The provided text is a 510(k) summary for the CP Bracket System, an orthodontic bracket. It describes the device, its intended use, and its technological characteristics. However, the text does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication as typically found in studies for AI/ML devices or studies directly comparing performance against specific metrics.

The submission focuses on establishing substantial equivalence to a predicate device (Mystique® Brackets) based on:

Prior use of components in legally marketed devices.
Biocompatibility testing.
Market experience in Japan (20,000 units sold with only four user-error complaints).

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document. The submission's approach is not based on a statistical performance study against defined acceptance criteria but rather on demonstrating equivalence and safety through material composition, biocompatibility, and limited market surveillance.

Here's a breakdown of what can be surmised or explicitly stated from the text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in text	The device components have been used in DENTSPLY's legally marketed devices.
Not specified in text	Biocompatibility testing was completed and results support the device.
Not specified in text	Approximately 20,000 units sold in Japan since 2003 with only 4 complaints (attributed to user error).

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

Sample Size: Not applicable in the context of a prospective clinical or technical "test set" as defined for performance studies. The document mentions "Approximately 20,000 units of this bracket have been sold in Japan since 2003," which represents real-world usage data, not a controlled test set.
Data Provenance: Japan (for the 20,000 units sold). Retrospective (market surveillance data).

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

Not applicable. There was no explicit "ground truth" establishment by experts for a test set described in this submission. The 4 complaints received were "investigated" and attributed to user error, implying some form of review, but not a formal expert panel for ground truth.

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

Not applicable. No formal adjudication method for a test set is described.

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:

No. This is a physical medical device (orthodontic bracket), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study involving AI assistance was performed.

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

No. This is a physical medical device.

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

For the market surveillance data, the "ground truth" for the complaints was the result of an "investigation" which concluded "user failing to follow the adhesive manufacturer's instructions." This is an outcome of an internal investigation rather than an independent expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary

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NOV - 1 2005 510(k) SUMMARY

Ko 5 2370

DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872

CONTACT: Helen Lewis August 25, 2005 DATE PREPARED: TRADE OR PROPRIETARY NAME: CP Bracket System Orthodontic bracket (872.5470) CLASSIFICATION NAME: PREDICATE DEVICES: Orthodontic Ceramic Brackets (K042178)

DEVICE DESCRIPTION: The CP Brackets are ceramic orthodontic brackets will be used for a complete orthodontic treatment. The brackets are single-use devices.

INTENDED USE: The CP Brackets are indicated for orthodontic movement of teeth.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in the CP Brackets have been used in DENTSPLY's legally marketed devices.

Biocompatibility testing was completed and the results support the device. A table of the results is included in this submission.

Approximately 20,000 units of this bracket have been sold in Japan since 2003. Only four complaints were received which, upon investigation, were caused by the user failing to follow the adhesive manufacturer's instructions.

We believe that the prior use of the components of the CP Brackets in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the CP Bracket System for the intended uses.

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Predicate Device Information:

Predicate Device 510(k) FDA Substantial Equivalence Letter and Indications for Use Page

Predicate Device Tradename

Mystique® Brackets

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs Dentsply International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17404-0872

Re: K052370

Trade/Device Name: CP Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: August 25, 2005 Received: August 30, 2005

Dear Ms. Lewis:

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.

NOV - 1 2005

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Page 2 - Ms. Lewis

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/industrv/support/index.html.

Sincerely yours.

Syutie y. Michai Oms.

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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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

10523 510(K) Number (if known)

CP Bracket System Device Name:

Indications for Use:

The CP Bracket System is indicated for orthodontic movement of teeth.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

an... I

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K052374

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.