The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.

Device Description

The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.

AI/ML Overview

The provided documents describe a DCI Edge Dental Chair with Operative Unit (K151987), which is a medical device. However, the information provided does not contain acceptance criteria related to device performance in terms of diagnostic accuracy or a study proving it meets such criteria.

The context of this document is a 510(k) premarket notification for a Class I dental chair. Class I devices are generally low-risk and subject to general controls. The review process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy or performance studies like those typically required for artificial intelligence (AI) or diagnostic devices.

Here's why the requested information cannot be fully provided based on the given text:

Type of Device: A dental chair and operative unit is a mechanical device designed for positioning patients and supporting dental tools. It does not perform diagnostic functions, analyze data, or make clinical interpretations that would require metrics like sensitivity, specificity, accuracy, or a comparison to a "ground truth" derived from expert consensus or pathology.
Regulatory Focus: The 510(k) summary (pages 3-5) and the FDA letter (pages 0-1) explicitly state the focus is on "substantial equivalence" to a predicate device (Foshion Chair Mounted Dental Unit K071353). This involves comparing intended use, technological characteristics, and safety standards, not diagnostic performance metrics.
"Acceptance Criteria" in this context: For this device, "acceptance criteria" primarily relate to compliance with recognized performance standards for medical electrical equipment, biological evaluation, risk management, and usability engineering, as listed in Section 8 "Non Clinical Testing" (page 5). It does not refer to clinical performance metrics for diagnosis or prediction.
"Study that proves the device meets the acceptance criteria": The "study" here is the non-clinical testing demonstrating compliance with the listed ISO/AAMI/IEC standards. This is a demonstration of safety and basic functionality, not clinical performance.

Therefore, many of the requested fields are not applicable to the information provided about this specific device.

However, I can extract the relevant information that is present in the document.

Summary of Information from the Document (where applicable):

Since the device is a dental chair and not an AI or diagnostic device, the requested table and many of the questions related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance/Compliance
Risk Management	ISO 14971 (Second Edition 2007-03-01) - Medical devices Application of risk management to medical devices.	Complies
Biocompatibility	AAMI ANSI ISO 10993-1:209/(R) 2013 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.	Complies
Electrical Safety	ANSI/AAMI ES60601-1:2005/(R)2012 (with C1:2009 (R)2012 and A2:2010/(R)2012) - Medical Electrical Equipment—Part 1: General requirements for basic safety and essential performance.	Complies
EMC	ISO 60601-1-2:2007 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and test.	Complies
Usability Engineering	IEC 62366 Edition 1.1 - Medical devices - Application of usability engineering to medical devices.	Complies
Dental Equipment Specific	IEC 80601-2-60:2012 - Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment.	Complies
Software "Level of Concern"	Moderate level of concern for software controlling chair movement (slow, preprogrammed, limited by sensors/hard stops).	Software described as pre-programmed and activated by button, moves slowly, limited by stop sensors and mechanical hard stops to prevent exceeding pre-programmed range.
Substantial Equivalence	Demonstrated equivalence to predicate device (K071353) in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.	Stated as demonstrated by DCI, ITL.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The "testing" referred to is compliance with engineering and safety standards, not clinical performance testing with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth for diagnostic or clinical performance was established, as this is a mechanical dental chair, not a diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable.

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

Not Applicable. This is not an AI-assisted diagnostic device.

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

Not Applicable. This is not an algorithm. The software controls the chair's mechanical movements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable.

8. The sample size for the training set

Not Applicable. Training data for an AI algorithm is not relevant to this device.

9. How the ground truth for the training set was established

Not Applicable.

In conclusion, the provided documentation focuses on the safety and functional equivalence of a dental chair to existing products, rather than the performance metrics of a diagnostic or AI-driven device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2016

DCI % Mr. Robert Bellingham Quality & Regulatory Manager 305 N. Springbrook Rd. Newberg, Oregon 97132

Re: K151987

Trade/Device Name: DCI Edge Dental Chair with Operative Unit Regulation Number: 21 CFR 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: I Product Code: KLC, EIA Dated: May 2, 2016 Received: May 2, 2016

Dear Mr. Bellingham:

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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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 (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known) K151987

Device Name

DCI Edge Dental Chair with operative unit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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305 N. Springbrook Road, Newberg, Oregon, USA 97132

K151987 510(k) Summary DCI Edge Dental Chair with Operative Unit

1 Sponsor

Dental Components Inc. 305 N. Springbrook Road Newberg, Oregon 97128 Telephone: 503-537-2431 Date Prepared: May 31, 2016

2 Device Name

Proprietary Names: DCI Edge Dental Chair with Operative Unit Common/Usual Name: Chair, Dental with Operative Unit Classification: Chair, dental, with operative unit Regulation Number: 21 CFR 872.6250 Class: 1 Product Code: KLC Secondary Product Code: EIA Establishment Registration Number: 3029780

3 Predicate Device

Foshion Chair Mounted Dental Unit (K071353)

4 Intended Use

5 Device Description and Function

Level of Concern 6

The software was determined to be of a moderate level of concern. The software controls the movement of the dental chair, and it is preprogrammed and activated by the push of a button. The chair then moves slowly up and down, and the backrest moved slowly from an upright or a reclined position. The movement is very slow and the movement is limited by a stop sensor and mechanical hard stop. There are sensors and hard stops to prevent the chair from going beyond its pre-programmed range.

