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The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

CardioDirect is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram based on a standard personal computer. It can also be used for a stress test if purchased with the proper interfaces. CardioDirect, when used as an electrocardiograph, has a special interface unit between the external connections (ECG electrodes, treadmill and blood-pressure device) and the computer. It permits either manual or automatic interpretation of electrocardiograms.

The provided 510(k) summary for the CardioDirect device does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study proving the device meets those criteria. The summary explicitly states that clinical tests were not necessary because the CardioDirect uses the same technology as the predicate device.

Therefore, the device's equivalence was established through non-clinical tests (AAMI EC11, validation tests, ISO 60601-1, ISO 60601-1-2) compared to a predicate device, rather than a standalone clinical study with specific acceptance criteria as you've outlined.

Below is a breakdown of the information that can be extracted or deduced from the provided document, along with explanations for the missing information.

Acceptance Criteria and Device Performance

Study Details

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

   • Not Applicable / Not Provided: The summary explicitly states, "Clinical tests are not necessary since CardioDirect uses the same technology as the predicate device." Therefore, there was no clinical test set for performance evaluation in the way typically required for new clinical claims. The evaluation was based on demonstrating equivalence to predicate devices through technical standards compliance.

2. 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 / Not Provided: As no clinical test set requiring ground truth establishment was conducted for the CardioDirect device itself, this information is not available.

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

   • Not Applicable / Not Provided: No clinical test set.

4. 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: The document does not mention any MRMC study. This device is an electrocardiograph with automatic interpretation, but the clearance was based on equivalence to predicate devices, not on a human-AI comparative effectiveness study.

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

   • No (in the context of clinical performance): While the device has "automatic interpretation," its standalone clinical performance (algorithm only) was not evaluated through a separate study for this 510(k) clearance. The clearance was based on technical standards and equivalence.

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

   • Not Applicable / Not Provided: No clinical test set for performance evaluation.

7. The sample size for the training set

   • Not Applicable / Not Provided: As "clinical tests are not necessary," and the device uses existing technology, there is no mention of a new training set or its size for the CardioDirect device in this submission. The "automatic interpretation" likely relies on algorithms common to the predicate devices, which would have been developed and validated previously.

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

   • Not Applicable / Not Provided: For the same reasons as #7, this information is not available in the provided summary.

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The Reynolds CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad. Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Reynolds Medical Ltd. CardioCollect device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "A series of electrocardiograms has been taken with CardioCollect." However, it does not specify the exact sample size (i.e., number of patients or ECGs) used for this clinical testing.
• Data Provenance: Not explicitly stated. There's no information about the country of origin of the data or whether the study was retrospective or prospective.

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

• None specified. The document mentions "A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made," but it does not detail how the "quality" was assessed or by whom. There is no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

• None specified. Given that there is no mention of experts or ground truth establishment, there is no adjudication method described.

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

• No such study was conducted or reported. The submission does not describe any study comparing human readers' performance with and without AI assistance. The CardioCollect device is an acquisition device, not an AI-based interpretation device.

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

• Yes, in the sense that the device's ability to acquire "quality tracings" was assessed independently. However, the CardioCollect is an ECG acquisition device, not an interpretation algorithm. The "performance" in this context refers to its ability to capture ECG signals meeting certain standards. An algorithm for interpretation would be a different category. The test described, "to show the quality of the tracings made," is an evaluation of the device's standalone capability to generate a readable ECG.

7. Type of Ground Truth Used

• Implicitly, a subjective assessment of "quality" of tracings. The document only states that the clinical tests were "to show the quality of the tracings made." There's no mention of a formal, objective ground truth (e.g., expert consensus on specific abnormalities, pathology, or outcomes data) being used. It appears to be an assessment against general expectations for a readable ECG tracing.

8. Sample Size for the Training Set

• Not applicable / not specified. The CardioCollect is an ECG acquisition device. It does not contain an AI algorithm that would require a "training set" in the machine learning sense. Its functionality is to record and store ECGs, not to interpret them or learn from data.

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

• Not applicable. As the device does not use a training set for an AI algorithm, this question is not relevant.

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The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient's ambulatory electrocardiogram. It is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days.

The device is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days (with the appropriate flashcard and battery). The unit uses a data compression system to store seven days of ECG data in extended mode. In "standard" mode (up to two days of recording) the unit is identical to the predicate device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder:

Based on the provided text, the device is explicitly stated to not have clinical testing requirements, as it is considered substantially equivalent to a predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics against ground truth are not applicable or cannot be extracted from this document.

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. The document explicitly states "Clinical tests: None required." The performance data section focuses on non-clinical tests and equivalence to a predicate device, not clinical performance against a test set.

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. As no clinical tests were required or performed, there was no test set requiring ground truth established by experts.

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

• Not Applicable. No clinical test set.

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. This device is a Holter recorder and explicitly states it "does no analysis." It is not an AI-assisted diagnostic tool, and no MRMC study was performed.

