The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm

AI/ML Overview

The provided text is a 510(k) summary for a medical device (B-Powder) and a clearance letter from the FDA. This type of documentation focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not present in the provided text.

Here's why and what can be extracted:

No Acceptance Criteria or Performance Reporting: The 510(k) process for this device (B-Powder) establishes that it is "substantially equivalent" to already marketed devices. This means the manufacturer did not have to conduct new clinical trials to prove efficacy or safety against specific performance metrics, but rather demonstrate that its characteristics and intended use are similar enough to existing, cleared devices.
Focus on Material Composition and Intended Use: The summary focuses on the material composition (beta-tricalcium phosphate with some hydroxyapatite) and its intended use (polishing/prophy powder) being similar to predicate devices.
Analytical Testing, Not Clinical Studies: The "studies" mentioned (X-ray diffraction, ICP/MS, atomic absorption spectrophotometry) are analytical tests to characterize the material, not clinical performance studies. These tests confirm the material content and the absence of harmful elements, but they don't assess clinical outcomes like cleaning effectiveness or polishing quality in a human population.
MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are typically relevant for AI-powered diagnostic or prognostic devices that perform classifications or measurements. The B-Powder is a physical dental material, so these types of studies are not applicable.

In summary, based only on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, expert ground truth, or AI study specifics because this information is not part of a 510(k) submission for this type of device.

The document states: "Compliance with Performance Standards: No performance standards are applicable." This directly indicates that there aren't formal quantitative acceptance criteria for this device that would be proven by a performance study.

Here's what I can extract and explain based on the provided text, addressing the spirit of your request where possible by highlighting what was not done or not required for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated for this device)	Reported Device Performance (Focus on equivalence to predicates)
Material Composition Equivalence	X-ray diffraction showed the main constituent is β-tricalcium phosphate with a small amount of hydroxyapatite, demonstrating similarity to materials used in existing devices.
Purity/Safety (Harmful Elements)	Inductively coupled plasma/mass spectroscopy (ICP/MS) for cadmium (Cd) and lead (Pb) and atomic absorption spectrophotometry for mercury (Hg) and arsenic (As) showed levels of these harmful elements below 0.5 ppm. This indicates acceptable material purity for its intended use and similarity to established safe materials.
Intended Use Equivalence	The device is intended for use as a polishing or prophy powder, which is the "same as that for Clinpro Prophy Powder (K021450) and New Prophy Powder (K014188)."
Technological Characteristics Equivalence	Described as "fine powders, relatively inert, biocompatible and previously used for periodontal purposes," similar to predicate devices.
Biocompatibility	Implicitly established by material composition and a history of use in similar devices. No specific biocompatibility study report is provided, but the materials are described as "well-established and well understood in the industry."
No performance standards are applicable. ("Compliance with Performance Standards" section in {0})	The device does not have specific quantitative performance standards to meet; rather, it demonstrates substantial equivalence to predicate devices which have already established safety and effectiveness for their intended use. Therefore, no direct clinical performance metrics (e.g., "removes X% of stain") are provided or required in this 510(k).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported as part of this 510(k) submission. The evaluation was based on material characterization and comparison to predicate devices, not clinical performance testing.

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)
Not applicable. No ground truth establishment by experts for a test set was required or mentioned for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used or 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
Not applicable. This device is a dental polishing powder, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental polishing powder, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for clearance was "substantial equivalence" to legally marketed predicate devices, not performance against an independently established clinical ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set
Not applicable. There was no "training set" for this device, as it is a material and not an algorithm.

9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of an algorithm's development was relevant or established for this submission.

Summary

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

K063236

510(k) Summary

FEB ! 6 2007

Submitter: Satoshi Noake, International Division, BrainBase Corporation, Tokyo, Japan, Phone: +81-3-3778-0745, Fax: + 81-3-3778-4910.

I. Classification Name and Number: Air Brush (accessory),
II. Product name(s):

XIV.

II.1 . Common or Usual Name: prophy powder, polishing powder
II.2. Proprietary Name: B-Powder
III. Registration No: 3005488486
Compliance with Performance Standards: No performance standards are applicable. IV. However we followed "Class II Special Controls Guidance: Document: Dental Bone Grafting Material Devices", issued April 28, 2005 where applicable because of the materials content.
V. Description of the Device: The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm
Labels and Labeling: Draft labels of ß-powder, instructions for use, warnings and VI. contraindications are provided.
Substantial Equivalence: ß Powder is intended for use as a polishing or prophy VII. powder. This use is the same as that for Clinpro Prophy Powder, cleared in K021450 by 3M Espe Dental Products, and New Prophy Powder, cleared in K014188 by Dentsply, Intl. The materials are the same or similar to those that have been used in commercially marketed products before.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use as predicate devices, for cleaning, polishing, and restoring the natural esthetics of teeth.

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

The technological characteristics for this product are similar to those of the predicate devices and those currently on the market They are fine powders, relatively inert, biocompatible and previously used for periodontal purposes.
Descriptive information provided shows that the materials from which this device is made are well-established and well understood in the industry and among professional users.
The FDA "Decision-Making Process" chart was used and appears in Appendix V.

(End of Summary)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus in its talons. The emblem is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Satoshi Noake Brainbase Corporation Yoneyama 2nd Building 6F, 22-13, Oi 1-chome Shinagawa-ku, Tokyo Japan 140-0014

FEB 16 2007

Re: K063236 Trade/Device Name: B-Powder Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: February 5, 2007 Received: February 9, 2007

Dear Mr. Noake:

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.

{3}------------------------------------------------

Page 2 - Mr. Noake

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.

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

{4}------------------------------------------------

XII. Indications for Use

510(k) Number: (not assigned)

Device Name: β - Powder

Indications for Use:

Cleaning, polishing and restoring natural esthetics of tooth enamel.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rung

Are (200 Off) ivisua of Anesthestology, General Hospital, non Control, Dental Devices

Repl. p. 6

K562236

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.”