(10 days)
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.
Not Found
This document describes the acceptance criteria and study proving a device's performance. However, there is no specific study described within the provided text that directly details acceptance criteria for a new AI/algorithm, a validation study with specific performance metrics (like sensitivity, specificity, or AUC), or a comparison against human readers.
The provided text describes a 510(k) summary for a hardware modification to an ECG event recorder (ER800 Series). The "Modification Background" section states: "In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47."
This indicates that the device's performance validation is against established electrical safety and performance standards for medical devices, not against a specific set of clinical performance metrics for an AI algorithm interpreting ECGs. The primary changes are hardware-related, with a reinstatement of existing arrhythmia functionality. The comparison table focuses on hardware features and basic functionalities like storage capacity, battery life, and on-board analysis.
Therefore, many of the requested points related to AI/algorithm validation, such as sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be directly answered from this document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
Since the document refers to compliance with established medical device standards rather than a new algorithm's performance metrics, the "acceptance criteria" are the requirements outlined in those standards. The "reported device performance" is the statement that the device meets these standards. A direct table of numeric performance metrics is not provided for clinical outcomes like arrhythmia detection accuracy.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| AAMI-EC38 (ECG Event Recorders) | Device meets standard |
| EN60601-1-1 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems) | Device meets standard |
| EN60601-1-2 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests) | Device meets standard |
| EN60601-2-47 (Medical Electrical Equipment - Particular Requirements for the Safety of Ambulatory Electrocardiographic Systems) | Device meets standard |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The validation is against engineering and safety standards, which typically involve testing components or the full device under various conditions, rather than a clinical "test set" of patients or ECGs.
- Data provenance: Not applicable in the context of clinical data. For testing against electrical standards, testing would be conducted in a laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/algorithm validation against clinical ground truth. Validation would be performed by qualified engineers or technicians in a laboratory setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No, an MRMC study was not done as this is a hardware modification of an existing device, not a new AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device has "On-board analysis: Yes" which implies some automated arrhythmia detection. The text states the modification "reinstates existing arrhythmia functionality." However, a standalone performance study report for this existing (not new) functionality is not provided in this excerpt. The focus of the submission is the hardware modification's continued compliance with general device standards, not a new or revalidated performance claim for its "on-board analysis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for performance relative to electrical and safety standards. If the "on-board analysis" functionality's original validation (which is pre-existing) involved ground truth, that information is not in this document.
8. The sample size for the training set:
- Not applicable as this is not a new AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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SECTION 3. 510(k) SUMMARY
. .
Substantially Equivalent (SE) To: . Ambulatory Devices
Braemar Model ER700 510(k) K981394
MAR 2 8 2003
Biosensor Model 1005 510(k) K950944
Braemar Model DXP1000 510(k) K993618
Modification Background
The essence of this modification is a change to the recorder hardware to a smaller configuration with reduced power consumption and to reinstate existing arrhythmia functionality to maintain competitiveness with other devices within the domestic marketplace. In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47.
The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device as is demonstrated in this submission.
| Attribute | ER800 | ER700 | Model 1005 | DXP1000 |
|---|---|---|---|---|
| Storage capacity | Up to 30 minutes,LoopingMemory | Up to 30 minutes,LoopingMemory | 1 day, 24 hours | 2 days, 48 hours |
| Memory type | Flash(non-volatile) | Flash(non-volatile) | Flash(non-volatile) | CompactFlash (non-volatile) |
| On-boardanalysis | Yes | No | Yes | No |
| Liquid CrystalDisplay (LCD) | No | Yes | No | Yes |
| Data transfermethod | TTPTranstelephonic | TTP or RS232Serial | Bi-directionalparallel I/O | USB I/O |
| Pacemakerdetection &reporting | Yes | No | Yes | Yes |
| Belt clip | Yes | No | No | Yes |
| Battery | One AA | Two AAA | Four AA | Two AA |
| Battery Life | 30 days | 14 days | 24 hours | 48 hours |
Comparison To The SE Devices: .
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a row. Above the profiles are three curved lines that resemble a stylized wing or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Braemar, Inc. c/o Mr. David Norberg Regulatory Affairs Representative 11481 Rupp Drive Burnsville, MN 55337
Re: K030856
Trade Name: ER800 Series ECG Event Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: March 12, 2003 Received: March 18, 2003
Dear Mr. Norberg:
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.
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
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Page 2 - Mr. David Norberg
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
XQeletM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE, INTENDED USE
Indications for Use: (No change from predicate devices)
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used noninvasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerful basis for evaluation of these biophysical signals.
Vellath
Prescription Use Only
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).