Search Results

The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.

Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data.

The CardioDay V2.5 system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.

Patient population includes both adult and pediatric human patients.

CardioDay V2.5 provides the user arrhythmia study and Holter analysis capabilities.

Data acquired may be used for the following indications:

• · Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances,
• · Evaluation of symptoms that may be due to myocardial ischemia,
• · Detection of ECG events that alter prognosis in certain forms of heart disease.
• · Detection and analysis of pacemaker function and failure,
• · Determination of cardiac response to lifestyle,
• · Evaluation of therapeutic interventions,
• · Investigations in epidemiology and clinical trials.

Prescription Device Statement: United States federal law restricts CardioDay to sale by or on the order of a physician.

CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording, to download and analyze the data, review it and produce printed reports. CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

The provided document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test and training sets, expert qualifications, or adjudication methods for CardioDay V2.5.

The document states:

• "No clinical testing was performed in order to support safety or effectiveness."
• "Non-clinical testing that has been conducted includes: a. ECG performance testing according to AAMI / ANSI / IEC 60601-2-47; b. Software development life cycle according to IEC 62304; c. Risk management process according to AAMI / ANSI / ISO 14971 and IEC /TR80002-1; d. Usability engineering process according to AAMI / ANSI / IEC 62366-1 and IEC 60601-1-6; e. Security tests to fulfill FDA Guidance for cybersecurity; f. Interface tests to fulfill FDA Guidance for interoperability."

Therefore, I cannot provide the requested table or detailed information as it is not present in the given text.

Summary of what's missing from the document based on your request:

1. Acceptance criteria and reported device performance table: Not provided. The document states "No clinical testing was performed."
2. Sample size for test set and data provenance: No clinical test set mentioned.
3. Number of experts and qualifications for ground truth: No ground truth establishment for a test set mentioned.
4. Adjudication method for test set: Not applicable as no clinical test set is mentioned.
5. MRMC comparative effectiveness study: Not applicable as "No clinical testing was performed."
6. Standalone performance study: Not applicable as "No clinical testing was performed."
7. Type of ground truth used: Not applicable as no clinical testing or ground truth is mentioned.
8. Sample size for training set: Not applicable as no machine learning training set is mentioned; the device is described as "Holter Analysis Software" that "does not perform any diagnosis of data by itself."
9. How ground truth for training set was established: Not applicable for the same reason as above.

Ask a specific question about this device

CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to judge their current cardiac functionality such as patients who have recently received pacemakers.

CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

This document describes the CardioDay® 2.4 Holter evaluation software.

No acceptance criteria or study demonstrating device performance for CardioDay® 2.4 is provided within the given text.

The submission is a 510(k) summary for CardioDay® 2.4, which states it is substantially equivalent to CardioDay® 2.0 (K070280).

Here's what can be extracted from the provided text:

• No information is provided for the following:
  • 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 and their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human readers improvement with/without AI. This device does not perform diagnosis, so an AI/human comparison is not applicable in this context.
  • Whether a standalone (algorithm only) performance study was done.
  • Type of ground truth used.
  • Sample size for the training set.
  • How the ground truth for the training set was established.

Key Findings from the 510(k) Summary:

• Device Name: CardioDay® version 2.4
• Predicate Device: CardioDay® 2.0 (K070280)
• Device Function: Software package for trained physicians/healthcare professionals to download, analyze, review, and print reports from long-term continuous electrocardiographic (ECG) recordings. It does not perform any diagnosis by itself but displays ECG morphologies and associated calculated graphs (heart rate trends, RR variability, statistical values).
• Changes from Predicate: Incremental changes in workflow, renaming of menu entries for usability, support for more Holter ECG recorders, and an identical FDA-approved TWA (T-Wave Alternance) algorithm (K032513) were implemented.
• Non-Clinical Testing: ECG performance testing according to AAMI / ANSI / EC 38 and software development life cycle according to AAMI / ANSI / IEC 62304 were conducted. These tests "did not demonstrate that CardioDay® 2.4 brought up any issues of safety or effectiveness."
• Clinical Testing: "No clinical testing was performed in order to support safety or effectiveness."
• Conclusion: The device is considered substantially equivalent to its predicate device with regard to intended use, indications for use, and operating principle. The changes "do not raise any new questions of safety and effectiveness."

In summary, the provided document does not contain an acceptance criteria table or a study proving the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing to demonstrate safety and effectiveness.

