The 4Sight is a multi-purpose diagnostic ophthalmic ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the internal structure of the eye.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic

Device Description

The 4sight device is designed to combine the functionalities of Accutome's A-scan Plus (K123349), B-scan Plus (K070943) and Accupach Pachymeter (K042752) devices into a combined, stand-alone platform. The device performs axial length measurements, corneal thickness measurements and images the internal structure of the eye using these 3 modalities. The 4Sight is a stand-alone system which runs on a Windows 8 platform consisting of a 4Sight control unit, transducers, footswitch, and keyboard.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document for the Accutome 4Sight device:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criteria	Acceptance Criteria	Reported Device Performance
A-scan Physical Accuracy Test	Well within 0.1mm	Both the A-scan function on the 4Sight and the predicate device were well within the 0.1mm acceptance criteria.
Pachymetry Comparison Test	All data met established acceptance criteria	All of the data met the established acceptance criteria.
Software Validation	317 software requirements met	All 317 software requirements were tested and validated. All bugs, except one minor anomaly, were corrected.
External Validation (Safety)	Ratings of 4 or 5 (5=best) on a 1-5 scale for overall rating, no 1s or 2s. Safety ranked 5.	Safety was ranked 5 by every user. The "Overall Rating" of the device was 4 or 5 by all users. There were no ratings of 1 or 2 in any of the tests.
External Validation (Usability/Functionality)	Ratings of 4 or 5 (5=best) on a 1-5 scale for overall rating, no 1s or 2s. Usability judged equivalent to predicate.	The "Overall Rating" of the device was 4 or 5 by all users. There were no ratings of 1 or 2 in any of the tests. Usability was judged to be equivalent to the predicate device during internal validation.

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

A-scan Physical Accuracy Test: The document does not specify a numerical sample size for this test. It refers to "the A-Scan function on the 4Sight" and "the predicate device," suggesting comparative measurements, but not how many such measurements were taken.
Pachymetry Comparison Test: The document does not specify a numerical sample size for this test. It refers to "critical parameter results between the two devices," implying multiple comparisons, but the exact number is not provided.
External Validation Tests: The device was evaluated at 4 different locations. The document does not specify the number of individual cases or patients involved.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective for the validation testing, as it involved evaluating the new 4Sight device.

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

A-scan Physical Accuracy Test: Ground truth was established by "physical distance measured by a mechanical dial indicator." This does not involve human experts in setting the ground truth, but rather a direct physical measurement.
Pachymetry Comparison Test: Ground truth for this test involved comparing the 4Sight's results to those of the predicate device (Accupach VI) using the "same input test fixture and values." The predicate device likely serves as the reference, which itself would have been validated against a form of ground truth or clinical standard.
External Validation Tests: "Experienced technicians/ophthalmologists" evaluated the device at 4 different locations. The exact number of experts is not specified beyond "users." Their specific years of experience or training are also not detailed, only that they were "experienced."

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for any of the tests.
For the External Validation Tests, the qualitative feedback (ratings) from "every user" or "all users" was aggregated to determine if the acceptance criteria were met. This implies a consensus or majority opinion approach rather than a formal adjudication process for discordant interpretations.

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

No, a formal MRMC comparative effectiveness study, as typically understood for AI evaluation, was not conducted.
The document describes a "Pachymetry Comparison Test" and an "A-scan Physical Accuracy Test" that compare the 4Sight to its predicate devices, but this is a device-to-device comparison, not an AI-assisted vs. unassisted human reader comparison.
The External Validation Tests involved multiple users, but the goal was to assess device usability and safety, not to quantify the effect size of AI on reader performance. There is no mention of "AI" in this context, as the device is an ultrasound system making measurements.

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

Yes, the performance of the device's measurement algorithms appears to have been evaluated in a standalone manner.
The A-scan Physical Accuracy Test directly measures the accuracy of the A-scan function against a physical standard.
The Pachymetry Comparison Test compares the 4Sight's output with that of a predicate device under controlled input conditions, essentially evaluating the algorithm's output.
The device itself is described as a "stand-alone system."

