Data recording and analysis is contained within a durable medical device that is used to record, analyze and display electrocardiographic signals from the body surface. The system features a power supply with battery back-up, signal acquisitioning and processing hardware and firmware, a computer and a software, including automated analysis software, a flat panel color display and a color printer.

The PRIME ECG System incorporates computer processing that can present conventional ECG waveforms as color images displayed on a simulated torso. Each PRIME ECG recording captures body surface potentials for analysis. The PRIME ECG System translates the segments of the ECG waveform into ranges of color based on measured values. The range from vellow to red is assigned to positive values, with deep red assigned to the highest value. Green is assigned to neutral values and shades of blue are assigned to negative values with deep blue assigned to the highest negative value. This information allows physicians to identify areas of abnormality for interrogation.

The PRIME Diagnostic Algorithm is an adjunct to the color displays of the underlying ECG waveforms to assist the physician in coming to a conclusion on the patient's cardiac status. The Diagnostic Algorithm uses multiple parameters of ECG potentials and ECG morphology to make a recommendation on whether the patient has a Normal, Abnormal or Acute MI condition. An explanation window describes to the physician the basis of the Diagnostic Algorithm conclusion. Thus, the physician is at liberty to interrogate the recommendation and agree to or override it.

The PRIME ECG data recording and analysis system is attached to a single-patient electrode array (vest) that is placed on the patient in two parts consisting of a 64 lead anterior and a 16 lead posterior segment. Electrodes and signal conduction pathways are screen-printed onto a clear plastic substrate. The vest is secured to the patient with a pre-applied conductive adhesive gel. The vest is a single use device and cannot be re-used.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as a target for the enhanced algorithm. Instead, it demonstrates improved comparative performance against a predecessor and the 12-lead ECG. The implication is that "improvement" is the de facto acceptance criterion.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Enhanced PRIME Algorithm)
Sensitivity	Improve over previous PRIME Algorithm (K030104)	47%
Specificity	Not significantly degrade from previous (K030104)	88% (compared to 90% for K030104)
Ratio of PRIME Sensitivity to 12-lead ECG	Increase over previous PRIME Algorithm (K030104)	2.1 (compared to 1.7 for K030104)

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

Test Set Description: The "FDA Troponin" set.
Sample Size (Positive Cases): 78 (True Positive cases for MI)
Sample Size (Negative Cases): 147 (False Positive cases for MI, implying these were non-MI patients from the overall cohort)
Total Test Set Size: 225 (78 + 147)
Data Provenance: This sub-set was generated from the Company's IDE study (G990171), which gathered data from "a number of institutions." The text implies this data was historic, and the specific "FDA Troponin" set was created retrospectively from this larger dataset, as it was used to confirm previous algorithm versions. The context suggests the IDE study was prospective data collection.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated, though the MI diagnosis was "confirmed by Troponin as a Gold Standard," indicating a clinical diagnostic process. The involvement of "institutions" suggests clinical experts were involved in the initial diagnosis.

4. Adjudication Method for the Test Set:

The document states that the original IDE study "allowed the institutions to follow their normal protocol in the treatment of suspect MI. As a result there were a number of methods of confirmation of the diagnosis, no one methodology had been mandated."
For the "FDA Troponin" sub-set, the MI diagnosis was specifically "confirmed by Troponin as a Gold Standard." This implies a biomarker-driven adjudication, rather than a human expert consensus adjudication for the ground truth of MI.

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

Was an MRMC study done? No. The study compares algorithmic performance to human interpretation and other algorithmic versions, but it does not describe an MRMC study where human readers interpret cases with and without AI assistance to measure improvement. The row "PRIME ECG, physician interpretation (K012414)" refers to a past evaluation of physician interpretation, not a concurrent AI-assisted reading study.

6. Standalone Performance Study:

Was a standalone study done? Yes. The "Enhanced PRIME Algorithm (this application)" row in Table 1 represents the standalone performance of the algorithm itself without human intervention (as it reports algorithm sensitivity and specificity). The purpose of the algorithm is to make a "recommendation," which a physician can then agree to or override, implying standalone assessment followed by physician review in practice.

7. Type of Ground Truth Used:

For the test set ("FDA Troponin" set): Biomarker (Troponin) confirmed MI was used as the "Gold Standard" for diagnosis.

8. Sample Size for the Training Set:

The Company "created 3 training sets of cases (called Alpha, Beta and Charlie)."
Specific sample sizes for Alpha, Beta, and Charlie are not provided.

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

The training cases "have been drawn from Acute Coronary Syndrome patients attending a UK hospital."
The exact method for establishing ground truth for these training sets is not explicitly stated, beyond being from diagnosed ACS patients. However, given the context of the "FDA Troponin" set, it is highly probable that clinical diagnoses, potentially involving biomarkers and other standard clinical assessments, were used to establish the ground truth for training.

Summary

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V. 510(K) SUMMARY

510(k) SUMMARY

Heartscape Technologies Ltd's PRIME ECG® with enhanced Diagnostic Algorithm

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Heartscape Technologies Ltd Unit 1, 6B Balloo Drive Bangor Co Down BT19 7QY United Kingdom

Phone: 011 44 2891 857500 Facsimile: 011 44 2891 857900

Contact Person: Paul Phillips

Date Prepared: 8th August 2008

Name of Device

PRIME ECG® with enhanced Diagnostic Algorithm

Common or Usual Name

PRIME ECG®

Classification Name/Product Code/CFR Reference

Electrocardiograph, classified under 21 CFR 870.2340

Predicate Devices

PRIME ECG The System: manufactured by Meridian Medical Technologies Ltd . (K012414)
PRIME ECG TM System with Diagnostic Algorithm: formerly manufactured by . Meridian Medical Technologies Ltd, now manufactured by Heartscape Technologies Ltd. (K030104)

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Intended Use / Indications for Use

The PRIME ECG® with enhanced Diagnostic Algorithm is intended to be used for the recording of electrocardiographic signals.

