The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

Device Description

The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System includes:

The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant)
A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ Sensor)
CardioMEMS EndoSure™ Electronics System

AI/ML Overview

The provided text details the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, information about adjudicated ground truth, or details about training and test sets as requested in the prompt.

The document is a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than a clinical study report with detailed performance data against pre-defined acceptance criteria.

Therefore, the majority of the requested information cannot be extracted from the provided text.

Here's a summary of what can be extracted and a clear indication of what is missing:

Acceptance Criteria and Study for CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document.	"Bench testing confirms that the device functions per its specifications." "Testing has shown the EndoSure Sensor with Delivery System to be biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators."

Missing Information: The document states that bench testing confirms the device functions per its specifications, but it does not detail what those specifications (i.e., acceptance criteria) are, nor does it provide quantitative performance data (e.g., accuracy, precision, error margins) from these tests.

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

Missing Information: There is no mention of a "test set" in the context of a clinical or performance study with a specific sample size. The document refers to "bench testing," which typically involves simulated conditions rather than patient data or a test set. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

Missing Information: There is no mention of a "test set" or experts establishing ground truth for performance evaluation in the provided text.

4. Adjudication method for the test set

Missing Information: There is no mention of a "test set" or an adjudication method.

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

Missing Information: This device is a pressure measurement system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be applicable and is not mentioned.

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

Missing Information: The document states the device "may be used as an adjunctive tool," implying a human-in-the-loop scenario. No standalone algorithm performance is described.

7. The type of ground truth used

Missing Information: Since specific performance studies with detailed data are not provided, the type of ground truth used (e.g., pathology, outcomes data) for evaluation is not described. The "bench testing" likely compared the device's pressure readings to known reference pressures.

8. The sample size for the training set

Missing Information: As this document describes a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not applicable and is not mentioned.

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

Missing Information: Not applicable as there is no training set described.

Conclusion from Provided Text:

The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence to a predicate device for market clearance. It broadly states that "Bench testing confirms that the device functions per its specifications" and is "biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators." However, it does not provide the detailed performance data, acceptance criteria, sample sizes, or ground truth methodologies that would be typically found in a comprehensive study report evaluating a device's performance against specific metrics.

Summary

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510(k) Summary

A. Submitter's Information

Submitter's Name: CardioMEMS. Inc. Submitter's Address: 75 Fifth St, NW Suite 440 Atlanta, GA 30308

Contact Person: Grace Powers Telephone Number: (404) 920-6719 Fax Number: (404) 885-9974

Date of Preparation: February 14, 2007

B. Trade Name: CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System
Common Name: AAA Pressure Measurement System
Classification Name: Implantable Intra-aneurysm Pressure Measurement System
C. Predicate Devices: CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System
D. Device Description

The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant) l
A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ । Sensor)
CardioMEMS EndoSure™ Electronics System ।
E. Intended Use:

MAR 1 5 2007

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F. Technological Characteristics Summary
The Sensor is implanted in the AAA or TAA sac during the time of stent graft deployment and is left in place in the excluded portion of the aneurysm as a permanent implant. The main body of the Sensor is manufactured from fused silica coated in silicone. Nitinol loops extend from the Sensor body. Radiopaque marker bands at each end of the Sensor body allow visualization of the device under fluoroscopy.

The Sensor is interrogated using the antenna of the EndoSure Electronics System. The antenna is placed over the patient's abdomen in the area of the Sensor. Once the signal is acquired, a pressure waveform and numerical pressure data are displayed on the touch-screen. A printout of the data and waveform is generated from a thermal printer which is incorporated in the Electronics.

ে. Performance Data

Testing has shown the EndoSure Sensor with Delivery System to be biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators. Bench testing confirms that the device functions per its specifications.

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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 lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all caps and is written in a simple, sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiomems, Inc. c/o Ms. Grace Powers Regulatory Affairs Specialist 75 Fifth Street, NW, Suite 440 Atlanta, GA 30308

MAR 1 5 2007

Re: K070448

CardioMEMS EndoSure AAA Pressure Measurement System Regulation Number: 21 CFR 870.2855 Regulation Name: Implantable Aneurysm Pressure Sensor Regulatory Class: Class II (Two) Product Code: NQH Dated: February 14, 2007 Received: February 15, 2007

Dear Ms. Powers:

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.

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Page 2 - Ms. Grace Powers

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 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) 276-0120. 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/cdrl/industry/support/index.html.

Sincerely yours.

una R.v.dunes

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): Not known K (070ЧЧВ

Device Name:

CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System

Indications for Use:

Prescription Use X (Part 21 CRF 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Dana R. Valines

(Division Sign-Off) (Division Sign-Off)
Division on Cardiovascular Devices

510(k) Number K070448

Regulation Number and Section

§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.

(a)
Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.