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In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to ctructures structures.

The provided text is a 510(k) summary for the Mercator MicroSyringe II Infusion Catheter and does not contain the detailed information requested regarding acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML model.

This document describes a medical device clearance for an infusion catheter, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML performance, ground truth, expert review, training sets, and comparative effectiveness studies are not applicable or detailed in this submission.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes (e.g., number of units tested, number of in-vivo subjects) for the mechanical, fluid delivery, biocompatibility, sterilization, or in-vivo safety testing. It also does not state the provenance of the data (e.g., country of origin, retrospective or prospective).

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. This is a medical device for infusion, not an AI/ML diagnostic or predictive device requiring expert-established ground truth in the context of image interpretation or similar. The "performance" assessment is based on engineering and biological testing.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes in that context. Device performance was likely assessed against engineering specifications and possibly animal studies in a direct, objective manner.

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 is not an AI-assisted device, and no MRMC study information is provided.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance of this physical device would typically be defined by:

• Engineering specifications and standards for mechanical and fluid delivery performance.
• Relevant ISO standards and guidelines for biocompatibility and sterilization validation.
• Pre-clinical (in-vivo animal) study results for safety.

The document states that "All components, subassemblies and/or full devices met the required specifications for the tests," implying these specifications served as the ground truth or target.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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The Mercator male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

Here's an analysis of the provided text regarding acceptance criteria and study details for the Mercator Male Latex Condom:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list a table of acceptance criteria with corresponding performance data from a specific study. Instead, it states that the device's design "is in conformance with ASTM Latex Condom Standard D3492" and "ISO 4074." These standards inherently contain acceptance criteria for various condom properties (e.g., burst strength, leakage, dimensions).

Therefore, the table below represents the implied acceptance criteria based on the referenced standards and the device's claim of conformance. The "Reported Device Performance" is inferred from the device's substantial equivalence claim and compliance with these standards.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the studies that demonstrate conformance to ASTM D3492 and ISO 4074. The submission primarily relies on the claim of conformance to established voluntary standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable or not provided in the context of this 510(k) notification. The evaluation of condom performance against standards like ASTM D3492 and ISO 4074 typically relies on standardized laboratory testing protocols, not expert consensus on individual "cases" in the medical sense.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or diagnostic results by human readers to establish a "ground truth" when a gold standard is not immediately available. For a device like a condom, performance is assessed through objective physical and material testing against predefined criteria in standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess improvements in diagnostic accuracy. It is not relevant for a male latex condom.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone "algorithm only" study was not conducted or mentioned. This concept applies to AI/ML software as a medical device (SaMD) where the algorithm performs a diagnostic or predictive task without direct human intervention. This device is a physical medical device (condom), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, as established by its conformance to ASTM D3492 and ISO 4074, is based on objective, standardized physical and mechanical test results. For example:

• Physical Testing: Water leakage tests, burst pressure and volume tests using specialized equipment.
• Dimensional Measurements: Using calipers or other precision measuring tools.
• Material Analysis: Ensuring the material is natural rubber latex.

These tests are the "ground truth" for determining if the condom meets the performance requirements of the standards.

8. The Sample Size for the Training Set

This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product, not an AI/ML system.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided for the reasons stated above (not an AI/ML device).

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The Mercator Atrial High Density Array Catheter is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). When used in conjunction with electrogram recording equipment and stimulators, the system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

The Mercator Atrial High Density Array Catheter can be used with:

• the Cardiac Pathways' Model 8100 Arrhythmia Mapping System and the Model 8300 . Signal Acquisition Module in conjunction with a stimulator, and
• Cardiac Pathways' EGM Adapter Cables (Models 2036, 2043, and 2044) in conjunction . with intracardiac electrogram recording equipment.

Prescription Use
(Per 21 CFR 801.109)

The Mercator High Density Array Catheter has an 8.5F catheter shaft with a collapsible, spheroid-shaped. 32-bipole-electrode array (64 electrodes) on the distal end, and an integrated cable/connector assembly on the proximal end. The device is designed to connect/mate directly with the Cardiac Pathways' Arrhythmia Mapping System and with Cardiac Pathways' EGM Adapter Cables. The EGM Adapter Cables can be connected to electrogram recording equipment.

The Mercator High Density Array Catheter has been described previously in the 510(k) Summary and the Device Description section in the 510(k) submission file number K982540.

There are three different EGM Adapter Cables for use with the Mercator Catheter. The distal end of the cable is identical in each of the three cable types and defined as the end that connects to the Mercator High Density Array Catheter. The proximal end connects to electrogram recording equipment.

