The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including measurement of the axial length for determination of IOL power.

Device Description

The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan and B-Scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

AI/ML Overview

This document presents information about the OTI-Scan 3000, an ultrasonic ophthalmic A-Scan and B-Scan system. However, it does not contain explicit acceptance criteria or a detailed study description proving that the device meets specific performance criteria. The information provided primarily focuses on regulatory approval (510(k) summary) rather than a performance study.

Here's an analysis of the provided text with respect to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Based solely on the provided text, explicit quantitative acceptance criteria for device performance (e.g., accuracy thresholds, sensitivity, specificity) are not present. The document mentions "accuracy tests" were performed, but does not provide the results of these tests or the benchmarks they were measured against.

Acceptance Criteria	Reported Device Performance
(No explicit quantitative acceptance criteria are provided in the document)	"Accuracy tests" were performed. No specific performance metrics or outcomes are reported in the furnished text.
Ultrasonic emissions teat compliance	Passed (implied by 510(k) clearance)
Electrical safety test compliance	Passed (implied by 510(k) clearance)
Software validation test compliance	Passed (implied by 510(k) clearance)

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

The document mentions "Bench-top testing has been performed on the OTI-Scan 3000 including accuracy tests, ultrasonic emissions teats, electrical safety tests and software validation tests."

Sample Size for Test Set: Not specified. The nature of "bench-top testing" often implies testing performed on the device itself or phantoms, rather than a clinical patient dataset.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Since this refers to bench-top testing, it's not a clinical data provenance.

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

This information is not provided. Given that the listed tests are primarily technical bench-top tests (accuracy, emissions, electrical safety, software validation), the concept of "ground truth" established by clinical experts for a test set of images/data as one might find in an AI study for diagnostic performance is not applicable here. These tests would typically use known physical standards or calibrated equipment for "ground truth".

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically used in studies involving human interpretation of clinical data, which is not described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in the provided text. This document describes the device itself and its 510(k) clearance, not research on AI assistance or human reader improvement.

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

The OTI-Scan 3000 is an ultrasonic imaging system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" study is not applicable in this context. The device's performance is intrinsically tied to its hardware and integrated software for acquiring and processing ultrasound signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench-top tests described (accuracy, emissions, electrical safety, software validation), the "ground truth" would likely be:

Accuracy tests: Calibrated physical standards or phantoms with known dimensions/properties.
Ultrasonic emissions tests: Regulatory limits and measurements using specialized equipment.
Electrical safety tests: Electrical safety standards and measurement equipment.
Software validation tests: Software requirements specifications and expected outputs for given inputs.

Clinical "ground truth" (such as expert consensus or pathology) is not relevant for the tests described.

8. The sample size for the training set

This is not applicable. The OTI-Scan 3000 is a medical device, not an AI system that undergoes "training" in the machine learning sense. Its functionality is based on established physics principles of ultrasound.

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

This is not applicable as the device is not an AI system.

Summary

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DEC 2 3 2009

OPKO Instrumentation OTI-Scan 3000 510(k) Summarv

510(k) Summary
Company:	OPKO Instrumentation, LLC.621 W 20th StreetHialeah, FL 33010-2432Phone: 888-268-6756 or 305-575-4178
Contact:	Mario ArbesuDirector, Compliance and Regulatory AffairsOPKO Instrumentation, LLC.4400 Biscayne BoulevardMiami, FL 33137Phone 305.575.4631Fax 305.575.4140
Trade Name:	OTI-Scan 3000
Device Type:	Ultrasonic Pulsed Echo Imaging System
Classification Regulation:	892.1560
Class:	II
Panel:	Radiology
Product Code:	IYO
Predicate Devices:	OTI I-Scan (K960622)OTI Scan with Transducers (K030770)OTI-Scan HF Module System (K031391)
Device Description:	The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scanand B-Scan system that uses the principles of sonar(pulsed ultrasound) to measure the axial length of theeyes and to visualize the interior of the eye.
Indications for use:	The OTI-Scan 3000 ultrasound system is a multi-purposepersonal-computer based ultrasonic diagnosis system forophthalmic applications, intended to both visualize theinterior of the eye by means of ultrasound and to makemeasurements inside the eye, including measurement ofthe axial length for determination of IOL power.

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Performance Data:

September 2017

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Bench-top testing has been performed on the OTI-Scan 3000 including accuracy tests, ultrasonic emissions teats, electrical safety tests and software validation tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Mario Arbesu Direction, Compliance and Regulatory Affairs OPKO Instrumentation, Inc. 4400 Biscayne Blvd. MIAMI FL 33137

DEC 2 3 2009

Re: K092837

Trade/Device Name: OTI-Scan 3000 Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Codes: IYO and ITX Dated: August 28, 2009 Received: November 30, 2009

Dear Mr. Arbesu

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the OTI-Scan 3000, as described in your premarket notification:

Transducer Model Number

OTI - Scan 20 MHz HF B-Probe

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 - Mr. Mario Arbesu

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 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 market.

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/CDRH0ffices/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.

If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at (301) 796-6542.

Sincerely yours,

Joshua C Myppi

for

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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System: OTI-Scan 3000

Intended Use: The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based Intended Use: The OTF-Scall 3000 unrasound system a misualize the interior of the eye ulfrasonic dignosis system for opilliamite applications, measurement of the axial length for determination of IOL power.

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic	P						P(A-Mode)
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	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 = previous cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity ాల

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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 Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092837

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System: OTI-Scan 20 MHz HF B-Probe

Intended Use: Transducer for B-Scans with the OTI-Scan 3000 Ultrasound Imaging System.

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic	N
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	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 = previous cleared by FDA; E = added under this appendix

Examples of other modes of operation may include. A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hormi m why

(Division Sign-O Division in Reproductive, Abdominal, and Kadsoingical Devices 510/k) Mumber

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.