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

• Not Applicable. The device performs no analysis. Its function is data recording. The "compression algorithm has been separately tested," which is a standalone evaluation of that specific component, but not in the context of an overall diagnostic algorithm's performance against clinical ground truth.

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

• Not Applicable for clinical performance. For the non-clinical tests (AAMI EC38, IEC 601-1, IEC 601-1-2), the "ground truth" would be the specifications and requirements defined within those standards, which are typically measured against calibrated instruments and known electrical signals, not clinical outcomes or expert consensus. The software validation and compression algorithm tests would rely on their own internal verification and validation criteria, which would involve comparing outputs to expected results for known inputs.

8. The sample size for the training set

• Not Applicable. This document does not describe a machine learning or deep learning model that would require a "training set" in the conventional sense for clinical performance. The software and compression algorithm validation would involve internal test data, but not a "training set" like in AI/ML applications.

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

• Not Applicable. No training set for a clinical algorithm.

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The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

The EventStation enables the physician to receive and review ECG recordings transmitted by the patient from a Reynolds CardioCall event recorder and other compatible event recorders. The EventStation consists of a personal computer with voice modem, operating under Windows 98, and special software written by Reynolds Medical Ltd. The computer is assembled by Reynolds from standard components, and has been modified so that the operating system cannot be changed and unauthorized software cannot be loaded.

The provided text describes the Reynolds EventStation ECG Trans-Telephonic Receiving System and its 510(k) submission. However, it does not include detailed acceptance criteria or a specific study proving the device meets them, as requested.

The document states that an "Equivalence test has been done on patients, to show that the EventStation is equivalent to a predicate device," but it offers no details about this test, its methodology, results, or the acceptance criteria used.

Therefore, I cannot provide the complete table and information as requested because the necessary data is absent from the provided text.

Specifically, the following information is NOT available in the document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance Data" section (6) only mentions:

• Non-clinical tests: The software was tested in accordance with EN60950, EN 55022, and EN50082, and "undergone extensive validation testing." These are standards for safety and electromagnetic compatibility, not clinical performance metrics.
• Clinical tests: "An Equivalence test has been done on patients, to show that the EventStation is equivalent to a predicate device." No details of this test are provided.

Conclusion: The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed report of clinical study design, acceptance criteria, and specific performance metrics. It indicates that an equivalence test was conducted but does not provide the specifics required to answer your questions.

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The event recorder, called the "CardioCall," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

CardioCall Event Recorder offers the user the choice of a looping cardiac event recorder (records the electrocardiogram both before and after the event) or a post-activation recorder (records the electrocardiogram only after the event). Inserting the patient cable automatically changes the system from post-activation to looping. Embedded electrodes in the case are used for post-activation recording. The unit records one channel in looping mode and two channels in post-activation mode, and has a maximum recording time of 20 minutes. In looping, the unit records ten events with one minute before and one minute after the event. Recordings can either be transmitted transtelephonically to a central station equipped with a standard transtelephonic receiver, or downloaded directly into a PC with the CardioConnect software, available as an option. The unit features a special battery conservation mode, to conserve battery power. While the device is compatible with a number of transtelephonic systems (the requirements are in the instruction book), all transtelephonic testing was done with the PaceArt receiving station.

Here's a breakdown of the acceptance criteria and study information for the Reynolds Medical CardioCall Event Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated, described as "a series of tests on human volunteers." The exact number of volunteers is not provided.
• Data Provenance: Clinical tests were conducted on "human volunteers." It's implied this was prospective as it describes the device being compared in new tests. The country of origin is not explicitly stated for the volunteers, but the submission is from a UK company, making it likely the tests were conducted there or in a setting associated with their operations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study focuses on comparing the CardioCall's performance to predicate devices and demonstrating equivalency, rather than establishing ground truth against an external diagnostic standard as might be done for an AI-driven diagnostic device.

4. Adjudication method for the test set

This information is not provided in the document. The study design centers on demonstrating equivalent performance between devices, not on resolving discrepancies in interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study design was a comparison of the device's performance to predicate devices, not an assessment of human reader improvement with or without AI assistance. The CardioCall is an event recorder that captures ECG data, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone performance assessment was effectively performed for the device itself in comparison to the predicate devices. The "tests are included comparing the CardioCall to the predicate devices using an ECG simulator" and "the CardioCall was compared to the predicate devices in a series of tests on human volunteers," implying an evaluation of the device's ability to record and, if applicable, transmit ECG data accurately, independent of direct human interpretive assistance during the recording process.

7. The type of ground truth used

The "ground truth" in this context is the performance of the legally-marketed predicate devices (Ralin Heart-Aide Event recorder and Braemar ER700 Event Recorder, K923930). The study aimed to demonstrate that the CardioCall's performance was "equivalent" to these established devices, both in terms of data acquisition and transmission, and the absence of adverse events.

