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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.

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.

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

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.

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The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

The Micropace EPS320 Cardiac Stimulator (Clinical Stimulator) is an external programmable computerised diagnostic cardiac stimulator. It is used in specialised hospital electrophysiological diagnostic laboratories by specialist cardiologists to electrically stimulate the heart to initiate and terminate tachyarrhythmias and allow measurement of refractory and conduction properties of the heart by third party equipment. The EPS320 system consists of a Stimulus Generator Unit (SGU) comprising of a manufactured metal instrument case and a standard IBM clone type Personal Computer (PC), the two interconnected by a serial data connection. The device has two independent fully programmable and isolated constant current pulse generator channels intended for temporary programmacro and locativa third party transvenous intracardiac electrodes. The pacing stimulus is output via a Stimulus Connection Box and may typically be routed to the intravenous pacing electrodes via third party electronic switching equipment. During normal operation of the EPS320, custom software on the PC provides keyboard input device and a graphical user interface which the operator uses to control the stimulation process in real time. The custom PC software interprets the user instructions and sends specific real-time commands to the I he ousehi I O software and and to control its function and generate appropriate pacing stimulus pulses. The two isolated outputs can deliver stimulus pulse widths from 0.5ms to 10ms, adjustable in 0.5 to 1ms steps with current amplitudes adjustable from 0.1mA to 25mA in steps of 0.1mA. Current delivery is limited within the specified range by a maximum available output voltage of 26V. The EPS320 is not a life support device and may be used only in the presence of a backup cardiac THE LE SES IS .In case of failure of mains power supply, malfunction of the PC or its software, or loss of the data link, the SGU can operate independently of the PC in the Manual Backup mode, powered by an internal backup battery. This operational mode can provides regular pacing stimuli at intervals and pulse current amplitudes programmable from and displayed on the SGU's front panel. It may be used to briefly support a bradycardic patient until temporary external pacing is established using an approved temporary pacemaker. A secondary electrically self-contained Emergency Fixed Pace approved willing the front of the SGU may be used for the same purpose in case of loss of normal SGU function.

The provided text describes the Micropace Model EPS320 Clinical Stimulator and seeks 510(k) clearance based on its substantial equivalence to the predicate device, the DCI Model EP-2 Clinical Stimulator. The document primarily focuses on technical specifications and functional comparisons rather than a study demonstrating performance against specific acceptance criteria in a clinical setting.

Here's an analysis based on the provided input:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical thresholds. Instead, it aims to demonstrate that the EPS320 is substantially equivalent to the predicate device (DCI Model EP-2) and is as safe and effective. The "acceptance criteria" are implicitly met if the FDA agrees that the EPS320's specifications and functionality are comparable or improved, and its differences do not raise new questions of safety or effectiveness.

The "reported device performance" is presented through a direct comparison with the predicate device's specifications in Tables 5-1 and 5-2.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Breakdown of Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • The submission does not describe a specific "test set" or a formal clinical study with a defined sample size to prove the device meets acceptance criteria in a quantitative manner.
   • The provided information states that the EPS320 is an "expert-designed product, based upon the electrophysiological expertise of the cardiologist Managing Director and on extensive post market experience with an earlier EPS220 model in service in eight (8) Australian hospitals since 1995." It also mentions that "The current and earlier EPS320 models have been in clinical use in more than 40 clinical centres predominantly in Australia, Europe and India, as well as in Turkey, Vietnam and China for up to 4 years without significant adverse effects." This "post-market experience" serves as informal evidence of performance and safety rather than a structured clinical test set.
   • Data Provenance: Australia, Europe, India, Turkey, Vietnam, and China.
   • Retrospective/Prospective: The "post-market experience" suggests a retrospective review of observational data from clinical use, not a prospective study designed to evaluate the EPS320 against specific endpoints.

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

   • Since there's no formal "test set" or ground truth establishment process described for a specific study, this information is not directly applicable.
   • However, the device design itself is based on "electrophysiological expertise of the cardiologist Managing Director." This individual serves as a key "expert" influencing the device's design and functionality. The submission does not detail specific qualifications of this Managing Director beyond "cardiologist."

3. Adjudication Method for the Test Set:

   • Not applicable, as no formal test set and ground truth establishment with adjudication is described.

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:

   • Not applicable. This device is a cardiac stimulator, not an AI-driven diagnostic imaging device that uses multi-reader studies.

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

   • Not applicable. The EPS320 is a medical device that requires human operation by specialist cardiologists to apply electrical stimulation. It is not an autonomous algorithm.

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

   • No formal ground truth for a test set is described. The closest equivalent to "ground truth" for the device's design and effectiveness claims comes from:
     • Expert experience: "electrophysiological expertise of the cardiologist Managing Director."
     • Clinical outcomes/safety data: "4 years of post-market surveillance of the EPS320" and "clinical use in more than 40 clinical centres... for up to 4 years without significant adverse effects." This implicitly refers to positive clinical outcomes and lack of adverse events as evidence of safety and effectiveness in real-world scenarios.
     • Comparison to predicate: The EP-2's established safety and effectiveness serve as the baseline "ground truth" for the EPS320's substantial equivalence claim.

7. The Sample Size for the Training Set:

   • Not applicable. This submission does not describe an AI or machine learning algorithm that requires a "training set." The extensive clinical use of "current and earlier EPS320 models" in "more than 40 clinical centres" acts more as an extended real-world validation of the device's design and safety.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set described for an AI/ML algorithm.

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