(209 days)
The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.
The ArchiMed product line represents two (4210, 4220) versions of a portable, multi channel electrocardiograph machine. These units are intended for acquisition, digitization, display and recording of conventional diagnostic 12 simultaneous lead ECG waveforms. The 4220 model can be equipped with a resting interpretation program covering adult populations. This analysis program is offered to the physician on an advisory basis only and physician is asked to over-read and validate (or change) the ECG interpretation. Moreover, the 4220 may be equipped with a software package to be used for exercise stress testing, has wider connectivity characteristics and can print to a laser printer.
Here's an analysis based on the provided document, addressing your request. It's important to note that the provided text is a 510(k) summary for an electrocardiograph device (ArchiMed), and not a detailed study report with performance metrics in the way you might expect for a modern AI/device submission. The document focuses on substantial equivalence to a predicate device rather than presenting a novel AI's performance.
Therefore, many of your requested points, especially those related to AI-specific performance, sample sizes for training/test sets, ground truth establishment, and MRMC studies, are not present in this type of regulatory submission from 1998 for an "Electrocardiograph data analysis firmware." The "interpretive software" mentioned is likely a rule-based algorithm rather than a machine learning model as understood today.
Acceptance Criteria and Study for ArchiMed Electrocardiograph (K973922)
The provided document, a 510(k) Safety and Effectiveness Summary for the ArchiMed electrocardiograph, primarily establishes substantial equivalence to a predicate device (Esaote P210, K902368) rather than demonstrating performance against specific, pre-defined quantitative acceptance criteria for a novel AI algorithm. The device's "effectiveness" is implicitly demonstrated through its similarity to a legally marketed predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence, there are no explicit quantitative acceptance criteria or detailed performance metrics presented in the document in the format typically seen for novel AI device studies. The "performance" is primarily shown through a comparison chart demonstrating that its general characteristics, such as dimensions, weight, power supply, display, ECG storage, sampling frequency, and filter specifications, are "SAME" or comparable to the predicate device.
| Criterion Category | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (ArchiMed 4210/4220) |
|---|---|---|
| Physical/Technical Characteristics | Substantially equivalent to predicate device (Esaote P210, K902368) | - Dimensions: 328x254x75 mm (vs. 310x350x75 mm for predicate) - Weight: 3.3 kg (vs. 3.8kg for 4210, 4.8kg for 4220 of predicate) - Display: LCD, backlit, 480x640 pixels (SAME) - ECG storage: RAM Cards (vs. Floppy Disks for predicate; 4220 has HardDisk & Network) - Sampling frequency: 1000 Hz (SAME) - Common mode rejection: > 100 dB (SAME) - Frequency response: 0.05 to > 150 Hz (SAME) - Leads: 10 buffered with RL drive (SAME) - Number of signals recorded: 8 simultaneously, 4 mathematically derived (vs. 12 channels for predicate) - Recorder: Thermal print head (SAME) - Paper speed & size: SAME for speed, A4/Letter size with half length (vs. A4/Letter for predicate) |
| Clinical Intended Use | Same intended use as predicate device. | Records standard electrocardiographs at patient resting or exercising. Optional interpretive software for resting ECGs provides advisory interpretation which physician must over-read and validate. |
| Safety | Complies with general controls, good manufacturing practices, and similar safety profile to predicate. | Not explicitly detailed as performance metrics but implicitly deemed safe through substantial equivalence to a legally marketed device and compliance with regulations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of evaluating a machine learning algorithm. The submission is based on engineering specifications and the functional comparison to a predicate device. Therefore, no information on sample size or data provenance (country, retrospective/prospective) for an algorithmic test set is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As the "interpretive software" is likely rule-based and offers "advisory" interpretations to be "over-read and validate (or change)" by a physician, the concept of establishing ground truth by multiple experts for an algorithmic test set is not detailed in this 1998 regulatory summary. The "ground truth" for the overall device's function would be its accurate acquisition and display of ECG waveforms, which is implicitly benchmarked against the predicate device.
4. Adjudication Method for the Test Set
No adjudication method for an algorithmic test set is described, as such a test set is not presented in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or appears to have been conducted for this submission. The "interpretive program" is explicitly advisory, requiring physician over-read, indicating it is not intended to replace human interpretation but to assist it. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not provided.
6. Standalone (Algorithm Only) Performance Study
While the device includes "Electrocardiograph data analysis firmware" and an "interpretation program," the document does not present a standalone performance study of this algorithm. Its function is described as providing an "advisory" interpretation that requires physician validation, implying it's not a standalone diagnostic tool. The submission focuses on the device as a whole and its equivalence to a predicate, not isolated algorithm performance.
