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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.

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The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System includes:

• The CardioMEMS EndoSure™ s2 Sensor with radio-opaque markings -(implant)
• A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ s2 Sensor)
• CardioMEMS EndoSure™ Electronics System

The provided text is a 510(k) Summary for the CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System. It describes the device, its intended use, and technological characteristics. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

The "Performance Data" section in {1} states: "Testing has shown the EndoSure Sensor with Delivery System to be biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators. Bench testing confirms that the device functions per its specifications."

This statement confirms that testing was done and the device functions to its specifications, but it does not provide the acceptance criteria, the reported device performance in a table, or details about the specific studies (sample sizes, ground truth, experts, adjudication, etc.) that would allow for a complete answer to your request.

Therefore, I cannot fulfill your request for detailed acceptance criteria and study information based solely on the provided text. The document is primarily a regulatory submission summary, not a comprehensive technical study report.

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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.

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The CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.

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The provided text describes the Indications for Use for the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System. It states that the device is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.

However, the provided text does not contain any information regarding the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed points requested in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes or data provenance
3. Number and qualifications of experts
4. Adjudication method
5. MRMC study details or effect size
6. Standalone performance information
7. Type of ground truth used
8. Training set sample size
9. Method for establishing training set ground truth

To answer your request, I would need a different document, such as a 510(k) summary, clinical study report, or a detailed technical specification that describes the validation and performance testing of the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System.

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The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System includes:

• The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant)
• A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ Sensor)
• CardioMEMS EndoSure™ Electronics System

The provided text details the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, information about adjudicated ground truth, or details about training and test sets as requested in the prompt.

The document is a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than a clinical study report with detailed performance data against pre-defined acceptance criteria.

Therefore, the majority of the requested information cannot be extracted from the provided text.

Here's a summary of what can be extracted and a clear indication of what is missing:

Acceptance Criteria and Study for CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that bench testing confirms the device functions per its specifications, but it does not detail what those specifications (i.e., acceptance criteria) are, nor does it provide quantitative performance data (e.g., accuracy, precision, error margins) from these tests.

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

Missing Information: There is no mention of a "test set" in the context of a clinical or performance study with a specific sample size. The document refers to "bench testing," which typically involves simulated conditions rather than patient data or a test set. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

Missing Information: There is no mention of a "test set" or experts establishing ground truth for performance evaluation in the provided text.

4. Adjudication method for the test set

Missing Information: There is no mention of a "test set" or an adjudication method.

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

Missing Information: This device is a pressure measurement system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be applicable and is not mentioned.

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

Missing Information: The document states the device "may be used as an adjunctive tool," implying a human-in-the-loop scenario. No standalone algorithm performance is described.

7. The type of ground truth used

Missing Information: Since specific performance studies with detailed data are not provided, the type of ground truth used (e.g., pathology, outcomes data) for evaluation is not described. The "bench testing" likely compared the device's pressure readings to known reference pressures.

8. The sample size for the training set

Missing Information: As this document describes a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not applicable and is not mentioned.

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

Missing Information: Not applicable as there is no training set described.

Conclusion from Provided Text:

The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence to a predicate device for market clearance. It broadly states that "Bench testing confirms that the device functions per its specifications" and is "biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators." However, it does not provide the detailed performance data, acceptance criteria, sample sizes, or ground truth methodologies that would be typically found in a comprehensive study report evaluating a device's performance against specific metrics.

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The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.

The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure Wireless AAA Pressure Measurement System includes:

• The CardioMEMS EndoSure Sensor with radio-opaque markings (implant)
• A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure Sensor)
• CardioMEMS EndoSure Interrogator

This 510(k) summary for the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System primarily focuses on its equivalence to a predicate device and does not contain detailed acceptance criteria or a dedicated study section with the specifics requested. The document emphasizes safety and general performance.

However, based on the provided text, here's an attempt to extract and infer the information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Bench and clinical testing" but does not quantify the number of cases or patients in these tests.
• Data Provenance: Not explicitly stated beyond "Bench and clinical testing." There is no mention of country of origin or whether studies were retrospective or prospective.

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

• Number of Experts: Not applicable or not stated. The performance data section does not describe the establishment of a "ground truth" using expert consensus for the device's primary function of pressure measurement. The device directly measures pressure. For substantial equivalence, it's compared against a predicate, which implies its measurements are compared against an established method or device, not necessarily expert interpretation in the typical sense of diagnostic imaging.
• Qualifications of Experts: Not applicable or not stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not stated. The context of adjudication, typically seen in studies where multiple readers interpret data and discrepancies need resolution, is not present here. The device's primary function is direct pressure measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device directly measures pressure, rather than providing interpretative images or data that human readers would then analyze. The mention of its use as an "adjunctive tool in the detection of intraoperative endoleaks" could imply human interpretation, but no MRMC study details are provided.
• Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study involving human readers and AI assistance is described.

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

• Standalone Performance: Yes, implicitly. The device itself is described as measuring pressure and displaying data. The statement "Bench and clinical testing confirm that the device functions per its specifications" suggests standalone performance was evaluated. The device's "Technological Characteristics Summary" details how it remotely interrogates the sensor, records resonant frequency, and converts it to a pressure measurement, implying an automated, standalone process for acquiring the primary data.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the primary function of pressure measurement, the ground truth would inherently be established by direct comparison to a known, calibrated pressure standard (for bench testing) and/or comparison to other established clinical pressure measurement methods (for clinical testing). The text states it "functions per its specifications and is substantially equivalent to the predicate device," implying the predicate device's performance serves as a reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable or not stated. This device is a pressure sensor system, not a machine learning or AI algorithm that typically requires a discrete training set. Its functionality is based on physical principles (LC circuit, resonant frequency) rather than learned patterns from data.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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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.

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