1. Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
1. Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
1. Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
Porcelain etch substitute: for preparation of intaglio surface of porcelain 4. restorations in place of etching with hydrofluoric acid in the mouth.
1. Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
1. Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
1. Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
1. Endodontic post preparation : for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
Denture repairs: for preparation of denture base to facilitate repairs. 9.
1. Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before rebonding. For enhancement of adhesive to tooth structure.

Device Description

ACCU-PREP is virtually identical to the MICROETCHER in design and function. The two models of the device, Type I and Type II are identical in design and function but differ cosmetically. That is Type I is nearly identical to the MICROETCHER and Type II is esthetically more pleasing. In addition, Type II has the abrasive reservoir in the center of the handpiece as opposed to the back end as in the MICROETCHER and it is completely autoclavable. The ACCU-PREP operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional Equivalence	"Functionally identical to the predicate device"
Shear Bond Strength	"No statistically significant difference was found" in shear bond tests (p ≥ 0.05) compared to the predicate device.
Surface Abrasion Characteristics	"Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results" compared to the predicate device.
Material/Abrasive Compatibility	Both devices "employ 50 um aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 um"
Intended Uses	The ACCU-PREP is intended for a range of dental applications, with no specific performance metrics stated for each individual indication beyond functional equivalence to the predicate.
Aesthetic Difference	Type I is "nearly identical" to the predicate, and Type II is "esthetically more pleasing." (This is a design difference, not a functional performance criterion per se, but noted as a key distinction).
Operating Pressure	ACCU-PREP "operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document states that "Shear bond tests were performed on human extracted teeth." However, the exact sample size (number of teeth) is not specified.
Data Provenance:
- Country of Origin: Not specified, but implied to be in the US where BISCO, Inc. is located.
- Retrospective or Prospective: Not explicitly stated, but the description of performing "Shear bond tests" and "Examination of abraded surfaces using Scanning Electron Microscopy" suggests a prospective experimental study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study was conducted by James L. Sandrik, Ph.D., who is the Director of Technical Affairs at Bisco, Inc. While he authored the report and implicitly oversaw the testing, it's not clear if he or other external experts established a formal "ground truth" for the test results outside of standard scientific measurement and comparison.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The study involved objective measurements (shear bond strength, SEM imaging) and direct comparison to a predicate device, rather than subjective interpretation requiring adjudication among multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done?: No. This type of study is typically performed for diagnostic devices where human interpretation of images or other data is central to the device's function. The ACCU-PREP is a dental abrading device, and its performance is evaluated through material science and mechanical testing, not human-in-the-loop diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done?: Yes, in essence. The performance tests (shear bond, SEM) evaluated the device's physical effects and functional output directly, without ongoing human intervention in the operation of the device during the test or interpretation of the results in a human-in-the-loop fashion. The comparison was device-to-device.

7. Type of Ground Truth Used:

Ground Truth Type:
- Predicate Device Performance: The primary "ground truth" or reference point was the established performance of the legally marketed predicate device, MICROETCHER, in terms of shear bond strength and surface morphology.
- Objective Measurements: Shear bond tests (quantifying mechanical strength) and Scanning Electron Microscopy (visualizing surface characteristics) provided objective data for comparison.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This device is a physical tool, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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JUL 1 1997

BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for ACCU-PREP™

510(k) SUMMARY

As Required by the Safe Medical Devices Act of 1990

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE MICROETCHER™

MICROETCHER is a compressed air driven dental sandblasting device intended for intra-oral use to roughen dental hard tissues or restorative materials to enhance bonding of resin materials. The device is a hand held instrument resembling a dental handpiece in shape and function. The unit is operated at 60-100 psig of compressed air. A venturi principle forces an abrasive, aluminum oxide (50um particle size), toward the object to be abraded. The high velocity abrasive imparts sufficient energy to abrade and remove material.

The device can be used extra-orally for similar purposes, that is, to roughen dental restorations to enhance bonding or to behave as a cleaning device.

DESCRIPTION OF APPLICANT DEVICE

ACCU-PREP™

INTENDED USES OF APPLICANT DEVICE

ACCU-PREP is intended to be used to abrade and enhance the bond between the prepared tooth and cast dental metals for Maryland bridges, for cementation of cast metal restorations, for porcelain repair, as a porcelain etch substitute, to prepare indirect composite restorations for cementation, for repair of composite or resin restorations, repair of acrylic facings on cast restorations, endodontic post preparation, denture repairs, and orthodontic applications such as: preparation of brackets to enhance bonding, cement removal from brackets, and enhancement of adhesion to tooth structure.

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SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

The scientific concepts of this device are basic. A relatively high velocity stream of compressed gas (air), when blown across the opening of a tube set at 90 degrees to the air stream creates a low pressure at the opposite end of the perpendicular tube. This low pressure (vacuum) sucks up an abrasive powder from a reservoir and propels the abrasive thereby abrading the surface of an object in its path. The phenomenon is analogous to a perfume bottle. The abrasive powder behaves as the perfume, that is, as air is blown across the opening the abrasive powder is blown into the air stream.

Comparison of ACCU-PREP to the predicate device shows both are very similar with the major difference being esthetics. The proposed new products, Types I and II, are functionally identical to the predicate device but are more esthetically acceptable top the patient as well as to the dentistry and dental auxiliary. One notable difference between the tow is the applicant device operates at lower air pressure.

Both employ 50 um aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 um

Since both devices are appear essentially identical their performances were compared by testing in actual use situations. Shear bond tests were performed on human extracted teeth using identical conditions with the only difference being the device abrading the substrate. No statistically significant difference was found in this test at p ≥ 0.05. Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results.

James L. Sandvik

James L. Sandrik, Ph.D. BISCO. Inc. Itasca, IL 60143

February 7, 1997

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. James L. Sandrik, Ph.D. Director of Technical Affairs Bisco, Incorporated 1500 West Thorndale Avenue 60143 Itasca, Illinois

JUL ** 1 1997

K970484 Re : Accu-Prep Trade Name: Requlatory Class: III Product Code: KOJ February 7, 1997 Dated: February 10, 1997 Received:

Dear Dr. Sandrik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker 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 marrol one act. The general controls provisions of the Act -- include requirements for annual registration, listing of devices, qood 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) regulation (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. Please note: this response to your premarket not fication 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.

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Page 2 - Dr. Sandrik

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sio\n puivalence of your device to a legally Finalig of babbandabice results in a classification for your markets production of mits 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene orgulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 at (301) 443-6597.

Sincerely yours,

Timothy A. Ulatowski

y A. Ulatowski Timo 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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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for ACCU-PREP™

INDICATIONS for USE

510(k) Number (if known): --

Device Name: ACCU-PREP

Indications for Use:.

1. Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
1. Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
1. Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
Porcelain etch substitute: for preparation of intaglio surface of porcelain 4. restorations in place of etching with hydrofluoric acid in the mouth.
1. Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
1. Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
1. Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
1. Endodontic post preparation : for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
Denture repairs: for preparation of denture base to facilitate repairs. 9.
1. Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before rebonding. For enhancement of adhesive to tooth structure.

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

Concurrence of CDRL, Office of Device Evaluation (ODE)

(Division Sign-Off) Surar Rasver
Division of Dental, Infection Control,
and General Hospital Device
510(k) Number K170484

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.”