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The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the hurnan body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact

The Mikro-Cath is a disposable/single use, sterile cardiovascular pressure catheter transducer for monitoring and measuring pressure anywhere in the cardiovascular system with an appropriately sized guide catheter.

Here's an analysis of the provided text regarding the Mikro-Cath device, outlining acceptance criteria and studies:

I. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly state numerical acceptance criteria for a single performance metric with a corresponding reported device performance value in a table format. Instead, it indicates that the device's performance "maintain[s] the same levels of safety and effectiveness as the predicate devices currently in commercial distribution" by complying with applicable standards.

Therefore, the table below reflects this approach:

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

The provided document describes non-clinical tests (e.g., biocompatibility, sterility, EMC, packaging, performance testing to AAMI ANSI BP22). It does not mention specific clinical trials or a test set of patient data in the context of device performance to measure hemodynamic cardiac pressures. The performance testing refers to compliance with safety and effectiveness standards, likely through bench testing, rather than a clinical dataset.

Therefore, this information is not available in the provided text.

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

Given that no clinical test set of patient data is described, there is no mention of experts establishing ground truth for such a set. The expertise involved would be in conducting and interpreting the non-clinical tests according to the cited standards.

Therefore, this information is not available in the provided text.

IV. Adjudication Method for the Test Set

As no clinical test set requiring adjudication is described, this information is not applicable and not available in the provided text.

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

An MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not mentioned in the provided document. The device in question is a physical catheter transducer, not an AI or imaging diagnostic tool.

Therefore, this information is not applicable and not available in the provided text.

VI. Standalone (Algorithm Only) Performance Study

The Mikro-Cath is a physical medical device, specifically a catheter tip pressure transducer. It is not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable to this device.

Therefore, this information is not applicable and not available in the provided text.

VII. Type of Ground Truth Used

For the non-clinical performance testing (e.g., to AAMI ANSI BP22), the ground truth would be the physical measurements and specifications defined by the standard itself, obtained through laboratory or bench testing. For biocompatibility, it would be the results of in vitro and in vivo biological tests as defined by ISO 10993. For sterility, it would be the microbiological test results demonstrating a sterility assurance level as defined by ISO 11135.

There is no mention of ground truth based on expert consensus, pathology, or outcomes data in the context of clinical performance, as no clinical study is described.

VIII. Sample Size for the Training Set

The device is a physical catheter, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The manufacturing and design process would follow established engineering principles and quality systems rather than data-driven training.

Therefore, this information is not applicable and not available in the provided text.

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

As the device is not an AI/ML model, the concept of establishing ground truth for a training set is not applicable.

Therefore, this information is not applicable and not available in the provided text.

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The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS is a modified version of the SphygmoCor Px (K012487). Like its predecessor, the CvMS is a computerized tool for the assessment of a range of central vascular parameters, including blood pressure, by peripheral pulse wave detection, callbration, and analysis that can be derived from the calibrated peripheral pressure waveform. The CvMS is used with a tonometer over the radial artery, and is calibrated with a standard blood pressure cuff measurement. The CyMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises.

The CvMS is made up of three primary components: 1) a proprietary signal processing electronics module; 2) proprietary software; and 3) a Millar Micro-Tip Pulse Transducer tonometer (Millar tonometer).

One notable new feature incorporated into the CvMS is the addition of the capability to noninvasively measure Heart Rate Variability (HRV) data. The CvMS measures the variability in intervals between R waves ("R-R intervals") on a continuous beat-to-beat basis for a period of time to provide HRV data and to use standard analysis procedures to provide stable and evoked measures of HRV in response to certain controlled exercises. The CvMS is also capable of providing Central Blood Pressure (PWA) and Pulse Wave Velocity (PWV) measurements.

The CvMS system is available in three different configuration options based upon these measurement capabilities. These options allow the user to select a measurement system that suits their particular clinical needs. These configuration options include:

1. SphygmoCor Px Pulse Wave Analysis (PWA) System (Px);
2. SphygmoCor Vx Pulse Wave Velocity (PWV) System (Vx); and
3. SphygmoCor Hx Heart Rate Variability (HRV) System (Hx).

All measurements may be stored and viewed on an attached computer which is attached to the CvMS's signal processing electronics module via a standard USB cable. The patient study reports are displayed on an attached computer.

Here's a breakdown of the acceptance criteria and study information for the SphygmoCor Cardiovascular Management System (CvMS), based on the provided text:

Acceptance Criteria and Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards, rather than specific numerical acceptance benchmarks for clinical accuracy.

Study Information

The document describes performance testing and comparison testing rather than a formal clinical study with a specific test set.

• Sample Size Used for the Test Set and Data Provenance:

  • The document states "comparison testing between the CVMS and the SphygmoCor Px demonstrated that the devices performed substantially the same." However, it does not specify the sample size for this comparison or the data provenance (e.g., country of origin, retrospective/prospective).

• Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

  • Not applicable/Not specified. The testing described is a comparison against a predicate device and compliance with standards, not a ground truth established by experts on a test set in the traditional sense.

• Adjudication Method for the Test Set:

  • Not applicable/Not specified.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No. An MRMC study is not mentioned. The device is standalone, and the assessment is of its performance compared to a predicate device and safety standards, not an AI-assisted human reading task.

• Standalone Performance (Algorithm Only) Study:

  • Yes. The described "hardware and software verification and validation testing" and "comparison testing between the CVMS and the SphygmoCor Px" are essentially standalone performance assessments of the device's algorithms and functionality. The comparison confirms its performance matches the predicate device.

• Type of Ground Truth Used:

  • For the comparison testing of the derived ascending aortic blood pressure waveform and central arterial indices: The "ground truth" was the performance of the legally marketed predicate device, SphygmoCor Px (K012487).
  • For safety and electrical standards: Compliance with recognized industry standards (IEC60601-1, IEC60601-1-2, AAMI EC13:2002) served as the "ground truth" for meeting those requirements.

• Sample Size for the Training Set:

  • Not applicable/Not specified. This device is a modified version of an existing system, and the description focuses on verification and validation of the modified system, not the training of a new AI algorithm.

• How the Ground Truth for the Training Set Was Established:

  • Not applicable/Not specified. (See above)

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