(56 days)
The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs.
The provided text describes the T-Wave Alternans (TWA) Algorithm Option, a software algorithm for electrocardiographs. However, the document (K023380) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data.
Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not available within this document. The document primarily focuses on regulatory compliance and the intended use of the device.
Here's an attempt to answer the questions based on the available information, with clear indications of what is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (The document states "The results of these measures demonstrate T-Wave Alternans (TWA) Algorithm Option is as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System." This is a general statement of equivalency, not specific performance metrics against defined criteria.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided. (The document mentions "Verification and Validation" but does not detail the specific datasets used for these activities.)
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not 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
- MRMC study done: Not provided. The document focuses on the algorithm's performance itself and its equivalency to a predicate device, not on its impact on human reader performance.
- Effect size of human reader improvement with AI: Not applicable, as an MRMC study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: The document implies standalone testing in that it describes the algorithm as a "software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs" and states "Verification and Validation" were performed. However, specific details of a formal standalone performance study with metrics are not explicitly provided. The comparison is often implicitly against the performance of the predicate device's existing algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not provided.
8. The sample size for the training set
- Sample size for the training set: Not provided. The document focuses on regulatory approval, not on the developmental aspects like training data for the algorithm.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not provided.
Summary of available information:
The 510(k) summary (K023380) primarily indicates that the device underwent standard quality assurance measures, including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Code inspections
- Verification and Validation
These measures were deemed sufficient to demonstrate that the T-Wave Alternans (TWA) Algorithm Option is "as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System." The document does not disclose the detailed methodologies, datasets, or specific performance metrics from these verification and validation activities.
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DEC 0 3 2002
K023380 page 1 of 1
510(k) Summary of Safety and Effectiveness
| Date: | October 4, 2002 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | David WahligSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1705Fax: (414) 918-8112 |
| Device Trade Name: | T-Wave Alternans (TWA) Algorithm Option |
| Common/Usual Name: | ECG Analysis Algorithm |
| Classification Names: | Classification Name: 21 CFR 870.1425 Programmable diagnostic computerClassification Number: 74 DQK |
| Predicate Devices: | K991014 CASE 8000 Exercise Testing System |
| Device Description: | T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs. |
| Intended Use: | The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated. |
| Technology: | The T-Wave Alternans (TWA) Algorithm Option employs the same functional technology as the predicate device. |
| Test Summary: | The T-Wave Alternans (TWA) Algorithm Option and its host electrocardiograph comply with the voluntary standards as detailed in Section 9 of this submission.The following quality assurance measures were applied to the development of T-Wave Alternans (TWA) Algorithm Option:- Risk Analysis- Requirements Reviews- Design Reviews- Code inspections- Verification and Validation |
| Conclusion: | The results of these measures demonstrate T-Wave Alternans (TWA) Algorithm Option is as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System. |
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0 Cornorate Boulev ockville MD 20850
GE Medical Systems Information Technologies c/o Mr. David Wahlig Sr. Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K023380
Trade Name: T-Wave Alternans (TWA) Algorithm Option Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: October 4, 2002 Received: October 8, 2002
Dear Mr. Wahlig:
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. Iisting 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. David Wahlig
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 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 (OS) 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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Karthik
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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Page 1 of 1
510(k) Number (if known):
510(k) filed on October 4, 2002
Device Name: T-Wave Alternans (TWA) Algorithm Option
Indications For Use:
The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
CATTUR
KOSSO
§ 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).