SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or ﺴ
other compatible cassette tape recorder. -
In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or -
other compatible cassette tape recorder. -

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727) -

HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:

Patient symptoms such as syncope, dizziness or palpitations. .
Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
Function of an implanted pacemaker or defibrillator. .

Device Description

SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).

SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.

AI/ML Overview

The provided document is a 510(k) summary for ELA Medical's Holter ECG analysis software and related tools (SyneScope™, EasyScope™, SyneCom™, and HolterReader). It focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a study to prove performance against those criteria.

Therefore, the information requested in your prompt regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, and multi-reader multi-case studies is not present in this document.

The document does mention "functional testing" and "software verification and validation testing," but it defers the details to attachments (e.g., Attachment 10.6 for software verification and validation, Attachment 10.9 for safety and performance tests according to AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards, and Attachment 10.4 for field testing). Without these attachments, a complete answer to your request cannot be provided.

Based only on the provided text, here's what can be extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document mentions adherence to standards (AAMI/ANSI EC38:1998 & IEC 60601-2-47) and functional testing, but it does not present a table of specific quantitative acceptance criteria or device performance metrics against those criteria.

2. Sample size used for the test set and the data provenance

The document refers to "functional testing," "software verification and validation testing," and "field testing" but does not specify the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided 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

The document describes software for Holter ECG analysis and reporting, but it does not mention any MRMC comparative effectiveness study evaluating human reader improvement with or without AI assistance. This type of study is typically associated with AI-driven diagnostic aids. The device's description (Holter ECG analysis software) suggests it's an analysis tool, not necessarily an AI-assisted diagnostic system in the modern sense.

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

While the software performs automated analysis, the document emphasizes its use "under the supervision of licensed and trained practitioners." It does not present a standalone performance evaluation of the algorithm explicitly separate from human oversight. The "functional testing" and "software verification and validation" (references to attachments 10.6 and 10.9) likely cover the algorithm's performance, but the details are not included.

7. The type of ground truth used

The document refers to "functional testing" and "field validation," but it does not explicitly state the type of ground truth data used (e.g., expert consensus, pathology, outcomes data, etc.) for these evaluations. For Holter analysis, ground truth would typically come from expert cardiologist review of ECG recordings.

8. The sample size for the training set

The document does not mention a training set as this is a 510(k) for software functionality and equivalence, not explicitly for a machine learning or AI algorithm in the context of a "training set."

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

As no training set is mentioned, this information is not provided.

Summary of Studies Mentioned (without details):

The document states:

SyneScope™, EasyScope™, SyneCom™ and HolterReader safety and performance testing: "Safety and performance tests according to the AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards." (Details in Attachment 10.9)
SyneScope™, EasyScope™, SyneCom™ and HolterReader software verification and validation testing: "Module and functional testing for SyneScope™, EasyScope™, SyneCom™ and HolterReader software applications." (Details in Attachment 10.6)
SyneScope™, EasyScope™, SyneCom™ and HolterReader field testing: "Field validation protocol and evaluation form completion." (Details in Attachment 10.4)

In conclusion, while the document confirms that various tests were performed to demonstrate that the device performs in a safe and effective manner and complies with relevant standards, it does not provide the specific details of acceptance criteria, quantitative performance, sample sizes, ground truth establishment, or human-in-the-loop study results you requested. These details would likely be found in the referenced attachments.

Summary

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042002

page 1 of 5

510 (k) Summary of Safety and Effectiveness

Submitter:

ELA Medical, Inc. 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441 Phone: (763) 519-9400 Fax: (763) 519-9440

Contact Person:

Susan Olive, Regulatory Affairs Manager

Devices trade names / Common names:

Trade Name: SyneScope™ 道
- Common name: Holter ECG analysis software (or Holter ECG analyzer, or Holter O ECG scanner).
Trade Name: EasyScope™ 지
- Common name: Holter ECG analysis software (or Holter ECG analyzer, or Holter o ECG scanner).
Trade Name: SyneCom™ 해
- o Common name: Holter ECG data transfer software or system.
Trade Name: HolterReader 특
- Common name: Holter ECG report viewer and printing software or tool.

Note: SyneCom™ and HolterReader are considered accessories of Holter ECG analyzers (they can be distributed separately to analyzers but they are intended to be used in conjunction with them).

Classification name:

Computer, diagnostic, programmable DQK (21CFR 870.1425)

Predicate devices:

The legally marketed devices to which ELA Medical is claiming equivalence are:

SyneTec (ELA Medical): ELA Medical "SyneTec™" (510(1) K002817, ELA -Medical Inc.).
SyneView (ELA Medical): ELA Medical "SyneView™" (510(k) K990727, ELA ﺖ Medical Inc.) including SyneView2™
H-Scribe (Mortara): Mortara Instrument, Inc. "H-Scribe" (510(k) K004017, Mortara -Instrument, Inc.).

