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The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.

The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.

The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.

The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.

The provided text states that no clinical tests were performed for the Heart 2006 device. Therefore, a study proving the device meets acceptance criteria, as well as specific acceptance criteria related to clinical performance, a test set, expert involvement, and ground truth, cannot be described from this document.

The document indicates that the device's modifications were validated through non-clinical tests, specifically by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38. The conclusion drawn from these non-clinical tests was that the Heart 2006 is equivalent in safety and efficacy to its predicate device, Heart 2005.

Since no clinical study was conducted, the following information cannot be provided:

1. A table of acceptance criteria and the reported device performance: No clinical acceptance criteria are mentioned, and no clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set existed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set existed, thus no ground truth establishment by experts.
4. Adjudication method for the test set: No clinical test set existed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No clinical study was performed, and the device is a hardware event recorder, not an AI algorithm.
7. The type of ground truth used: No clinical ground truth was established.
8. The sample size for the training set: The device is a hardware event recorder, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as detailed above.

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The Aerotel Medical Systems (1998) Ltd. MPM-Net system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The system is not intended for patients with defibrillators.

The MPM-Net is an option for a modem/dialer system adapted for the purpose of following patients' blood pressures. It operates in conjunction with a cleared home-use blood pressure device. The system includes the computer program at a central station used for receiving data and preparing reports. The option allows reports to be retrieved over the internet.

The provided K030825 document is a 510(k) summary for the "MPM-Net" device. It is essentially an administrative filing to demonstrate equivalence to a predicate device, not a report of a scientific study designed to establish new performance criteria. Therefore, the document explicitly states there were no clinical tests performed for this specific submission to demonstrate accuracy or performance.

Here's a breakdown based on the information provided and the absence of certain elements:

1. A table of acceptance criteria and the reported device performance

• Explanation: The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for blood pressure measurement, nor does it report numerical device performance metrics for the MPM-Net itself. It relies on demonstrating equivalence to predicate devices which would have undergone such testing.

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: 0 (No clinical tests were performed for this submission).
• Data Provenance: Not applicable.

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 applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: 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

• MRMC Study: No, an MRMC study was not done. The device is a blood pressure monitor and transmission system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the context of this 510(k) submission. The device is a system that includes a home blood pressure monitor and a transmission system, not a standalone algorithm for diagnostic interpretation. The emphasis is on the transmission and reporting capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable for this submission as no clinical tests were performed. For the predicate blood pressure monitors, the ground truth would typically be established through comparison with a reference standard validated blood pressure measurement device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The document does not describe a machine learning algorithm or a "training set" in the context of its development. The validation mentioned was for the system itself (software validation, electrical/mechanical characteristics), not the training of an AI model.

9. How the ground truth for the training set was established

• How Ground Truth was Established: Not applicable.

Summary of the Study (as described in K030825):

The document explicitly states: "No clinical tests were performed."

Instead, the study to demonstrate the device meets acceptance criteria (which are implicitly tied to the predicate devices) relied on:

• Non-clinical tests: "The modifications were validated by a validation test for the system." This likely refers to engineering, software, and functional testing to ensure the modifications (primarily the internet retrieval of reports) work as intended and do not negatively impact the core functionality, which is the transmission of blood pressure data.
• Comparison to Predicate Devices: The primary argument for safety and effectiveness is that the "MPM-Net is a modified version of the predicate device. It has basically the same electrical and mechanical characteristics, and the use of the two devices by the patient is equivalent. It permits the reports to be retrieved over the internet." The predicate devices (BP-Tel K983717 and TeleCliniQ K021447) would have undergone their own clinical testing to establish accuracy and performance. This 510(k) relies on the established safety and effectiveness of those predicates, asserting that the new modification (internet reporting) does not alter the fundamental performance or safety.

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The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station

The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.

The HeartOne is a battery-powered ECG event recorder and transmitter that is capable of recording and storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station.

The HeartOne is a battery powered post-event ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as the Aerotel Heartline Receiving Station K022073 or equivalent.

The provided document is a 510(k) summary for the Aerotel Medical Systems (1998) Ltd. HeartOne Cardiac Event Recorder. It describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, sample sizes for training/test sets, expert adjudication, and MRMC studies is not applicable to this document.

However, I can extract the relevant information from the document regarding the device's performance validation.

