The ArcScan Insight 100 is indicated for use in adults to measure dimensions of the human eye. To provide tomographic, high-resolution ultrasound images of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

Device Description

ArcScan Insight 100 is a precision ultrasound device for imaging and biometry of the eye. It uses a 20-60 MHz transducer that scans the eye in an arc whose curvature approximates the anterior ocular surfaces. Specifically, the ArcScan Insight 100 can measure the thickness of the cornea and its individual layers, the epithelium, stroma, and surgically induced surfaces. Measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width. Measurements can be made of pathologic structures such as solid masses and cysts.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ArcScan Insight 100 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (as demonstrated)
Axial Resolution	Met specifications
Lateral Resolution	Met specifications
Thickness Measurement	Met specifications
Lateral Measurement	Met specifications

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device's measurement performance capability was "demonstrated to meet specifications."

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. The device appears to be a diagnostic imaging and measurement device, not an AI-assisted diagnostic tool in the sense of comparing human reader performance.

6. Standalone (Algorithm Only) Performance Study:

The document describes the performance of the device itself in its ability to take measurements and produce images. This implies a standalone evaluation of the algorithm's performance in generating these outputs against its specifications. However, it doesn't explicitly frame it as an "algorithm-only" study in the modern sense of comparing it against human performance or other algorithms. It verifies that the device, as an integrated system, performs as specified.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of the device (precision measurement of ocular structures), the ground truth for "meeting specifications" would likely involve:

Physical Phantoms or Standards: For validating axial and lateral resolution, and the accuracy of physical measurements (thickness, lateral dimensions).
Known Anatomical Dimensions: For validating measurements against established anatomical norms or surgically confirmed dimensions, if human subjects were used.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is consistent with the device being a precision ultrasound measurement system rather than a machine learning or AI-driven diagnostic algorithm that typically relies on extensive training data.

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

As no training set is mentioned in the context of machine learning or AI, the document does not provide information on how ground truth for a training set was established. The "ground truth" implicitly referred to is the accuracy of the device's measurements against objective physical standards or precise reference measurements.

Summary

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

February 2, 2016

ArcScan, Inc. % Mr. John Mann Director RAQA Evergreen Research 433 Park Point Drive, Suite 140 GOLDEN CO 80401

Re: K153416

Trade/Device Name: ArcScan Insight 100 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: January 12, 2016 Received: January 13, 2016

Dear Mr. Mann:

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.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Division of Industry and Consumer Education 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,

Robert Oolo

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153416

Device Name ArcScan Insight 100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Diagnostic Ultrasound Indications for Use

System: ArcScan Insight 100 Transducer: Blatek AT20573

Intended Use: The ArcScan Insight 100 is indicated for use in adults to measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or plaming of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, turnors, cysts, glaucoma and hypotony.

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
(Track 1 Only)	(Tracks 1 & 3)							A-mode (P)
Ophthalmic	Ophthalmic	P
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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510(k) Summary ArcScan Insight 100™

SUBMITTER INFORMATION

Company name / address	ArcScan, Inc.433 Park Point DriveGolden CO 80401
510(k) contact name / numbers	Andy LevienPhone +1 877.363.7226alevien@arcscan.com
Date summary prepared	11/23/2015
DEVICE IDENTIFICATION
Trade names	ArcScan Insight 100TM
Common name	Ultrasound Bio Microscope
Classification name	Ultrasonic pulsed echo imaging system, 90-IYO,892.1560Diagnostic ultrasonic transducer, 90-ITX, 892.1570
PREDICATE DEVICE
Trade names	Artemis VHF Ultrasonic Arcscan System (Artemis2)
510(k) number	K021333

DEVICE DESCRIPTION

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INDICATION FOR USE

The ArcScan Insight 100 is indicated for use in adults to measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angleto-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

Substantial Equivalence: The ArcScan Insight 100 is substantially equivalent to the classified device described in CFR 21 891.1560, "Ultrasonic Pulsed Echo Imaging System" and to other ultrasound systems that have been cleared by the 510(k) process, particularly the Artemis™ VHF Ultrasonic Arc-scan System cleared by ArcScan, Inc. (formerly Ultralink LLC) in K021333.

The 510(k) Substantial Equivalence Decision-making Process (detailed)from The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] was followed as described below:

1. These products have the same intended use, to produce high-resolution ultrasound images of the anterior portion of the eye, and to measure these tissues such as the thickness of the cornea and its individual layers, the epithelium stroma and surgically induced surfaces. They can also be used to measure pathologic structures such as solid masses or cysts.
1. The products have the same fundamental scientifictechnology.
1. The technological characteristics of this device are the same as those for the predicate device except for the method by which the larger radius of motion is achieved.
1. The acoustic output of this device is similar to that of predicate devices and is well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
1. The products have the same sterility assurance level of SAL10-6.
1. The products have the same biocompatibility for the patient contact surfaces.

PERFORMANCE DATA

The ArcScan Insight 100 complies with IEC 60601-1, Ed. 3: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1(2006): Corrigendum 2(2007). The ArcScan Insight 100 complies with IEC 60601-1-2 Ed 3.0: Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.IEC 60601-1, General Electrical Safety.

The ArcScan Insight 100 Acoustic Power was demonstrated to be less than the preamendment levels for Track 1.

The ArcScan Insight 100 measurement performance capability was demonstrated to meet specifications for the following characteristics:

Axial resolution
Lateral resolution ●
Thickness measurement
Lateral measurement ●

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CONCLUSION

The ArcScan Insight 100 is substantially equivalent to the ArcScan Artemis 2.

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.