7. Type of Ground Truth Used
For the interpretive software, the ground truth for its internal logic would likely have been established based on medical guidelines and expert consensus for ECG interpretation at the time of its development. However, the document itself does not specify how the ground truth was established for the "interpretive program." Given the context, it would not involve pathology or outcomes data directly for the algorithm's performance described here.
8. Sample Size for the Training Set
No information on a training set or its sample size is provided, as the software described is likely a rule-based expert system rather than a machine learning model requiring a discrete training phase with data in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, there is no information on how its ground truth was established. For a rule-based system, the "ground truth" for its logic would be derived from clinical knowledge and established ECG interpretation criteria.
{0}------------------------------------------------
MAY 1 2 1998
Safety and Effectiveness Summary ArchiMed Biosound Esaote
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Colleen Hittle, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1916 Facsimile: (317) 577-9070
Contact Person: Colleen Hittle
Date: October 3, 1997
807.92(a)(2)
Trade Name: ArchiMed
Electrocardiograph data analysis firmware Common Name:
Classification Name(s): System, ECG Analysis 870.2340
Classification Number: 74LOS
807.92(a)(3)
Predicate Device(s)
P210 K902368 Esaote
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
{1}------------------------------------------------
Safety and Effectiveness Summary ArchiMed Biosound Esaote
ESAOTE P210 ESAOTE 4210 - 4220 General Characteristics (K#902368) 310x350x75 Dimensions (1.w.h) in mm 328x254x75 3.3 kg Weight 3.8 kg (4210) 4.8 kg (4220) SAME 12V Ni-Cd rechargeable battery Power Supply Mains supply 100 - 240 V. SAME 20-60Hz LCD, backlit, 480x640 pixels, SAME Display adjustable viewing angle ECG storage RAM Cards Floppy Disks Digital device . HardDisk (Mod.4220) Yes (RS232) (RS232, Network for Yes ● Remote data storage Mod.4220) Up to 500 Hz ● Digital storage resolution 500 Hz Environmental Conditions SAME +10 / + 40°C Operating temperature ● SAME 25 to 95% RH . Relative humidity Standard, Cabrera SAME Leads 10 buffered leads with RL drive SAME ECG patient cable SAME Defibrillation protected Patient Input Fully floating and isolated SAME ECG amplifier 8 leads simultaneously acquired, SAME . Number of signals recorded 4 mathematically derived 200 Hz . Sampling frequency 1000 Hz ± 300 mV Max. DC polarization ±450 mV ● SAME . > 100 dB Common mode rejection 0.05 to > 150 Hz SAME . Frequency response 50/60 Hz adaptive digital filter SAME Filters 30/45 Hz digital low-pass filter, SAME programmable Recorder Thermal print head (8 dots/mm) SAME Paper speed 5, 12.5, 25, 50 mm/s SAME . A4 or Letter (Z folded) SAME. but Paper size . with half length 6 channels Recording tracks 12 channels .
Comparison Chart for Substantial Equivalence
{2}------------------------------------------------
Safety and Effectiveness Summary ArchiMed Biosound Esaole
807.92(a)(4)
Device Description
The ArchiMed product line represents two (4210, 4220) versions of a portable, multi channel electrocardiograph machine. These units are intended for acquisition, digitization, display and recording of conventional diagnostic 12 simultaneous lead ECG waveforms. The 4220 model can be equipped with a resting interpretation program covering adult populations. This analysis program is offered to the physician on an advisory basis only and physician is asked to over-read and validate (or change) the ECG interpretation. Moreover, the 4220 may be equipped with a software package to be used for exercise stress testing, has wider connectivity characteristics and can print to a laser printer.
807.92(a)(5)
Intended Use(s)
The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.
{3}------------------------------------------------
Image /page/3/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. In the center of the circle is an abstract symbol that resembles a stylized human figure or a caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 2 |998
Biosound Esaote, Inc. c/o Ms. Colleen J. Hittle 8000 Castleway Drive Indianapolis, IN 46250
Re: K973922 ArchiMed Electrocardiographs Models 4210 and 4220 Requlatory Class: III (three) Product Code: 74 LOS Dated: February 10, 1998 Received: February 11, 1998
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{4}------------------------------------------------
Page 2 - Ms. Colleen J. Hittle
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications For Use
510(k) Number (if known):
Device Name: ArchiMed
Indications for Use:
The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Mr. Puye
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number.
N/A