The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.

Device Description

The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site. The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.

AI/ML Overview

The provided text describes a 510(k) submission for an "Amorphous Diamond Coated Drill" and its comparison to a predicate device. It specifically states "Biological and mechanical test data were performed to support the indications for use." However, it does not provide specific details about the acceptance criteria or the actual results of these tests, nor does it detail a study proving the device meets these criteria.

Therefore, for almost all points requested in the prompt, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Not Available. The document states that "Biological and mechanical test data were performed to support the indications for use," but it does not specify what those acceptance criteria were or what the reported performance was.

2. Sample sized used for the test set and the data provenance:

Not Available. The document mentions "biological and mechanical test data" but does not provide any details about the sample sizes used or the provenance of the data (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Available. This information typically pertains to studies involving human interpretation or clinical outcomes, which are not detailed here. The tests mentioned are "biological and mechanical," suggesting laboratory or bench testing.

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

Not Applicable/Not Available. As above, this is usually relevant for studies requiring expert consensus on a subjective outcome, not for mechanical or biological bench testing.

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 device is a surgical drill, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a surgical drill.

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

Not Available. The document states "Biological and mechanical test data were performed," implying the ground truth would be based on established biological (e.g., biocompatibility standards) and mechanical (e.g., wear resistance, cutting efficiency standards) testing methodologies. However, the specific types of ground truth (e.g., specific ASTM standards, ISO standards) are not mentioned.

8. The sample size for the training set:

Not Applicable. This device is a physical surgical tool and does not involve AI/machine learning, so there is no training set in the conventional sense.

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

Not Applicable. As above, no training set for this type of device.

Summary of available information regarding performance:

The manufacturer states: "Biological and mechanical test data were performed to support the indications for use."
The device's intended use is "to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool."
The comparison table lists characteristics of the new device against a predicate device, noting differences in "Coating" (Amorphous Diamond vs. Titanium Nitride) and "Cutting Flutes" (Three vs. Two). This implies that the biological and mechanical tests would focus on these differing characteristics relative to the predicate device to demonstrate substantial equivalence, particularly concerning corrosion resistance and longevity.

Conclusion:

While the document confirms that performance data were generated, it does not provide the specific details regarding acceptance criteria, study methodology, sample sizes, or results that your prompt requests. This level of detail is typically found in the predicate device's 510(k) or in external reports, not always summarized comprehensively in the 510(k) notification itself during the initial submission.

Summary

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JUN 10 1999

Original 510(k) Amorphous Diamond Coated Drill

Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be 'K990896'. The writing style is cursive and somewhat stylized, with some characters connected to each other. The image is in black and white.

Section 6 510(k) Summary

Manufacturer Information:

... . . . -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Submitter's Name:	Nobel Biocare USA, Inc.
Address:	22895 Eastpark DriveYorba Linda, CA 92887USA
Contact Name:	Kim RendonRegulatory Affairs Analyst
Phone:	714-282-4800
Date Prepared:	March 1999

Device Name:

Common Name:	Surgical Drill.
Trade Name:	Amorphous Diamond Coated Drill.
Classification Name:	Bone cutting instrument and accessories.

Predicate Device:

Substantial equivalence is claimed to Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill.

Device Description:

Device Function: The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site.

Scientific Concepts: Bone cutting instrument.

Page 1 of 2

Nobel Biocare USA March 1999

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Characteristics: The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.

Intended Use:

The drill is used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.

Comparison to Predicate:

Characteristic	Nobel BiocareSteri-Oss SystemTitanium Nitride CoatedDrills	Amorphous DiamondCoated Drill
Material	Stainless Steel	Same
Coating	Titanium Nitride	Amorphous Diamond
Design	Latch end to use withhandpiece	Same
Cutting Flutes	Two	Three
Irrigation	Internal	Internal or external
Sterility	Non-sterile	Same
Packaging	Plastic vial with foaminserts	Same

Performance Data:

Biological and mechanical test data were performed to support the indications for use.

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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 an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

Ms. Kim Rendon Regulatory Affairs Analyst Nobel Biocare USA, Incorporated 22895 East Park Drive Yorba Linda, California 92887

Re : K990846 Amorphous Diamond Coated Drill Trade Name: Requlatory Class: II Product Code: DZI Dated: March 12, 1999 Received: March 15, 1999

Dear Ms. Rendon:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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) requlation (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 requlation 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 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 - Ms. Rendon

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 requlation (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" (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 (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours

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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Original 510(k) Amorphous Diamond Coated Drill

Section 8 Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: Amorphous Diamond Coated Drill

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Kunn
	(Division Sign-Off)
	Division of Dental, Infection Control,
	and General Hospital Devices
510(k) Number	K990846
Prescription Use _(Per 21 CFR 801.109)	OR Over-The-Counter Use _

(Optional Format 1-2-96)

Nobel Biocare USA March 1999

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.