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The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac Stimulator System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.

The Bloom2™ Cardiac Stimulator System (Bloom²) is a programmable pulse generator used for electrophysiological testing of the human heart. The Bloom² has three main components, the Bloom2 Console, the Bloom2 Stimulator Unit and the Bloom2 Increment / Decrement Floater. The Console and the Floater contain the main user controls of the system. The Console consists of a touch screen and will allow the operator to setup the functions and parameters of the system. The user interface of the Console is based on the proven and familiar interface of the Bloom DTU-215B. The Floater provides additional user controls and will provide the operator with tactile feedback on those functions that the user is expected to use while going through their protocols. The Stimulator is the heart and brains of the system. The Stimulator has four, independent output channels that have a direct connection to the patient through third party catheters.

The provided text is a 510(k) summary for the Bloom2 Cardiac Stimulator System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical outcomes. Instead, it focuses on non-clinical performance and safety testing.

Therefore, most of the requested information cannot be extracted from this document, particularly regarding studies related to AI performance, expert adjudication, or ground truth establishment relevant to an AI/diagnostic device.

However, I can provide what is discussed regarding non-clinical performance:

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):
No information about sample size, test sets, or data provenance in the context of clinical or diagnostic performance is provided, as no such study was conducted. The non-clinical tests relate to the device itself and its components.

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, as no expert-adjudicated test set is detailed. The device is a stimulator, not an AI diagnostic tool requiring ground truth from medical experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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. This device is a cardiac stimulator, not an AI system for diagnostic image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" would be the specifications and requirements of the safety and EMC standards (e.g., IEC 60601-1). The tests demonstrated that the device met these engineering and safety standards.

8. The sample size for the training set:
Not applicable, as no training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established:
Not applicable.

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The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures. The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.

The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols. The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.

The provided document is a 510(k) premarket notification for the EP-4™ Cardiac Stimulator, which is an external programmable pacemaker pulse generator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the EP-4™ Clinical Stimulator (K040207).

The document does not contain acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological parameters with defined thresholds) or a formal study designed to "prove" the device meets such criteria through a statistical analysis against a ground truth.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). The "study" described is primarily bench testing to confirm that design changes did not adversely affect safety or efficacy.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

   The document does not provide a table of acceptance criteria with numerical performance metrics. The "acceptance criteria" in the context of this 510(k) submission are implicitly tied to demonstrating that the EP-4 Cardiac Stimulator is "substantially equivalent" to its predicate device (EP-4 Clinical Stimulator).

   The reported "performance" is described qualitatively:

   • "Bench testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the product."
   • "Where design differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness."
   • The device has the "same intended use and fundamental scientific technology" and "all technological characteristics... are substantially equivalent" to the predicate.

   No specific numerical performance values (e.g., stimulation accuracy within a certain mV or ms, battery life, etc.) that would typically be associated with explicit acceptance criteria are provided in this regulatory summary.

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

   Not applicable. The document describes "bench testing," which refers to laboratory testing of the device itself, not a clinical study involving patients or a dataset of patient data. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance.

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. As this was bench testing for substantial equivalence, clinical ground truth establishment in the traditional sense (e.g., by medical experts for diagnostic accuracy) was not the focus. The "ground truth" for bench testing would be engineering specifications and predicate device performance, verified by engineers and quality control personnel. No information on specific expert qualifications for this type of verification is provided.

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

   Not applicable, as there is no specific "test set" of patient data requiring clinical 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

   No. The EP-4 Cardiac Stimulator is a medical device for electrical stimulation, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.

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

   Not applicable. This device is a hardware system with embedded software for cardiac stimulation, not an algorithm being tested in isolation. The device's functionality is inherently "standalone" in operation once programmed, but this is distinct from testing an AI algorithm's performance without human interaction.

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

   For bench testing, the "ground truth" would be established against the design requirements, engineering specifications, and performance characteristics of the predicate device. The goal was to confirm that the changes "met design requirements" and did not "adversely affect the safety or efficacy" when compared to the predicate. This is verified through a combination of standard engineering tests, electrical measurements, and functional checks.

8. The sample size for the training set

   Not applicable. The device's software is menu-driven and firmware-based, controlling stimulation functions. It's not described as a machine learning system that requires a "training set" in the AI sense. The software's development followed "St. Jude Medical's Quality System requirements" and "design controls requirements documented in 21 CFR 820.30," which dictate rigorous testing and verification, but not "training data" in the AI context.

