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The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

The PressureWire™ Sensor consists of a pressure and temperature sensitive sensor mounted on a steerable guidewire to perform real-time invasive physiological measurement in the circulatory system and a detachable cable for connection to a diagnostic computer of the manufacturer's. The detachable cable has an identification memory chip containing the individual calibration parameters for the sensor.

The guidewire has an outer diameter of .014" and comes in two lenghts 183 and 300 cm. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

The signals from the sensor are used for calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR). By also using the temperature sensitivity in the cables within the device also flow ratios such as Coronary Flow Reserve (CFR) could be derived.

The provided text describes a 510(k) summary for the PressureWire™ Sensor, a medical device used for physiological measurements in the circulatory system. However, the document does not contain information about explicit acceptance criteria or a specific study proving the device meets said criteria in a quantitative manner (e.g., performance metrics, statistical analysis).

Instead, the submission emphasizes that the device is technically identical to its predicate device (K002962) with the exception of a single capacitor. The justification for this change is to improve the device's immunity to disturbing electrical signals, particularly for temperature measurements used in Coronary Flow Reserve (CFR) calculations.

The core of the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a de novo study with acceptance criteria for a novel device performance claim. Therefore, many of the requested elements for a detailed study description are not available in this document.

Here's an attempt to answer the questions based on the available information, noting where details are missing:

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

Note: The primary "acceptance criteria" for this 510(k) submission appears to be demonstrating that the modified device performs at least as well as, or better than (in terms of noise reduction), the predicate device, and continues to meet its intended use. Explicit quantitative performance thresholds for characteristics like accuracy or precision are not provided in this summary.

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

This information is not provided in the 510(k) summary. The submission focuses on the technical modification (adding a capacitor) and the resulting impact on noise, rather than a clinical or performance study with a dedicated test set. The claim regarding "tenfold decrease in noise" suggests internal testing, but details are not given.

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)

This information is not provided. As no clinical or expert-reviewed performance study is detailed, the concept of "ground truth" as established by experts for a test set is not applicable here.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or complex evaluations, which are not described in this technical modification summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The PressureWire™ Sensor is a diagnostic device for measuring physiological parameters, not an AI-powered image analysis tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

The device is a sensor that measures physiological parameters. Its function is "standalone" in the sense that it directly measures pressure and temperature. The "calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR)" are performed by the manufacturer's RADIAnalyzer™, which is mentioned as a concurrent 510(k) submission. The performance of the sensor itself, as a standalone measurement device, is what's being discussed in terms of its operational range and noise reduction.

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

The ground truth for the sensor's performance would primarily relate to its accuracy in measuring pressure and temperature against established physical standards and its ability to reduce electrical noise. However, the specific methodology and "ground truth" used for demonstrating the "tenfold decrease in noise" are not detailed in this summary. It can be inferred that the ground truth would be based on electrical engineering measurements in a controlled environment.

8. The sample size for the training set

This information is not provided. The device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The design and modification (adding a capacitor) are based on electrical engineering principles.

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

This information is not applicable/provided. There is no mention of a "training set" in the context of an AI/machine learning algorithm. The "ground truth" for the device's fundamental performance likely refers to physical calibration standards and electrical noise measurements.

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