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The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

The CareLink SmartSync Device Manager system is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device. The Base pairs with the app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes analyzer hardware and patient cable connections, ECG cable connections, and Bluetooth wireless technology. The Base contains a microprocessor that maintains the pacing engine logic function. The PSA hardware within the Base consists of two main integrated circuits (ICs): a Micro Controller Unit and a Mixed Signal Integrated Circuit. The App is the primary user interface and includes a Host Application, a Platform Application, a Common Application, and a PSA Application component. The Analyzer tools in the App display and report on the cardiac lead and ECG data transmitted from the base.

The provided text describes a 510(k) premarket notification for the Medtronic CareLink SmartSync Device Manager Pacing System Analyzer (K163008). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, ground truth experts, and MRMC analysis as typically understood for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) based on the provided document.

The document outlines performance data collected to support the substantial equivalence claim, which includes: Biocompatibility testing, Electrical safety and electromagnetic compatibility (EMC) testing, Software Verification and Validation Testing, and Mechanical Testing.

Here's a breakdown of the information that is available in the document, mapped against your request:

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

The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the typical sense of a clinical validation study for an AI/ML device. Instead, it demonstrates compliance with relevant standards and functionality of a medical device (a Pacing System Analyzer). The "performance" is primarily shown through a comparison to predicate devices and adherence to regulatory standards.

Here's an interpretation based on the provided "Key Performance Specifications/Characteristics of the Device" table, which functions like a set of performance criteria, and the statement of compliance:

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 for Test Set: Not applicable. This submission is for a hardware/software medical device (Pacing System Analyzer), not an AI/ML algorithm requiring a specific patient test set for performance evaluation in the clinical sense you described. Performance is demonstrated through engineering verification and validation, and comparison to a predicate device.
• Data Provenance: Not applicable for an AI/ML algorithm test set. The testing conducted is primarily laboratory-based engineering and software verification.

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)

• N/A. Ground truth establishment by experts for a test set is not relevant to this type of device submission. The device's function is to objectively measure electrical performance of cardiac leads and display waveforms, not to interpret medical images or signals in a way that requires human expert adjudication for "ground truth."

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

• N/A. Adjudication methods are not applicable for this device submission.

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

• N/A. This device is a Pacing System Analyzer, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to assess human reader performance improvement.

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

• N/A. The device itself is a "standalone" system in that it performs its measurements according to its specifications. There isn't an "algorithm only" component that generates a decision or output that would then be compared to human performance in the context of an AI/ML device. Its function is to provide objective electrical measurements to a clinician.

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

• N/A. The "ground truth" for this device's performance relates to its ability to accurately measure electrical parameters (e.g., amplitude, impedance, rates) and display waveforms as per engineering specifications and comparison to predicate devices, rather than a clinical ground truth like disease presence or absence. Measurements are validated against known inputs and established engineering principles.

8. The sample size for the training set

• N/A. This document does not describe the development or validation of an AI/ML algorithm that requires a "training set" in the machine learning sense. The software described is traditional deterministic software.

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

• N/A. As no AI/ML training set is mentioned or implied, this question is not applicable.

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The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads.

The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.

The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads.

Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting.

The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable.

Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables

Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161.

Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.

The provided document, K101982, describes the premarket notification for the Merlin™ PSA Patient Cable EX3150 and Merlin™ PSA Patient Cable Adapters EX3170 and EX3180. This submission focuses on demonstrating substantial equivalence to predicate devices for these accessories to a Pacemaker System Analyzer (PSA). As such, the studies described are primarily engineering verification and validation tests rather than clinical studies involving human readers, ground truth establishment, or comparative effectiveness with AI.

Therefore, many of the requested categories related to clinical studies and AI performance are not applicable to this 510(k) summary. I will answer the applicable questions based on the provided text.

Acceptance Criteria and Device Performance

The acceptance criteria are generally implied by the successful completion of the various verification and validation activities listed. The device performance is deemed acceptable if these tests pass, demonstrating the device's fitness for its intended use and substantial equivalence to predicate devices.

Additional Information:

1. 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 provide specific numerical sample sizes for each test listed (e.g., how many cables were tested for biocompatibility, or how many packages for shipping). It generally states that "All units tested passed the acceptance criteria" or that tests "were carried out and are reported."
   • Data provenance is not specified. The tests are engineering or laboratory-based verification and validation activities.

2. 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 accessory 510(k) focusing on physical and electrical performance, sterility, and biocompatibility, not on diagnostic accuracy based on expert interpretation. The "ground truth" for these tests would be established by objective measurements against predefined specifications (e.g., sterility level, material properties, electrical continuity, packaging integrity).

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

   • Not applicable for the reasons stated above.

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 is not an AI-enabled device and no MRMC studies were conducted.

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

   • Not applicable. This is not an AI-enabled device. The "standalone" performance refers to the device's functional and safety performance as an accessory to the Merlin PSA system.

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

   • Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established through:
     • Standardized Test Methods and Specifications: e.g., electrical resistance measurements, material composition analysis, sterility assurance level (SAL) requirements, packaging integrity standards (ISTA 3A), and biocompatibility standards.
     • Industry Standards and Regulations: Conformance to relevant national and international standards for medical devices and their accessories.

7. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable.

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The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. . Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. . Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.

The provided document is a 510(k) Premarket Notification for a modification to the BIOTRONIK ERA 300 Pacing System Analyzer (PSA). The modification concerns the additional battery supplier for the device, not the device's main functionalities or its performance in diagnostic tasks. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance evaluation, sample sizes, ground truth establishment, expert roles, and comparative effectiveness studies is not directly applicable to this specific 510(k) submission.