Here's the information that can be extracted, and where the requested AI-specific information is not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No clinical test set was used for this device for performance evaluation in the context of an AI model. The validation was based on non-clinical engineering tests.

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)

• Not applicable. No ground truth established by experts in the context of AI model evaluation. The non-clinical tests rely on established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication was used.

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. This is a medical device, not an AI algorithm for diagnostic assistance. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated based on its ability to record and transmit ECGs, not on an algorithm's diagnostic capabilities.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" is defined by adherence to established engineering standards such as IEC 601-1, IEC 601-1-2, and EC38.

8. The sample size for the training set

• Not applicable. There is no AI model or training set described in this document.

9. How the ground truth for the training set was established

• Not applicable. There is no AI model or training set described in this document.

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The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment.

The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.

The provided text describes a 510(k) submission for the Aerotel Medical Systems "Heartline Receiving Station". However, it explicitly states that clinical tests were "Not required" and no specific acceptance criteria or performance studies were conducted to prove the device meets such criteria.

Therefore, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided, as clinical tests were not required. The submission only states the device was "thoroughly verified and validated" and the system "has been validated" but no performance metrics are given.
2. Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
4. Adjudication method for the test set: Not applicable as no clinical test set was used.
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: Not applicable as no clinical study was done and this device is described as a "software system" that displays data for "physicians analysis and comment," not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance study was done.
7. The type of ground truth used: Not applicable as no clinical performance study was done.
8. The sample size for the training set: Not applicable as no machine learning algorithm is described as being trained in a clinical context. The device is a "software system" for receiving and displaying ECG signals, not an AI model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Basis for Acceptance:

The submission for the Heartline Receiving Station relies on non-clinical tests and substantial equivalence to a legally marketed predicate device (Aerotel Heartline receiving Console, K930314, cleared by FDA in 1993) rather than a clinical performance study with defined acceptance criteria.

• Non-clinical tests: "The programs for the Heartline Receiving Station have been thoroughly verified and validated. The recommended computers meet international standards for electrical safety and electronic emissions. The entire system has been validated."

The FDA's decision to clear the device (K022073) was based on a finding of substantial equivalence to this predicate device, which implies that the new device is as safe and effective as the predicate and shares the same indications for use. The FDA letter confirms, "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...".

Therefore, the "acceptance criteria" were met by demonstrating that the device's design, software functionality, and intended use were comparable to an already cleared device, along with verification and validation of its non-clinical aspects (software programs, electrical safety, emissions). No specific performance metrics for diagnostic accuracy or clinical outcomes are provided or required in this submission context.

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The Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission System is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit (purchased separaetly) and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports. The Tele-CliniQ is not intended for patients with defibrillators.

The system includes a home blood-pressure measuring device that makes use of the oscillometric system (purchased separately), a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.

The provided document does not contain information about specific acceptance criteria, a detailed study proving the device meets acceptance criteria, or most of the requested study parameters. The submission is a 510(k) summary for a Special 510(k), which typically relies on equivalence to a predicate device rather than extensive new clinical trials.

Here's a breakdown of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific numerical or qualitative acceptance criteria for clinical performance (e.g., accuracy against a gold standard for blood pressure measurement, data transmission success rate, software reliability metrics, user interface usability guidelines).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical tests: Not required." This indicates that a specific test set, in the sense of a clinical study cohort, was not used for this 510(k) submission. The FDA clearance is based on the device's technical specifications, validation of its software, and the prior clearance of its associated blood pressure measurement device (UA 767 PC), along with equivalence to a predicate device (Aerotel BP-Tel, K 983717).

Missing Information: Since clinical tests were not required, there is no information on sample size, country of origin, or retrospective/prospective nature of a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Missing Information: As clinical tests were "not required," no experts were explicitly used to establish ground truth in a clinical study context for this submission.

4. Adjudication Method

Missing Information: No adjudication method is mentioned, as no clinical study with expert review was performed or required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information: No MRMC study was done, as this refers to comparative studies involving human readers, which are not relevant for a blood pressure data transmission system that aims to digitize and transmit measurements from an already cleared device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a "Clinical Data Transmission System for Blood Pressure." Its primary function is to transmit data. The "algorithm" here would largely pertain to the data transmission and storage functionalities.