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

K042002
page 2 of 5

Holter For Windows + (Rozinn): Rozinn Electronics, Inc. "Holter For Windows +" (based on 510(k) K930564, Northeast Monitoring, Inc.) including also Rozinn Electronics, Inc. "Netlink/NetScan" (510(k) K020213, Rozinn Electronics, Inc.).
Mida (Ortivus sold by Philips Medical Systems): based on "Mida System Models -1000/1100" (510(k) K896396, Medical Graphics Corp.)

Device description:

SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.

Intended use:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or -
other compatible cassette tape recorder. -

In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or -
other compatible cassette tape recorder. ﺳ

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466) or -
SyneFlash™ Holter ECG (K990727). -

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

042002
page 3 of 5

HolterReader is intended to view and print Holter report from SyneScope™, EasyScope™ and SyneCom™.

SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. all superville for Holter monitoring include, but are not limited to, evaluation of the following:

Patient symptoms such as syncope, dizziness or palpitations. .
Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
Function of an implanted pacemaker or defibrillator. .

Model	SyneScope	EasyScope	SyneTec	SyneView/SyneView 2	H-Scribe	Holter forWindows
Company	ELA Medical	ELA Medical	ELA Medical	ELA Medical	Mortara	Rozinn
510(k) Number			K002817	K990727	K004017	K930564
CE / MDDcertification	Yes	Yes	Yes	Yes	Yes	Yes
Type	Holter Analyzer	Holter Analyzer	Holter Analyzer	Holter Analyzer	Holter Analyzer	Holter Analyzer
PC based	Yes	Yes	Yes	Yes	Yes	Yes
OperatingSystem	MicrosoftWindows	MicrosoftWindows	MicrosoftWindows	MicrosoftWindows	MicrosoftWindows	MicrosoftWindows
NetworkCompatible	Yes	Yes	Yes	Yes	Yes	Yes
Read digital	Yes	Yes	Yes	Yes	Yes	Yes
Cassette Tape	Yes	Yes	Yes	Yes	Yes	Yes
ECG Channels	Basic: 2/3	Basic: 2/3	Basic: 2/3	Basic: 2/3	Basic: 2/3	Basic: 2/3
	Max: 12	Max: 3	Max: 3	Max: 3	Max: 12	Max: 12
Multi-ChannelArrhythmiaAnalysis	Yes	Yes	Yes	Yes	Yes	Yes
24H FullDisclosure	Yes	Yes	Yes	Yes	Yes	Yes
ST deviationanalysis	Yes	Yes	Yes	Yes	Yes	Yes
PacemakerActivity	Yes	Yes	Yes	Yes	Yes	Yes
Trend Review	Yes	Yes	Yes	Yes	Yes	Yes
Templatesediting	Yes	Yes	Yes	Yes	Yes	Yes
Beat to Beatediting	Yes	Yes	Yes	Yes	Yes	Yes
Strip editing	Yes	Yes	Yes	Yes	Yes	Yes
ECGSuperimposition	Yes	Yes	Yes	Yes	Yes	Yes
Page Mode	Yes	Yes	Yes	Yes	Yes	Yes
Editing report	Yes	Yes	Yes	Yes	Yes	Yes
Model	SyneScope	EasyScope	SyneTec	Syne View/SyneView 2	H-Scribe	Holter forWindows+
Company	ELA Medical	ELA Medical	ELA Medical	ELA Medical	Mortara	Rozinn
510(k) Number			K002817	K990727	K004017	K930564
Customizedreport	Yes	Yes	Yes	Yes	Yes	Yes
Archiving	Yes	Yes	Yes	Yes	Yes	Yes
Printing ECGstrip	Yes	Yes	Yes	Yes	Yes	Yes
Printing FullDisclosure	Yes	Yes	Yes	Yes	Yes	Yes
Import/Exportcapabilities	Yes	No	Yes	No	Yes	Yes
Import ASCIIRR Files	Yes	No	Yes	No
Export Results inASCII format	Yes	No	Yes	No
Export RR orHR files in ASCIIformat	Yes	No	Yes	No
Export ECG filesin ISHNE format	Yes	No	Yes	No
Read HighResolution ECGfile	Yes	No	Yes	No
Export HighResolution ECGfiles in ISHNEformat	Yes	No	Yes	No
Heart RateVariability(HRV)	Yes	Partial	Yes	Partial	Yes	Yes
Time Domain(TD)	Yes	No	Yes	No	Yes	Yes
FrequencyDomain (FD)	Yes	No	Yes	No	No	Yes
Multiday	Yes (96H)	Yes (96H)	No	No	Yes (48H)	Yes (48H)
True 12-LeadECG	Yes	No	No	No	Yes	Yes
12-Lead ECGDerived	Yes (Dowermethod - fromXYZ-Leadsystem)*	No	No	No	No	No
12-Lead STsegment analysis	Yes	No	No	No	Yes	Yes
Holter DataTransfer	Yes(like SYNECOM)	Yes(like SYNECOM)	No	No	Yes	Yes
Holter ECGReportViewer/Editor	Yes (HolterReader)	Yes (HolterReader)	No	No	Yes	Yes
Import ISHNEECG file	Yes	No	No	No	No	No
Internet	Yes	Yes	No	No	Yes	Yes (withNetlink/Netscan)

Comparison of technology characteristics to predicate devices:

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

042002
page 4 of 5

see Attachment 10.8 for details.

