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Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.

Device Description

The True Pulse Disposable Blood Pressure Kit from Sentra medical devices LLC consists of a Arterial extension line (available in various standard lengths) is attached via a luer connection to the catheter that is inserted into the patient, (the male portion of the lumen is a part of the kit and the female portion of the lumen is a part of the catheter is not a part of this device) a stopcock, a monitoring line, to another stopcock, a transducer, a continuous flow flush device, and an IV set all connected by standard luer connections.

The device functions by continuously monitoring changes in blood pressure from the function of the heart. The pressure waves generated in the heart are transmitted through the vacult of system, to the catheter and then through the saline fluid - filled tubing to a transducer. Up on reaching the transducer, pressure waves from the fluid pathway depress a diaphragm, changing the resistance to the flow of current through a circuit. The change in resistance produces an electrical event that creates a signal that is then transmitted t o a monitor through a cable and displaying pressure reading and a wave form on a monitor. (The cather and monitor are not parts of this kit).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sentra True Pulse Invasive Pressure Monitoring Kit, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list numerical acceptance criteria for functional performance tests. Instead, it states that the Sentra Kits "served the same functions with the same degree of safety as the Edward's Kits" based on a comparison. The basis for this determination is primarily demonstrated through meeting industry consensus standards and showing substantial equivalence in functional tests compared to the predicate device.

Test/Criteria	Description of Performance/Outcome
Industry Consensus Standards
Transducer compliance with AAMI BP22: 1995 R 2001 (combines AAMI BP22: 1986 Blood pressure transducers and AAMI BP23: 1986 Interchangeability and performance of resistive bridge type blood pressure transducers)	The Sentra kit's pressure transducer meets or exceeds the standards that the Edwards transducer meets (AAMI BP23: 1986). Results provided by the transducer supplier in 510(k) Exhibit 1.
Functional Bench Tests (Compared to Predicate Device)	The bench testing of Sentra Kits as compared to Edwards Kits showed that "the Sentra Kit served the same functions with the same degree of safety as the Edward's Kits" for these tests.
Luer inspection per ISO 594	Performance was deemed equivalent to the predicate device.
De-bubbling and leak	Performance was deemed equivalent to the predicate device.
Output flow	Performance was deemed equivalent to the predicate device.
Transducer Zero setting	Performance was deemed equivalent to the predicate device.
Square wave response	Performance was deemed equivalent to the predicate device.
Prolonged exposure dwell with 300 mmHg saline pressure, and pressure accuracy during and after prolonged exposure	Performance was deemed equivalent to the predicate device.
Volume of kit CC	Performance was deemed equivalent to the predicate device.
Other Tests
Sterilization tests	The Sentra Kit has passed sterilization tests.
Biocompatibility requirements	The Sentra Kit has passed biocompatibility requirements.
Product performance standards set forth by Sentra	The Sentra Kit has passed these standards, as proven in bench tests. (Specific numerical acceptance criteria for "product performance standards" are not provided in this summary, but would be detailed in the full 510(k) submission).

Study Information

The provided text focuses on a series of bench tests for demonstrating substantial equivalence rather than a clinical trial or a study involving human readers.

Sample sizes used for the test set and data provenance:
- Sample Size: Functional tests were performed on 4 samples each of the Sentra device and the predicate device.
- Data Provenance: The data is from bench testing conducted by Sentra Medical Devices LLC. The country of origin is implied to be the USA (Canton, MI). The data is prospective as it was generated specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable as the studies described are bench tests comparing device performance to a predicate device and industry standards, not diagnostic studies requiring expert review for ground truth.
Adjudication method for the test set:
- This section is not applicable for bench testing. The evaluation was likely based on direct measurement and comparison to predefined tolerances (for standard compliance) or the predicate's performance.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an invasive pressure monitoring kit, not an AI-powered diagnostic tool for image or data interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a medical hardware kit, not a software algorithm.
The type of ground truth used:
- For compliance with AAMI standards: The "ground truth" is defined by the specifications and performance limits set forth in the AAMI BP22: 1995 R 2001 and AAMI BP23: 1986 industry consensus standards.
- For comparison to the predicate device: The "ground truth" or reference performance was the measured performance of the predicate device (Edwards Lifesciences Pressure Monitoring Kit with TruWave Disposable Pressure Transducer) for the specified functional tests.
The sample size for the training set:
- This section is not applicable as this describes a hardware medical device and associated bench testing, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established:
- This section is not applicable for the same reason as above.

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