The PRIME ECG® with enhanced Diagnostic Algorithm is indicated for the recording of electrocardiographic signals on the body surface

Technological Characteristics

The device consists of the following components and accessories:

PRIME ECG Cart .

PRIME ECG Algorithm .

PRIME ECG Single-Use Patient Vest .

The PRIME ECG data recording and analysis system is attached to a single-patient electrode array (vest) that is placed on the patient in two parts consisting of a 64 lead

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anterior and a 16 lead posterior segment. Electrodes and signal conduction pathways are screen-printed onto a clear plastic substrate. The vest is secured to the patient with a pre-applied conductive adhesive gel. The vest is a single use device and cannot be re-used.

The device complies with the relevant parts of EN60601 and AAMI 11. In overview:

The device has features to isolate the patient from mains AC electricity supply, even . in the event of fault conditions.
The device is meant to be removed from contact with the patient before defibrillation. . However, it has features to protect itself and users in the event of defibrillation of the patient whilst the device is still attached to the patient.
The device conforms to the required standards for ElectroMagnetic Compatibility . ("EMC"), both in its proof against external sources of interference and in limiting its own electromagnetic radiations.

Performance Data

The purpose of this 510(k) submission is to change the labeling of the device to incorporate the effects of enhancements to the Diagnostic Algorithm. These enhancements have resulted in an improved sensitivity in the detection of Myocardial Infarctions (MIs) over both the predecessor version (as cleared under K030104) and also the ubiquitous 12-lead ECG type of device.

The Company's IDE study (G990171) gathered data from a number of institutions to compare the sensitivity and specificity of both the 12-lead and PRIME ECG in the detection of MIs. This data was used as the basis for the 510(k) submission for K012414, demonstrating equivalence between the 12 lead as a predicate and PRIME ECG.

The IDE study had allowed the institutions to follow their normal protocol in the treatment of suspect MI. As a result there were a number of methods of confirmation of the diagnosis, no one methodology had been mandated. A sub-set of the IDE data was generated, the so called "FDA Troponin" set, where the MI diagnosis had been confirmed by Troponin as a Gold Standard. This sub-set was used to confirm that the Diagnostic Aleorithm in the 510(k) submission for K030104 was at least as effective as the 12 lead in the detection of MI. Since the submission for K030104, the Company has added further enhancements to the Diagnostic Algorithm that improve its sensitivity to MI, whilst not significantly degrading its specificity. A table of comparison is below:

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Test	TruePositive(n=78)	FalsePositive(n=147)	Sensitivity	Specificity	Ratio of PRIMESensitivity to12-lead ECG
12-lead ECG	17	7	22%	95%	not applicable
PRIME ECG, physicianinterpretation (K012414)	26	10	33%	93%	1.5
PRIME Algorithm(K030104)	29	14	37%	90%	1.7
Enhanced PRIMEAlgorithm(this application)	37	17	47%	88%	2.1

Table 1: Comparative Device Performance among patients with Biomarker confirmed MI

The Company has created 3 training sets of cases (called Alpha, Beta and Charlie) for the development of the Diagnostic Algorithm. These cases have been drawn from Acute Coronary Syndrome patients attending a UK hospital and have no overlap with the FDA Troponin set. The Alpha, Beta and Charlie sets are used for the testing/training of possible enhancements to the Diagnostic Algorithm. The Troponin set is reserved solely for the final validation of MI detection performance.

Substantial Equivalence

The version of PRIME ECG, with enhanced Diagnostic Algorithm, that is the subject of this submission is as safe and effective as the predicate versions of PRIME ECG. The device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the PRIME ECG with enhance Diagnostic Algorithm and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the PRIME ECG with enhanced Diagnostic Algorithm is as safe and effective as the predicate PRIME ECG with Diagnostic Algorithm and the PRIME ECG. Thus, the PRIME ECG with enhanced Diagnostic Algorithm is substantially equivalent.

Labeling Change

The main purpose of this 510(k) application is the desire to have a change to the labeling of the device that informs the user of the improved comparative performance of the device over the 12-lead EKG (the predicate of the original PRIME ECG) in the detection of ST Elevation Myocardial Infarction.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

Heartscape Technologies Ltd c/o Mr. Paul Phillips Director Unit 1, 6B Balloo Drive Bangor Co Down BT19 7QY United Kingdom

Re: K082312

Trade/Device Name: PRIME ECG ® Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: August 8, 2008 Received: August 13, 2008

Dear Mr. Phillips:

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. Paul Phillips

Please he advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html,

Sincerely yours,

Duma R. Va. Vamer

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

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Enclosure

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IV. INDICATIONS FOR USE STATEMENT

Indications for Use Statement

510(k) Number (if known): K082 31 2 ---------

Device Name: PRIME ECG®

Indications for Use:

The PRIME ECG® with enhanced Diagnostic Algorithm system is intended for the recording of electrocardiographic signals from the body surface

メ Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Mines

vision Sign-Off) ivision of Cardiovascular Devices

K082312 510(k) Number

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510k_prime1_enhanced da_application-080808.doc

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).