Ask a specific question about this device

The SEER 1000 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The SEER 1000 Holter recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of patients for up to 7 days. The device stores the acquired ECG data in its on-board flash memory. Patient demographic information can be downloaded from a PC application or from a mobile application (IPhone, IPod, IPad) into the SEER 1000 recorder via Bluetooth during hookup time. With the PC application or mobile application you can start or stop a recording and you can check signal quality of the ECG data during hookup time or recording. At the end of the recording, the SEER 1000 can be directly connected to a PC via an USB cable to download the recorded data for later evaluation. It is not possible to connect an USB cable and an ECG patient cable to the recorder at the same time.

The provided text describes the SEER 1000 Holter recorder and its 510(k) summary. However, it explicitly states that no clinical testing was performed and that the device's substantial equivalence was determined based on non-clinical tests (electromagnetic compatibility, electrical safety, and ECG performance according to AAMI ANSI EC 38).

Therefore, the following information, which typically relies on clinical studies with human participants, cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: No performance metrics for diagnosing conditions in a clinical setting are provided. The "device performance" mentioned in the non-clinical tests refers to compliance with electrical and ECG standards, not diagnostic accuracy.
2. Sample size used for the test set and the data provenance: No test set of patient data was used as there were no clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable due to the absence of clinical studies.
4. Adjudication method for the test set: 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: Not applicable. The SEER 1000 is a Holter recorder without analysis capabilities; it does not incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a recorder, not an analytical algorithm.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" was compliance with established engineering and performance standards (IEC 60601-1-2, IEC 60601-1, AAMI ANSI EC 38).
8. The sample size for the training set: Not applicable as there is no algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and Testing:

The SEER 1000 Holter recorder achieved 510(k) clearance based on substantial equivalence to predicate devices (SEER Light Extend Compact Digital Holter System and CardioMem® CM 3000-12BT). The key argument for substantial equivalence was that the SEER 1000, like its predicates, continuously records ECG data and does not perform cardiac analysis itself. It is intended to be used with an ECG analysis software package by a trained physician or healthcare professional.

Acceptance Criteria and Study for the SEER 1000:

The acceptance criteria for the SEER 1000 were primarily related to safety, electrical performance, and electromagnetic compatibility, aligning it with recognized industry standards.

• Sample size for the test set and data provenance: Not applicable. No patient data or clinical test sets were used.
• Number of experts used to establish ground truth for test set: Not applicable. For non-clinical tests, "ground truth" is defined by compliance with the referenced standards.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. The device performs no analysis and does not involve AI or human reader improvement studies.
• Standalone (algorithm-only) performance: Not applicable. The device is a recorder, not an algorithm.
• Type of ground truth used: For the non-clinical tests, the ground truth was the requirements and methodologies defined within the specified international and national standards (IEC 60601-1-2, IEC 60601-1, AAMI ANSI EC 38).
• Sample size for the training set: Not applicable. No algorithms were involved that required a training set.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The CardioMem® Models CM 4000/CM 4000B are Holter recorders which are indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record ECG data. The CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with a Holter ECG Analysis Software package. The recorder supports the user throughout all phases of recording Holter ECGs, from applying the electrodes and entering patient demographic data up to inspecting the ECG waveforms. The digital recorders CardioMem® Models CM 4000/CM 4000B devices allow a qualified trained physician or health care professional to record the patient's ECG for the long term. The data is then downloaded to a computer containing a Holter ECG Analysis Software package. This data is then reviewed by a qualified health professional or a physician.

The only difference between the two CM 4000 models CM 4000 and CM 4000B is the battery size. The CM 4000 has a AAA battery compartment whereas the CM 4000B has a AA battery compartment, which results in a different shape of the weight of the recorder.

Here's a breakdown of the acceptance criteria and study information for the CardioMem® Models CM 4000/CM 4000B, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. This is likely because the device is a Holter recorder that doesn't perform cardiac analysis itself. Its primary function is to continuously record ECG data for later evaluation by software and a physician.

Instead of performance metrics, the acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through non-clinical testing and ensuring the device performs its intended function safely and effectively.

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

• Sample Size for Test Set: Not applicable / Not explicitly stated for a clinical test set. The provided document emphasizes non-clinical testing.
• Data Provenance: The non-clinical testing (Electromagnetic compatibility, Electrical safety, and Software validation) was performed by GETEMED Medizin- und Informationstechnik AG (Germany). The original device name is CardioMem® Models CM 4000/CM 4000B, manufacturer based in Germany. The data is retrospective in the sense that it's reported by the manufacturer for the specific device being submitted.

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

• Not applicable. No clinical test set with human ground truth labeling was used as "No clinical testing was performed in order to support safety or effectiveness."