7. The Type of Ground Truth Used

A-scan Physical Accuracy Test: Direct physical measurement (physical distance measured by a mechanical dial indicator).
Pachymetry Comparison Test: Comparison against a predicate device's measurements using the same input. The predicate device's measurements are implicitly treated as the ground truth for this comparison.
Software Validation: Ground truth was meeting the 317 specified software requirements.
External Validation Tests: Expert opinion/feedback (ratings from experienced technicians/ophthalmologists) regarding usability and safety.

8. The Sample Size for the Training Set

The document does not describe the development of an AI algorithm that would require a "training set." The 4Sight device is described as combining functionalities and algorithms from existing predicate devices (A-scan Plus, B-scan Plus, Accupach Pachymeter).
The software modifications were primarily for integrating these functionalities into a single standalone unit and graphical interface, not for developing new measurement algorithms that would typically rely on training data. Therefore, the concept of a training set as applied to AI/ML is not relevant here.

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

As the device does not appear to employ new AI/ML algorithms requiring a training set in the conventional sense, this information is not applicable and therefore not provided in the document. The algorithms for critical functions were stated to be "exactly the same as in the predicate devices."

Summary

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

November 25, 2015

Accutome, Inc. % Mr. Adam Pickholtz Quality/Regulatory Manager 3222 Phoenixville Pike MALVERN PA 19355

Re: K152573 Trade/Device Name: 4Sight Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 28, 2015 Received: October 30, 2015

Dear Mr. Pickholtz:

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 Oels

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) K152573

Device Name 4Sight

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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4Sight 510(k) Notification

System: 4Sight

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined (A, B)	A
Ophthalmic	Ophthalmic						P

System: 4Sight Transducer: Pachymeter

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	A
Ophthalmic	Ophthalmic							P

System: 4Sight Transducer: A-scan -------------------

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B M	PWD	CWD	ColorDoppler	Combined(Specify)	A
Ophthalmic	Ophthalmic						P

System: 4Sight Transducer: B-scan

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B M PWD CWD	ColorDoppler	Combined(Specify)	A
Ophthalmic	Ophthalmic	P

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Image /page/4/Picture/1 description: The image shows the logo for Accutome. The logo features a dark blue circle with a white triangle inside, resembling the number 4. Below the circle, the word "ACCUTOME" is written in a bold, sans-serif font, also in dark blue.

510(k) SUMMARY: 4Sight

Applicant:	Accutome, Inc.
Address:	3222 Phoenixville PikeMalvern, PA 19355
Contact Person:	Adam PickholtzManager QA/QC
Telephone:	(610) 889-0200(610) 889-3233 Fax
Preparation Date:	8/10/15
Trade Name:	4Sight
Common Name:	Ophthalmic Diagnostic Ultrasound System
Classification Name:	System, Imaging, Pulsed Echo, Ultrasonic(21 CFR 892.1560, Product Code: IYO)Diagnostic Ultrasound Transducer(21 CFR 892.1570, Product Code: ITX)
Legally MarketedPredicate Devices:	A-Scan Plus Connect (K123349)B-scan Plus (K070943)Accupach V Pachymeter (K042752)● No prior FDA submissions have been submitted for acombination unit by Accutome, Inc.
Description of the Device:	The 4sight device is designed to combine thefunctionalities of Accutome's A-scan Plus (K123349), B-scan Plus (K070943) and Accupach Pachymeter (K042752)devices into a combined, stand-alone platform.

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The device performs axial length measurements, corneal thickness measurements and images the internal structure of the eye using these 3 modalities.

The 4Sight is a stand-alone system which runs on a Windows 8 platform consisting of a 4Sight control unit, transducers, footswitch, and keyboard.

The 4Sight is a multi-purpose diagnostic ophthalmic Indications for Use: ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the eye and visualize the internal structure of the eye.

