The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

Device Description

The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the AtriCure Dissector™. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, ground truth, or expert involvement in such a study.

The document does mention:

"Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device."
"These activities included Risk Analysis, Process Verification, and Biocompatibility Testing."
"Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (<24 hrs) as a patient contacting device."

This indicates that internal testing was performed to ensure the device met its design specifications and was biocompatible. However, it does not provide the specific performance acceptance criteria or the results of those tests in a way that can be presented in the requested table format.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria as you've outlined.

Here's a breakdown of why each specific point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: Not provided. The document states "conformance to product specification" but doesn't list the specifications or the performance metrics.
Sample sized used for the test set and the data provenance: Not provided for performance testing. Biocompatibility testing is mentioned but without sample sizes or provenance details.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance testing details are not provided.
Adjudication method for the test set: Not applicable. Performance testing details are not provided.
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 instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a human-operated surgical device.
The type of ground truth used: Not applicable. Performance testing details are not provided.
The sample size for the training set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable. (See #8).

Summary

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K///.020

ATRICURE DISSECTOR™ 510(k) SUMMARY

General Information

Date Compiled	April 11, 2011
Classification	Class II (Surgical Lamp)21 CFR 878.4580
Product Code	FTD, GDI
Trade Name	AtriCure DissectorTM
Manufacturer	AtriCure, Inc6217 Centre Park DriveWest Chester, OH 45069
Contact	James L. LuckyVP of Quality Assurance and Regulatory Affairs(513) 755-5754

Indications for Use

Cleared Device

The device proposed for modification in this submission is the AtriCure Dissector™ (K041681).

Device Description

Materials

All materials used in the manufacture of the AtriCure Dissector™ are suitable for their intended use and have been used in numerous previously cleared products. Materials used include, but are not limited to, medical grade silicone, stainless steel, medical grade adhesive, and acrylic epoxy resin. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

Testing

Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device. These activities included Risk

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Analysis, Process Verification, and Biocompatibility Testing. Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (<24 hrs) as a patient contacting device. .

Summary of Substantial Eguivalence
substantially equivalent to the Dissector™ (MID1) device cleared via K041681. The modification does not affect the technological characteristics, scientific principles, or performance specifications. The indications for use, basic overall function, and materials used are substantially equivalent.

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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 features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 9 2011

AtriCure, Inc. % Mr. James L. Lucky VP, Quality Assurance and Regulatory Affairs 6217 Centre Park Drive West Chester, Ohio 45069

Re: K111020

Trade/Device Name: AtriCure Dissector"™ Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTD, GDI Dated: May 19, 2011 Received: May 23, 2011

Dear Mr. Lucky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. James L. Lucky

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdai.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours. Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KII/020 510(k) Number (if known):

Device Name: AtriCure Dissector™

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Neil R.P. Ogden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number.

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.