The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses.

Device Description

The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.

AI/ML Overview

The provided text indicates that the device, an Ophthalmic Ultrasonic A-scan System A-scan 100, is substantially equivalent to a predicate device (OTI i-scan, K960622). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance figures, or information on study methodologies for clinical performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Anticipated)	Reported Device Performance
Accuracy	The A-scan 100 has had accuracy tests. (No specific values provided)
Ultrasonic Emissions	Ultrasonic emissions tests performed. (No specific results provided)
Electrical Safety	Electrical safety tests performed. (No specific results provided)
Software Validation	Software validation tests performed. (No specific results provided)
Clinical Equivalence	The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device. (No specific clinical performance metrics provided)

Missing Information:

Specific numerical acceptance criteria for accuracy, precision, or other performance metrics. The document only states that tests were conducted.
Actual numerical results or metrics for the device's performance against any established criteria.

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

According to the document:

Sample Size: "Clinical tests: Not required." This indicates that no separate clinical test set was used for this 510(k) submission, as the device's equivalence was established through non-clinical testing and comparison to a predicate.
Data Provenance: Not applicable for clinical tests, as none were conducted.

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

Missing Information: Not applicable, as no clinical test set was used requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Missing Information: Not applicable, as no clinical test set was used.

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

Missing Information/Not Applicable: The document explicitly states "Clinical tests: Not required." Therefore, no MRMC study was performed or reported for this submission.

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

The device is an "Ophthalmic Ultrasonic A-scan System" and likely involves direct measurement rather than an algorithm performing a standalone diagnostic task. While "software validation tests" were performed, there's no indication of a standalone algorithm performance evaluation in the context of interpretation or diagnosis without human involvement. The focus is on the device's ability to measure axial length and calculate IOL power.

7. The Type of Ground Truth Used

Missing Information/Not Applicable: Since clinical tests were not required, the concept of establishing ground truth for a clinical dataset does not apply here. The "accuracy tests" would have likely used a known standard or calibrated phantom as ground truth, but the details are not provided.

8. The Sample Size for the Training Set

Missing Information/Not Applicable: The device is described as an "Ophthalmic Ultrasonic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes." It includes "four popular formulas to calculate the implanted IOL power." This description suggests a deterministic system based on physical principles and established formulas, rather than a machine learning or AI-based system that would require a "training set" in the conventional sense.

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

Missing Information/Not Applicable: As there is no indication of a machine learning component requiring a training set, this information is not relevant to this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary for the A-scan 100 does not describe a clinical study with acceptance criteria and reported performance in the traditional sense of evaluating diagnostic accuracy against a ground truth. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OTI i-scan, K960622) through non-clinical testing.

The relevant section, "(6) Performance Data," states:

(a) Non-clinical tests: "The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."
(b) Clinical tests: "Not required."
(c) Conclusions: "The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device."

This means the "study" that proves the device meets the acceptance criteria is a compilation of engineering and bench testing, not a human clinical trial. The exact acceptance criteria for these non-clinical tests (e.g., accuracy within a certain tolerance for axial length measurement) are not detailed in the provided document, nor are the specific results of those tests. The conclusion of equivalence is based on these non-clinical tests demonstrating that the new device performs comparably to the predicate device in terms of fundamental operational and safety characteristics.

Summary

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K024114

Section A

510(k) Summary

・

JAN 1 0 2003

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KO24/114

Ophthalmic Technologies Inc. Special 510(k) Submission Ophthalmic Ultrasonic A-scan System A-scan 100

510(k) Summary December 10, 2002

(1) Submitter Information

Name: Ophthalmic Technologies Inc.

Address:

Ophthalmic Technologies Inc. 37 Kodiak Crescent, Unit 16 Downsview, Ontario, Canada M3J 3E5

Telephone number:

416-631-9123 • 1-800-517-4444

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708

Date Prepared: December 10, 2002

(2) Name of Device

Trade Name: A-scan 100 Common Name: Ophthalmic A-scan biometry system Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO

(3) Equivalent legally-marketed devices.

OTI i-scan, K960622

(4) Description

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/<02-4///4

(5) Intended Use

The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL).

(6) Performance Data

(a) Non-clinical tests
The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
(b) Clinical tests
Not required.

The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing people, in a flowing, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2003

George H. Meyers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K024114

Trade Name: A-Scan 100 Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: December 11. 2002 Received: December 13, 2002

Dear Mr. Meyers:

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 A-Scan 100 Ophthalmic Ultrasound System, as described in your premarket notification:

Transducer Model Number

A-Scan

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

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Page 2 - Mr. Meyers

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Bergman

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page 9 Diagnostic Ultrasound Indications for Use Form

Page 2011 - of of ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K024114

Device Name: A-scan 100

Intended Use:

The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in th eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiri. intraocular lenses,

CLINICALAPPLICATION	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
Ophthalmic	P
Fetal
Abdominal
Intra-operative(specify)
Intra-operative
Neurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 810.109)
------------------------------------------	--

Over-the-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K02411

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.