The distal end of the EGM Adapter Cables is a threaded-body style connector that has contacts for each of the 64 electrodes of the Mercator High-Density Array Catheter and a contact for a shield wire. The proximal end of the cable distinguishes the three EGM Adapter Cables. The Model 2036 EGM Adapter Cable allows for general connection of individual electrodes to electrogram recorders and stimulators. This cable has 64 independent connectors on the proximal end. Model 2043 and Model 2044 EGM Adapter Cables have connector configurations that can mate with Prucka CardioLab recording systems. These cables have two connectors on the proximal end. On each of these two connectors, 33 contacts connect 32 electrodes and 1 shield wire from the Mercator High-Density Array Catheter to the inputs on the Prucka system. The two Prucka connector cable models differ in that one model has pin-type contacts and the other model has socket-type contacts to adapt to suitable models of the Prucka recording system. The EGM Adapter Cables are not sterilized since they are not in the sterile field during a procedure.

The provided text describes a 510(k) summary for the Mercator Atrial High Density Array Catheter and Cardiac Pathways EGM Adapter Cables. It focuses on device description, indications for use, and a statement of substantial equivalence to a predicate device (K982540). The document mentions that the Mercator catheter was subjected to bench, animal, and clinical testing, and the EGM Adapter Cables underwent electrical and mechanical tests.

However, the specific details required to answer your questions regarding acceptance criteria and the comprehensive study that proves the device meets them are not provided in the given text. The document states that the testing for the catheter has been "described previously in the 510(k) Summary for the 510(k) submission file number, K982540," and for the cables, it only states that "The device met the specifications" without listing those specifications or the details of the tests.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the catheter in this document. For the cables, it only states "met the specifications" for electrical and mechanical tests, but the specifications themselves are not detailed.
• Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country, retrospective/prospective) is present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment details are provided.
• Adjudication method for the test set: Not applicable.
• 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: This device is a catheter and adapter cables, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers assessing AI performance is not relevant to this product.
• If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth information is provided.
• The sample size for the training set: Not applicable, as this is a hardware device, not a machine learning algorithm.
• How the ground truth for the training set was established: Not applicable.

The document essentially refers to a prior 510(k) summary (K982540) for the performance data of the Mercator Catheter and provides only a very high-level summary for the EGM Adapter Cables. To answer your questions comprehensively, the original 510(k) summary (K982540) would need to be reviewed.

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The Mercator Atrial High-Density Array Catheter, used in conjunction with the Cardiac Pathways' Model 8100 Arrhythmia Mapping System and the Model 8300 Signal Acquisition Module, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

The Mercator High Density Array Catheter has an 8.5F catheter shaft with a collapsible, spheroidal-shaped, 32 bipole electrode array on the distal end, and an integrated cable/connector assembly on the proximal end. The device is designed to interface with the Cardiac Pathways' Arrhythmia Mapping System. There are three sizes of arrays for the right atrium based on the atrial volume derived from transthoracic echocardiograms: 70 cc, 100 cc, and 130 cc.

The electrode array consists of eight equidistant arms fixed at each end to form a spheroid. The arms terminate into an atraumatic tip on the distal end, and transition into the catheter shaft on the proximal end. The arms are made of a compliant material that maintains contact against the atrial walls during the cardiac cycle. The arms are labeled A through H in a clockwise direction. The array orientation is ascertained using three radiopaque markers positioned on arms A (distal), B (mid) and C (proximal). Each arm has four electrode pairs spaced equidistant from each other along the length of each arm. Each electrode is 0.75 mm wide by 0.25 mm high. The electrode spacing is the same for all three sizes of catheters: 1 mm between electrodes in a bipole and 8 mm between bipoles when measured center to center.

The electrical connections between the electrodes on the array and the connector on the proximal end of the catheter are made via cables. The cables run the length of the catheter shaft and connector bump tubing. The catheter shaft terminates at the proximal end at the Y-arm assembly. The center lumen of the catheter is contiguous with the luer fitting on the straight arm of the Y-arm assembly and is used for flushing the catheter. The angled arm on the Y-arm assembly provides the interface for the connector bump tubing.

The connector has 79 pins, and interfaces with a mating receptacle on the Arrhythmia Mapping System. The terminations of the cables at the connector are housed inside a backshell that provides a smooth transition from the connector to the connector burnp tubing.

The 11 F Guiding Sheath and the 30° Angled Guiding Sheath have an 11 F braided catheter shaft that terminates into a short, atraumatic tip on the distal end and a luer fitting on the proximal end. On the 30° Angled Guiding Sheath, the distal 4.5 cm of the catheter shaft is angled 30° from the proximal shaft of the catheter. The 11 F Guiding Sheath and the 30° Angled Guiding Sheath are used in conjunction with the 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter, respectively, to position the High Density Array Catheter in the right atrium.

