The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.

Device Description

The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill. The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.

AI/ML Overview

The provided text is a 510(k) summary for the Mach 7 device, an air abrasion pneumatic device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with acceptance criteria and performance metrics in the way modern AI/ML device submissions do.

Therefore, many of the requested fields cannot be directly extracted from this document as the type of study and data required for AI/ML device approval were not applicable to this 2000 submission for a dental device.

However, I can extract information related to the device's indications for use and the basis for its approval.

Here's an attempt to answer using the provided text, noting where specific information is absent due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly stated in the provided 510(k) summary. For a device like the Mach 7, which is a physical dental instrument, typical "acceptance criteria" would likely revolve around technical specifications (e.g., air pressure, particulate feed rate, handpiece design) and potentially performance against predicate devices in terms of efficiency or safety through non-clinical testing. However, these specific criteria and the reported performance against them are not detailed in this summary. The submission relies on "substantial equivalence" to predicate devices.

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

This information is not provided in the document. No specific "test set" in the context of data for performance evaluation is mentioned, as this is not an AI/ML device. The basis for approval is substantial equivalence to legally marketed predicate devices.

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)

This information is not applicable and not provided. No "ground truth" using experts for a test set is mentioned, as this is not an AI/ML device.

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

This information is not applicable and not provided. No adjudication method for a test set is mentioned.

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 and not provided. A MRMC comparative effectiveness study is relevant for AI/ML-assisted diagnostic devices. The Mach 7 is a physical dental device, not an AI system.

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

This information is not applicable and not provided. The Mach 7 is a physical dental device, not an algorithm.

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

This information is not applicable and not provided. No "ground truth" data is mentioned for this device. The basis for approval is substantial equivalence to predicate devices for its intended use.

8. The sample size for the training set

This information is not applicable and not provided. No "training set" is relevant for this physical dental device in the context of an AI/ML submission.

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

This information is not applicable and not provided.

Summary of Device and Basis of Approval (extracted from the document):

Device Name: Mach 7
Company: Kreativ, Inc.
Device Type: Air abrasion pneumatic device
Indications for Use:
- Cavity preparation in Classes I, III, III, IV, and V (Note: Classes I, III, IV, and V are correctly stated, there seems to be a typo repeating "III" in the original text).
- Removal of tooth structure and restorative dental materials.
- Site preparation for pit and fissure sealant therapy.
- Bonding of porcelain and ceramic.
- Restoration prophylaxis.
Mechanism: Combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles.
Predicate Devices: KCP 2000 (K921748), MicroPrep (K932997), Mach 5 (K980216), Mach 6 (K980216).
Basis for Approval: "Substantial equivalence" to the predicate devices. The document states that the "intended use and technical specifications of the Mach 7 are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations." This indicates that the study (or more accurately, the comparison provided to the FDA) was a demonstration of this substantial equivalence, likely through detailed comparisons of specifications, materials, and intended uses against the predicate devices, rather than a clinical trial with specific performance metrics and acceptance criteria as would be expected for a novel AI/ML diagnostic or therapeutic device.

Summary

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JUN 1 5 2000

510K Summary

K 990000

Regulatory Authority: Safe Medical Devices Act of 1990. CFR 807.87

Company Name:

Krcativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123

Company Contact:

Joe Forehand Kreativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123 (619) 514-4235

Device Name:

Mach 7

Predicate Devices:

KCP 2000	K921748	American Dental Technologies
MicroPrep	K932997	Sunrise Technologies
Mach 5	K980216	Kreativ, Inc.
Mach 6	K980216	Kreativ, Inc.

Device and indications for use:

The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill.

The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.

Discussion:

Since the intended use and technical specifications of the Mach 7 are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations, we believe that the Mach 7 is substantially equivalent to the predicate devices and can be marketed under Section 510 (k) of the FD&C Act.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 5 2000

Mr. Joseph M. Forehand Vice President and General Manager Kreativ, Incorporated 9025 Balboa Avenue San Diego, California 92123-1509

K990060 Re : Trade Name: Mach 7 Requlatory Class: II Product Code: KOJ January 8, 1999 Dated: Received: January 8, 1999

Dear Mr. Forehand:

This letter corrects our substantially equivalent letter of June 15, 2000, regarding the Regulatory Class.

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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against mishranding 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug

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Page 2 - Mr. Forehand

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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 53. through 542 of the Act for devices under the Rlectronic 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 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 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 premarket notification" (21CFR 807.97). Other 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/dsma/dsmamain.html".

Sincerely,

Susan Renner

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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Indications Statement

510(k) Number:

Device Name: Mach 7

Indication for Use:

(Please do not write below this line-continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over the Counter Use_

Optional Format 1-2-96

Quentin Humphrey
MD, PhD

(Division Sign-Off) Division of Dental, Infection : ontrol. and General Hospital Devices 14991 510(k) Number _

Regulation Number and Section

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”