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Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor compatible Reynolds Monitoring products and also to act as a "control panel" for thes that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied with all products. The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated data bases are replaced by the Sentinel database. Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common data base, Sentinel stores data collected from each patient in the section of the database, dedicated to that patient. When used as a method for operating the device, the user selects the iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program. Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later. Sentinel will work on a single computer, but it has been re-configured to be also used in a network

The provided text describes Sentinel, a software product for managing cardiology device databases. It is a Special 510(k) submission, meaning it compares the device to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include specific quantitative acceptance criteria or detailed device performance metrics. Instead, it states:

2. Sample Size for Test Set and Data Provenance

The document does not specify a sample size for a test set. It mentions "extensive validation" but provides no details on the number of cases, patients, or the origin (country, retrospective/prospective) of any data used for testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention any experts being used to establish ground truth. Given that this is a database management and control panel software, the "ground truth" would likely be related to data integrity, successful data transfer, and correct device operation rather than clinical interpretation requiring expert consensus.

4. Adjudication Method

The document does not specify any adjudication method, as there's no mention of expert review or clinical assessment.

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

A MRMC comparative effectiveness study was not done or reported. The device is a database management system, not an interpretive algorithm that would be used by human readers for diagnosis.

6. Standalone Performance Study

The text states: "Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." However, no specific standalone performance study with quantifiable results is described. The validation appears to be functional and integration testing rather than an algorithmic performance study in the typical sense.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Based on the device's function, the "ground truth" would likely relate to:

• Data Integrity: Verifying that data captured by the monitoring devices is correctly and completely stored, retrieved, and displayed by Sentinel.
• Functional Correctness: Ensuring that Sentinel correctly acts as a "control panel" for compatible devices, allowing users to configure devices and receive downloaded data as intended.
• System Compatibility: Confirming that Sentinel works with various compatible Del Mar Reynolds Medical monitoring products.

8. Sample Size for Training Set

The document does not specify a sample size for a training set. This type of software (database management and control panel) typically undergoes software development and functional testing rather than machine learning training that requires a "training set."

9. How Ground Truth for Training Set Was Established

Since there is no mention of a training set for machine learning, the establishment of ground truth for a training set is not applicable to this document. The "ground truth" in the context of this software would be defined by the functional requirements and specifications of the system and its integration with the compatible monitoring devices.

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The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram.

Voyager 12 is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram. Voyager 12 is a portable, self-contained unit with an internal printer. It permits either manual or automatic interpretation of electrocardiograms.

Here's a breakdown of the acceptance criteria and study information for the Del Mar Reynolds Medical Voyager 12, based on the provided text:

No clinical studies were performed for the Del Mar Reynolds Medical Voyager 12 for its 510(k) submission. The submission states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."

Therefore, many of the requested categories regarding clinical study details cannot be filled as they are not applicable to this specific submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance data is provided for the Voyager 12 itself, and the submission relies on substantial equivalence to predicate devices, specific acceptance criteria in terms of clinical performance metrics are not detailed in the provided text. The "acceptance criteria" here would primarily relate to meeting recognized electrical and safety standards and demonstrating technological similarity to predicate devices.

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

Not applicable. No clinical test set was used for the Voyager 12's 510(k) submission. The device's performance was not evaluated through a separate clinical test set.

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

Not applicable. No clinical test set required ground truth establishment by experts for this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not performed. The submission explicitly states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the context of a standalone clinical performance study. While the device does have automated interpretation, its performance in this regard was not tested in a standalone clinical trial for this 510(k) submission. Instead, it relies on the predicate device's established performance.

7. The Type of Ground Truth Used

Not applicable for a clinical performance study. For the non-clinical tests, the "ground truth" would be the successful adherence to the standards listed (e.g., meeting specific electrical parameters, signal quality benchmarks defined by the IEC standards).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that undergoes a training phase with a specific dataset in the way modern AI devices do. Its "interpretation" functionality likely derives from fixed algorithms or rule-based systems, or algorithms validated with prior data by the predicate device.

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

Not applicable due to the reasons stated in point 8.

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CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds monitoring products and also to act as a "control panel" for these products. The software that formerly was used with these devices has been transferred to sections of CardioNavigator Plus. The program itself is supplied with all products.

The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated databases are replaced by the Cardio Navigator Plus database.

CardioNavigator Plus maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common database, CardioNavigator Plus stores data collected from each patient in the section of the database dedicated to that patient. When used as a method for operating the device, the user selects the icon associated with the device. The user then sees the opening screen for the operation of that device, and all succeeding screens, as they were seen when the device was used with its dedicated program.

CardioNavigator Plus has no capacity for analyzing electrocardiograms. When CardioNavigator Plus is uses with the Pathfinder Holter analysis program, the Pathfinder program is loaded into the same computer, and CardioNavigator can call Pathfinder, but there are no other links.

CardioNavigator Plus can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. CardioNavigator Plus will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later.

