national standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 7494-1, ISO 7494-2, ISO 14971, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 17655-1, ISO 16954). The pass/fail criteria for these tests define the "ground truth" for performance and safety.
• Predicate Device Specifications: The detailed characteristics and performance of the legally marketed predicate device (Pelton & Crane Spirit 1500, K143696) serve as a benchmark for substantial equivalence.
• Biocompatibility/Material Safety: EPA standards for drinking water and established ISO standards for biocompatibility (e.g., cytotoxicity, irritation) define the "ground truth" for material safety.

8. The Sample Size for the Training Set

This information is not applicable. The Forest Dental Unit is a physical medical device, not a machine learning or AI model, and therefore does not involve a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

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The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTarive 200XDA Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by an integrated electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handpieces such as the COMFORTdrive 200XDA. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip/cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist.

The provided documents are 510(k) summaries for two dental devices: the COMFORTdrive 200XDA Handpieces and the COMFORTtronic 4894. These are submissions to the FDA to demonstrate substantial equivalence to existing legally marketed devices, rather than studies designed to prove a device meets specific acceptance criteria through performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from these documents.

The documents focus on:

• Device Name: COMFORTdrive 200XDA Handpieces and COMFORTtronic 4894
• Common Name: Dental Handpiece and Accessories, Operative Dental Unit
• Classification Name: Handpiece, AC-Powered, Dental (21 CFR § 872.4200); Operative Dental Unit and Accessories (21 CFR § 872.6640)
• Intended Use:
  • COMFORTdrive 200XDA Handpieces: For removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces by a trained professional in general dentistry.
  • COMFORTtronic 4894: To convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces by a trained professional in general dentistry.
• Predicate Devices:
  • COMFORTdrive 200XDA Handpieces: A-dec/W&H, Synea Air-Driven Highspeed Handpieces (K070663)
  • COMFORTtronic 4894: Bien Air., Optima MX (K042759) and Sirona Dental Systems GmbH. Sirotorque L (K031584)
• Substantial Equivalence: Asserted based on identical intended use and similar design, application, function, and technical characteristics to the predicate devices.

There is no data presented in these 510(k) summaries that describes: performance metrics, acceptance criteria, study sizes, ground truth establishment, expert involvement, or any form of comparative effectiveness study. These types of details are typically found in more extensive technical reports or clinical study summaries, which are not part of the provided 510(k) summary text.

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