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The Firstar Dental Unit is 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 Firstar Dental Unit is intended for use by dental practitioners in a clinical environment.

The Firstar Dental Unit (also known as the delivery unit or delivery system) is a combination of dental equipment components used to carry, position, and control the devices used in the practice of dentistry. Delivery systems provide for hand pieces and other various accessories by delivering air, water, vacuum and low voltage electricity to the dentist during procedures. Depending on the configuration, it includes combinations of a Doctor Control Head (delivery head), Delivery System Foot Switch (sometimes referred to as a rheostat), Cuspidor, Side Box (Control Box), High Volume Evacuator (HVE), Saliva Ejector (SE), and an Air and Water Multifunction Syringe.

Air, water, vacuum, drainage, and electrical power utilities are delivered through the shut-off valves, pressure regulators, and electrical transformers located in the post mounted utility box. Subsequently, internal tubing delivers the air, water and vacuum to the control head and to the dental hand pieces and multifunction syringe. Low voltage electricity is delivered to the control head for operating items such as scalers, electric hand pieces and fiber optic light sources.

The Firstar Dental Unit is available in various configurations and mounting styles including dental chair mounted, mobile cart mounted, and wall mounted on a dental chair, the Firstar Dental Unit can be configured in two distinct styles - a pivot mounted unit which allows for ambidextrous access to the patient, and a post mounted unit which includes a side box located on one side of the dental chair that can mount a cuspitor (spittoon) on it. Despite the various applications, the key elements of the Dental Unit such as the internal plumbing, tubing, materials, power sources, utility connections, delivery head internal components, and overall operating principles remain the same.

The control head allows operators to place surgical equipment on top of the tray and it provides controls for hand piece water pressure, air pressure and electrical power. Additionally, controls for a Firstar Dental Chair are often integrated on the control head if the dental unit is configured to mount on a dental chair. If equipped, the cuspidor bowl allows 90 decrees ande rotation that provides access to collect the patient's saliva during dental treatment. The side box provides controls for the cuspidor cup fill, bowl rinse, air, and pressure regulators for the air and water quick disconnect outlets.

Various ancillary devices can be connected to the Firstar Dental Unit by means of standard ISO 9168-20 connections including but not limited to: pneumatic handpieces, electric micromotors and handpieces, air/water syringes, piezo or magnetostrictive dental scalers, curing lights, intraoral cameras, saliva ejectors, and high volume evacuators. 24VAC power supplied from the Junction Box Power Supply can be used to power electrically operated ancillary equipment such as electrical handpieces, dental does not manufacture the aforementioned devices except for the air/water syringes, saliva ejectors, and high volume evacuators.

The document provided is a 510(k) Pre-market Notification from the FDA for the Firstar Dental Unit. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information about specific acceptance criteria, reported device performance data, sample sizes, ground truth establishment, or clinical study specifics that you are requesting.

The document only states:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Non-Clinical verification and validation tests have been performed with regards to the intended use, requirement specifications and the risk management results. The non-clinical testing was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below."
• Standards Applied:
  • IEC 80601-2-60:2019 Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment.
  • ISO 7494-1:2018 Dentistry Stationary dental units and dental patient chairs Part 1: General requirements.
  • ISO 7494-2:2015 Dentistry Dental units Part 2: Air, water, suction and wastewater systems.
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
• Conclusion: "The test results demonstrate that the Firstar Dental Unit conforms with the relevant FDA-recognized consensus standards and guidance documents and meets the acceptance criteria. Therefore, the subject device, Firstar Dental Unit, is substantially equivalent to the predicate device."

Based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria and study particulars because the document only states that non-clinical verification and validation tests were performed and met acceptance criteria based on recognized consensus standards, but it does not provide the specifics of those criteria or the study results.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size with or without AI-assistance.
6. Information if a standalone (algorithm only) performance study was done.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory clearance letter, not a detailed study report. Such specific information would typically be found in the full 510(k) submission, which is not publicly available in this detail, or in a separate clinical study report.

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