The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Cardima Ablation System, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and detailed device performance metrics are NOT available. The document only states:

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	"Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended use."
Biocompatibility	"The materials used in the Cardima Ablation System meets the requirements of ISO 10993-1."
Functional Equivalence	Demonstrated substantial equivalence to predicate devices (Boston Scientific Electrosurgical Probe, AtriCure Bipolar Coagulator, Medtronic Cardioblate Surgical Ablation Pen).
Intended Use	"The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy."

Missing Information:

The summary does not provide quantitative acceptance criteria (e.g., specific thresholds for ablation depth, temperature, lesion size, or success rates) or detailed performance data (e.g., actual measured ablation parameters, complication rates, success rates in a clinical context). The statement "safe and effective" is a high-level conclusion, not a detailed performance metric.

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

Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" but does not provide details on the number of samples, devices, or tests performed.
Data Provenance: The testing appears to be in-vitro, meaning conducted in a controlled laboratory environment rather than on live subjects. The country of origin of the data is not specified, but the applicant (Cardima, Inc.) is based in Fremont, CA, USA, suggesting the testing was likely conducted in the US.

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

Not Applicable / Not Specified. For in-vitro testing of an ablation system, "ground truth" would typically be established by physical measurements (e.g., using calipers, thermometers, oscilloscopes, or histological analysis of tissue models) rather than expert interpretation of images or clinical data. There is no mention of human experts establishing ground truth for the in-vitro performance tests described.

4. Adjudication Method for the Test Set

Not Applicable / Not Specified. Since the ground truth for in-vitro tests is typically objective measurement, an adjudication method for human expert disagreements would not be relevant or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an ablation system, and the reported testing is primarily in-vitro performance, not related to image interpretation by humans. No mention of such a study is made.

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

Not Applicable / Not Specified. This device is a manual-use surgical tool, not an AI algorithm. "Standalone performance" in this context refers to the device operating as intended without human intervention for automated tasks. While the device itself operates "standalone" in delivering energy, the concept of "algorithm only" or "human-in-the-loop" performance doesn't apply as it's not an AI-driven diagnostic or automated system. The reported in-vitro testing can be considered an evaluation of the device's standalone physical performance parameters.

7. The Type of Ground Truth Used

Physical/Objective Measurements: For "in-vitro testing," the ground truth would have been established through objective measurements of physical parameters such as temperature, energy delivery, lesion size, depth, or electrical characteristics in tissue models or non-biological materials. The specific type of measurements or the gold standard used for these measurements is not detailed in the summary.

8. The Sample Size for the Training Set

Not Applicable / Not Specified. This device is an electrosurgical ablation system, not an AI/machine learning device that requires a "training set." Therefore, there is no training set in the context of AI.

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

Not Applicable / Not Specified. As there's no training set for an AI algorithm, this question is not relevant to the provided document.

Summary

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: June 17, 2002

510(k) number:	K022008
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JAN 2 9 2003

Applicant Information:

Cardimal. Inc. 47266 Benicia Street Fremont. CA 94538-7330

Contact Person

Marianne Baldwin
Phone Number:	(510) 354-0330
Fax Number:	(510) 657-4476

Device Information:

Classification: Class II Trade Name: Cardima® Ablation System Classification Name: Electrosurgical Cutting and Coaqulating Device

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Boston Scientific Electrosurgical Probe (K981981), the AtriCure Bipolar Coagulator (K011722); and the Medtronic Cardioblate Surgical Ablation Pen (K013392).

Intended Use:

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Test Results:

Performance
Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended use.

Biocompatibility

The materials used in the Cardima Ablation System meets the requirements of ISO 10993-1.

Summary: Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head turned to the left. The eagle's body is formed by three curved lines. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardima, Inc. c/o Robert A. Chin, Ph.D. Regulatory Consultant 25 Hartford Avenue San Carlos, CA 94070

Re: K022008

Trade/Device Name: Cardima Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: November 15, 2002 Received: November 19, 2002

Dear Dr. Chin:

This letter corrects our substantially equivalent letter of January 29, 2003.

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.

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Page 2 - Dr. Eric Chin

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 vour 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 vours.

ee.gmee

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

Enclosure

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Indications for Use

510(k) Number (if known):
K022008

Device Name:

Cardima® Ablation System

Indications for Use:

The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

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

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K022008

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use __

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

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.