ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: Patients with suspected cardiac abnormalities Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. Stress Testing Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bioycle, treadmill, or other means, while the ECG is monitored continuously. Exercise body of treading, on one may of The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, andreasonals phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. HyperQ™ The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

Device Description

The HyperQ™ AD-100 System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HyperQ™ AD-100 System, structured to address your specific points.

Important Note: The provided document is a 510(k) Summary of Safety & Effectiveness for a medical device. This type of document is a summary and often refers to detailed reports (e.g., validation results) not included in the summary itself. Therefore, some specific details you requested (like exact sample sizes for test/training, number/qualifications of experts, or specific effect sizes from MRMC studies) are often not explicitly stated in a 510(k) summary, as these are typically found in the full submission. I will extract what is explicitly available and note where information is not provided.

Acceptance Criteria and Device Performance Study for HyperQ™ AD-100 System

Based on the provided K102579 510(k) Summary, the device is largely presented as "substantially equivalent" to a predicate device (HyperQ™ System K082564). The primary difference is the ability to be an accessory. The summary states that "Based upon the validation results, BSP believes this change does not raise additional safety or efficacy concerns." This indicates that the new device is expected to perform at least as well as the predicate and that the validation study aimed to confirm this.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a specific table for "reported device performance" in the way one might expect for a new diagnostic accuracy claim (e.g., sensitivity, specificity thresholds). Instead, the performance is generally framed around its "substantial equivalence" to the predicate device and the continuation of its intended use.

The closest we get to performance criteria are the technical specifications, which are identical to the predicate device, implying that meeting these specifications is a form of acceptance criterion to maintain equivalence. The "performance" is then demonstrating that the modified device still adheres to these specifications and intended uses, particularly regarding the HyperQ™ analysis and ST segment monitoring.

Characteristic	Predicate Device (System) (Acceptance Criterion - implicit)	Modified Device (System) (Reported Performance)
Number of Electrodes	10	same (10)
Number of Leads	12	same (12)
ECG Samples/second	1000	same (1000)
A/D Bits	16 (0.15 µVLSB)	same (16 (0.15 µVLSB))
Defibrillation Protection	Built In	same (utilizes a defibrillation proof patient cable)
Input Signal dynamic range	10 mV	same (10 mV)
Simultaneously 12L	Yes, with sample/hold circuitry to assure zero delay between leads	same (Yes, with sample/hold circuitry to assure zero delay between leads)
CMMR	> 100 dB	same (> 100 dB)
Input Impedance	> 100M Ohm	same (> 100M Ohm)
DC max input	±330 mV	same (±330 mV)
Frequency Range (-3db)	0.05-300 Hz	same (0.05-300 Hz)
Low pass filter (software)	35 Hz	same (35 Hz)
Line pass filter (software)	50/60 Hz	same (50/60 Hz)
Safety Standard	IEC 60601-1, EN 60601-2, IEC 60601-2-25, IEC 60601-2-27, EC11 ST Segment Analysis EC 38-1999	Same
Operating Temperature	0°C to 50°C	same (0°C to 50°C)
Treadmill Control	yes	no (This is a difference, but the submission claims it doesn't raise new concerns)
On Line ECG	yes	no (This is a difference, but the submission claims it doesn't raise new concerns)
HyperQ calculated from on line ECG	yes	yes
Power	5 V	same (5 V)
Current	80 mA	200 mA (This is a difference, but likely addressed by electrical safety testing)
Dimensions	15 x 12 x 2 cm	17 x 11 x 2.5 cm (This is a difference, likely addressed by electrical safety testing)
Weight	200 grams	same (200 grams)
Storing Temperature	-20°C to 60°C	same (-20°C to 60°C)
Humidity	0.85%	same (0.85%)
Functional Acceptance (Implicit)	Provides HyperQ analysis from acquired ECG; ST segment algorithm accuracy tested.	Device provides HyperQ analysis from acquired ECG; passed IEC Electrical Safety & EMC tests.

The core "acceptance criterion" for this 510(k) appears to be demonstrating that the new device, despite being an accessory and having slight physical differences, performs the intended functions (ECG, stress testing, HyperQ analysis, ST segment monitoring) to the same standard as the predicate device, especially regarding safety and efficacy.

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

Sample Size for Test Set: The document explicitly states "a database is used as a tool for performance testing" for the ST segment algorithm and refers to "validation results" for the device as a whole. However, the specific sample size (number of patients/cases) used for these test sets is not provided in this summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is based in Israel, so it's possible the data originated there, but this is not confirmed.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: Not explicitly mentioned. The focus is on the device's technical specifications and maintaining its intended functions, rather than a direct comparison of human readers with and without AI assistance. The HyperQ™ Software is "intended to be used as an aid," implying human-in-the-loop, but no study comparing human performance with and without this specific AI aid is described here.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study details are provided.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done?: Yes, to an extent. The document states, "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." This implies an evaluation of the algorithm's output (ST segment data) against a reference, which is a standalone assessment. Similarly, the statement "In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root, mean-square (RMS) values, are compared to the resting values" describes an algorithmic function. The summary itself does not provide quantitative results (e.g., sensitivity, specificity) of this standalone performance.

7. Type of Ground Truth Used

Ground Truth Type:
- For ST segment algorithm accuracy: "a database is used as a tool for performance testing." While not explicitly stated, clinical consensus from expert cardiologists or reference ECG analyses would be the most common ground truth for such assessments.
- For HyperQ™ analysis: The ground truth is implicit in the comparison "changes in the high frequency of the mid QRS complex...are compared to the resting values." This suggests a comparative approach to a baseline, rather than an external "ground truth" for the HyperQ™ values themselves. The significance of these changes, however, "must be determined by a physician," implying that the ultimate clinical ground truth relies on expert interpretation in context.

