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The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.

The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a system used to provide endoscopic access to the portal and hepatic veins to measure local blood pressure. As shown in Figure 1, the system is composed of: 1. EchoTip Insight Endoscopic Ultrasound Needle 2. Connecting Tube 3. 10 mL syringe 4. Stopcock 5. Compass CT Pressure Transducer (K133624). The EchoTip® Insight™ Needle functions to provide access to the venous vasculature related to the portal circulation and hepatic outflow to facilitate the measurement of physiological pressure by the Compass® CT pressure transducer, a disposable manometer (cleared under K133624). The needle is enclosed within a 5.2 Fr. outer sheath for protection. The sheath has an adjustable length (0-5 cm) to allow the user to adjust for the working length of the endoscope. The sheath length extension lock ring allows the sheath to be secured in place by tightening the thumbscrew. The needle extension is also adjustable and ranges from 0-8 cm. The "zero" reference ensures complete needle retraction within the sheath. The handle has a safety ring that slides and locks using the thumbscrew at the desired needle extension. The Connecting Tube is used for the transfer of liquids (heparinized saline) between the EchoTip® Insight™ Needle and the Compass® CT pressure transducer. The Connecting Tube uses a female Luer lock to connect to the Compass CT pressure transducer, and a male Luer lock to connect to the stopcock. The Compass CT is a disposable, point-of-use blood pressure measurement and monitoring device that incorporates an embedded pressure sensor and an integrated, pre-programmed diagnostic computer chip with a liquid crystal display. Once the system is connected and primed with heparinized saline, the EchoTipe Insight™ Needle is passed through the accessory channel of an ultrasound endoscope and the needle is advanced to the desired vasculature (portal or hepatic vein) through the liver parenchyma. Using ultrasound guidance, the needle is placed at the desired location, allowed to stabilize, and a measurement reading is taken.

The provided text describes a medical device, the EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System, and its regulatory approval process, including performance testing. However, it does not explicitly define acceptance criteria in a table format with specific numerical targets. The "acceptance criteria" are implied by the successful completion of various tests and the statement that the probable benefits outweigh the probable risks.

Since a table of acceptance criteria and reported device performance, and several other requested pieces of information are not explicitly stated, I will extract and infer as much as possible from the provided text.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria are not provided. The "reported device performance" is described through the successful completion of various tests.

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

• Bench Performance Test (Simulated Use): "A statistically significant number of distinct needle devices, connecting tubes, and Compass CT transducers were tested..." (Actual number not specified). This was a prospective, benchtop test.
• Animal Study: 17 pressure measurements were carried out in three swine. This was a prospective animal study. Data provenance not explicitly stated, but the authors are from "Gastrointestinal Endoscopy, 2016 Aug" and "2017 May", implying likely US-based research or internationally recognized publication.
• Human Clinical Study: 28 patients. This was a single-center, prospective human pilot study. Data provenance not explicitly stated (journal and authors provided, but not specific country of origin).

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)

The concept of "ground truth" and "experts" as typically understood in AI/ML validation (e.g., for image classification) does not directly apply to this device. This device measures a physiological parameter directly.

• Bench Performance Test: "Known values" of pressure were created by filling a column of liquid. The ground truth was these known physical pressures. No human experts were involved in establishing this ground truth.
• Animal Study: The comparative method used was an "interventional radiologic (IR) trans-jugular balloon catheter tip," which is considered the standard of care for obtaining indirect portal/hepatic pressure. This method itself provides the "ground truth" for comparison. The study was conducted by researchers (likely experts in gastroenterology/endoscopy and interventional radiology, as implied by the journal type and comparison method reference in the title).
• Human Clinical Study: The study provided confirmatory evidence that the device could safely measure PPG. The "ground truth" for pressure measurements was established by the device itself in a clinical setting compared to expected physiological ranges, with safety as the primary endpoint. The clinicians performing the procedure (e.g., gastroenterologists) were experts in their field, overseeing the measurements.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data (e.g., images) and their decisions need to be reconciled. This device is a measurement system, not an interpretive one. Therefore, no formal adjudication method was required or described for assessing its performance.

• In the animal study, the comparison was between two measurement techniques.
• In the human study, the focus was on safety and the device's ability to obtain measurements.

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 such MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool that aids human readers in interpretation. It is a direct physiological measurement device.

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

This question is not directly applicable. The device is a standalone measurement system in that it physically measures pressure. However, it requires a human operator for insertion and operation, and the Compass CT pressure transducer contains an "integrated, pre-programmed diagnostic computer chip with a liquid crystal display" for measurement and monitoring, effectively making its measurement "standalone" once the physical connection is made. There's no separate "algorithm only" performance reported distinct from the device's main function.

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

• Bench Performance Test: Known physical pressures created by a liquid column.
• Animal Study: Measurements obtained from the standard interventional radiologic (IR) trans-jugular balloon catheter method.
• Human Clinical Study: The device's direct pressure measurements, assessed primarily for safety and its ability to obtain these measurements in a clinical setting. Clinical signs and symptoms indicative of cirrhosis in 19 patients provided context for the measurements.

8. The sample size for the training set

No training set is mentioned or applicable to this type of device. The EchoTip® Insight™ is a physical measurement system, not a machine learning model that requires a distinct training phase. The Compass CT pressure transducer has a pre-programmed chip, but its "programming" doesn't involve a machine learning training set in the typical sense.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.

The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory).

The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical.

The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device:

1. Wireless Pressure Receiver - GE Monitor (CWMG001-5)
2. Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The provided text describes information about the submission of the "Compass Cast and MAP System" for FDA clearance. However, it does not contain explicit acceptance criteria and device performance data in a tabular format, nor does it detail a study that proves the device meets specific performance criteria related to its core function of physiological pressure measurement beyond stating adherence to existing standards.

The document focuses heavily on demonstrating substantial equivalence to a predicate device (Compass CT Port) by highlighting the technological characteristics and the modifications made (addition of Bluetooth capability and a reusable Monitor Accessory Plug - MAP). Performance data mentioned primarily concerns safety aspects due to these modifications, such as sterility, EO residuals, and electromagnetic compatibility.

Therefore, many of the requested items cannot be fully answered from the provided text.

Based on the available information:

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

The document does not explicitly state a table of new acceptance criteria established for the Compass Cast and MAP system itself in terms of pressure measurement performance. Instead, it states that the device's fundamental pressure accuracy and functional performance are "identical" to the predicate device and "Meet or exceed ANSI/AAMI BP22:1994(R)2006".

The only "acceptance criteria" and "reported performance" directly stated are for safety and compatibility tests related to the new wireless functionality and sterilization.

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