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

   Not applicable, as there is no "training set" for an AI algorithm.

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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 Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.

The Z6 Stimulator is a cardiac pulse generator designed for use in an Electrophysiology Laboratory during electrophysiological studies. The system operates in conjunction with ECC Recording devices to deliver electrical stimulus to the patient's heart through up to four simultaneously operable output channels. The Z6 Stimulator is controlled by a CPU based Workstation with Windows XP. This provides programmability and flexibility with regard to the stimulus program and allows access to system users. Additionally, the system features a graphical interface with a Windows XP look and feel.

Each of the four independent output channels of the Z6 Stimulator is capable of generating between 0.1 and 25 mAs of current to the patient, with voltages up to 20 Volts. The System is capable of delivering pulses on all channels simultaneously. The duration of the pulses can be programmed to be between 0.5 and 10 ms, maintaining timing accuracy (> +/- 0.15 ms).

The provided document, K070743, is a 510(k) premarket notification for the Z6 Stimulator, a programmable cardiac electrophysiological stimulator. The purpose of this notification is to demonstrate that the Z6 Stimulator is substantially equivalent to a legally marketed predicate device, the Micropace Pty Ltd. EPS320 Clinical Stimulator.

Here's an analysis of the acceptance criteria and the study presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document uses the specifications of the predicate device, the Micropace EP320 Stimulator, as the acceptance criteria for the Z6 Stimulator's performance. The "Non-clinical Testing" section explicitly states that the Z6 Stimulator's output pulses were compared to these specifications and "found to be within the specifications."

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

• The document does not specify a sample size for the test set. The non-clinical testing appears to be a technical verification comparing the Z6 Stimulator's output characteristics against the published specifications of the predicate device.
• The data provenance is not explicitly stated as country of origin or retrospective/prospective. As it's a technical verification of the device itself rather than patient data, these categories might not be applicable in the traditional sense. It's an internal validation of the Z6 Stimulator's hardware and software performance.

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

• This is not applicable to this type of submission. The ground truth for this technical verification is the published specifications of the predicate device, which are objective engineering parameters. Clinical expert consensus is not used for this.

4. Adjudication Method for the Test Set:

• This is not applicable. The "test set" here refers to the device's output parameters which are objectively measured and compared to numerical specifications. There is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of device specifications, not on clinical effectiveness in human readers. The Z6 Stimulator is a tool used by clinicians, not an AI diagnostic tool that assists human readers.

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

• Yes, in spirit. The non-clinical testing for the Z6 Stimulator is inherently a "standalone" evaluation of the device's functional performance (timing, amplitude accuracy) against established specifications. It's the performance of the device itself, independent of a human operator's cognitive input in interpreting results.

7. The Type of Ground Truth Used:

• Engineering specifications and published data of the predicate device. The Z6 Stimulator's output pulses (timing and amplitude accuracy) were compared against the "specifications of the EP320 Stimulator output pulses."

8. The Sample Size for the Training Set:

• Not applicable. This submission is for a medical device (a stimulator), not an AI algorithm that requires a "training set" in the machine learning sense. The device is designed based on engineering principles and validated against specifications.

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

• Not applicable. As stated above, there is no "training set" in the context of this device and submission.

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The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

Not Found

I am sorry. I cannot answer your question. The document does not describe the acceptance criteria, the study details, or the performance of the device. It is a 510(k) clearance letter and an "Indications for Use" statement for a medical device called the "EP-4 Clinical Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended uses.

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The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called the "EP-4 Clinical Stimulator." This document confirms that the FDA has reviewed the premarket notification and found the device to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (like MRMC or standalone studies). This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The requested information would typically be found in a separate submission, such as an engineering report, validation study report, or clinical trial documentation, which is not part of this 510(k) clearance letter.

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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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The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment of supraventricular and other miscellaneous arrhythmias.

The EPstim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The system provides for compilation, storage and rapid execution of a customized series of stimulator outputs and provides for automated detection of capture during cardiac electrophysiological testing.

The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory setting under the direction of qualified personnel trained to administer electrophysiological procedures.

EPStim Software and Bloom DTU Electrophysiology Program Stimulator

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EPStim Software and Bloom DTU Electrophysiology Program Stimulator.

While it states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications for Use," it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes.
6. Details about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance process and the intended use of the device, rather than the specifics of its performance validation testing.

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