The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.

Device Description

The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.

AI/ML Overview

The provided text describes the 510(k) summary for the dBG 300 Digital Ballistocardiograph, but it does not contain acceptance criteria or detailed study results that prove the device meets specific performance metrics.

The document discusses substantial equivalence to a predicate device (Seismed SCG-2000 Seismocardiograph) and mentions clinical data collected to compare cardiac event timings with an echocardiograph. However, it does not provide the specifics of this clinical data in a way that allows for a comprehensive description of acceptance criteria and a study proving their fulfillment.

Therefore, I cannot fulfill all parts of your request with the information provided. I can, however, extract what is available regarding clinical data and ground truth establishment:

Missing Information

The provided text does not contain the following information:

A table of acceptance criteria or specific reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity, agreement thresholds).
Sample size used for the test set.
Number of experts used to establish ground truth for the test set or their qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with/without AI assistance.
If a standalone (algorithm only) performance study was done with specific results.
Sample size for the training set.
How the ground truth for the training set was established.

Available Information Related to Studies and Ground Truth

While specific acceptance criteria and detailed study results are absent, the document does mention a clinical study and the type of ground truth used:

A table of acceptance criteria and the reported device performance:
- Information not available: Specific acceptance criteria (e.g., "timing measurements must be within X ms of echocardiograph measurements") and quantitative reported device performance against such criteria are not provided.
- The document implies that "equivalent intended use, manufacturing materials, operating principles, physical and operational specifications" to the predicate device (Seismed SCG-2000) serve as a basis for substantial equivalence, rather than direct performance metrics against specific criteria.
Sample size used for the test set and the data provenance:
- Information not available: The exact sample size for the clinical data is not specified.
- Data provenance: "clinical data collected to compare the subjects device's finding of the times of occurrence of cardiac events such as aortic valve opening or closing with that of an echocardiograph." This implies prospective data collection for comparison. The country of origin is not explicitly stated for the clinical data itself, though the submitter is from Canada and the regulatory correspondent from the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information not available: This detail is not provided.
Adjudication method for the test set:
- Information not available: This detail is not provided.
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:
- Information not available: The device is described as a tool to measure timing events; there is no mention of an "AI" component or human-in-the-loop performance improvement study in the context of MRMC. The document predates widespread AI in medical devices (2009).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied: The comparison to echocardiograph measurements suggests a standalone performance evaluation of the device's ability to measure cardiac event timings. However, specific performance metrics or detailed study design for this "standalone" evaluation are not provided.
The type of ground truth used:
- Ground truth type: The clinical data compares the dBG 300's findings with "that of an echocardiograph." Therefore, echocardiography serves as the ground truth for measuring the timing of cardiac events (e.g., aortic valve opening or closing).
The sample size for the training set:
- Information not available: No explicit mention of a separate "training set" or its size is made, suggesting a traditional device validation approach rather than an AI/machine learning model.
How the ground truth for the training set was established:
- Information not available: Given the lack of an explicit training set, this information is not provided.

Summary

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510(K) SUMMARY - K 081603 (as required by 807.92(c))

Regulatory Correspondent

Submitter of 510(k):

AJW Technology Consultants Inc. 962 Allegro Lane Apollo Beach, FL 33572

JUL 9 4 2009

HeartForce Medical, Inc Suite 200-100 Park Royal South Vancouver, BC V7T 1A2 Canada Phone: (604)-566-8200 Fax: (604)-566-8201 . . . .

Adrian Somers

Date of Summary:

Contact Person:

Trade/Proprictary Name:

Classification Name:

Product Code:

Intended Use: .

Device Description:

Predicate Device:

Substantial Equivalence:

07/21/09

dBG Digital Ballistocardiograph

Ballistocardiograph

DXR

K910994 Modified Seismocardiograph - Seismed Instruments, Inc

Heart Force claims the proposed device to be substantially equivalent to the previously cleared device by FDA in K910994. Heart Force claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, physical and operational specifications as compared to the predicate device.