Comparison of Technological Characteristics to the predicate device:

All of the critical functions of the 4Sight device are calculated in exactly the same manner as in the predicate devices. The Ascan, B-scan, and pachymetry probes used with the 4Sight are exactly the same as the probe used on the predicate devices. The software algorithms for clinically critical functions, i.e. to process ultrasound measurements and calculate intraocular lens parameters remain exactly the same as in the predicate devices.

The new standalone 4Sight model uses a standalone control unit as the main computing vehicle and display instead of the personal computer. The software modifications in the 4sight model are those necessary to interface the processing, data storage, display, and printing capabilities of a combined, standalone control unit.

The 4Sight control unit consists of (4) printed circuit boards enclosed in a plastic case. This includes a 1 PCB for power management, 1 PCB to control the pachymeter function, 1 PCB to control the A-scan function and 1 PCB to act as a connector board. The PCB for A-scan functionality is unchanged from the A-scan Plus Connect predicate device.

The energy source for the 4Sight is AC to DC adapter used to power the Accupach Pachymeter predicate device.

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	The chemical composition of patient contact materials isidentical to that of the predicate device as the probes have notchanged.
Standards Testing:	EN 60601-1 Medical Electronic Equipment Part 1: GeneralRequirements for SafetyBoth this device and the predicates were tested to, and found tobe compliant with EN 60601-1.
	EN 60601-1-2 Collateral Standard: ElectromagneticCompatibility – Requirements and TestsBoth this device and the predicate were tested to, and found tobe compliant with EN 60601-1-2.
	IEC 60601-2-37 - Safety of Ultrasonic Medical Diagnostic andMonitoring EquipmentAcoustic Measurements for the predicate devices have beenevaluated by Acertara Laboratories and Sonora Laboratories.
	EN/ISO 10993 - Biological Evaluation of Medical DevicesThe same probes are used with this device as with the predicatedevice which were tested to ISO10993; the materials have notchanged.
Verification Testing:	A-scan Physical Accuracy TestThis test compares the distance measured ultrasonically by theA-Scan function on the 4sight and the physical distancemeasured by a mechanical dial indicator. The test results forboth the A-Scan function and the predicate device were wellwithin the 0.1mm acceptance criteria.
	Results:Both the A-scan Plus Connect model and the predicate devicewere well within the 0.1mm acceptance criteria.
	Pachymetry Comparison Test: Accupach VI (predicate) vs.4SightThe objective of this test is to compare critical parameterresults between the two devices under conditions of the sameinput test fixture and values.
	Results:

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All of the data met the established acceptance criteria

Internal Validation Tests Validation Testing:

A test plan was developed to evaluate proper operation and usability for all device modes/options.

Results:

All operations and features were fully functional. There were no errors or deficiencies in the patient information. The usability was judged to be equivalent to the predicate device.

Software Validation Testing

317 software requirements specified in the software requirement specification were tested and validated during the software validation process.

All software bugs discovered during the validation process, with the exception of one minor anomaly, were corrected during the process.

External Validation Tests

A checklist was developed which requests quantified critique regarding the safety, functionality and usability of the device. A Rating Scale from 1 to 5 was used with: 5 = best, very user friendly, no problems; and 1 = not acceptable, very unfriendly, significant problem that must be corrected.

Results:

The device was evaluated at 4 different locations by experienced technicians/ophthalmologists.

Safety was ranked 5 by every user. The "Overall Rating" of the device was 4 or 5 by all users. There were no ratings of 1 or 2 in any of the tests.

Validation Tests Summary

The internal and external validation tests demonstrate along with risk analysis and testing to applicable standards that there are no known safety issues with the 4Sight device.

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The tests further demonstrate that there are no significant functionality issues and that the usability of the device is equivalent to that of the predicate device.

Conclusion:

The positive results of the testing above, along with the risk analysis performed, demonstrate that the 4Sight is at least as safe and as effective as the predicate devices.

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.