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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Implied by 510(k))	Reported Device Performance (Summary)
Technological Equivalence:	The SmartWire/SmartMap Pressure System uses the "same fundamental scientific technology" as the predicate device.
Intended Use Equivalence:	The intended use is the same as the predicate device: "measure blood pressure during diagnostic and/or interventional procedures" in coronary and peripheral arteries.
Performance Comparability:	"Applicable testing was performed to evaluate the changes... The testing results were found to be comparable to those of the predicate device."
Biocompatibility:	"All new materials were tested for biocompatibility according to ISO 10993."

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.

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.
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.
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.
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.
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.
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.
The sample size for the training set:
- Not applicable. This device is hardware, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set or AI algorithm is involved.

Summary

{0}------------------------------------------------

Jomed Inc. April 2002 SmartWire/SmartMa Special 510(k)

510K) Summary of Safety and Effectiveness

Date Prepared:	April 12, 2002
Submitted by:	Jomed Inc.2870 Kilgore Rd.Rancho Cordova, CA 95670
Contact Person:	Terry SchultzRegulatory Affairs Manager
Phone Number:	(858) 673-0189 Ext. 286
Fax Number:	(858) 673-3837
Device Name:	Jometrics SmartWire/SmartMap Pressure System
Classification Name:	Catheter guide wireCardiovascular blood flow meterCatheter tip pressure transducerVessel occlusion transducerPatient transducer and electrical cable (including connector)
Predicate Device:	WaveWire/WaveMap Pressure System. K965140

Device Description:

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.

{1}------------------------------------------------

Jomed Inc. April 2002

510(k) Summary (cont'd)

Intended Use:

Device Technological Characteristics and Comparison to Predicate Device:

The SmartWire/SmartMap Pressure System uses the same fundamental scientific technology and intended use as that of the predicate device, the WaveWire/WaveMap Pressure System.

Performance Data:

Applicable testing was performed to evaluate the changes in the SmartWire/SmartMap Pressure System. The testing results were found to be comparable to those of the predicate device, the WaveWire/WaveMap Pressure System. All new materials were tested for biocompatibility according to ISO 10993.

Conclusion:

The SmartWire/SmartMap Pressure System utilizes the same fundamental scientific technology as that of the predicate device, the WaveWire/WaveMap Pressure System. The performance data and a declaration of conformity with design controls support a determination of substantial equivalence of the modified device, SmartWire/SmartMap Pressure System to the predicate device, WaveWire/WaveMap Pressure System.

KO21219

_Premarket Notification [510(k)] Number

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three human profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2002

Mr. Terry Schultz Regulatory Affairs Manager Jomed, Inc. 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K021219

SmartWire/SmartMap Pressure System Regulation Number: 870.1330, 870.2870 Regulation Name: Catheter guide wire, Catheter tip pressure transducer Regulatory Class: II (two) Product Code: 74 DQX, DXD Dated: April 16, 2002 Received: April 17, 2002

Dear Mr. Schultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Terry Schultz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

N.G. Tiller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Jomed Inc. April 2002 SmartWire/SmartMap Special 510(k)

510(k) Number (if known):

Device Name: SmartWire/SmartMap Pressure System

Indications for Use:

K021219

The intended use and indications for use of the modified device as described in its labeling The included use and microations for ientific technology of the modified device has not changed.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------

Prescription Use (Per 21 CFR 801.19)	✓
--------------------------------------	----------------------------------------

Over-the Counter Use
----------------------	--

Division of Carding: 510(k) Number

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.