OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

AI/ML Overview

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

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

This information is not present in the document. Since a specific performance study with a test set is not described, these details are not provided.

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):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

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

This information is not present in the document.

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:

This information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

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

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

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

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

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

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

Summary

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510(k) Summary of safety and effectiveness information for equivalence determination.

Device	OB1 Obstetrical Doppler
Common Name	Handheld Fetal Doppler
Manufacturer	D. E. Hokanson, Inc.12840 NE 21st PlaceBellevue, WA 98005Phone: (425) 882-1689Fax: (425) 881-1636
EstablishmentRegistration Number	3019130
Contact	D. Eugene Hokanson, President
Preparation Date	September 26, 2003
Classification	Class II per FR 884.2660, Fetal Ultrasonic Monitor
Indications for Use	This product will be used to detect fetal heartbeats to helpdetermine fetal viability.
Description	OB1 Obstetrical Doppler is a handheld, internally-poweredDoppler audio instrument used for detecting fetal heart beats.There are only four user controls; Up and Down audiovolume, Freeze Display, and Power On/Off. A three inchloudspeaker provides good Doppler audio. A digital LCDreadout shows the fetal heart rate when it is stable for threeor four seconds.
Substantial Equivalenceto Predicate Devices	Huntleigh Technologies, Manalapan, NJDopplex II Pocket Doppler, K930200, cleared 6/24/94Medasonics Incorporated, Newark, CACadance Doppler Ultrasound System, K991441, cleared12/28/99Summit Doppler Systems, Inc., Arvada, COLifeDop Doppler Ultrasound System, K024197, cleared1/03/03
Technology Summary	Doppler ultrasound technology in the OB1 is substantiallyequivalent to that in the predicate devices listed above.Recursive filter techniques are used to detect the fetal heartrate displayed on the digital readout. This achieves similarresults as the techniques (not published) in the predicatedevices.
Conclusion	Based on comparisons of device features, materials,intended use and performance, the OB1 Obstetrical Doppleris substantially equivalent to the commercially available andlegally marketed devices listed above.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2003

Mr. D. Eugene Hokanson President D. E. Hokanson. Inc. 12840 Northeast 21st Place BELLEVUE WA 98005

Re: K033156

Trade Name: OB1 Obstetrical Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: November 11, 2003 Received: November 17, 2003

Dear Mr. Hokanson:

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 OB1 Obstetrical Doppler, as described in your premarket notification:

Transducer Model Number

2.25 MHz CW Fetal 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. Hokanson

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.

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".

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Page 3 – Mr. Hokanson

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

Sincerely yours,

David A. Lyman

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

2.25 MHz CW Fetal Probe

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletalSuperficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Although the transducer can be disconnected from the main unit there is only a 2.25MHz probe available for the OB1 at this time.

(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) ✔

David G. Hanson

(Division Sion-C Division of and Radio 510(k) Nu

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Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).