The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.

Device Description

The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

AI/ML Overview

The provided text describes the AtriCure Cryo Module System (ACM, Cryo1, and cryolCE), which is intended for cryosurgical treatment of cardiac arrhythmias. However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI-powered device are not applicable or cannot be extracted from this document, as it describes a non-AI medical device and its regulatory submission.

Here's an attempt to answer the questions based only on the provided text, with explicit notes about what information is missing or not relevant for this type of submission:

Acceptance Criteria and Device Performance for AtriCure Cryo Module System

This 510(k) submission focuses on demonstrating substantial equivalence of the AtriCure Cryo Module System to its predicate device (AtriCure Cryo Module System [K111042]). As such, the "acceptance criteria" are primarily related to conforming to product specifications, relevant safety standards, and demonstrating equivalent performance characteristics to the predicate device, rather than specific clinical performance metrics with predefined thresholds typical for novel AI/ML device evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on 510(k) summary interpretation)	Reported Device Performance (based on 510(k) summary)
Safety: Conformance to electrical safety standards (e.g., UL 60601-1, EN 60601-1)	Testing completed; indicated conformance to product specifications and international standards.
Electromagnetic Compatibility: Conformance to EMC standards (e.g., IEC 60601-1-2, EN 55011)	Testing completed; indicated conformance to product specifications and international standards.
Material Biocompatibility: Materials safe and suitable for intended use, biocompatibility of probes (ISO 10993-1)	"All materials used in the manufacture of the AtriCure Crvo Module System are safe and suitable for their intended use... Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure cryo-ablation probes."
Packaging/Transit Safety: Conformance to transit testing standards (e.g., ISTA Procedure 3A)	Testing completed; indicated conformance (transit testing was completed).
Cryosurgical Performance: Conformance to cryosurgical instrument standards (e.g., ASTM F882-84)	Testing completed; indicated conformance to product specifications and international standards.
Software Validation: Conformance to FDA Guidance for Software in Medical Devices	Software validation completed.
Substantial Equivalence: Equivalent intended use, method of operation, construction, and materials to predicate device.	"The AtriCure Cryo Module System is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products."
General Product Specifications: Conformance to internal design specifications.	"Appropriate product testing was conducted to evaluate conformance to product specification..."

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided in the context of this 510(k) submission. The testing described primarily involves bench comparison testing, transit testing, electromagnetic compatibility, design verification, and software validation of a physical electro-mechanical medical device, not a data-driven AI/ML system tested on a clinical "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. Ground truth in the context of clinical data for AI/ML models is not relevant to this submission for a hardware medical device. The "ground truth" for this device would be its ability to perform its intended cryoablation function and meet engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies to establish a consensus ground truth from expert readers for a dataset, which is not described here.

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

This information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for this non-AI medical device.

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

This information is not applicable/not provided. This device is not an algorithm; it is a physical cryosurgical system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not refer to "ground truth" in the manner relevant to AI/ML devices. For this device, the "truth" is established through:

Conformance to engineering specifications and design validation.
Compliance with safety and performance standards (e.g., UL, EN, IEC, ASTM).
Demonstration of biocompatibility (ISO 10993-1).
Proof of functional performance in bench testing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As there is no training set, there is no ground truth to establish for one.

Summary

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

K112072
AUG - 3 2011

ATRICURE CRYO MODULE SYSTEM 510(K) SUMMARY

GENERAL INFORMATION

Trade Name	AtriCure Cryo Module System (ACM, Cryo1 and cryolCE)
Manufacturer	AtriCure, Inc6217 Centre Park DriveWest Chester, OH 45069
Contact	James L. LuckyVP of Quality Assurance and Requlatory Affairs(513) 755-5754
EstablishmentRegistrationNumber	3003502395
Predicate Device	AtriCure Cryo Module System (ACM, Cryo1 and cryolCE) [K111042]
Date Compiled	June 24, 2011
Classification	Class II
Regulation	21 CFR 878.4350
Product Code	GEH

Indications for Use

DEVICE_DESCRIPTION

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

MATERIALS

All materials used in the manufacture of the AtriCure Crvo Module System are safe and suitable for their intended use and suitable for their use with pressurized nitrous oxide. The ACM is not intended for patient contact. Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure cryo-ablation probes (Cryo1 and cryolCE).

TESTING

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Bench comparison testing, transit testing, electromagnetic compatibility, design verification and validation, software validation, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications. The standards and FDA Guidance used to determine substantial equivalence include, but are not limited to:

. UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety. (2006)
. EN 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety (1998) +A1 +A2, 2nd Edition
. IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility - Reg. & Tests (2007)
. EN 55011: Industrial, scientific and medical (ISM) radio-frequency Equipment. Electromagnetic disturbance characteristics. Limits and methods of measurement. (2007)
ISTA Procedure 3A: Packaged - Product for Parcel Delivery System Shipment 70kg (150 lb) or Less: (2008)
. ASTM F882-84: Standard Performance and Safety Specification for Cryosurgical Medical Instrument's (2002)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (Issued May 11, 2005)

SUMMARY OF SUBSTANTIAL EQUIVALENCE

The AtriCure Cryo Module System is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products.

{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 features a stylized eagle with three wing feathers, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

AtriCure, Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25" Street NW Buffalo, MN 53313

AUG - 3 2011

Re: K112072

Trade/Device Name: AtriCure Cryo Module System (ACM, Cryo1 and cryolCE) Regulatory Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: GEH Dated: July 19, 2011 Received: July 20, 2011

Dear Mr. Job:

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 10 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 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. Mark Job

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); 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.fda.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

for 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): _(21/2072

Device Name: AtriCure Cryo Module System (ACM, Cryo1 and cryolCE)

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K112072

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.