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring 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 type of study was not conducted. The device is a Holter recorder, not an AI-powered analysis tool. It records data for later use with existing ECG analysis software, which may or may not incorporate AI. The submission focuses on the recorder itself.

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

• Yes, in spirit, but not in the context of an "algorithm" as typically defined for AI. The "standalone" performance was assessed through the non-clinical tests (EMC, electrical safety, software validation) to ensure the device's hardware and software components function correctly as a standalone recorder. However, it's crucial to reiterate that the device itself performs "no cardiac analysis."

7. The Type of Ground Truth Used

• For the non-clinical tests:
  • Regulatory Standards: Ground truth was established by relevant international standards for electromagnetic compatibility (IEC 60601-1-2) and electrical safety (IEC 60601-1).
  • Software Design Specifications/Requirements: For software validation, the ground truth would be the defined software requirements and specifications.
  • Predicate Device Performance: Implicitly, the performance and safety profile of the predicate devices (CardioMem® CM 3000-12 BT and CardioMem® CM 3000) served as a benchmark for "ground truth" concerning acceptable levels of safety and effectiveness for a Holter recorder.

8. The Sample Size for the Training Set

• Not applicable. The device is a medical device hardware (Holter recorder) and associated operating software, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

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

• Not applicable. As noted above, there is no "training set" for this type of device.

Ask a specific question about this device

The CardioMem® CM 3000-12BT is a Hotter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, to enter patient's ID and name, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.

ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT

Here's an analysis of the provided text regarding the CardioMem CM 3000-12BT, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics from a test study. Instead, it relies on a comparison to predicate devices and adherence to relevant standards. The "New/Modified Device" column serves as the "reported device performance" in this context, compared against the "Legally Marketed Device" columns.

Ask a specific question about this device

CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

The provided document describes a Special 510(k) notification for the CardioDay® software, which is a Holter ECG device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (CardioDay® Version 1.9.5, K051471) rather than presenting a performance study with specific acceptance criteria that would typically involve numerical metrics like sensitivity, specificity, or accuracy for an AI/algorithm-driven device.

The "acceptance criteria" in this context are primarily related to the functional equivalence of the new version (CardioDay® Version 2.0) to the predicate device and compliance with relevant medical device standards. The study proving this effectively involves comparing the technical and functional characteristics of the new device to the predicate.

Here's an analysis based on the provided text, addressing your specific points:

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

Since this is a Special 510(k) for a software update rather than a new device with novel AI algorithms, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) but rather as functional and technical equivalence to the predicate device and compliance with standards. The "reported device performance" is the demonstration that these equivalences and compliances are met.

Below is a summary table based on the document's comparison of the new device (CardioDay® Version 2.0) to the legally marketed predicate (CardioDay® Version 1.9.5). The acceptance criterion implicitly embedded in this type of submission is "maintains all predicate functionalities" and "introduces no new safety or effectiveness concerns."

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

The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness." This implies there was no formal "test set" of patient data used in the sense of a clinical trial or performance evaluation for the software's diagnostic capabilities. The evaluation was primarily based on a comparison of technical and functional specifications and compliance with standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable or not provided in this submission.

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)

Since clinical testing was not performed and no patient data test set was used for diagnostic performance evaluation, there were no experts used to establish ground truth for a test set. The submission focuses on software verification and validation, ensuring that the software functions as intended and is equivalent to the predicate device.

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

As no clinical test set was utilized for evaluating diagnostic performance, no adjudication method was applied to a 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

No MRMC comparative effectiveness study was done. The CardioDay® software, as described, "does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected." It is a tool for physicians to review and analyze Holter ECG data, not an AI diagnostic algorithm that assists human readers in making a diagnosis from scratch.

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

The software is explicitly stated to be a tool for physicians and "does not perform any diagnosis of data by itself." Therefore, a standalone performance evaluation (algorithm only) designed to establish diagnostic accuracy was not performed nor would it be appropriate for a device with this stated functionality. Its performance is tied to its role as a display and analysis tool for human interpretation.

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

Given that no clinical performance study was conducted, there was no ground truth established for diagnostic accuracy. The "ground truth" for this submission revolves around the software's functional correctness and compliance with its own specifications and relevant standards.

8. The sample size for the training set

The document does not describe any machine learning or AI models requiring a "training set." Therefore, information on the sample size for a training set is not applicable or not provided.

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

As there is no mention of a training set for machine learning/AI, this point is not applicable. The "ground truth" for the software's development likely refers to software requirements specifications, design documents, and medical device standards against which its functionality was verified.

Ask a specific question about this device

The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.

Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.

This device is available only upon the order of a physician or other licensed medical professional.