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

y2002
page 5 of 5

Summary of Studies:

The following functional testing was performed on the SyneScope™, EasyScope™ SyneCom™ and HolterReader:

Test group	Tests	Report of results
SyneScopeTM, EasyScopeTM,SyneComTM and HolterReadersafety and performancetesting.	Safety and performance testsaccording to the AAMI/ANSIEC38:1998 & IEC 60601-2-47standards.	See Attachment 10.9.
SyneScopeTM, EasyScopeTM,SyneComTM and HolterReadersoftware verification andvalidation testing.	Module and functional testingfor SyneScopeTM,EasyScopeTM, SyneComTMand HolterReader softwareapplications	See Attachment 10.6.
SyneScopeTM, EasyScopeTM,SyneComTM and HolterReaderfield testing	Field validation protocol andevaluation form completion.	See Attachment 10.4.

All test systems were representative of final production devices unless otherwise specified.

Compliance with European Medical Device Directive 93/42/CEE and European standards IEC-60601-2-47 was verified.

See Attachment 10.7 for copies of the SyneScope™, EasyScope™, SyneCom™ and HolterReader declarations of conformity and CE certificates.

Conclusion:

The information presented in this submission provides reasonable assurance that the SyneScope™, EasyScope™, SyneCom™ and HolterReader will perform in a safe and effective manner.

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

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

ELA Medical, Inc. c/o Ms. Susan Olive Regulatory Affairs Manager 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441

Re: K042002

K042002
Trade Name: SyneScope™, EasyScope™, SyneCom™, and HolterReader Holter Analyzers
11:11 PM EasyScope™, EasyScope 1125 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 23, 2004 Received: July 26, 2004

Dear Ms. Olive:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premainer is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments. for use stated in the enclosure) to regary manced produce aredical Device Ameralments, or to
commerce prior to May 28, 1976, the enactment of the wassision of the Federal Foo commerce prior to May 28, 1976, the enaculient and of the Federal Food. Drug, devices that have been reclassified in accordance who are approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. T and Cosmetic Act (Act) that do not require approval or a pal controls provisions of the Act. The
You may, therefore, market the device, subject to the general conversior at You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende requirements as a seasonst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (secaded) in clicier case in personations affecting your device can
may be subject to such additional controls. Existing major regulations allec may be subject to such additional controlist Extrong may on to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Federal Regaralier, our device in the Federal Register.

{6}------------------------------------------------

Page 2 - Ms. Susan Olive

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance oquires with other requirements of the Act
that FDA has made a determination that your device adders Reguirements of the that FDA has made a determination in a your develop other Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listing or any Federal statutes and regulations and limited to registration and listing (21
comply with all the Act's requirements, including, but not limited to registration as set comply with all the Act s requirements, including practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing nd if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050. forth in the quality systems (QS) regulanton (2 - CF (CFR) 0f the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Sections 351-37), and recorp), as in the stock of S (VC)
This letter will allow you to TB (Secures restants againstical nyour device to This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales on thus premarket notification. The PDA inding of subsamial equively .
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
rstiled. If you desire specific advice for your device of bar noomig the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please not of the regulation contact the Office of Compliatics at (301) 57 1 107.07) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtained from the "Misbranding by reference to premarket nothlivanom (210) Act may be obtained from the Other general information on your responsionial and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its Division of Simall Mail Mail 2011 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Hummer for

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

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number: K042002

Device Name:

Boves Hames
SyneScope™ (Holter ECG analysis software or Holter ECG analyzer, or Holter ECG scanner).

ecanner)
EasyScope™ (Holter ECG analysis software or Holter ECG analyzer, or Holter ECG scanner)

SyneCom™ (Holter ECG data transfer software or system)

HolterReader (Holter ECG report viewer and printing software or tool)

Indications For Use:

SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-Synescope - Is Intended to anialyze, radult patients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or ﺴ
other compatible cassette tape recorder. -

In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel Easyocope - 13 intended to analyal etients (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727), or -
other compatible cassette tape recorder. -

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel Synecom "Is Intended to download intinuts (for periods up to 96 hours). These recordings are provided by:

SpiderView™ Holter ECG recorder (K032466), -
SyneFlash™ Holter ECG (K990727) -

HolterReader is intended to view and print Holter reports from SyneScope™ p
orts of TM and Comment The TW EasyScope™ and SyneCom™ .

page 1 of 2

{8}------------------------------------------------

Patient symptoms such as syncope, dizziness or palpitations. .
Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
Function of an implanted pacemaker or defibrillator. .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.B. Simmons

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

Page 2
1 of 2

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).