The StimLab Cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.

Device Description

The StimLab™ is an EPS320 cardiac stimulator modified by the addition of a remote bedside touch monitor. The system consists of a manually controllable pulse generator issuing standard cardiac pacing pulses, normally controlled by a separate computer containing a graphic touch user interface and pre-programmed complex stimulation patterns suited to electrophysiology (EP) studies. In the StimLab™, a second remotely locatable beside control touch screen duplicates the video display and touch controls allowing verification and control of stimulator settings from two locations, one typically located in an electrophysiology laboratory central control room and the second at the operating table. The device is not a life support device and makes no diagnoses.

AI/ML Overview

The provided document is a 510(k) summary for the StimLab™ Dual Control Computerized Diagnostic Programmable Cardiac Stimulator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding acceptance criteria, specific device performance metrics, or a study design with sample sizes, expert qualifications, or ground truth establishment.

Therefore, many of the requested sections regarding acceptance criteria and the study that proves the device meets them cannot be filled from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific quantitative acceptance criteria.

Here's an attempt to answer based only on the provided text, indicating where information is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states: "Appropriate risk-analysis driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device." However, the specific "product specifications" and the criteria for "conformance" are not detailed.	The device was found to be "substantially equivalent" to the predicate device (Micropace EPS320 Cardiac Stimulator - K011826). The summary states: "The StimLab™ Cardiac Stimulator is equivalent to the predicate product. The indications for use, basic overall function, and materials used are equivalent." This implies that its performance met the standards of the predicate device.

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

Sample Size: Not specified in the document.
Data Provenance: Not specified in the document. It mentions "product testing," but details about the origin or type of data involved are absent.
Retrospective/Prospective: Not specified in the document.

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)

Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for a test set. The review is based on substantial equivalence to a predicate device, which implies that the predicate device's performance (established through prior testing/clinical use) serves as the benchmark.

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

Not applicable/Not specified. No adjudication method is mentioned as there's no described test set requiring expert adjudication.

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

Not applicable. The StimLab™ is described as a "dual control computerized diagnostic programmable cardiac stimulator," not an AI-assisted diagnostic tool for human readers. It's a stimulator for diagnostic electrical stimulation of the heart. Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this device.

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

Not applicable. The device is a "stimulator" with "manually controllable pulse generator" and "graphic touch user interface." It is not an algorithm working independently to make diagnoses. The document explicitly states: "The device is not a life support device and makes no diagnoses." Its purpose is to facilitate diagnostic procedures by stimulating the heart.

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

Not specified. Given the nature of a cardiac stimulator, "ground truth" would typically relate to the accuracy of the stimulation parameters, electrical output, timing, and safety, as compared to established physiological responses or engineering specifications. The document only states "conformance to product specification and substantial equivalence to the predicate device" as the basis for testing.

8. The sample size for the training set

Not applicable/Not specified. This device is hardware with software control for stimulation, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable/Not specified. As mentioned above, there is no indication of a "training set" for this device.

Summary

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6. 510(k) SUMMARY

007 26 2007

General Information

Classification	Class II
Trade Name	StimLab™ Dual Control Computerized DiagnosticProgrammable Cardiac Stimulator
Manufacturer	Micropace Pty LtdSuite 7, 186-188 Canterbury Rd,CanterburyNSW 2193 Sydney Australia
Contact	Dr Michael CejnarManaging Director

Intended Use / Indications for use (unaltered from predicate device):

The StimLab cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction. This is the same intended use as previously cleared for the EPS320, K011826.

Predicate Device

The predicate devices is the Micropace EPS320 Cardiac Stimulator - K011826, 24 Jan 2002

Device Description

Materials

The materials in the StimLab™ Cardiac stimulator are suitable for their intended use and have been used in previously cleared products. The device is not patient contacting and therefore no biocompatibility testing was required.

Testing

Appropriate risk-analysis driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device.

Summary of Substantial Equivalence

The StimLab™ Cardiac Stimulator is equivalent to the predicate product. The indications for use, basic overall function, and materials used are equivalent.

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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 26 7007

Micropace PTY LTD c/o Dr. Michael Cejnar Founding Managing Director Canterbury, NSW Australia 2193

Re: K072200

StimLab™ Programmable Cardiac Electrophysiological Stimulator Regulation Number: 21 CFR 870.1750 Regulation Name: External programmable pacemaker pulse generator Regulatory Class: Class II (two) Product Code: JOQ Dated: October 17, 2007 Received: October 19, 2007

Dear Dr. Cejnar:

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.

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Page 2 - Dr. Michael Cejnar

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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Summerfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10. Indications for Use Statement

510(k) Number (if known): ИО72200

Device Name:

StimLab™ Programmable Cardiac Electrophysiological Stimulator

Indications For Use:

B.B. Emmons

ascular Devices

Regulation Number and Section

§ 870.1750 External programmable pacemaker pulse generator.

(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).