AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Device Description

AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). AIM consists of four (4) principal components: an electromagnetic position tracking system; tracking sensors and mounts for the ultrasound transducer and the needle; custom guidance software installed on a computer; and a stereoscopic monitor with passive glasses for viewing the monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the AIM device, based on the provided 510(k) Premarket Application:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal Implied)	Reported Device Performance
Capable of safely and accurately performing the stated intended use.	Novice user success rate with AIM guidance: 92%
Similar effectiveness to the predicate device (InVision System K083728).	Novice user success rate without AIM guidance: 8% (This indirectly supports the "similar effectiveness" by demonstrating the value of AIM guidance, implying the predicate also offered such an improvement).

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

Sample Size: Not explicitly stated as a number of distinct attempts or phantom targets. However, the study involved "placement attempts in tumor mimics within agar phantom gels, both with and without AlM's guidance, at two different angles of approach - 0 degrees ("in plane"), and 90 degrees ("out of plane")." This implies multiple attempts were made.
Data Provenance: The study used "agar phantom gels." This indicates a prospective study conducted in a controlled phantom environment. The country of origin for the data is not specified, but given the submission to the FDA, it's likely U.S.-based or conducted under relevant U.S. guidelines.

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

The documentation does not explicitly state the use of "experts" to establish ground truth for the test set.
The study involved a "novice user" performing placement attempts. The ground truth for success (i.e., accurate placement within the tumor mimic) would have been objectively determined based on the physical outcome of the needle placement within the phantom (e.g., visual confirmation of the needle tip within the target).

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the phantom study and objective success criteria.
Success was likely determined objectively by direct observation or measurement of the needle's final position relative to the phantom's target.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted.
The study involved a single "novice user" comparing their own performance with and without AIM's guidance. This is a within-subject comparison for a single user, not an MRMC study.
Effect Size (if interpreting the novice user's improvement): The improvement with AIM was substantial: 92% success rate with AIM vs. 8% without. This represents an 84 percentage point increase in success for the novice user.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done.
The device (AIM) is an accessory for guidance with a human user in the loop, specifically guiding needle placement. The study evaluates the human user's performance with the assistance of the AIM device.

7. The Type of Ground Truth Used

The ground truth used was objective physical placement within "tumor mimics within agar phantom gels." Success was defined by the needle being accurately placed within these targets. This is a form of experimental ground truth derived from a controlled physical setup.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The AIM device is described as
an accessory that provides real-time guidance based on electromagnetic tracking and an overlay, implying it's not a machine learning model that requires a distinct "training set" in the conventional sense for its core functionality. Its "training" might relate more to calibration procedures.

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

As no training set is mentioned in the context of machine learning, there is no information on how ground truth for a training set was established.

Summary

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510k Premarket Application

1 3 2012

Section 5: 510(k) Summary

Submitted by:

InnerOptic Technology, Inc

Contact:

Caroline K. Green Ouality and Regulatory Manager 106-A N. Churton St. Chapel Hill, NC 27278 Ph. 919-732-2090 Email: caroline@inneroptic.com

Date Summary Prepared: 005/17/2012

Proprietary Name:	AIM
Common Name:	Ultrasonic pulsed echo imaging system
Regulatory Class:	Class II per 21 CFR 892.1560
Product Codes:	IYO: system, imaging, pulsed echo, ultrasonic
	OEW: tracking, soft tissue, intraoperative

Device Description: AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).

AIM consists of four (4) principal components:

an electromagnetic position tracking system; (1)
tracking sensors and mounts for the ultrasound transducer and the needle; (2)
custom guidance software installed on a computer; and (3)
a stereoscopic monitor with passive glasses for viewing the monitor. (4)

Intended Use: AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an

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aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

Technological characteristics, comparison to predicate device: The technological characteristics and indications for use of AIM are the same or similar to those found in the predicate device. AM is substantially equivalent to InnerOptic's InVision System cleared in K083728.

The AIM device labeling contains instructions for use, including indications for use, cautions, contraindications, warnings and planning guidance. This information assures safe and effective use of this device.

Discussion of performance testing: Testing was conducted to evaluate the performance characteristics of AIM. A novice user made placement attempts in tumor mimics within agar phantom gels, both with and without AlM's guidance, at two different angles of approach - 0 degrees ("in plane"), and 90 degrees ("out of plane"). The novice's success rate with AIM's guidance was 92%, and without it was 8%. The results of these studies demonstrate that AM is capable of safely and accurately performing the stated intended use. The results also show similar effectiveness to AIM's predicate device, the InVision System (K083728).

Conclusion: AnM is equivalent to the predicate device in safety and effectiveness.

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Image /page/2/Picture/0 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 encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SEP 13 2012

Ms. Caroline Green Regulatory Manager InnerOptic Technology, Inc. 106-A N. Churton Street HILLSBOROUGH NC 27278

Re: K121479

Trade/Device Name: AIM Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and OEW Dated: August 15, 2012 Received: August 20, 2012

Dear Ms. Green:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 9 ro(x) premise is substantially equivalent (for the indications relerenced above and nave decembined we as a comments marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce proc to May 26, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in above approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require apple of the general controls provisions of the Act. The You may, uleretore, market me device, sanyon to use no use ments for annual registration, listing of general controls provisionis of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (sec above) into exase ff (St your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Oode of Poucharies concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a succemines with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a decemmanon that your correct by other Federal agencies. You must or any Federal statutes and regulations adminities to: registration and listing (21)
comply with all the Act's requirements, including, but not any any a many of comply with an the Act 3 requirements, incruding, or medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket with anow you to begal mading 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 Parts 801 and 11 you don't contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 I va may 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number: AIM Device Name:

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 Radiological Devices

. I Ok

Page 1 of __ 1

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.