The 11 F Guiding Sheaths have a large inside diameter through which the High Density Array Catheter is inserted into and withdrawn from the cardiovascular system. The shaft of the Guiding Sheath is radiopaque. The Guiding Sheath terminates into a female luer fitting on the proximal end. This luer fitting is used to flush the Guiding Sheath and to introduce the High Density Array Catheter into the Guiding Sheath. The working length of the Guiding Sheath is 110 cm.

The purpose of the Guiding Sheath is to "guide" the High Density Array Catheter to a position in the right atrium found using the 8.5 F Pigtail Catheter. The Guiding Sheath is also used to collapse and withdraw the electrode array on the High Density Array Catheter when mapping is complete

The 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter have an 8.5 F braided catheter shaft on the proximal end attached to a soft distal extrusion that is necked down and formed into a radius known as a " pigtail". The 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter are used in conjunction with the 11 F Guiding Sheath to position the High Density Array Catheter in the right atrium.

The Pigtail Catheters have an open center lumen and 12 side holes positioned equidistant from each other in the distal extrusion, proximal to the pigtail. These holes can be used to deliver contrast media into the right atrium for visualization of catheter position and to assess the size of the atrium. The center lumen is accessible for flushing using a female luer lock fitting on the proximal end of the Pigtail Catheter. The braided shaft is radiopaque and gives the catheter good torque transmission.

The diameter of the pigtail tip is 1.3 cm. The purpose of this large diameter tip is to facilitate atraumatic placement into the right atrium. It also helps to avoid prolapsing of the High Density Array Catheter through the tricuspid valve into the right ventricle. The working length of the Pigtail Catheter is 135 cm.

A pigtail stylet is packaged in the Deployment Kit to straighten out the distal radius of the pigtail when inserting it inside the Guiding Sheath. The stylet is a stainless steel mandrel with a ball on the end to prevent advancing it all the way into the center lumen of the Pigtail Catheters. The pigtail stylet is used only in the preparation of the Guiding Sheath/Pigtail Catheter assembly and is not intended to be inserted into a patient. It is removed after the Pigtail Catheter is positioned inside the Guiding Sheath.

The Mercator Atrial High Density Array Catheter is intended to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for diagnostic provocative stimulation during an electrophysiology procedure in the right atrium of patients with complex arrhythmias.

Here is an analysis of its acceptance criteria and the study proving its performance:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The performance data assesses diagnostic quality, signal quality, rhythm interpretations, and baseline noise compared to standard catheters. Since the device is intended to enable diagnosis, the ability to successfully record and interpret signals is paramount.

2. Sample Size and Data Provenance

• Test Set Sample Size: 74 patients for data analysis in the clinical study. A total of 79 patients were enrolled, but 5 were excluded because the HDAC was not deployed.
  • For matched electrogram analysis in sinus rhythm: 41 patients.
  • For matched electrogram analysis in atrial arrhythmia: 45 patients.
• Data Provenance: Prospective clinical study conducted at eight centers. The country of origin is not explicitly stated, but given the FDA 510(k) submission, it is almost certainly a US-based study or a multinational study that includes US sites.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A "blinded independent expert" was used to perform the primary analyses of equivalence. Only one expert is explicitly mentioned for this comparative assessment.
• Qualifications of Experts: The specific qualifications (e.g., "Radiologist with 10 years of experience") are not detailed for the independent expert, only that they were an "expert." For an electrophysiology study, such an expert would typically be an electrophysiologist with significant experience in interpreting intracardiac electrograms.

4. Adjudication Method

The document states that the "primary analyses of equivalence... were performed by a blinded independent expert." This suggests a single expert's interpretation formed the basis of the comparison without an explicit multi-reader adjudication method (e.g., 2+1 or 3+1 consensus). However, the study also compared diagnoses to "predefined diagnostic categories," implying a structured framework for assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly mentioned to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the device and its equivalence to predicate devices, with human readers (the "independent expert") evaluating the quality of the signals from both the investigational and predicate devices. This device is a diagnostic catheter, not an AI assistance tool.

6. Standalone Performance Study (Algorithm-Only)

A standalone performance study was done in the sense that the device's ability to record and pace was evaluated on its own merits alongside the comparison to predicate devices. The study assessed:

• The device's ability to capture pacing (96.9% consistent capture at 5 mA).
• The intrinsic qualities of its recorded electrograms (diagnostic quality, signal quality, baseline noise) as interpreted by an expert, compared to standard catheters.
• The device's mechanical and electrical specifications compliance through laboratory testing. These are inherently "standalone" assessments of the device itself.

