(208 days)
The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.
The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series. The multipole method generates several parameters, multipoles, where every single one describes the HRV.
The provided text is a 510(k) summary for the HeartTrends™ software (K012825). It focuses on the device's intended use, classification, and substantial equivalence to a predicate device. However, it does not contain information regarding acceptance criteria, specific performance study results, sample sizes for test or training sets, expert qualifications, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study from the given text.
Here is what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document describes the device's function and intended use but does not provide any specific performance metrics or acceptance criteria for heart rate variability (HRV) analysis accuracy or other aspects of its function.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on a test set, sample size, or data provenance is 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)
- Missing. There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information on a test set or adjudication method is provided.
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
- Missing. The document does not describe any MRMC or comparative effectiveness study involving human readers or AI assistance. The HeartTrends™ software is presented as a "measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment," implying it aids clinicians in their analysis rather than directly comparing human performance with and without AI assistance in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing (implicitly stands alone as an analysis tool). The text states, "The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data." This implies a standalone algorithmic analysis of ECG data to derive HRV parameters, which are then presented to a clinician. However, it doesn't describe a formal "standalone performance study" with metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. No specific ground truth type is mentioned. The device analyzes pre-recorded ambulatory ECG data to produce HRV parameters. Accuracy would likely be judged against established methods for calculating HRV from ECGs, but this is not detailed.
8. The sample size for the training set
- Missing. No information on a training set or its sample size is provided. The device is based on "an algorithm, which is constructed The HeartTronos - service, based on a physical-mathematical description of complex time series," suggesting a more model-driven approach than a purely data-driven machine learning one requiring a distinct "training set."
9. How the ground truth for the training set was established
- Missing. No training set or ground truth establishment for it is mentioned.
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Image /page/0/Picture/0 description: The image shows a drawing of a heart with an electrocardiogram (ECG) line running through it. The heart is drawn in a simple, slightly rough style, and the ECG line is jagged and uneven. The drawing is done in black on a white background, giving it a stark, graphic look. The overall impression is one of love and health, or perhaps a reminder of the importance of heart health.
510(k) Summary Lev-El, Ltd.'s HeartTrends™ 510(k) Number K012825
MAR 1 9 2002
Applicant's Name:
Lev-El, Ltd. P.O.B 3 Ariel Israel 44837
Contact Person:
Avner Ben-Harush Lev-El, Ltd. P.O.B 3 Ariel Israel 44837 Telephone: 972-3-9367489 Fax: 972-3-9060472
Date Prepared:
15 August 2001
Trade Name:
HeartTrends™
Classification Name:
Programmable Diagnostic Computer
Classification:
The FDA has classified Programmable Diagnostic Computer devices as class II device (product code DQK) and it is reviewed by the Cardiovascular Advisory Committee.
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Predicate Devices:
The HeartTrends™ is substantially equivalent to the Biosensor The Treason Ambulatory (Holter) Recording System cleared under K950944.
Performance Standards:
The HeartTrends ™ complies with the following standards and regulations: cGMP/QSR, MDD 93/42 EEC (1993), ISO 9001 (1994), EN 46002 (1996), EN 60601-1-4 (1997), EN 1441 (1998).
Indication for Use:
The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.
Device Description:
The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series.
The multipole method generates several parameters, multipoles, where every single one describes the HRV.
Substantial Equivalence:
Lev-El Ltd. believes that the HeartTrends™ is substantially equivalent to the Biosensor Corporation Ambulatory (Holter) Recording System cleared under K950944 in respect to intended use, technological characteristics, performance, and labeling.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Lev-El, Ltd. c/o Ms. Einat Shammai Arazy Group Mizpe Aviv Industrial Park 13 M.P. Misgav, 20187 ISRAEL
Re: K012825
Trade Name: HeartTrends™ Software, Version 1.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 16, 2001 Received: December 19, 2001
Dear Ms. Shammai:
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 - Ms. Einat Shammai
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DT has made a active manufactions administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with an all aller of 21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic rord in and quality by some (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) I mis lotter will and w your to by finding of substantial equivalence of your device to a legally marketed predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of I Crain 6646. Additionally, for questions on the promotion and advertising of Compinates at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thisocialism" responsibilities under the Act may be obtained from the Ourision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
ha. Dertteth
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K012825 510(k) Number:
HeartTrends™ Device Name:
Indications for Use:
The HeartTrends™ software is intended for the analysis, summary and reporting of up The Ficart Fredesto 3 channels of prerecorded ambulatory ECG data.
to 3 channels of prevecorded antouratory DOC caref the MPW (Multipole Paramater Weighted) HRV.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use ﮐﮯ (Per 21 CFR 801.109)
OR
Over the Counter Use_
Division of Cardiovascular & Respiratory Devices
510(k) Number K012885
12
§ 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).