The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva to be more easily removed from the body shell of the handpiece thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.

AI/ML Overview

The provided text describes a 510(k) summary for the "Vector F Series" High-speed Dental Handpieces, aiming to demonstrate substantial equivalence to existing predicate devices. The information provided focuses on the physical and functional characteristics of the device compared to its predicates, rather than a clinical study evaluating diagnostic or treatment performance with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document as it pertains to a medical device clearance process for a dental handpiece, not an AI-powered diagnostic tool.

However, I can extract the information relevant to the device's characteristics and its comparison to the predicate devices, which serve as the basis for its "acceptance" from a regulatory standpoint (substantial equivalence).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental handpiece), "acceptance criteria" are typically defined by demonstrating substantial equivalence to predicate devices in terms of intended use, materials, energy source, and sterilization methods. The performance is assessed against these established characteristics of the predicate, not against clinical outcome metrics you'd expect from a diagnostic AI.

Element of Comparison	Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Vector F Series)
Intended Use	General dentistry by trained professional (StarDental 430 Series; KaVO 625/634)	SAME
Materials	As per predicate devices (implied by "constructed of identical materials")	Handpiece housing: Copper-tin Bronze
		Turbine Housing: Nickel silver CDA alloy
		Turbine housing cap: Stainless steel
		Plating: Chrome
Energy Source	Air pressure, 30-32 psi (StarDental 430 Series; KaVO 625/634)	SAME, 30-35 psi
Sterilization	Steam autoclave or chemical vapor (StarDental 430 Series; KaVO 625/634)	SAME (and "ability to repeatedly sterilize the devices has been confirmed through performance of a validation protocol")
Bur Retention Strength	6 lbs (KaVo 625CD - implied as predicate's performance)	8 lbs (increased from predicate)
Weight	Not explicitly stated for predicate, but implied as a design element	2 oz (reduced from predicate)
Knurling	Not explicitly stated for predicate	Softened (to improve cleaning and tactile sense)

2. Sample size used for the test set and the data provenance

This information is not applicable to this document. The submission is for a physical medical device (dental handpiece) and does not involve a "test set" of data in the context of an AI or diagnostic study. The "test" here refers to validation protocols for manufacturing and sterilization, not a clinical trial or performance study on a patient dataset.

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. There is no "ground truth" establishment by experts in the context of a dataset for a dental handpiece's mechanical performance.

4. Adjudication method for the test set

This information is not applicable. There is no test set or adjudication method described for a diagnostic or AI study.

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. This is not an AI-assisted device, and no MRMC study was conducted or described.

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

This information is not applicable. This is not an algorithm or AI device.

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

This information is not applicable. The "ground truth" for a dental handpiece relates to its engineering specifications, material properties, and functionality (e.g., sterilization effectiveness, bur retention strength), which are verified through engineering tests and validation protocols, not clinical ground truth.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a machine learning model for a physical dental handpiece.

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

This information is not applicable. As there is no training set, there is no ground truth for one to be established.

Summary based on the provided document:

The "acceptance criteria" for the Vector F Series dental handpiece, as described in this 510(k) summary, are met by demonstrating its "substantial equivalence" to legally marketed predicate devices (Star Dental 430 Series and KaVO 625/634 Handpieces). This means the device's intended use, materials, energy source, and sterilization methods are either identical or functionally equivalent to the predicates. The primary "study" proving this substantial equivalence is the comparison of specifications and design characteristics presented in the 510(k) submission, along with a validation protocol for repeated sterilization to confirm its effectiveness. The document highlights specific improvements in bur retention strength (8 lbs vs. 6 lbs of predicate) and reduced weight, which are presented as enhancements without compromising safety or effectiveness.

Summary

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MAY 1 7 2002

EXHIBIT 2 Vector Research & Development 1909 70th Ave W, #C University Place, WA 98466 Tel (253) 564-5084 Fax (253) 564-4927 December 13, 2001 Contact: Brent Bigler

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: "Vector F Series" High-speed Dental Handpieces. Classification Name: EFB Common/Usual Name: HANDPIECE, AIR-POWERED, DENTAL
1. Equivalent legally marketed device: Star Dental 430 Series High Speed Handpiece, K982593 and KaVO 625/634 Handpieces, K760929
1. Indications for Use (intended use) The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
1. Description of the Device: The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva to be more easily removed from the body shell of the handpiece thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.

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Element of Comparison	StarDental 430 Series,K982593; KaVO 625/634Handpieces, K760929	Vector F Series
Intended Use	General dentistry by trained professional.	SAME
Materials:	Handpiece housing	Copper-tin Bronze
	Turbine Housing	Nickel silver CDA alloy
	Turbine housing cap	Stainless steel
	Plating	Chrome
Energy source	Air pressure, 30-32 psi	SAME, 30-35 psi
Sterilization	Steam autoclave or chemical vapor	SAME

1. Safety and Effectiveness, comparison to predicate device:
1. Conclusion: In all respects, the Vector F Series High-speed Dental Handpieces are substantially equivalent to one or more air-powered dental handpieces currently marketed in the USA. The handpieces are constructed of identical materials and marketed in and Obstandards. The ability to repeatedly sterilize the devices has been confirmed through performance of a validation protocol.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2002

Vector Research & Development C/O Mr. Daniel Kamm Kamm & Associates P. O. Box 7007 Deerfield, Illinois 60015

Re: K020113

Trade/Device Name: Vector F Series High-Speed Dental Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece Regulatory Class: I Product Code: EBF Dated: March 25, 2002 Received: March 26, 2002

Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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.

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Page 2 - Mr. Kamm

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cucciniello

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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KO20113

j) Indications for Use

510(k) Number

Device Name: "Vector F Series" High-speed Dental Handpieces.

Indications for Use: The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use OR Prescription Use V (Per 21 CFR 801.109) seen (Division Sign-Off)
Division of Dental, (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Deviceുപ്പുഴ (Division of Dental, Innection)
and General Hospital Devices (000) and GeNember –

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.