The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile).

AI/ML Overview

The provided text is a 510(k) summary for the nContact Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics that would typically be found in a clinical or non-clinical validation report.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC study, ground truth details, training set size) cannot be answered from the provided document.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance results. Instead, it states:

Criterion Type	Acceptance Criteria	Reported Device Performance
Intended Use	The device should be capable of coagulating cardiac tissue using radiofrequency (RF) energy.	The nContact Coagulation System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy. (This is a statement of intent, not a measured performance against a criterion).
Technological Characteristics & Principle of Operation	Must be comparable to listed predicate devices. The features of the subject device should be covered by those in at least one predicate device to demonstrate substantial equivalence.	"The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. All of the features specified for the subject device are covered by those listed in at least one predicate device."
Safety and Efficacy	Must not raise new questions of safety and efficacy compared to predicate devices.	"The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy."
Performance Testing	Performance testing should validate its intended use. (Specific metrics or thresholds for "validation" are not provided.)	"Performance testing was completed to validate its intended use." (No specific results are given.)

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

The document states that "Performance testing was completed," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). This document is a 510(k) summary, which often summarizes testing without full detail.

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparison and non-clinical performance, rather than an expert-adjudicated test set typically used for AI algorithms.

4. Adjudication method for the test set

This information is not provided in the document, as no specific test set requiring expert adjudication 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

An MRMC comparative effectiveness study is not mentioned in the document. This submission pertains to a medical device for coagulation, not an AI-assisted diagnostic or interpretative tool for human readers.

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

The nContact Coagulation System is a physical medical device (electrode device and electrosurgical generator), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" as typically applied to AI does not apply in this context. The non-clinical performance testing implicitly refers to the device's functional integrity.

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

The document implies that "performance testing" was conducted to validate its intended use (coagulation of cardiac tissue). However, the specific type of "ground truth" (e.g., histological assessment of coagulation, functional cardiac outcomes) used to evaluate this performance is not described. For a device that performs coagulation, "ground truth" would likely involve objective measures of tissue effect.

8. The sample size for the training set

The concept of a "training set" is not applicable to this device. The nContact Coagulation System is a traditional medical device (electrosurgical) and does not involve AI or machine learning that would require a training set.

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

As the device is not an AI/ML system, there is no training set, and therefore no ground truth established for it in that context.

Summary

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

DEC - I 2006

nContact Surgical, Inc.
Coagulation System 510k Submission
Traditional Premarket Notification

Page	1 of 12
------	---------

0 63012 510(k) Summary:

Application Date:	September 29, 2006
Sponsor:	nContact Surgical, Inc.2880 Slater Road, Suite 103,Morrisville, NC 27560
Correspondent:	Jane RicuperoDirector of Regulatory & Quality2880 Slater Road, Suite 103,Morrisville, NC 27560
Contact Numbers:	Phone: 919 466-9810 x3013Fax: 919 466-9811E-mail: jane@ncontact.us
Device Proprietary Name:	nContact Coagulation SystemModel number: CSK
Device Common Name:	Electrosurgical device andaccessories
Device Classification:	21 CFR 878.4400
Product Code:	GEI
Classification Name:	Electrosurgical cutting andcoagulation device and accessories
Predicate Device(s):	Electrosurgical Cutting & CoagulationDevice
Predicate Device Classification:	21 CFR 878.4400
Predicate Device Descriptions:	1. Medtronic, Inc., CardioblateRadiofrequency Ablation System(K013392)2. Endoscopic Technologies, EstechCobra Adhere Surgical System(K041599, K053326)

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

Page 2 of (2)

Device Description:

63012

Intended Use:

The nContact Coagulation System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy.

Non-clinical Performance:

The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. Performance testing was completed to validate its intended use. All of the features specified for the subject device are covered by those listed in at least one predicate device.

Substantial Equivalence:

The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

nContact Surgical, Inc. c/o Ms. Jane Ricupero 2880 Slater Road, Suite 103 Morrisville, NC 27560

Re: K063012

Trade/Device Name: nContact Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: September 29, 2006 Received: October 2, 2006

Dear Ms. Ricupero:

This letter corrects our substantially equivalent letter of December 1, 2006.

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 (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 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 - Ms. Jane Ricupero

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 continue 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

elgmee

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): _ K (16 3012

per (UNKNOWN): 10301α

Device Name: nContact Coagulation System

Indications for Use: The nContact Coagulation System is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.

Prescription Use (Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---	--------	---------------------------------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorat

and Neurological Devices

Section 4 - Indications for Use Statement Page 4-1 of 4-1	510(k) Number	K063012
-----------------------------------------------------------	---------------	---------

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.