In addition to bench data, the submittal includes clinical data collected to compare the subjects device's finding of the times of occurrence of cardiac events such as aortic valve opening or closing with that of an echocardiograph.

Page 1 of 3

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Features and Functions	Seismed SCG- 2000Seismocardiograph	HeartforcedBG 300
dBG Software
Record Management and Platform
Tests Stored as individual files	Yes	Yes
Save Test	Yes	Yes
File Retrieval	From 3.5" floppy disk	From Hard Drive or external drive
Operating System	Proprietary	Windows XP, Windows Vista
PC-Based Software	No, Proprietarysoftware onproprietary operating	Yes
Printing	Yes	Yes
Networked	No	No
Modem Data Transfer	Yes	No
Security
Printer	Yes	No (may use standard WindowsPrinters)
Patient Demographics
Patient Name	Yes	Yes
Gender	No	Yes
Date of Birth	No	Yes
Comments	Yes	Yes
Patient ID	Yes	No
Physician Demographics (for ModemTransfer)	Yes	Yes
Recording Test
ECG - BCG Syncrhonized Stacked Display	Yes	Yes (ECG & 3 Axis X, Y, Z BCG)
Rhythm Strip	No	Yes
ECG	3 Lead	No, Single Lead Rhythm Strip
X Axis BCG	No	Yes
Y Axis BCG	No	Yes
Z Axis BCG	Yes	Yes
Preset Recording time	30 Secs	User Configurable 10 secs, 30 secs,60 Secs
Pre Exercise Test	Yes	Yes
Post Exercise Test	Yes	Yes
Recovery Test	Yes	No
ECG - BCG Review
Waveform Markers	No	Yes, User Applies Markers for ACC
		recognized waves (Mitral Valve
		Close, J, Mitral Valve Open, Aortic
		Value Open, Aortic Valve Close, EarlyDiastole)
Scroll BCG	Yes	Yes
Zoom BCG	No	Yes
Measurements	No	Yes
Signal Averaging	Yes	Yes
Reports
BCG Complex	Yes	Yes
MVC to AVO: Shows the Mitral ValveClose to Aortic Valve Open time	No	Yes
AVO to AVC: Shows the systolic ejectionperiod	No	Yes
AVC to MVC: Shows the isovolumic	No	Yes
MVO to ED: Shows the Mitral Valve Opento Early Diastole time	No	Yes
AVO: Aortic Valve Opening	No	Yes
MVO: Mitral Valve Opening	No	Yes
dBG Hardware
Portable Unit	Semi Portable BesideUnit	Portable hand held unit,
Battery Power	No	Yes
Tri-axial Accelerometer	No (2 Axis)	Yes
Detachable Patient Cable (ECG, BCG)	Yes	Yes
ECG Lead Wires	Yes	No (ECG adhesive patches applied tosensor and patient)
Data Transmission	Built in unit	Wireless Bluetooth transmissionfrom dBG 300 device to dBGSoftware on a PC

・・

・

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and the control of the comments of the comments of

Page 3 of 3

.....

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HeartForce Medical, Inc. c/o Mr. Arthur Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572

JUL 2 4 2009

Re: K081603

Trade/Device Name: dBG 300 Digital Ballistocardiograph Regulatory Number: 21 CFR 870.2320 Regulation Name: Ballistocardiograph Regulatory Class: Class II (Two) Product Code: DXR, DSB Dated: May 27, 2009 Received: May 28, 2009

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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. Arthur Ward

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 letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K 081603

Device Name: dBG 300 Digital Ballistocardiograph

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for B Zuckerman(Division Sign-Off) 7124189 Division of Cardiovascular Devices 510(k) Number KO81603

Page 1 of 1

Regulation Number and Section

§ 870.2320 Ballistocardiograph.

(a)
Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.(b)
Classification. Class II (performance standards).