The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

Device Description

The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.

The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.

AI/ML Overview

The provided text describes a 510(k) submission for a Dental Unit with Chair (Model S2310) and does not contain detailed information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Dental Unit with Chair S2318, K080438) through non-clinical bench testing and comparison of specifications.

Therefore, many of the questions regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for AI/ML performance cannot be answered from the provided text.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (as presented in the document)

The "acceptance criteria" in this context are implicitly met if the proposed device's performance aligns with relevant safety and technical standards and is substantially equivalent to the predicate device.

Acceptance Criteria (Implied by adherence to standards and comparison to predicate)	Reported Device Performance (Proposed Device: Dental Unit with Chair S2310)
Safety and General Requirements (IEC 60601-1)	Complies with IEC 60601-1, Amendment 1, Amendment 2
Electromagnetic Compatibility (IEC 60601-1-2)	Complies with IEC 60601-1-2: 2007
Dentistry - Dental Units (General Requirements) (ISO 7494-1)	Complies with ISO7494-1: 2004
Dentistry - Dental Units (Water & Air Supply) (ISO 7494-2)	Complies with ISO7494-2: 2003
Dental Patient Chair (ISO 6875)	Complies with ISO 6875: 1995
Sterilization of Health Care Products (ANSI/AAMI/ISO 17665-1)	Complies with ANSI/AAMI/ISO17665-1: 2006
Intended Use	Identical to predicate: Supply power to and serve as a base for dental devices and accessories in a dental clinic/office setting.
Power Supply	110V (Identical to predicate)
Frequency	50/60Hz (Identical to predicate)
Power (with dental chair)	400VA (Predicate: 600VA; difference discussed as not affecting safety/effectiveness)
Operating Light Power Supply	AC12V / 5W (Predicate: AC 12V / 50W; difference discussed as not affecting safety/effectiveness)
Operating Light Illumination	≤20000lx (Predicate: Weak: ≤8000lx, Intense: ≥15000lx; difference discussed as not affecting safety/effectiveness)
Pressure of Water Supply	0.2MPa-0.4MPa (Identical to predicate)
Air Supply Pressure	0.6MPa-0.8MPa (Identical to predicate)
Dental Chair Loading Capacity	200kg (Predicate: 135kg; difference discussed as not affecting safety/effectiveness)
Dental Chair Movement Range (Chair)	390mm-740mm (Predicate: 410mm-750mm; difference discussed as not affecting safety/effectiveness)
Dental Chair Movement Range (Backrest)	1°-70° (Predicate: 0°-70°; difference discussed as not affecting safety/effectiveness)
Dental Chair Movement Range (Headrest)	150mm (Identical to predicate)
Attachable Accessories	Identical to predicate (e.g., High Speed Handpiece, Scaler, Dental Chair, etc.)
Operation Method	Identical to predicate (Control Panel, Assistant Control Panel, Foot Controller)

The study that proves the device meets the acceptance criteria is the non-clinical bench testing comparing the proposed device to the predicate device and assessing compliance with various international standards. The document states: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."

Information Not Applicable or Not Provided in the Document:

The following information is typically relevant for AI/ML-driven medical devices but is not present in this submission, as it concerns a traditional medical device (Dental Unit with Chair) and not an AI/ML algorithm.

Sample size used for the test set and the data provenance: Not applicable. This was a physical device undergoing bench testing, not an AI/ML model evaluated on a data set.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/ML (e.g., expert labels on images) is not a concept for this type of device submission. Compliance with standards and functional tests determined "truth."
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study evaluates human performance with and without AI assistance, which is not relevant for a dental unit.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission was successful adherence to established engineering standards (e.g., IEC, ISO) and the functional specifications of the predicate device, demonstrated through bench testing.
The sample size for the training set: Not applicable. This device does not use a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for a conventional medical device (Dental Unit with Chair) where "acceptance criteria" are met through compliance with established safety and performance standards and demonstrating substantial equivalence to a legally marketed predicate device via non-clinical bench testing. It does not involve AI/ML technology, and therefore, the related questions for AI/ML device evaluation are not addressed.

