The 3M ESPE Lava Chairside Oral Scanner (Lava COS) is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.

Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.

In this 510K pre-market notification, a powdering material and powder sprayer is added as an accessory. The 'patterning powder' to be applied to the teeth prior to obtaining 3D CAD/CAM images. The powder is intended to enhance the contrast level of the image and allow for better resolution and accuracy of the CAD/CAM images obtained by the 3M ESPE Lava Chairside Oral Scanner System. This powder is similar in composition to powders sold for use with the predicate device and as a 'stand alone' material. The powder provided by Brontes meets the applicable requirements for biocompatibility under the recognized standard ISO 10993 and does not add any new issues of safety or effectiveness.

AI/ML Overview

The provided text is a 510(k) summary for the 3M ESPE Lava Chairside Oral Scanner (COS). It details the device's intended use and performance standards but lacks specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot fully complete the requested table or answer all sub-questions based solely on the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to general performance standards and biocompatibility requirements.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets those criteria are not available. The document states the device "meets the following Performance Standards" which are general regulatory and safety standards, not specific performance metrics like accuracy, resolution, or scanning speed.

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Not explicitly stated in the document)
Specific quantitative performance metrics (e.g., accuracy, resolution, scan time, ease of use) are not provided in this 510(k) summary.	Specific quantitative performance results are not provided in this 510(k) summary. The document generally concludes that the device is "safe and effective, as indicated, for the intended use" when used according to instructions.
Compliance with ISO 10993 for biocompatibility of powder material	Powder meets applicable requirements for biocompatibility under ISO 10993.
Compliance with various IEC and ISO standards for medical electrical equipment and risk management.	The device meets these performance standards (listed in section {1}).

Study Details (Based on available information)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the document. The 510(k) summary does not describe a specific clinical or performance study with a defined test set sample size. The focus is on regulatory compliance and substantial equivalence to a predicate device.
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 explicitly stated in the document. This type of information would typically be part of a detailed performance study, which is not summarized here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated in the document. Adjudication methods are usually relevant for studies involving human interpretation or subjective assessments, which are not described in this regulatory summary.
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:
- No. Not applicable/Not performed. The 3M ESPE Lava Chairside Oral Scanner is an "optical impression system (CAD/CAM) used to record the topographical characteristics of teeth." It is a device for image acquisition to create 3D models, not an AI-assisted diagnostic tool that would involve human readers or interpretation in the way an MRMC study typically assesses. The document does not describe any AI component in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance implied for core function but details absent. The device's primary function is to capture 3D topographical data. The software automatically creates a 3D model. While this process is inherently "standalone" in its data capture and model generation, the document does not provide metrics for this standalone performance (e.g., accuracy of the 3D model compared to a physical reference) from a specific study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the document. For a device that measures topographical characteristics, ground truth would typically be highly accurate physical measurements (e.g., from CMMs or highly precise optical scanners) of the actual teeth/models. However, no such ground truth method is described. The biocompatibility ground truth is established via ISO standard testing.
The sample size for the training set:
- Not applicable/Not stated. This device is an optical scanner and CAD/CAM system, not typically an AI/machine learning system that relies on a "training set" in the conventional sense for deep learning. Its performance is based on optical principles and software algorithms for 3D reconstruction.
How the ground truth for the training set was established:
- Not applicable/Not stated. As above, the concept of a training set and its associated ground truth doesn't apply to the described device in the manner usually associated with AI/ML systems.

Summary of what is known:

The device is an optical impression system for CAD/CAM in dentistry.
It captures 3D images of teeth using a wand, computer, and proprietary software.
A powder accessory enhances contrast for better resolution and accuracy.
The powder's biocompatibility was assessed according to ISO 10993.
The device claims to meet various regulatory and safety standards (listed under "Performance Standards").
The 510(k) established substantial equivalence to the Sirona Dental Systems GmbH. CEREC 3 Ceramic Dental Restoration System.

What is not provided in this 510(k) summary:

Specific quantitative acceptance criteria for performance metrics (e.g., accuracy, precision, resolution).
Results from any specific performance study, including sample sizes, data provenance, ground truth methodologies, or expert involvement.
Information about AI components, MRMC studies, or training sets.

Summary

{0}------------------------------------------------

K073199

5.0 510K Summary

Applicant: Brontes Technologies, Inc. 10 Maguire Road, Suite 310 Lexington, MA 02421 Tel: (781) 541-5200

Contact: Mark Olsen

DEC 2 1 2007

510(k) Numbers and Product Codes of equivalent devices:

Brontes Technologies, Inc. (A 3M Company), Lexington, MA 3M ESPE Lava Chairside Oral Scanner Code: NOF; 510K Exempt

Sirona Dental Systems GmbH. CEREC 3 Ceramic Dental Restoration Systern: Code: ELW; (K994172) S.E. January 7, 2000

Indications for Use

The 3M ESPE Lava Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

Device Description

Performance Standards

The 3M ESPE Lava Chairside Oral Scanner (COS) meets the following Performance Standards:

. Tripartite Guidance - 1987 (G87-1)

{1}------------------------------------------------

Special Controls Guidance Document: Optical Impression Systems for . Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, Part . I: Evaluation and Testing
ISO/EN 10993-5; 1999 Tests for In-Vitro Cytotoxicity, 200 Ed .
. ISO/EN 10993-10; 2002 Tests for Irritation and Delayed Type Hypersensitivity, 2nd Ed
. IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment Part 1 General . Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests
IEC 60601-1-4 medical Electrical Equipment Part 1 Medical . Electrical Equipment part 1-4: General Requirements for Collateral Standard: Programmable Electrical Medical Systems
FDA Guidance on Dental Handpieces (Draft) July 1995 .
ISO 7405 Pre-Clinical evaluation of Biocompatibility of medical . devices used in dentistry, test methods for dental materials.
FDA; Guidance for the Content of Pre-market Submissions for . Software Contained in Medical Devices - May 2005
. FDA Guidance; Cyber Security for Networked Medical Devices Containing Off the Shelf Software
. ISO 14971 - Medical devices - Risk management - Part 1: Application of risk analysis

Conclusion:

There are more similarities than differences between the predicate devices and the 3M ESPE Lava Chairside Oral Scanner (COS). The predicate devices and 3M ESPE Lava Chairside Oral Scanner have the same intended use, warnings and contraindications. Both the 3M ESPE Lava Chairside Oral Scanner and predicate device (CEREC 3) may be used with a powder and powdering delivery system. When used in accordance with the instructions for use, by qualified personnel, the 3M ESPE Lava Chairside Oral Scanner is safe and effective, as indicated, for the intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Brontes Technologies, Incorporated C/O Mr. John Greenbaum President Generic Devices Consulting, Incorporated 20310 SW 48th Street Southwest Ranches, Florida 33332

Re: K073199

Trade/Device Name: 3M ESPE Lava Chairside Oral Scanner (COS) Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 13, 2007 Received: November 13, 2007

Dear Mr. Greenbaum:

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.

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Page 2 - Mr. Christenson

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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sheila H. Murphy, DPs, Charter R.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K073199

Device Name: 3M ESPE Lava Chairside Oral Scanner (COS)

Indications For Use:

The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

Prescription Use X (Per 21 CRF 801.109)

Over - The - Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

(Division Sign-Off Division of Anesthesiology C neral Hospital Infection Control, Dental Devices

510(k) Number: K073144

Regulation Number and Section

§ 872.3661 Optical Impression Systems for CAD/CAM.

(a)
Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.(b)
Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).