The CardioMem® CM 3000-12 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode hookup and placement to provide CardioDay® with 12 channels of full disclosure for H analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, to enter patient's ID and name, to check lead quality during hook-up. and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12 has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.

The provided document is a 510(k) summary for the CardioMem® CM 3000-12 Holter recorder. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

The device, CardioMem® CM 3000-12, is a Holter recorder that acquires, digitizes, and stores ECG data. Crucially, the document states: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data." and "The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®."

Therefore, the "acceptance criteria" and "device performance" in this context do not refer to diagnostic accuracy or clinical effectiveness metrics, but rather to the recorder's technical specifications and compliance with regulatory standards for device safety and electrical performance. The study described is not a clinical performance study but a series of tests to confirm safety and efficacy based on technical standards.

Here's a breakdown of the requested information based on the provided text:

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

The document implicitly defines "acceptance criteria" through comparison with predicate devices and adherence to regulatory standards (IEC and AAMI). The "reported device performance" is essentially that the device meets these technical specifications and standards.

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

The document does not describe a clinical "test set" in the traditional sense involving patient data for diagnostic evaluation. The "tests" mentioned are primarily engineering and electrical safety tests, not performance on a clinical dataset. Therefore, there is no sample size of patients or data provenance (country, retrospective/prospective) for a clinical test set.

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

Not applicable. As this is not a clinical performance study involving diagnostic outputs, there was no ground truth for a test set established by medical experts. The device explicitly states it performs no analysis or diagnosis.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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, not an AI analysis tool. It does not perform analysis itself, nor does it involve human readers interpreting AI-assisted outputs.

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

Not applicable. The device is a data acquisition and storage tool, not an algorithm performing standalone analysis.

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

Not applicable. The "ground truth" for this device's acceptance is its adherence to technical specifications and safety standards, rather than diagnostic accuracy against clinical ground truth.

8. The sample size for the training set

Not applicable. This document is about a hardware device, a Holter recorder, not an AI or analytical algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

CardioDay" is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.

This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.

Federal law restricts CardioDay® to use on order of a physician.

CardioDay is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

WARNING:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values.

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.

CardioDay® is a software package which is delivered on CD.

The provided document is a 510(k) summary for CardioDay®, a Holter ECG software. The submission aims to establish substantial equivalence to a predicate device, Holter for Windows®. The document focuses on comparing the new device against the predicate in terms of various characteristics and functionality, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not explicitly available in the provided text. The document primarily makes a claim of substantial equivalence based on comparison rather than a standalone performance study with defined criteria.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a formal table of device performance metrics against such criteria. Instead, equivalence is established through qualitative comparisons of features and functionalities with the predicate device. The performance is implied to be equivalent to the predicate.

Below is a summary of the comparative analysis, which serves as the basis for claiming "performance":

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

The document mentions that "The impact of all parameters, especially those specified above, is evaluated with the help of the data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) and performance evaluations." This indicates that public domain databases (AHA and MIT-BIH Arrhythmia Database are commonly used for Holter analysis algorithm validation) were used for performance evaluations. However, the specific sample size used from these databases for the test set, or details on data provenance (e.g., country of origin, retrospective/prospective) are not specified in this summary.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for any test set derived from the AHA or MIT databases. These databases typically come with expert-verified annotations, but this fact is not explicitly stated in relation to this device's validation.

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

The document does not describe any specific adjudication method used for a 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

The document does not mention any MRMC study or any study evaluating the improvement of human readers with or without AI assistance. The device is described as a software for trained professionals to review, edit, and print data, explicitly stating that it "does not perform any diagnosis of data by itself." This implies it's an analysis and presentation tool, not an AI-powered diagnostic aid designed to directly assist human readers in improving their diagnostic accuracy.

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

The document notes that performance evaluations used "data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT)." This implies that the algorithms within CardioDay® were tested against these reference databases, which constitutes a form of standalone performance evaluation. However, specific metrics, methodology, and results are not provided in this summary. The output of the device (ECG morphologies, graphs, statistical values) is then reviewed and edited by human users.

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

Given the mention of AHA and MIT databases, the ground truth for the algorithm evaluation would typically be expert annotations/consensus provided with these publicly available arrhythmia databases.

8. The sample size for the training set

The document does not provide any information about the sample size used for a training set. As a rule-based or conventional signal processing software (not explicitly stated as AI/machine learning), it might not have a "training set" in the modern sense. If it did employ machine learning, this detail is omitted.

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

Not applicable, as no training set information is provided. If the algorithms were trained, the ground truth would likely be derived from expert annotations, similar to the test set ground truth.

Ask a specific question about this device