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7 Technological Characteristics Summary

The technological characteristics between the predicate and proposed device are similar physically and technically. While the wording of the Indications for Use differs, both the subject and predicate devices share the same intended use, as well as equivalent material composition, fundamental scientific technology, principles of operation, and basic design. The predicate device does offer several accessories as standard, such as x-ray viewer and dental handpiece. The DCI Edge chair does not offer these as standard. However, the intended use and the fundamental scientific technology are still the same. The x-ray viewer and dental handpieces are available from other companies as aftermarket devices.

PARAMETER	DCI EDGE CHAIRW/OPERATIVE UNIT(K151987)	DCI DENTAL UNIT(K944271)	FOSHION DENTALCHAIR W/OPERATIVE UNIT (K071353)
Intended Use	The DCI Edge Dental Chairwith operative unit is a deviceintended to position the patientin such a manner to provideto the dental practitionervisual and manual accessto the oral cavity. This deviceshould provide for the ergonomicnecessities of most patients, bothadults and children, throughoutits range of movement. Thedevice shall also be the meansof supporting delivery systemsfor the purpose of standarddental procedures.	The DCI Dental Unit isintended to supply powerand serve as a base fordental devices and accessories.The product includes a dentalunit, 3-way syringe and airfoot control. The unit isintended for use in thedental office or clinic and isused by trained dentistsand/or technicians andassistants. It can be attachedto a chair or stand alone.	The Foshion Chair MountedDental Unit is intended tosupply power and serve as abase for dental devices andaccessories. The productincludes a dental chair,operating light x-ray viewer,control panel, low and highspeed turbine handpieces,3- way syringe and air footcontrol. The unit is intendedfor use in the dental officeor clinic and is used bytrained dentists and/ordental technicians andassistants.
Features
Seat and backrestpositioning	Pre-programmed settings.	N/A	Pre-programmed settings.
Multiple HandpieceAutomatic ControlSystem	Three handpiece controls arestandard, up to five handpiecesoptional. Handpieces are notsold with the unit.	Three handpiece controls arestandard, up to fivehandpieces optional.Handpieces are not sold withthe unit.	Three handpiece controlsare standard, up to fivehandpiece optional. Unit issold with handpieces.
Water Control Systemfor Handpieces andSyringes	Non-retracting water system forhandpieces and syringes.Retracting available with check-valve.	Non-retracting water systemfor handpieces and syringes.Retracting available withcheck-valve.	Non-retracting watersystem for handpieces andsyringes. Retractingavailable with check-valve.
3-Way Syringe	3-Way syringe with quickdisconnect tip andautoclavable tips standard.	3-Way syringe with quickdisconnect tip andautoclavable tips standard.	3-Way syringe with quickdisconnect tip andautoclavable tipsstandard.
Instrument Holders	Multiple position holder.	Multiple position	Multiple position holder.
		holder.
Assistant Holders	Multiple position holder.	Multiple position	Multiple position holder.
		holder.
Gravity Drain Cuspidor	Cuspidor available.	Cuspidor available.	Cuspidor available.
Mounting	Chair and cart.	Chair and cart.	Chair and cart.
Vacuum System	HVE and saliva	HVE and saliva ejectors	HVE and saliva ejectors
	ejectors available.	available.	available.
Foot Control	Standard.	Standard.	Standard.
Utility Box with Air and	Standard.	Optional w/Chair	Standard.
Water Shut-off,
Regulators and Filters
Control Pad for	Standard	Optional w/Chair	Standard
Chair Movement
and Light
Heated Water Supply	Available.	Optional w/Chair	Available.
Dental Light	Available.	Available	Available.
Turbines	Can be added.	Can be added	Standard
Upholstery	Standard	Standard if ordered	Standard
		w/Chair
Arm Rest	Standard	Standard if ordered	Standard
		w/Chair
Materials
Construction	Metal structural support,	Metal structural support,	Metal structural support,
	sheet metal, plastic	sheet metal plastic	sheet metal, plastic covers.
	covers. Details contain in	covers.
	product manual.

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305 N. Springbrook Road, Newberg, Oregon, USA 97132

8 Non Clinical Testing

The DCI Edge Dental Chair with Operative Unit complies with the following performance standards:

ISO 14971 Second Edition 2007-03-01 Medical devices Application of risk management to medical devices.
· AAMI ANSI ISO 10993-1:209/(R) 2013 Biological evaluation of medical devices-Part1: Evaluation and testing within a risk management process.
ANSI/AAMI ES60601-1:2005/(R)2012 Issued: 2012/01/17 Medical Electrical Equipment—Part 1: General requirements for basic safety and essential performance with C1:2009 (R)2012 and A2:2010/(R)2012
· ISO 60601-1-2:2007 Medical electrical equipment –Part1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and test.
· IEC 62366 Edition 1.1 Medical devices-Application of usability engineering to medical devices.
· IEC 80601-2-60:2012 Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment.

9 Conclusion

DCI, ITL has demonstrated that, for the purposes of FDA's regulation of medical devices, the DCI Edge Dental Chair with Operative Unit is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

Regulation Number and Section

§ 872.6250 Dental chair and accessories.

(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.