CardioNavigator Plus will work on a single computer, but it has also been reconfigured to use as a server-workstation system (where the server and the workstation are still personal computers). If a single CardioNavigator Plus will still work on a single computer, but it has been re-configured to use a server-workstation system (where the server and the workstation are still personal computers). If a single computer is used, the server and workstation are combined in that computer

Based on the provided 510(k) summary for CardioNavigator Plus, here's an analysis of the acceptance criteria and study information:

It's important to note that the CardioNavigator Plus is a software product for organizing and managing databases for compatible cardiology monitoring devices and acts as a "control panel." It does not analyze electrocardiograms or other medical data. Therefore, the acceptance criteria and study design are focused on software functionality and equivalence, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "extensively validated," but no specific number of test cases, patient data sets, or usage scenarios is provided for the non-clinical validation.
• Data Provenance: Not explicitly stated for the validation data. The product itself manages data from "Del Mar Reynolds monitoring products," which collect "cardiology patient data (ECG or blood pressure)." Whether the validation used synthetic data, existing patient data, or a mix is not specified. The study is prospective in the sense that the new software was developed and then "validated," rather than analyzing existing outcomes.

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

• This information is not provided. Given that this is a software utility product for data management and control, rather than a diagnostic device, the concept of "expert ground truth" in the typical clinical sense (e.g., radiologists interpreting images) is not directly applicable. The validation would likely be against functional requirements and software specifications.

4. Adjudication Method for the Test Set

• This information is not provided. As above, for a software utility, formal adjudication by clinical experts is unlikely to be the primary validation method. Validation would likely involve software testing methodologies, functional verification, and integration testing.

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 comparative effectiveness study was not done.
• The CardioNavigator Plus does not involve AI or analysis of medical data. It is a data management and control application. Therefore, there is no concept of human readers improving with or without AI assistance in the context of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone validation was done, but it's not an "algorithm" in the diagnostic sense. The document states: "CardioNavigator Plus has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." This indicates that the software was tested independently for its functional requirements (standalone) and its interaction with other devices (without human-in-the-loop diagnostic performance being the metric).

7. The Type of Ground Truth Used

• The type of "ground truth" used would be based on software specifications and functional requirements. For example, ground truth for database management would be correct storage, retrieval, and organization of data according to predefined rules. Ground truth for control panel functionality would be successful execution of commands to compatible devices. It is not clinical ground truth like pathology or outcomes data, as the device is not diagnostic.

8. The Sample Size for the Training Set

• This information is not applicable and not provided.
• CardioNavigator Plus is a rule-based software product for data management and control, not a machine learning or AI algorithm. Therefore, it does not have a "training set" in the context of machine learning.

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

• This information is not applicable and not provided, as there is no training set for this type of software.

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HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses

HRV Tools is a software product (supplied on a CD) that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis).

Here's an analysis of the provided text regarding the HRV Tools device, focusing on acceptance criteria and study data:

Unfortunately, the provided 510(k) summary for HRV Tools (K040313) is very brief and lacks detailed information regarding specific acceptance criteria, study sizes, expert qualifications, or detailed performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with explicit acceptance criteria.

Based on the information available:

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

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

• Sample Size: Not specified. The document mentions "Tests with input data from the MIT database" as a non-clinical test. The MIT-BIH Arrhythmia Database is a public repository, but the specific number of records or patients used from it for testing is not stated.
• Data Provenance: The MIT-BIH Arrhythmia Database is likely the source for a portion of the test data. The country of origin for the database is primarily the US (collected at Boston's Beth Israel Hospital and Women's and Infants' Hospital). The study is retrospective in the sense that the database contains previously recorded data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For the MIT-BIH Arrhythmia Database, annotations (which serve as ground truth) are typically performed by cardiologists or trained technicians, but the document does not elaborate on this for the device's specific testing.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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 comparative effectiveness study was not explicitly mentioned or performed. The device is a "Heart Rate Variability Analysis Program" and provides numerical analyses, not diagnostic interpretations for human readers to improve upon. The submission states, "It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses."

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

• Standalone Performance: Yes, the testing described appears to be standalone performance. The device analyzes RR intervals and provides numerical outputs. The non-clinical tests would evaluate the algorithm's performance in processing the input data and generating these numerical analyses. The statement "Clinical tests are not necessary since HRV Tools uses the same technology as the predicate devices" further supports that the focus was on the algorithm's standalone accuracy against known data/reference standards, rather than clinical utility in a human-in-the-loop scenario.

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

• Type of Ground Truth: For the "Tests with input data from the MIT database," the ground truth would likely be the expert-annotated RR intervals and arrhythmia information that are part of the MIT-BIH Arrhythmia Database. The submission does not specify ground truth for other "Validation tests" or "Accuracy tests."

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document only mentions testing with the MIT database, not explicit training data. It's possible the device uses well-established algorithms that don't require novel "training" in the machine learning sense, or that the training data details were not considered necessary for a 510(k) submission focused on substantial equivalence for this type of software.

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

• How Ground Truth for Training Set was Established: Not specified, as training set details are absent.

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