8. Sample Size for the Training Set

Sample Size for Training Set: Not provided. The summary mentions "a database" for testing, but doesn't elaborate on specific training data. Given the context of a 510(k) for an accessory that builds on an existing predicate, there might have been a development database for the original HyperQ™ system, but details for the AD-100's specific training are not in this summary.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not provided. (See point 8).

In summary, this 510(k) document primarily asserts substantial equivalence based on technical specifications and the continued intended use of the device's analytical capabilities (HyperQ™ and ST segment monitoring). While it states that "validation results" confirm that changes do not raise new safety or efficacy concerns and that the ST segment algorithm has been "tested for accuracy," it does not provide granular details on the methodologies (sample sizes, expert qualifications, specific performance metrics, ground truth establishment) of these validation studies as would typically be found in a full scientific publication or the more extensive 510(k) submission itself.

Summary

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

K102579 pl/3

510(k) Summary of Safety & Effectiveness

.:'

DEC = 2 2011

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a)	SubmitterAddress:	George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com
1. (b)ManufacturerAddress:		Biological Signal Processing Ltd.22a Raul Wallenberg StreetTel-Aviv 69719, Israel
	Mfg. Phone:	Tel.: 972-3-647-4840
	Contact Person:	Eran Toledo
	Date:	August 31, 2010
2.	Device &ClassificationName:	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)device as a class II device (product code MWI, 21 CFR 870.2300)HyperQ™ AD-100 System
3.	Predicate Device:	HyperQ™ System K082564
4.	Description:	The HyperQ™ AD-100 System is a compact monitor for measuring,processing, storing, and displaying information derived from anelectrocardiogram (ECG). The device analyzes and records the highfrequency components of the QRS complex of standard ECG.
5.	Intended Use:	ECG
		ECG is intended to disclose either normal condition or patterns ofarrhythmia, myocardial ischemia, rate abnormalities, or features ofprognostic value in the following cases:Patients with suspected cardiac abnormalitiesPopulations of patients at an age or period in which a routine baselineevaluation of ECG characteristics is desired.
		Stress Testing
		Angina pectoris (chest pain) is a clinical syndrome resulting from myocardialischemia, indicative of reduced blood supply to the cardiac muscle. Theelectrocardiogram may establish the diagnosis of ischemic heart disease ifcharacteristic changes are present.Stress testing is the most widely used method to decide whether this chest

: ,

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

K102579
p2/3

pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG,records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root, meansquare (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential.

ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

HyperQ TM

The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex.

The significance of the HF-QRS changes must be determined by a physician.____________________________________________________________________________________________________________________________________________________________________ Carlos Concession Company Concession Company Concession Company Concession Company Controller Company Controller Company Controller Company Controller Company Controller Comp

Comparison of Technological Characteristics:

With respect to technology and intended use, the Modified HyperQ™ System (HyperQ™ AD-100 System) is substantially equivalent to its predicate device which is the HyperQ™ System. The primary difference is that the modified device has the ability to be an accessory (add-on) to a legally marketed ECG Stress System to provide HyperQ analysis from the acquired ECG. Based upon the validation results, BSP believes this change does not raise additional safety of efficacy concerns. In addition, the system has passed IEC Electrical Safety Testing as well as EMC.

The following predicate comparison table delinerates the specific similarities and differences:

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

K102579
P3/3

Characteristic	Predicate Device (System)	Modified Device (System)
Number ofElectrodes	10	same
Number of Leads	12	same
ECGSamples/second	1000	same
A/D Bits	16 (0.15 µVLSB)	same
DefibrillationProtection	Built In	same (utilizes adefibrillation proofpatient cable)
Input Signaldynamic range	10 mV	same
Simultaneously12L	Yes, withsample/holdcircuitry to assurezero delaybetween leads	same
CMMR	> 100 dB	same
Input Impedance	> 100M Ohm	same
DC max input	±330 mV	same
Frequency Range(-3db)	0.05-300 Hz	same
Low pass filter(software)	35 Hz	same
Line pass filter(software)	50/60 Hz	same
Safety Standard	IEC 60601-1, EN60601-2, IEC60601-2-25, IEC60601-2-27, EC11ST SegmentAnalysisEC 38-1999	Same
OperatingTemperature	0°C to 50°C	same
Treadmill Control	yes	no
On Line ECG	yes	no
HyperQ calculatedfrom on line ECG	yes	yes
Power	5 V	same
Current	80 mA	200 mA
Dimensions	15 x 12 x 2 cm	17 x 11 x 2.5 cm
Weight	200 grams	same
StoringTemperature	-20°C to 60°C	same
Humidity	0.85%	same

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biological Signal Processing, Ltd. c/o Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, MA 02726

DEC - 2 2010

Re: K102579

Trade/Device Name: Hyper-QTM AD-100 System Regulatory Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: October 26, 2010 Received: November 2, 2010

Dear Mr. Hattub:

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 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.

{4}------------------------------------------------

Page 2 – Mr. George J. Hattub

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

{5}------------------------------------------------

K102579

Indications for Use

510(k) Number (if known):

DEC - 2 2010

Device Name: HyperQ™System

Indications For Use: ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

· Patients with suspected cardiac abnormalities

• Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.

Stress Testing

Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present.

Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bioycle, treadmill, or other means, while the ECG is monitored continuously. Exercise body of treading, on one may of The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, andreasonals phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values.

Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential.

The significance of the ST segment changes must be determined by a physician.

HyperQ™

The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex.

The significance of the HF-QRS changes must be determined by a physician.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

J.M.

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).