The Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument.

Device Description

The StarDental® Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument. The Air Controlled Sterile Irrigation System consists of a connector assembly and pinch valve assembly which can be autoclaved.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the "StarDental® aXcs Sterile Water System," also referred to as the "StarDental® Air Controlled Sterile Irrigation System." This document is a regulatory submission to the FDA, not a study report. It focuses on demonstrating substantial equivalence to existing devices, not on providing performance data or clinical study results in the way you've described for AI/algorithm performance.

Therefore, most of the information you've requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. These elements are typically found in clinical trial reports or validation studies for new technologies, especially those involving AI or complex performance claims.

Here's a breakdown of why the information isn't available and what is available:

This document:

Is a 510(k) Summary: This is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of design, materials, intended use, and operational principles, rather than extensive clinical performance studies.
Focuses on "Substantial Equivalence": The core argument is that the new device is as safe and effective as predicate devices that are already on the market.
Describes Device Purpose: It clearly states the device's intended use: "delivery of sterile water for oral surgical procedures, specifically for cooling a dental rotary instrument."

Why your requested information is largely absent:

No Acceptance Criteria Table or Reported Device Performance: This document doesn't typically include specific performance metrics or thresholds the device must meet, nor does it report on a study directly measuring those metrics. Substantial equivalence is often argued based on design similarity and known performance of predicate devices.
No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These are all hallmarks of a clinical study or a performance validation for an AI/algorithm-driven device. This irrigation system is a mechanical device, not an AI system. Therefore, these types of studies were not conducted or reported here.
No Information on Training Set Size or Ground Truth Establishment (for training): Again, this is not an AI/algorithm device, so there is no "training set."

What can be inferred or extracted from the document related to "performance" in a broad sense:

While not formal acceptance criteria as you'd find for AI, the document implies that the device must:

Deliver sterile water: This is fundamental to its intended use in oral surgical procedures. The design aims to maintain sterility.
Be air-controlled: This describes its mechanism of operation.
Be safe and effective for cooling dental rotary instruments: This is the ultimate goal of the sterile water delivery.
Meet general controls provisions: These are FDA requirements for medical devices (registration, listing, GMP, labeling, etc.) which implicitly ensure a baseline of safety and effectiveness.

In summary, based solely on the provided text, I cannot provide most of the requested information because it describes a regulatory filing for a mechanical device demonstrating substantial equivalence, not a performance study for an AI or complex diagnostic system.

If this were an AI device, the 510(k) summary would typically refer to a separate validation report where these details would be found.

Summary

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KA90844

510(k) SUMMARY StarDental® Air Controlled Sterile Irrigation System

Company: StarDental®, Division of DentalEZ® Owner/operator number 2520265

Contact Person:

Frank Oellig Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717)-291-1161 Fax: (717)-291-9742

Device Trade Name:

StarDental® aXcs Sterile Water System

Common or Usual Name:

Dental Accessories

Predicate Devices:

Steri Water System, Lares, NSK, Satelec and other manufacturers of water delivery systems.

CONFIDENTIAL

Description/Intended Use:

Substantial Equivalence:

The Air Controlled Sterile Irrigation System as submitted is substantially equivalent to SteriWater, AquaSept and Surgic II currently being marketed by Waggoner Dental Manufacturing, Lares and NSK and additionally substantially equivalent to Suprasson P Max and Suni currently being marketed by Satelec and other water delivery systems currently being marketed by Baxter and Abbott Labs. Materials used to manufacture the components are similar. Means of operation are similar, compressed air controls the pinch valve while electrical signal controls the solenoid valves. The main difference in design is that the Air Controlled Sterile Irrigation System consists of a connector assembly and pinch valve assembly which can be autoclaved as compared to a SteriWater which must be disassembled and autoclaved and also infusion pumps that utilize disposable components.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1999

Mr. Frank Oellig Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K990844 Trade Name: StarDental®, aXcs Sterile Water System Requlatory Class: I Product Code: EIA Dated: March 12, 1999 Received: March 15, 1999

Dear Mr. Frank Oellig:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Frank Oellig

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion onereida, "Mebblanding af Bother general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cavenitfor

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use

The Air Controlled Sterile Irrigation System is used by dental professionals for delivery of sterile water for oral surgical procedures, specifically for cooling a dental rotary instrument.

CONFIDENTIAL

Press . (Per 21 CFR 801.109)

! Prescription Use (Per 21 CFR 801.109)

Susan Burr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ની GG 510(k) Number -

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.