7. Type of Ground Truth Used

The ground truth for the clinical study was primarily established by:

• Expert Interpretation/Diagnosis: The "blinded independent expert" determined the diagnostic quality, rhythm diagnoses, and signal quality based on the electrogram recordings. This represents expert consensus on the interpretation of physiological signals.
• Patient Diagnosis/Medical History: The study population itself had verified arrhythmias (e.g., atrial flutter, AV nodal tachycardia), which served as the clinical context for evaluating the diagnostic performance of the catheters.
• Objective Measurements: For baseline noise, objective measurements (peak-to-peak absolute amplitude) were taken from the signals.

8. Sample Size for the Training Set

This document describes a clinical validation study and does not mention a "training set" in the context of an AI/machine learning algorithm, as the device itself is a physical medical instrument (catheter), not a software algorithm that requires a training set. The clinical study acts as the validation set for the device's performance against its intended use.

9. How the Ground Truth for the Training Set was Established

As mentioned above, there is no "training set" in the context of an AI/machine learning algorithm for this device. The physical device's design and engineering would have been guided by prior medical knowledge, engineering principles, and potentially animal or bench testing (which are not detailed here for ground truth establishment). The ground truth for the clinical validation was established through expert interpretation of electrograms and patient clinical diagnosis.

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Mercator is intended to be used as a data management tool for physicians and cardiac clinics to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. Mercator is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. Mercator does not offer diagnosis or medical alarms.

Mercator is a software product designed for the Microsoft Windows 95 and Microsoft Windows NT operating systems running on an IBM compatible platform. Mercator consists of a user interface that enables health care professionals to input, store, and output data from a relational database.

The product consists of a set of modules that can be "plugged in" to customize the application to individual users' needs.

Mercator is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software supports many aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, doctor notes, pacemaker/ICD data and associated reports. Mercator also supports appointment scheduling and stores information on physicians, facilities, allied health care professionals, and insurance providers.

Mercator is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

The Mercator 510(k) summary does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner. The document focuses on regulatory submission requirements for substantial equivalence.

Here's a breakdown of the available information and what's missing, based on your requested headings:

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

Missing:

• Specific, quantifiable acceptance criteria (e.g., "Software shall perform X with Y% accuracy" or "System uptime shall be Z%").
• Quantitative performance metrics and results against those criteria. The statements are qualitative ("thoroughly," "proper functionality," "safe and reliable").

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

• Sample Size: Not specified. The document mentions testing "all software modules" and "the ECG module," but does not provide details on the specific data sets or number of test cases used.
• Data Provenance: Not specified. Given the nature of the device (ECG data management software), the "test set" would likely refer to the data used during software testing, not patient data for clinical evaluation. The document primarily discusses software functionality and compliance with a standard, not clinical performance with patient data.

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. The "ground truth" concept, as typically applied to performance evaluation with expert adjudication, is not relevant here. The testing described is primarily focused on software functionality, adherence to design specifications, and compliance with a technical standard (ANSI/AAMI EC38 - 1994), not diagnostic accuracy against a clinical ground truth.

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

Not applicable. As noted above, the testing is for software functionality and technical standard compliance, not clinical diagnostic accuracy requiring adjudicated ground truth.

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. This is not mentioned. The Mercator is described as a "data management tool" and explicitly states, "Mercator does not offer diagnosis or medical alarms." Therefore, an MRMC study comparing human reader performance with and without AI assistance isOutside the scope of its intended use.

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

No. This is not applicable, as Mercator is a data management tool, not an algorithm providing a diagnostic output. The document explicitly states, "It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data."

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

Not applicable. The "ground truth" in the context of Mercator's testing would be verifying that the software performed its intended functions (e.g., storing, retrieving, displaying ECG data correctly) according to its design specifications and the relevant technical standard. This is not a clinical ground truth regarding disease state.

8. The sample size for the training set

Not applicable. Mercator is a data management software, not a machine learning or AI-driven diagnostic device that would require a "training set" in the conventional sense.

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

Not applicable, as there is no mention of a training set for Mercator.

Summary of Device Evaluation in the 510(k) document:

The 510(k) submission for Mercator primarily focuses on demonstrating substantial equivalence to predicate devices by comparing technological characteristics and showing compliance with relevant software development and testing practices. The "Performance Testing and Conclusions" section states that:

• All software modules underwent multi-level testing (unit, integration, system) by trained staff using manual and automated test suites.
• The ECG module was tested against "applicable sections of the ANSI/AAMI EC38 - 1994 Standard for Ambulatory Electrocardiographs concerned with effectiveness and safety."
• The results indicated the product is "safe and reliable" and "All test plans were passed in accordance with the Mercator Product Release Test Plan."

This type of documentation is typical for software products of this era (1998) that act as data management tools rather than advanced diagnostic or AI-powered devices. The focus is on demonstrating that the software functions as designed and meets recognized industry standards for medical devices of its class. The absence of detailed clinical performance data, expert adjudication, or AI-specific evaluation metrics is consistent with its intended use as a data management tool, not a diagnostic aid.

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