POD PAC-20M by PORTABLE OPHTHALMIC DEVICES, INC.

The provided text is a 510(k) summary for the POD Pac-20m Corneal Pachymeter System, dated March 21, 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results for device performance.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. The document states that the technological characteristics are "the same as those for the predicate device except for the models of some of the components, and the user interface." It also mentions that the acoustic output is "similar to that of predicate devices and below the preamendment levels." However, specific acceptance criteria for measurement accuracy, precision, or other performance metrics for the POD Pac-20m are not provided, nor are detailed reported performance values. The clearance is based on substantial equivalence, implying that its performance is expected to be comparable to the predicate, but no specific performance data is given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. The document does not describe any specific clinical or performance test set, its sample size, or data provenance. The 510(k) summary is for substantial equivalence and does not include details of a clinical study for the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. As no specific clinical or performance test set is described, there's no mention of experts establishing ground truth.

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

Cannot be extracted. No test set is described, so no adjudication method is mentioned.

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

Cannot be extracted. This device is an "Ultrasonic Corneal Pachymeter," which is an imaging and measurement device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Cannot be extracted directly, but inferred as "yes" in practice. As a measurement device for corneal thickness, its primary function is standalone measurement. The document doesn't explicitly describe a "standalone performance study" in the context of an algorithm, but the device's intended use is to directly measure thickness, which inherently implies its standalone function. No performance metrics are provided to quantify this, however.

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

Cannot be extracted. No ground truth establishment is described in this document.

8. The sample size for the training set

Cannot be extracted. This document describes an ultrasonic measurement device, not an AI/machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

Cannot be extracted. As there's no training set, there's no ground truth establishment for it mentioned.

Summary of available information from the document related to device validation:

The document relies on substantial equivalence to a previously cleared predicate device, the Quantel "Pocket" Ultrasonic Pachymeter (K993674), and the classified device described in 21CFR892.1560 "Ultrasonic Pulsed Echo Imaging System," for its clearance.

The key points for substantial equivalence are:

Same intended use: To measure the thickness of the cornea.
Same technological characteristics: Except for models of some components and the user interface.
Same patient-contact materials.
Similar acoustic output: Below pre-amendment levels.

The FDA's letter mentions a 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." This is a post-market requirement for validation, not part of the pre-market submission detailed in this summary.

Summary

{0}------------------------------------------------

K030610

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

I. Submitter: Tim Ehrecke, Portable Ophthalmic Devices, Inc. 4413 Winston Place, Bettendorf, Iowa 52722. FAX 563-449-9184 Ph: 563-529-3536

MAR 2 1 2003

II. Classification Names and Numbers:	Ultrasonic Pulsed Echo Imaging System,90-IYO, 21CFR892.1560
III. Common/Usual Name:	Ultrasonic Corneal Pachymeter
IV. Proprietary Names:	POD Pac-20m™
V. Establishment Registration Number:	in progress
VI. Classification:	Class II, Tier II. Described in 21CFR892.1560

VII. Substantial Equivalence: We believe the POD Pac-20m™ is substantially equivalent to the classified device described in 21CFR892.1560, "Ultrasonic Pulsed Echo Imaging System," and to other ultrasound systems that have been cleared by the 510(k) process, such as the Quantel "Pocket" Ultrasonic Pachymeter (K993674).

The 510(k) Substantial Equivalence Decision-making Process (detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, to measure the thickness of the cornea.
The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the user interface.
The materials from which the patient-contact portions of the device are made are the same as in the predicate device.
The acoustic output of this device is similar to that of predicate devices and below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, resembling a family or group.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Mr. Tim Ehrecke President and CEO Portable Ophthalmic Devices, Inc. 4413 Winston Place BETTENDORF IA 52772

Re: K030610

Trade Name: POD Pac-20m Corneal Pachymeter System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: February 25, 2003 Received: February 26, 2003

Dear Mr. Ehrecke:

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 POD Pac-20m Corneal Pachymeter System, as described in your premarket notification:

Transducer Model Number

Blatek AT15399/AT15387 (20 MHz)

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); 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.

{2}------------------------------------------------

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. B ogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{3}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510(k) Number: K030 610

Device Name: POD Pac-20m Corneal Pachymeter System

Intended Use:	To measure thickness of the cornea in the human eye using ultrasound energy.
---------------	------------------------------------------------------------------------------

Clinic al App lication		Mode of Operation
	A	B	M	PW D	CWD	ColorDop pler	AmplitudeDop pler	ColorVelocityImaging	Com bined(specify)	Other(specify)
O ph thalm ic	N
Fetal
Ab dom inal
Intraoperative (specify)
Intraoperative N eurologic al
Pediatric
Small Organ (specify)
Neonatal C ephalic
Adult Cephalic
Cardiac
Transesophageal
Trans rectal
Trans vaginal
Trans urethr al
Intravasc ular
Peripheral Vascular
Laparos cop ic
Mu sculo-s keletalCon ventional
Mu sculo-s keletalSu perficial
Other (specify)

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 801.109)

Nancy Cbrogdon
(Division Sign-Om)
Division of Reprodative, Abdominal,

510k

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.