8. The sample size for the training set

This information is not applicable as the CardioCall Event Recorder is not an AI-based device that would require a "training set" in the machine learning sense. It's a hardware device for recording ECGs.

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

This information is not applicable for the same reason as above (not an AI-based device requiring a training set).

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The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).

The Pathfinder 700 Holter ECG analyzer is a high-speed Holter cassette analyzer capable of analyzing tapes recorded at 1.47 mm/second and 1.0 mm/second as well as solid-state recorders such as the Reynolds eRAM and the Braemar DL700. It is a successor to the Reynolds Pathfinder 3 analyzer, marketing of which has been approved by the FDA under 510 (k) number K871344. The unit features arrhythmia analysis, ST analysis, pacemaker beat deviation detection, and determination of beat types, in both an automatic and interactive mode. The system uses an icon-based, mousecontrolled, Graphical User Interface ("GUI"), visually similar to those found on the well-known Apple and Windows operating systems. Analysis is performed at 1000 times the recording speed, obtained by using parallel computations and a 188 megabyte random-access memory, in addition to a 1000 megabyte hard disk. Thus a 24 hours lible megabyte hard disk. Thus, a 24 hour Holter tape can be analyzed in approximately 1.5 minutes. A 486 motherboard is used to provide disk control and keyboard/mouse interfacing, while the analysis sections use parallel computing, based on the T400 and T425 transputers, a computer element which forms the basis of many parallel computing systems. Pathfinder system is mouse-controlled, and uses a cathoderay tube display and keyboard. The analysis is based on the Neilson principle or algorithm, which have been used on the previous Reynolds analyzers, and which have received in all approval. The backs and which have received 510(k) approval. The basic principles of the analysis are the same as those used previously by Reynolds; the new features of this system lie principally in its new electronic features, which have led to re-programming the equations and analysis principles.

The Reynolds Pathfinder 700 Holter Analyzer is a device designed to analyze ambulatory electrocardiograms (Holter tapes) for arrhythmias and ST segment deviations. The provided 510(k) summary focuses primarily on the device's technical specifications and comparison to predicate devices, rather than detailed performance metrics and a specific study design to prove acceptance criteria. Therefore, a comprehensive table of acceptance criteria and reported performance with exact numerical values is not explicitly available within this document.

However, based on the information provided, we can infer the general acceptance criteria and the type of evidence presented to support the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and precise performance metrics are not explicitly stated in the 510(k) summary. The document describes the types of tests performed and the conclusion that the device meets safety and effectiveness standards comparable to predicate devices.

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

• Sample Size: The document mentions the use of "standard AHA test tapes" for clinical testing. It does not specify the number of AHA test tapes used.
• Data Provenance: The "standard AHA test tapes" are generally synthetic or well-characterized recordings used industry-wide for performance evaluation. Their specific country of origin or whether they represent retrospective or prospective patient data is not stated, but they are a standardized, known benchmark.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the "standard AHA test tapes." For standardized test tapes like AHA, the "ground truth" (i.e., known arrhythmias, ST changes) is inherent to the design and composition of the tape itself, often established through expert consensus at the time of their creation. It is unlikely that new experts were recruited specifically for this 510(k) submission to re-establish the ground truth of these pre-existing standard tapes.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned for the test set. Given that "standard AHA test tapes" were used, the ground truth is pre-defined within the tapes themselves, making re-adjudication by experts for each test typically unnecessary.

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

No MRMC comparative effectiveness study is mentioned. The study described compares the device's analysis (Pathfinder 700) to the analysis provided by predicate devices (Pathfinder 3, Marquette 8000) on standard test tapes. This is an algorithm-to-algorithm comparison, not a human reader comparison with or without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "clinical tests" described explicitly compare the "analysis of the Pathfinder 700" to the "analysis provided by a predicate device" and another system (Marquette 8000) using "standard AHA test tapes." This is a direct evaluation of the algorithm's performance without human intervention, specifically in its "automatic mode." The summary states the system can operate in both automatic (no operator intervention) and interactive modes, and the comparison with predicate devices on test tapes would primarily evaluate its automatic, standalone capabilities.

7. Type of Ground Truth Used

The ground truth used for the clinical tests was standardized test data (AHA test tapes). For these tapes, the presence, type, and timing of arrhythmias and ST changes are pre-defined and known, serving as the benchmark against which the device's analysis is compared.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. It primarily discusses the device's hardware, software principles, and validation against predicate devices and standard tapes.

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

The document does not provide information on how the ground truth for any training set was established. Given the age of the device (1995 submission), detailed information on machine learning model training (including training data specifics and ground truth establishment) might not have been a standard requirement or reported in the same way as for modern AI/ML submissions. The analysis is based on the "Neilson principle or algorithm" which was utilized in previous Reynolds analyzers, suggesting an established, possibly rule-based or empirically developed, analytical methodology rather than a purely data-driven machine learning approach that would necessitate a large, explicitly defined training set with ground truth.

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