Clinical Application: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify)6, Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify)7, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Specify), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Specify), Peripheral vessel, Other (Specify), Musculo-skel (conventional), Musculo-skel (superficial)

Mode of Operation: B, M, PWD, CWD, Color Doppler, Combined, Others

Notes:

Combined modes are: B+M, B+M+Color, B+PW, B+PW(CVI), B+PW+Color
Harmonics (Tissue and Contrast) - Previously Cleared
Angio - Previously Cleared
Real-time 3D imaging- New
Real-time Bi-plane imaging- New
Intraoperative applications include: Cardiac, Vascular Previously Cleared
Small Parts applications include: Thyroid, scrotum, prostate, breast - Previously Cleared

Device Description

The M2424 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducer. It is substantially equivalent to the generic class of ultrasound systems including previous versions of the Philips Medical Systems M2424 (K002470) system and the Voluson 730 (K003525).

The 21315 transducer is substantially equivalent to the generic class of ultrasound transducers including previously cleared Philips Medical Systems transducers (K002470).

The M2424 system and 21315 transducer function in a manner identical to all ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into a ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals, processed, and sent back to the system. In the system, advanced signal processing technologies further convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Ultrasound M2424 Diagnostic Ultrasound System with the 21315 ultrasound transducer. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. Crucially, this document is a regulatory submission for a diagnostic ultrasound system, not an AI/ML powered device. Therefore, the concepts of acceptance criteria, study design for AI performance, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not directly applicable in the AI/ML context that your detailed questions imply.

The information provided focuses on demonstrating the device's technical specifications, safety, and equivalence to existing ultrasound systems, rather than advanced algorithmic performance.

Here's an analysis of what can be extracted, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't outline specific, quantitative acceptance criteria in the way one would expect for an AI/ML model's performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for this traditional medical device are regulatory in nature, based on demonstrating substantial equivalence to predicate devices.

The "reported device performance" is framed in terms of meeting these equivalence criteria:

Acceptance Criteria (Regulatory Equivalence)	Reported Device Performance
1. Intended Use Equivalence: Indications for use are same as predicate device.	The M2424 system with the 21315 transducer is "intended for diagnostic ultrasound imaging and fluid flow analysis." This is stated to be substantially equivalent to predicates having the "diagnostic ultrasonic imaging and fluid flow analysis."
2. Technical Capabilities Equivalence: Same gray-scale and Doppler capabilities. Equivalent technologies for imaging, Doppler functions, and signal processing.	"Both the predicate device and the M2424 have the same gray-scale and Doppler capabilities." "Both the predicate device and the M2424 use essentially the same technologies for imaging, Doppler functions and signal processing."
3. Safety Standards Equivalence: Acoustic output levels below FDA limits. Manufactured under equivalent quality systems. Made of materials with equivalent biosafety. Designed and manufactured to the same electrical and physical safety standards.	"Both the predicate device and the M2424 have acoustic output levels below the applicable FDA limits." "Both the predicate device and the M2424 are manufactured under equivalent quality systems." "Both the predicate device and the M2424 are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application." "Both the predicate device and M2424 are designed and manufactured to the same electrical and physical safety standards." A special report on acoustic output measurements based on production line devices is required post-clearance.

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

This information is not provided in the document as it pertains to a traditional device clearance, not an AI/ML performance study. There isn't a "test set" in the sense of a dataset for evaluating algorithm performance. The evaluation is based on engineering comparisons and adherence to standards.

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

This information is not provided and is irrelevant for a traditional ultrasound device submission. There is no concept of "ground truth" established by experts for image interpretation in the context of this 510(k) summary, as it's not an AI/ML product.

4. Adjudication Method for the Test Set:

This information is not provided and is irrelevant for this type of device submission.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, which is not applicable to a conventional ultrasound system.

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

No, a standalone algorithm performance study was not done. This pertains to AI/ML models, which this device is not. The M2424 is the diagnostic ultrasound system itself, not an algorithm that interprets images.

7. The Type of Ground Truth Used:

Not applicable. For a diagnostic ultrasound system, the "ground truth" of its operation is its ability to produce diagnostic images and perform fluid flow analysis as intended, verified through engineering tests and comparison to predicate devices, rather than through labeled data for an algorithm.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. As a traditional ultrasound system, there is no "training set" or a process of establishing ground truth for it in the AI/ML sense.

Summary

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K022303

JUL 3 0 2002

3 Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. §807.92.

