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Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder. It is completely non-invasive and is operated with two 9 Volt batteries.
The provided text describes a medical device called "Log-a-Rhythm Model 100", a cardiotachometer and ECG recorder. Here's a breakdown of the acceptance criteria and the study as described:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy in measuring intervals > 97% concordance with expert-scored values. | Concordance of Log-a-Rhythm with the scored values was better than 97 percent. |
Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated, but it utilized the "American Heart Association ECG database".
- Data Provenance: The "American Heart Association ECG database". No country of origin is specified, but it's an established medical database. The description suggests it's retrospective as the database was "scored by medical experts" presumably prior to the device's testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified ("medical experts" in plural is used, implying more than one).
- Qualifications of Experts: "Medical experts". No specific qualifications (e.g., cardiologist, years of experience) are provided.
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Adjudication method for the test set:
- Not specified. The description just states the database was "scored by medical experts" without detailing how disagreements among experts (if multiple were involved) were resolved.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The study described focuses on the device's accuracy against an expert-scored database, not on comparing human readers with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. The study assessed the "Concordance of Log-a-Rhythm with the scored values," indicating the device's performance independently in measuring intervals.
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The type of ground truth used:
- Expert consensus (based on the American Heart Association ECG database, which has been "scored by medical experts").
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The sample size for the training set:
- Not applicable/Not provided. The text describes a validation study against an existing database, not the training of an AI algorithm. If this device did use an AI algorithm, the training set size is not mentioned.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as the text describes a validation study, not an AI training process.
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K95 2790
OCT 17 1996
Summary & Certification
OCT 17 1996
Summary of safety and effectiveness
Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder. It is completely non-invasive and is operated with two 9 Volt batteries. Use of Log-a-Rhythm Model 100 poses no hazards, electrical, chemical, or physical, to the patient. Log-a-Rhythm is effective in accurately measuring and storing consecutive beat to-beat intervals during sinus rhythm. Its accuracy in measuring intervals was tested using the American Heart Association ECG database, which has been scored by medical experts. Concordance of Log-a-Rhythm with the scored values was better than 97 percent. Log-a-Rhythm display software calculates, displays, and optionally prints the heart rate and RR interval data using a computer with a 80386 processor or higher.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).