The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

Device Description

The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.

AI/ML Overview

The provided text describes a Premarket Notification [510(k)] Summary for the Nfocus Neuromedical Acta™ Vessel Occlusion System (VOS). This device is an arterial embolization device. The document primarily focuses on establishing substantial equivalence to a predicate device (Amplatzer Vascular Plug) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way one might typically find for an AI/ML medical device.

Therefore, many of the requested categories (especially those related to AI/ML device performance, human reader studies, and ground truth establishment for training/test sets) are not directly applicable or explicitly mentioned in this type of regulatory submission for a physical medical device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or reported device performance in a table format that mimics an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various tests that have been or will be performed prior to commercialization to ensure the product meets requirements and conforms to needs and intended uses. These are related to the physical integrity, material properties, and functionality of the device.

Criteria Category	Specific Test / Implication	Reported Device Performance (Implied)
Delivery System	Dimensional	Not explicitly stated, but implied to meet defined engineering specifications for dimensions.
	Tensile Strength	Not explicitly stated, but implied to meet defined engineering specifications for strength.
	Corrosion Resistance	Not explicitly stated, but implied to meet defined engineering specifications for corrosion resistance.
	Force to Deploy	Not explicitly stated, but implied to meet defined engineering specifications for deployment force.
Implant	Dimensional	Not explicitly stated, but implied to meet defined engineering specifications for dimensions.
	Tensile Testing	Not explicitly stated, but implied to meet defined engineering specifications for tensile properties.
	Recapture Force	Not explicitly stated, but implied to meet defined engineering specifications for recapture force.
	Radial Force	Not explicitly stated, but implied to meet defined engineering specifications for radial force.
	Corrosion	Not explicitly stated, but implied to meet defined engineering specifications for corrosion resistance.
	MRI Compatibility	Not explicitly stated, but implied to meet defined engineering specifications for MRI compatibility.
	Radiopacity	Not explicitly stated, but implied to meet defined engineering specifications for visibility under X-ray.
	Fatigue	Not explicitly stated, but implied to meet defined engineering specifications for fatigue life.
System	Simulated Device Use	Not explicitly stated, but implied that the device will perform as intended during simulated use scenarios, confirming functionality for vascular occlusion.
Substantial Equivalence	"Any differences in technological characteristics... do not raise any new issues of safety or effectiveness."	The overall conclusion is that the Acta VOS is substantially equivalent to the predicate device, implying its performance is comparable and safe/effective for its intended use based on these tests and design similarities. This is the primary "performance" reported in this 510(k) summary.

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

Sample Size: Not specified. The document refers to "testing" (e.g., tensile strength, corrosion, simulated use) which typically involves a number of physical units, but the specific sample sizes for each test are not provided.
Data Provenance: Not applicable in the context of this device type. These are engineering and biocompatibility tests performed on the physical device, not clinical data from patients.

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

This is not applicable for a physical device like the Acta VOS. "Ground truth" in this context would be engineering specifications and standards, verified by qualified engineers and lab personnel, not medical experts establishing a diagnosis from patient data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert reads of medical images/data. For device performance testing, results are measured against established engineering standards and specifications.

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

No. This is a physical medical device, not an AI/ML algorithm intended to assist human readers. Therefore, an MRMC study is not relevant.

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

No. This is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance testing would be established technical specifications, engineering standards, biocompatibility requirements, and regulatory guidelines (e.g., for MRI compatibility, material properties). The device's performance is measured against these established quantitative and qualitative criteria to demonstrate safety and effectiveness and substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

Summary

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K 0.911952

PREMARKET NOTIFICATION [510(K)] SUMMARY 5.

Applicant:

Nfocus™ Neuromedical, Inc. 2191 E. Bayshore Road, Suite 100 Palo Alto, CA 94303 . USA Tel: 415-640-3377 Fax: 650-813-1869 June 29, 2009 " Robert H. O'Holla Vice President, Regulatory Acta" VESSEL OCCLUSION SYSTEM Arterial Embolization Device (KRD) Class II, 21 CFR 870.3300, Product Code KRD

Contact Person:

Date Prepared:

Proprietary Device Name:

Common Device Name:

Classification:

Legally marketed device to which your firm is claiming equivalence:

SEP 1 0 2010

Device Description:

Amplatzer Vascular plug

Intended Use:

The Acta VOS is indicated for arterial and venous embolizations in the peripheral vasculature.

Technological Characteristics of the Device Compared to the Predicate Device: The Acta VOS uses similar technology, has similar intended use, functions and method of operation as the predicate device.

	Acta VOS	Amplatzer Plug
Intended Use	The Acta VOS is indicated for arterial and venous embolizations in the peripheral vasculature.	Amplatzer vascular plug is indicated for arterial and venous embolizations in the peripheral vasculature.
Device Function	Creates a physical barrier to effect vascular occlusion	Creates a physical barrier to effect vascular occlusion
Implant Materials	Nitinol	Nitinol

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	Acta VOS	Amplatzer Plug
Implant Shape	Ovoid	Cylindrical
Method ofdetachment fromdelivery system	Controlled detachment fromcatheter	Controlled detachment fromcatheter

Summary of Studies: ·

As per the guidance for Abbreviated 510(k)s and the applicable standards, performance, sterilization and biocompatibility testing will be conducted and the results of the testing will verify that the Acta VOS product and system requirements are met ensuring that the product design conforms to the user needs and intended uses.

The following tests have been or will be performed prior to commercialization:

Delivery System

Dimensional .
Tensile Strength
Corrosion Resistance
Force to Deploy

Implant

Dimensional .
Tensile Testing
Recapture Force
Radial Force
Corrosion
MRI Compatibility
Radiopacity
Fatigue
System • Simulated Device Use

Conclusion:

NFocus Neuromedical considers the Acta VOS to be substantially equivalent to the legally marketed predicate device with respect to the device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Acta VOS and the predicate device do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Nfocus Neuromedical c/o Mr. Robert O'Holla Vice President, Regulatory Affairs 2191 E. Bayshore Road, Suite 100 Palo Alto, CA 94303

SEP 1 0 2010

Re: K091952

Trade/Device Name: Acta Vessel Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: September 2, 2010 Received: September 3, 2010

Dear Mr. O'Holla:

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.

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Page 2 - Mr. Robert O'Holla

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,
W.M.

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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INDICATION FOR USE STATEMENT 4.

1091952 510(K) Number (if known):

Device Name: Nfocus™ Neuromedical Acta™ Vessel Occlusion System

Indications for Use:

The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

Prescription Use ___X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

SEP 1 0 2010

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.P

n Sian-C of Cardiovascular Devices

510(k) Number

3-1

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).