The submitter of this premarket notification is:

Paul Smolenski Regulatory Engineer Philips Ultrasound 3000 Minuteman Road, MS 0135 Andover, MA 01810 Tel: (978) 659-3380 Fax: (978) 975-7324

This summary was prepared on June 21st, 2002

The proprietary name of the device is the M2424 Diagnostic Ultrasound System with the 21315 ultrasound transducer. These devices are commonly known as a diagnostic ultrasound system and transducer.

These devices are classified as follows:

90IYN	Ultrasonic Pulsed Doppler Imaging System
90IYO	Ultrasonic Pulsed Echo Imaging System
90ITX	Diagnostic Ultrasound Transducer

As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

The 21315 transducer is substantially equivalent to the generic class of ultrasound transducers including previously cleared Philips Medical Systems transducers (K002470).

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pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals, processed, and sent back to the system. In the system, advanced signal processing technologies further convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The M2424 system with the 21315 transducer is intended for diagnostic ultrasound imaging and fluid flow analysis.

The M2424 system with the 21315 transducer is substantially equivalent in safety and effectiveness to the predicates identified above:

Both the predicate device and the M2424 are indicated for the diagnostic ultrasonic . imaging and fluid flow analysis.
Both the predicate device and the M2424 have the same gray-scale and Doppler . capabilities.
Both the predicate device and the M2424 use essentially the same technologies for . imaging, Doppler functions and signal processing.
Both the predicate device and the M2424 have acoustic output levels below the . applicable FDA limits.
Both the predicate device and the M2424 are manufactured under equivalent quality . systems.
Both the predicate device and the M2424 are manufactured of materials with . equivalent biosafety. The materials have been evaluated and found to be safe for this application.
Both the predicate device and M2424 are designed and manufactured to the same . electrical and physical safety standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2002

Philips Ultrasound, Inc. c/o Mr. Mark Job Responsible Third Party Official TUV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K022303

Trade Name: Philips Ultrasound M2424 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 IYN, 90 IYO and 90 ITX Dated: July 15, 2002 Received: July 16, 2002

Dear Mr. Job:

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 Philips Ultrasound M2424 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

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Page 2- Mr. Mark Job

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.

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.

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Page 3 - Mr. Mark Job

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. Lynn

for

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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Indications for Use Summary 4.3.2

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Philips Ultrasound M2424 Diagnostic Ultrasound System System:

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

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined	Others
Ophthalmic	Ophthalmic	P		P		P
	Fetal	P	P	P	P	P	P	2,3,4
	Abdominal	P	P	P	P	P	P	2,3,4
	Intra-operative (Specify)6	P	P	P	P	P	P	2,3,4
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric	P	P	P	P	P	P	2,3,4,5
	Small Organ (Specify)7	P	P	P	P	P	P	2,3
	Neonatal Cephalic	P	P	P	P	P	P	2,3
	Adult Cephalic	P	P	P	P	P	P	2,3
	Trans-rectal	P	P			P	P
	Trans-vaginal	P	P			P	P
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	2,3
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P	P	P	P	P	P	2,3,4,5
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	2,3,4,5
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	2,3
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	2,3,4,5
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)

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

Notes:

Combined modes are: B+M, B+M+Color, B+PW, B+PW(CVI), B+PW+Color
Harmonics (Tissue and Contrast) - Previously Cleared
Angio - Previously Cleared
Real-time 3D imaging- New

1. Real-time Bi-plane imaging- New
1. Intraoperative applications include: Cardiac, Vascular Previously Cleared

Small Parts applications include: Thyroid, scrotum, prostate, breast - Previously Cleared

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

David he. hygm
(Division Sign-Off)
Cly HD

(Division Sign-On)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022303

Page 17

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Philips Ultrasound M2424 Diagnostic Ultrasound System System: Transducer: 21315 Phased array transducer

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

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	2,3,4,5
	Abdominal	N	N	N	N	N	N	2,3,4,5
	Intra-operative (Specify)1	N	N	N	N	N	N	2,3,4,5
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	2,3,4,5
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	N	N	N	N	N	N	2,3,4,5
	Cardiac Pediatric	N	N	N	N	N	N	2,3,4,5
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)
	Musculo-skel (conventional)
	Musculo-skel (superficial)

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

*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: Other Modes include Amplitude Doppler.

Note 1: Intraoperative uses include abdominal and cardiac (including vessels) applications.

Note 2: Other conventional modes includes Angio
Note 3: Real-time 3D imaging - New

Note 4: Real-time Bi-plane imaging - New

Note 5: Harmonics (Tissue and Contrast)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

David h. Eymm

"Division Sign Off

(Division Sign-Of Division of Reproductive. Al and Radiological Device 510(k) Number

Page 18

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.