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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Inferred from Comparison/Testing)	Reported Device Performance (Forest Dental Unit)
Intended Use: Serve as a base for ancillary dental devices providing air, water, vacuum, and low voltage electrical power to handheld dental instruments for diagnostic and therapeutic treatment by dental practitioners in a clinical environment.	Same as Primary Predicate Device.
Regulation Number: 21 CFR 872.6640	Same as Primary Predicate Device.
Regulation Name: Dental operative unit and accessories	Same as Primary Predicate Device.
Regulation Class: I	Same as Primary Predicate Device.
Product Code: EIA	Same as Primary Predicate Device.
Electrical Classifications: Class I, Type B applied part, IPX0, continuous operation	Same as Primary Predicate Device.
Transportation/Storage Temperature: No specific numerical acceptance criterion stated, but the predicate device has a range of -68°F to 122°F.	-20°F to 140°F. (Stated as not affecting substantial equivalence as testing parameters are reasonable and adequate).
Relative Humidity Range: No specific numerical acceptance criterion stated, but the predicate device has a range of 10% to 90%.	25% to 90%. (Stated as not affecting substantial equivalence as testing parameters are reasonable and adequate).
Operating Temperature Range: 68°F to 76°F	Same as Primary Predicate Device.
Air Supply Pressure Range: 80-105 psi	Same as Primary Predicate Device.
Air/Oil Separator: Gauze pad	Same as Primary Predicate Device.
Water Supply Pressure Range: 40-80 psi	Same as Primary Predicate Device.
Isolated Water Bottle System: Optional (for predicate)	Standard Feature (Stated as improving patient safety).
Hand Piece Control System: Valve block	Same as Primary Predicate Device.
Coolant Air Flow Control: Adjustable	Same as Primary Predicate Device.
Hand Piece Air and Water Bypass: Not necessary for predicate	Same as Primary Predicate Device.
Remote Hand Piece Activation with Water Toggle: Via foot control	Same as Primary Predicate Device.
Delivery unit head positioning: Flex arm	Same as Primary Predicate Device.
Flex arm brake release: Mechanically Integrated	Same as Primary Predicate Device.
Maximum Load on Flex Arm Mounted Units: 10 lbs (for predicate)	10 lbs (Forest Dental maximum capacity for the flex arm is 4.5lbs, which is in addition to the weight of the control head).
Endodontic capability: Offered	Same as Primary Predicate Device.
Hand piece flush: Standard feature	Same as Primary Predicate Device.
Air/Water quick connect ports: Offered	Same as Primary Predicate Device.
Unit Configurations for Dominant Hand: Left/Right	Same as Primary Predicate Device.
Compliance with Electrical Safety Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2	Compliant; all tests passed.
Compliance with Dental Equipment Specific Standards: IEC 80601-2-60, ISO 7494-1, ISO 7494-2	Compliant; all tests passed.
Compliance with Risk Management & Usability: ISO 14971, IEC 62366	Compliant.
Biocompatibility: Non-cytotoxic, non-irritant, compliant with EPA drinking water standards (for water line quality).	Cytotoxicity testing on water and air line components found non-cytotoxic. Dermal irritation testing on upholstery found non-irritant. Heavy metal analysis showed water line quality compliant with EPA standards.
Sterilization: Acceptable sterility assurance level for reusable components (air/water syringe tip, HVE, SE).	Sterilization reports in accordance with ISO 17655-1:2006 confirm acceptable sterility assurance.
Cleaning and Disinfection: Validated for clinical contact surfaces.	Cleaning and disinfection validation conducted.
Waterline Disinfection: Validated according to ISO 16954:2015.	Waterlines validated according to ISO 16954:2015.

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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