Corneal thickness measurements are useful for screening potential laser refractive surgery patients, glaucoma screening, and monitoring corneal swelling.

Device Description

The DGH 55 is a handheld ultrasonic pachymeter that uses echo spike techniques to measure the thickness of the cornea.

AI/ML Overview

The provided text is a 510(k) summary for the DGH 55 Handheld Pachymeter. It outlines the device's technical characteristics, intended use, and the tests performed to demonstrate substantial equivalence to a predicate device. However, it does not provide detailed acceptance criteria or a specific study proving the device meets particular numerical performance targets.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device (DGH 500 Ultrasonic Pachymeter, K920906A) through various performance tests. The "acceptance criteria" in this context are implicitly that the new device performs comparably to the predicate device and meets relevant safety and electromagnetic compatibility standards.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Comparative corneal thickness measurement tests: New device performs comparably to predicate device.	"The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device."
Comparative water bath/phantom tests: New device performs comparably to predicate device.	"The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device."
Comparative electronic calibration verification tests: New device performs comparably to predicate device.	"The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device."
EN 60601-1 (Medical electrical equipment - General requirements for safety): Device meets safety standards.	Listed as a performed test, implying compliance.
EN 60601-1-2 (Medical electrical equipment - Collateral standard: Electromagnetic compatibility): Device meets EMC standards.	Listed as a performed test, implying compliance.
IEC 60601-2-37 (Medical electrical equipment - Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment): Device meets specific ultrasonic safety (Clause 42.3 tested under condition 2).	Listed as a performed test, implying compliance.
Acoustic Output Reporting per FDA Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers": Acoustic output is within acceptable limits.	Listed as a performed test, implying compliance. Post-clearance special report required for production units.
Technological characteristics: Unchanged from predicate device, with technology updates not changing functionality.	Stated that "The technological characteristics are unchanged from the predicate device. The new microprocessor and associated hardware, and the new software implement the same algorithmic approach as the predicate device. The changes represent technology updates without changing functionality."

Note on "Acceptance Criteria" for performance: The document does not specify quantitative thresholds (e.g., "accuracy within X microns" or "agreement within Y standard deviations"). Instead, the acceptance criterion for the comparative tests is implicit in the statement of substantial equivalence: the new device must perform comparably to the predicate.

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

Sample size for the test set: Not specified.
Data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.

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

Number of experts: Not applicable. The "ground truth" for the comparative tests would likely be the measurements obtained by the predicate device or a known standard, not expert consensus in the typical sense of interpreting medical images.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not specified. Given the nature of a comparative measurement device, adjudication by consensus of multiple human readers is unlikely to be the method. The comparison would likely be statistical.

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

MRMC study: Not applicable. This device is a handheld pachymeter, not an AI-assisted diagnostic tool that would involve human readers interpreting images. It performs a direct measurement.

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

This device is a standalone measurement device. It provides corneal thickness measurements directly. The performance tests ("Comparative corneal thickness measurement tests," "Comparative water bath/phantom tests," "Comparative electronic calibration verification tests") would assess its standalone accuracy and consistency.

7. The type of ground truth used

For "Comparative corneal thickness measurement tests": The ground truth would likely be established by measurements from the legally marketed predicate device (DGH 500 Ultrasonic Pachymeter) or possibly a highly accurate alternative measurement method, though this is not explicitly stated.
For "Comparative water bath/phantom tests": The ground truth would be the known thickness of the phantoms/standards used in the water bath.

8. The sample size for the training set

Not applicable. This is a measurement device based on a previously established algorithmic approach, not a machine learning model that requires a distinct "training set" in the common sense. The document states, "The new microprocessor and associated hardware, and the new software implement the same algorithmic approach as the predicate device."

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for DGH Technology, Inc. The letters 'DGH' are in a bold, sans-serif font, with a horizontal line extending from the 'H' to the right. Above the line, the words 'TECHNOLOGY, INC.' are printed in a smaller, sans-serif font.

NOV - 7 2003

K033385
1 of 2

DGH Handheld Pachymeter 510(k) Summary

Submitter:	DGH Technology, Inc.110 Summit Drive, Suite BExton, PA 19341
Contact Person:	M. Luther DetweilerVice President, Regulatory Affairs
	Phone: 610-594-9100 / Fax: 610-594-0390E-mail: Lou@DGHKOI.com
Date summary prepared:	10/7/2003
Device trade name:	DGH 55 Handheld Pachymeter (Pachmate)
Device common name:	Ultrasound Pachymeter
Device classification name:	System, Imaging, Pulsed Echo, Ultrasonic
Legally marketed devicesto which the device issubstantially equivalent:	DGH 500 Ultrasonic Pachymeter (K920906A)
Description of device:	The DGH 55 is a handheld ultrasonic pachymeterthat uses echo spike techniques to measure thethickness of the cornea.
Intended use of the device:	Corneal thickness measurements are useful forscreening potential laser refractive surgery patients,glaucoma screening, and monitoring cornealswelling.
Technological characteristics:	The technological characteristics are unchangedfrom the predicate device. The new microprocessorand associated hardware, and the new softwareimplement the same algorithmic approach as thepredicate device. The changes represent technologyupdates without changing functionality.

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Image /page/1/Picture/0 description: The image shows the logo for DGH Technology, Inc. The letters "DGH" are in bold, block letters on the left side of the image. To the right of the letters, the words "TECHNOLOGY, INC." are written in a smaller, sans-serif font. A thick, black line extends from the bottom of the "H" in "DGH" to the right, underlining the words "TECHNOLOGY, INC."

Image /page/1/Picture/1 description: The image contains a handwritten sequence of characters and numbers. The sequence starts with the letters 'K' and 'O', followed by the numbers '33385'. Below the 'KO' is the sequence '2gz2'. The handwriting is somewhat cursive and the characters are not perfectly aligned.

Performance tests:

The following tests were performed to demonstrate substantial equivalence:

□□ Comparative corneal thickness measurement tests
□□ Comparative water bath/phantom tests
口 Comparative electronic calibration verification tests
□□ EN 60601-1: Medical electrical equipment -Part 1: General requirements for safety -IEC 601-1.
DO EN 60601-1-2: Medical electrical equipment -Part 1: General requirements for safety. Collateral standard: Electromagnetic compatibility requirements and tests. IEC 60101-2, and
□□ IEC 60601-2-37: Medical electrical equipment Part 2 - 37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (Clause 42.3 tested under condition 2 only.)
□□ Acoustic Output Reporting per section 4.6 of FDA Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued on September 30, 1997.

Conclusions: The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human figures connected at the shoulders, forming a sort of abstract bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2003

DGH Technology, Inc. % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K033385

Trade Name: DGH 55 Handheld Pachymeter (Pachmate) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasound pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: October 7, 2003 Received: October 23, 2003

Dear Mr. Devine:

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 DGH 55 Handheld Pachymeter (Pachmate), as described in your premarket notification:

Transducer Model Number

DGH2006DET

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.

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);

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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 determination of substantial equivalence is granted on the condition that prior to shipping the first device. you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30. 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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,

Nancy C Brogdon

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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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic	P
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Above indication for use is for the DGH55 Handheld Pachymeter with the DGH2006DET Detachable Probe.

(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 801.109) Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices

510(k) Number K033385

Kk) Number ___________________________________________________________________________________________________________________________________________________________________

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.