The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.

Device Description

The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ULTRATINE Forehead™ device. It describes the device's intended use and claims substantial equivalence to predicate devices. However, this type of regulatory document does not typically include detailed acceptance criteria or the results of a formal study with statistical performance values.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through comprehensive studies with specific performance metrics. The document states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but it does not provide those specific acceptance criteria or the study data itself.

Therefore, I cannot provide the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study results for the ULTRATINE Forehead™ device from the given text.

Based on the provided information, I can offer the following:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the document. The document refers to "applicable standards and fulfill the device requirements as defined in the user specifications," but these specifications are not included.
Reported Device Performance: Not numerically reported in the document. The document generally states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." This is a general claim rather than specific performance data.

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

Sample Size (Test Set): Not provided.
Data Provenance: Not provided. The document mentions "performance evaluations and comparison testing to the predicate devices" but does not detail the nature or source of this data.

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

Not applicable. The document does not describe a study involving expert-established ground truth.

4. Adjudication method for the test set:

Not applicable. The document does not describe a study involving adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 bioabsorbable implant for surgical fixation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not relevant to this product.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

Not applicable. The document does not describe a study that would require a ground truth as typically defined for diagnostic or AI-based devices. The "performance data" likely refers to biomechanical testing, material properties, and biocompatibility, which are assessed against engineering standards rather than a clinical "ground truth."

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device and would not have a training set in that context.

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

Not applicable. (See #8)

In summary, the provided 510(k) document is for a medical device that demonstrates substantial equivalence based on design, materials, function, and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria in the manner one would expect for an AI or diagnostic device.

Summary

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Coapt Systems, Inc.

K060249 f 1 of 2.

510(k) Premarket Notification ULTRATINE Forehead™

510(k) SUMMARY 11

510(k) Summary 11.0

JUN 1 2 2006

Coapt Systems is providing a summary of the safety and effectiveness information available for the ULTRATINE Forehead™ Device. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 8807.92 and pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990.

SPONSOR/APPLICANT NAME AND ADDRESS

Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7600 Facsimile: (650) 213-9336

CONTACT INFORMATION

Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: lruedy@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

January 31, 2006

DEVICE TRADE OR PROPRIETARY NAME

ULTRATINE Forehead™ Device

DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 878.3040 Class: II HWC Product Code:

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06c249p.2of2

510(k) Premarket Notification ULTRATINE ForeheadTM

IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS BEING CLAIMED

Name of Predicate Device	Product Code	Name of Manufacturer	510(k) or PMANumber
ENDOTINE Forehead™	HWC	Coapt Systems, Inc	K023922
Vicryl	GAM	Ethicon	K944110

DEVICE DESCRIPTION

The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.

INTENDED USE STATEMENT

The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.

SUBSTANTIAL EQUIVALANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the ULTRATINE Forehead™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices. The selected predicate devices are used in forehead lift procedures. The differences between the ULTRATINE Forehead™ and the predicate devices does not affect the safety and effectiveness of the ULTRATINE Forehead™.

2. Technological Characteristics Summary

The ULTRATINE Forehead™ is substantially equivalent in design, materials and fundamental scientific technology to the predicate devices. Further, the technological characteristics of the ULTRATINE Forehead™ are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ULTRATINE Forehead™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness.

3. Performance Summary

The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.

SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the ULTRATINE Forehead™ is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the ULTRATINE Forehead™ Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

Coapt Systems, Inc. % Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, California 94303

Re: K060249

Trade/Device Name: ULTRATINE Forehead™ Regulation Code: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC Dated: April 28, 2006 Received: April 28, 2006

Dear Ms. Ruedy:

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.

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

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Page 2 - Ms. Linda Ruedy

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/dsma/dsmamain.html

Sincerely yours,

Qmall

Or Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060249 P. 1.13

Indications for Use

510(k) Number (if known): K060249

ULTRATINE Forehead™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number_K060249

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.