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The RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT). The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.

The RadiAnalyzer™ is a blood pressure computer, to be used as a diagnostic tool when the diagnosis is based on patient blood pressures. The device comprises a graphic display that presents real-time pressure curves as well as numerical values, and is operated via a remote control. The device has two entries for pressure signals, one for a PressureWire™ Sensor, and another for an External Pressure Transducer (EPT) and corresponding outlets for connection to a cardiac monitor. The RadiAnalyzer™ could also be connected to a RadiAnalyzer™-Printer or to a PC with the RadiView™ software installed.

This submission, KD13943, is a 510(k) summary for the RadiAnalyzer™ System, a blood pressure computer. The manufacturer, RADI Medical Systems AB, is seeking clearance for a device that is "identical to the predicate devices" in its mechanical, electrical, and signal properties, with the only stated new feature being a "new PC-software for digital transfer of RadiAnalyzer™ physiological recordings."

Given the nature of a 510(k) submission for a device largely identical to a predicate and the provided document content, it is highly unlikely that a comprehensive standalone study with extensive performance metrics, ground truth establishment, or comparative effectiveness studies (MRMC) were conducted or are detailed in this summary. 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new, elaborate clinical performance studies unless the device introduces significant new technology, intended uses, or raises new questions of safety and effectiveness. This case appears to be a modification of an existing cleared device (K002067).

Therefore, the information regarding acceptance criteria and performance studies will be limited to what can be inferred or directly stated in the provided text, which primarily focuses on substantial equivalence based on technical characteristics rather than a new performance validation study as might be seen for novel AI algorithms.

Here's an analysis based on the provided text, acknowledging the limitations inherent in a 510(k) summary for a substantially equivalent device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit "acceptance criteria" or a detailed "reported device performance" table as one might expect for a novel device or AI algorithm. The core of this 510(k) is to demonstrate substantial equivalence to its predicate device (RadiAnalyzer™ System 510(k) # K002067). The key "performance" criterion for this submission is that the device's technical characteristics are identical to the predicate, apart from the new software component.

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

The provided text does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is consistent with a 510(k) submission largely based on substantial equivalence to an existing device rather than a new performance study. The "test set" for this type of submission would primarily involve engineering verification and validation that the new device (or its modified component, the software) continues to function as intended and comparably to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of expert involvement for establishing ground truth as there is no specific performance test set described in the provided document. For a blood pressure computer, the "ground truth" for its core function (measuring and calculating pressures and FFR) would typically be the physical fluid dynamics and pressure readings themselves, validated through bench testing and, for the predicate, potentially prior clinical studies to correlate with clinical outcomes.

4. Adjudication Method for the Test Set

As no specific test set or clinical study is detailed for this 510(k) submission, there is no information regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not conducted or described in this document. This device is a blood pressure computer that directly measures and calculates physiological parameters (BP, HR, FFR). It does not involve "human readers" interpreting images or data in a way that would lend itself to an MRMC study or "AI assistance" in the sense of an interpretive algorithm. Its function is to provide raw and calculated numerical data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself, the RadiAnalyzer, is a standalone instrument in that it performs calculations (Fractional Flow Reserve, systolic, diastolic, mean blood pressure, heart rate) based on sensor inputs without human intervention in the calculation process. However, the term "standalone performance" often refers to the performance of an algorithm in generating a diagnostic output without human interpretation or modification.

Since the device's function is to directly measure and calculate established physiological parameters from sensor data, its "standalone performance" is embedded in its engineering validation for accuracy, precision, and consistency of these measurements and calculations. The 510(k) relies on the fact that these core mechanical, electrical, and signal properties are identical to the predicate device. Therefore, the standalone performance, as recognized and cleared in the predicate device, is considered to be maintained. There is no new standalone algorithm described that would warrant a separate performance study of its own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that this is a blood pressure computer measuring physical values, the ground truth for its core functions (blood pressure, heart rate, FFR calculations) would primarily be based on:

• Physical Reference Measurements: Comparison to highly accurate reference pressure transducers and flow models during design and verification.
• Physiological Principles: The FFR calculation itself is based on established physiological principles and equations.
• Prior Clinical Validation (of the predicate): The predicate device would have undergone validation to ensure its measurements correlate with clinical understanding and possibly patient outcomes, although specific details are not in this summary.

No human expert consensus, pathology, or outcomes data is explicitly mentioned as being used for ground truth in this specific 510(k) submission.

8. The Sample Size for the Training Set

There is no mention of a training set or its sample size. This device is not an AI/ML algorithm that requires training data in the typical sense. It is a hardware and software system for measuring and calculating physiological parameters.

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

As there is no training set described, there is no information on how ground truth for a training set was established.

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