The 510(k) essentially states that a new battery supplier (pbq) has been identified because the previous supplier (Panasonic) will no longer manufacture the existing 8 Volt battery. The key point for this regulatory submission is that the newly sourced battery meets the same internal specifications as the original one, thus ensuring that the core device's performance remains unchanged.

However, I can extract information related to the device's general description, intended use, and the regulatory aspect of the modification.

Here's an interpretation based on the provided document, addressing your points where possible, and explicitly stating when the information is not present or relevant to this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) about a battery supplier change, the acceptance criteria are that the new battery meets the existing internal specifications for the ERA 300 PSA. The "device performance" refers to the new battery performing indistinguishably from the old one, thereby maintaining the ERA 300's established performance.

Note: The document does not detail the specific performance specifications (e.g., battery life, voltage output range, charge time) as these are presumed to be the same as established for the original battery and are internal BIOTRONIK specifications. The crucial aspect is equivalence.

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

• Test Set Sample Size: Not applicable. This submission is for a battery supplier change, not a performance study comparing the ERA 300's diagnostic capabilities. The "test set" here would refer to the new battery being tested against specifications, not a clinical data set. The document does not specify the number of batteries tested.
• Data Provenance: Not applicable. No clinical or observational data are described. The testing described relates to internal product specifications for the battery.

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

Not applicable. There is no "ground truth" in the diagnostic sense for this battery modification. The "truth" is whether the new battery meets the specifications. Biotronik's internal engineers and quality control personnel would be responsible for verifying this, but their number and specific qualifications (beyond being competent in product testing) are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" (e.g., 2+1, 3+1 consensus) in the medical imaging or diagnostic sense for this type of component change. The assessment is against pre-defined engineering and performance specifications.

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

No. This type of study is completely irrelevant to a 510(k) for an additional battery supplier. An MRMC study would be used to evaluate the diagnostic accuracy of a system, potentially comparing human readers' performance with and without AI assistance on a given task (e.g., interpreting medical images). This document is not about such a system or AI.

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

No. This submission is for a medical device (Pacing System Analyzer), not an algorithm or AI. Standalone performance studies are typically for AI/CAD systems.

7. The Type of Ground Truth Used

The "ground truth" in this context is the pre-established internal BIOTRONIK specifications for the 8 Volt battery used in the ERA 300 PSA. The new battery needed to demonstrate that it met these specifications. This is a technical specification truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no AI/algorithm being trained.

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

Not applicable. There is no AI/algorithm being trained.

Summary regarding the device's overall performance (as described in the document, but not the focus of this specific 510(k)):

The ERA 300 Pacing System Analyzer is broadly characterized by its functionalities, which include:

• Temporary External Pacing: Provides temporary stimulation under various modalities (DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO).
• Lead Threshold Determination: Determines in situ lead characteristics (impedance, capture threshold, P/R wave amplitude, P/R wave slew rate) and in vivo retrograde conduction time.
• Pacemaker Function Test: Tests and analyzes in vitro operation of pulse generators to determine parameters such as pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

The original ERA 300 Pacing System Analyzer (K964190, cleared 07-10-97 and K033613, cleared on 12-08-03) would have had performance studies and acceptance criteria related to these functionalities. This 510(k) for the battery change relies on the substantial equivalence principle, meaning the change (new battery) does not alter the fundamental safety or effectiveness parameters that were established for the predicate device.

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The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.

The provided text is a 510(k) summary for the Remington Medical Inc. Model 6149 Pacing Vector Selector Patient Adapter Cable. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, as these are typically part of a detailed study report or testing documentation, not a 510(k) summary.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

I can only extract the following relevant information from the provided text:

• Device Name: Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable
• Device Description: A manually operated 3-channel Patient Adapter Cable designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It has no active circuits or power sources. It features a 2-pole, 5-position switch to select between five pacing vector options.
• Intended Use: Used during chronic implantation of a pacing or defibrillation lead system for PSA measurements, providing the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
• Technological Characteristics Summary: The Model 6149 is an accessory to the ERA 300, and its addition is considered minor, raising no safety or effectiveness concerns.

To answer your specific questions, information not present in the provided text includes:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. The device is a passive adapter cable, not an AI or imaging device that would typically undergo such a study.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Not present. The device is an adapter, not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed performance study report. It indicates the device is a simple, manually operated adapter cable with no active components, making many of your questions about AI study methodologies (like training sets, ground truth establishment, and expert adjudication) not applicable to this particular device.

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The ERA 300 is intended for use during invasive pacemaker procedures in the following activities:

• Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations.
• Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
• Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Deternines the following parameters: pulse and width, sensitivity, refractory period, AV delay, and rate/interval.

The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.

I am unable to provide a response based on the request. The document describes a medical device called the BIOTRONIK ERA 300 Pacing System Analyzer and a modification made to it. It also references a 510(k) summary and an FDA clearance letter.

However, the provided text does not contain any information about acceptance criteria, device performance results, sample sizes for testing, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth for the training set was established.

The document primarily focuses on:

• The device's name, classification, and general description.
• The specific modification made (plastic foil on the battery).
• Predicate devices.
• Indications for use.
• Manufacturing and contact information.
• The FDA's 510(k) clearance letter stating substantial equivalence to predicate devices.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided input.

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The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:

• Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, A00, or ODO modalities during implantable pacemaker procedures or physician evaluations.
• Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
• Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.

The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof confiquration to help prevent hazardous connection between patients and electrical power sources.

The provided text describes the ERA 3000 Dual Chamber Pacing System Analyzer and its indications for use, but does not contain information about acceptance criteria, device performance, or any studies conducted to prove device performance.

Therefore, I cannot provide the requested information in the format specified. The document is primarily a 510(k) summary for regulatory clearance, outlining the device's purpose, predicate devices, and an FDA clearance letter. It does not include the results of performance studies or validation data.

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