• Non-clinical tests: The MPM (presumably "Medical Patient Monitoring" or similar) software "has undergone extensive validation testing." This would be the closest analogue to a standalone evaluation of the software's data handling capabilities. However, specific performance metrics or a detailed study of this validation are not provided.
• The FDA-cleared UA 767 PC blood pressure monitor itself would have undergone standalone performance evaluation for blood pressure accuracy prior to its clearance.

Missing Information: Specific details of the "extensive validation testing" for the MPM software, including metrics, methodologies, and results that would demonstrate standalone performance.

7. Type of Ground Truth Used

• For the electrical safety and EMC testing, the "ground truth" would be compliance with the respective EN 60950 and electromagnetic compatibility standards.
• For the MPM software validation, the "ground truth" would likely involve software engineering best practices, data integrity tests, and functional requirements to ensure accurate data transmission, storage, and reporting.
• For the blood pressure measurements themselves, the "ground truth" would have been established during the clearance of the UA 767 PC device, likely against invasively measured blood pressure or highly accurate reference non-invasive devices.

Missing Information: Specific details on how ground truth was established for the software validation in terms of what constitutes "accurate" data transmission and storage.

8. Sample Size for the Training Set

Missing Information: The document does not mention a training set, as this type of device (a data transmission system) does not typically involve machine learning or AI models that require a "training set" in the conventional sense. The "training" here would be the development and testing of robust software code.

9. How the Ground Truth for the Training Set Was Established

Missing Information: Not applicable, as there is no mention of a training set.

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The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.

The system includes a home blood-pressure measuring device that makes use of the oscillometric system, a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.

The provided document, a 510(k) summary for the Aerotel BP-Tel Trans-Telephonic Blood Pressure Measurement System, offers limited information regarding specific acceptance criteria and the detailed study proving it. However, based on the available text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: "The entire system has been tested in a clinical test with volunteer subjects." The exact number of volunteer subjects is not specified in the document.
• Data Provenance: The study was a "clinical test." The country of origin is not explicitly stated for the clinical test, but the company is based in Israel, so it's plausible the study was conducted there or in the US (given the FDA submission). It was a prospective study as it involved testing the system in a clinical setting.

3. Number of Experts and Qualifications

• Not applicable / Not specified. The document does not mention the use of experts to establish a ground truth for the clinical test beyond the standard clinical assessment methods that would be used for blood pressure measurement. The core blood pressure device itself was a "cleared device," implying its accuracy was already established.

4. Adjudication Method

• Not applicable / Not specified. Given the nature of a blood pressure measurement device testing, an adjudication method like 2+1 or 3+1 typically applies to subjective interpretations (e.g., radiology images). For quantitative measurements like blood pressure, the ground truth is usually established through a reference standard measurement, not expert consensus on interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not mentioned as this device is for measuring and transmitting blood pressure, not for interpretation tasks that involve human readers. The clinical test involved the device's performance, not a comparison of human readers with and without AI assistance.

6. Standalone Performance Study

• Most likely, yes, for a component. The statement "The actual blood-pressure device is a cleared device purchased for this system" implies that the core blood pressure measurement algorithm (which could be considered a standalone algorithm) had undergone its own performance evaluation to achieve clearance. The current submission focuses on the system (measurement + telephonic transmission). The "extensive validation testing" for the MPM software also indicates a standalone assessment of that software component.

7. Type of Ground Truth Used

• Reference Standard Measurement (Inferred): For the blood pressure component, the ground truth would have been established by comparing the device's readings against a recognized standard method for blood pressure measurement (e.g., a mercury sphygmomanometer or another validated oscillometric device).
• System Functionality Verification: For the transmission and data handling aspects, the ground truth would be whether the data was accurately transmitted, stored, and displayed as received from the device's measurements.

8. Sample Size for the Training Set

• Not applicable / Not specified. Blood pressure monitors typically rely on established physiological principles and algorithms rather than machine learning models that require large training sets in the same way an AI diagnostic tool would. While there might be some internal calibration or algorithm development, the document doesn't mention a distinct "training set" in the context of an AI/ML algorithm. The core blood pressure device was "cleared," meaning its underlying algorithms and parameters were already validated.

9. How Ground Truth for Training Set was Established

• Not applicable / Not specified. As mentioned above, a traditional "training set" with ground truth in the AI/ML sense is not indicated for this type of device. The accuracy of the blood pressure measurement component would have been established during its original clearance, likely through comparison to gold-standard manual measurements on a diverse population.

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