Summary

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Exhibit #9 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

Date of Submission: January 25, 2013 1.
JUL 26. 2013
1. Sponsor
  Xianyang North West Medical Instrument (Group) Co., Ltd No.3, Biyuan Road, Xianyang, Shaanxi, 712000, China

Establishment Registration Number: 3007031016

Contact Person: Hongmei, Shangguan Position: Quality Engineer Tel: 86 29 33286870 Fax: 86 29 33212053 Email: xyshangguanhongmei@126.com

Submission Correspondent 3. Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1. Proposed Device Identification

Proposed Device Name: Dental Unit with Chair Proposed Device Model: S2310 Device Common Name: operative dental unit

Classification: I Product Code: ELA Regulation Number: 21 CFR 872.6640 Review Panel: Dental

Ed-I

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Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K080438 Product Name: Dental Unit with Chair Manufacturer: North West Medical Instrument (Group) Co., Ltd
Device Description 6.
The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.

The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.

ISO7494-1: 2004, Dentistry - Dental units - Part 1: General requirements and test methods.

ISO7494-2: 2003, Dentistry - Dental units - Part 2: Water and air supply.

ISO 6875: 1995, Dental patient chair.

ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

After performing non-clinical performance studies, the data shows that the proposed device E9-2

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Substantially Equivalent (SE) to the predicate device.

Substantially Equivalent Comparison and Conclusion 8.

Table III-1 Substantially Equivalent Comparison

ITEM	Proposed DeviceDental Unit with Chair S2310	Predicate DeviceDental Unit with Chair S2318 (K080438)
Product Code	EIA	EIA
Regulation No.	21 CFR 872.6640	21 CFR 872.6640
Class	I	I
Intended Use	The Dental Unit with Chair is intended tosupply power to and serve as a base for dentaldevices and accessories. It is intended for usein the dental clinic/office environment andused by trained dentists and/or dentaltechnicians and assistants. This product isattached with a dental chair.	The Dental Unit with Chair is intended tosupply power to and serve as a base fordental devices and accessories. It is intendedfor use in the dental clinic/officeenvironment and used by trained dentistsand/or dental technicians and assistants. Thisproduct is attached with a dental chair.
Power Supply	110V	110V
Frequency	50/60Hz	50/60Hz
Power (with dental chair)	400VA	600VA
OperatingLight	Power Supply	AC12V / 5W	AC 12V / 50W
	Illumination	≤20000lx	Weak: ≤8000lxIntense: ≥15000lx
Pressure of Water Supply	0.2MPa-0.4MPa	0.2MPa-0.4MPa
Air Supply Pressure	0.6MPa-0.8MPa	0.6MPa-0.8MPa
DentalChair	Loading Capacity	200kg	135kg
	Movement Range(Chair)	390mm-740mm	410mm-750mm
	Movement Range(Backrest)	1°-70°	0°-70°
	Movement Range(Headrest)	150mm	150mm
	Accessories can be attached tothe device	High Speed Handpiece / Fiber OpticHandpiece/ Low Speed Handpiece / Scaler /Curing Light / Dental Chair /Three-way-Syringe	High Speed Handpiece / Fiber OpticHandpiece/ Low Speed Handpiece / Scaler /Curing Light / Dental Chair /Three-way-Syringe
	Operation Method	Control Panel / Assistant Control Panel / FootController	Control Panel / Assistant Control Panel /Foot Controller

Difference in Power (with dental chair), Illumination, and Dental Chair between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

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The proposed device, Dental Unit with Chair S2310, is determined to be Substantially Equivalent (SE) to the predicate device, Dental Unit with Chair (K080438), in respect of safety and effectiveness.

E9-4

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G601 Silver Spring, MD 20993-0002

July 26, 2013

Xianyang North West Medical Instrument (Group) Company, Limited C/O Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, China 200237

Re: K130410

Trade/Device Name: Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 25, 2013 Received: June 28, 2013

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/8 description: The image shows the name "Mary S. Bunner -S" in a bold, sans-serif font. The letters "Mary" and "-S" are in a solid black color, while the letters "S. Bunner" appear to be filled with a pattern of smaller letters or symbols, giving them a textured look. The text is horizontally oriented and appears to be a title or heading.

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k) Submission

Section II Indications for Use

510(k) Number: K130410
Device Name: Dental Unit with Chair

Indications for Use:

The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinicoffice environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of I

Mary S. Runner -S

Susan Runnn DOS, MA 2013.07.26
10:50:57-04'00'

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K130410

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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.