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The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures.

The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000.

The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity.

The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system.

The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures.

The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.

The provided document is a 510(k) summary for the Jomed SmartWire/SmartMap Pressure System, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. As such, the document does not contain details about specific acceptance criteria, a standalone study proving those criteria, or information typically found in studies for AI/software devices (like sample sizes for test/training sets, ground truth establishment, or expert involvement).

Here's a breakdown of why many of your requested items cannot be found in this document:

• Device Type: This is a physical medical device (a guide wire and pressure system) from 2002, not a software or AI-based device. Therefore, the types of studies mentioned in your request (MRMC, standalone algorithm performance, AI vs. human assistance) are not applicable or typical for this kind of device at that time.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This often involves bench testing, material characterization, and comparison of technological characteristics, rather than extensive clinical trials that establish acceptance criteria and then prove them with a dedicated study against a "ground truth" as you've outlined.

Given these limitations of the source document, here's the information that can be extracted or inferred, alongside explanations for what cannot be provided:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criterion for this 510(k) submission was substantial equivalence to the predicate device, the WaveWire/WaveMap Pressure System (K965140). This means the device's technological characteristics and performance had to be "comparable" to the predicate.

Study Details and Explanation for Missing Information

The provided document describes a 510(k) submission for a physical medical device (catheter guide wire and pressure system) in 2002. This regulatory pathway focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving de novo safety and effectiveness through extensive, detailed clinical trials with the specific types of studies you've requested for AI/software. Therefore, much of the requested information is not present or applicable to this document.

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

   • Not explicitly stated. The document refers to "Applicable testing" but does not detail the nature, sample size, or specific methodologies of these tests beyond stating they were found "comparable" to the predicate. Device testing for 510(k)s often includes bench testing (e.g., pressure accuracy, fatigue, burst strength), and potentially animal or limited human use data, but the specifics are not in this summary.

2. 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):

   • Not applicable/Not stated. "Ground truth" in the context of clinical expert consensus (as often used for AI diagnostics) is not a concept typically applied to the performance evaluation of a physical pressure wire system for a 510(k). Performance comparision would likely involve engineering and clinical validation against established standards or the predicate device's measured performance.

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

   • Not applicable/Not stated. This concept is relevant for expert review in clinical studies for diagnostic accuracy, which is not the primary focus of this 510(k) summary.

4. 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. An MRMC study is not relevant here. This device is a physical pressure sensing system used by clinicians, not a diagnostic imaging or AI system that assists human readers.

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

   • Not applicable. This device is a physical instrument for measuring pressure, not an algorithm. Its function inherently involves human operators and interaction with existing hemodynamic systems.

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

   • Not applicable/Not stated in the context of AI ground truth. The "ground truth" for a pressure system would be established by validated reference pressure measurement devices or methods. The document states "Applicable testing was performed," implying comparison against established benchmarks or the predicate.

7. The sample size for the training set:

   • Not applicable. This device is hardware, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set or AI algorithm is involved.

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