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The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality.

The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.

This document is a 510(k) summary for the Boston Scientific PSA Cable, Model 6763. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria with numerical performance targets for an AI device.

Therefore, many of the requested sections about acceptance criteria, performance metrics, sample sizes, and expert adjudication are not applicable or cannot be extracted from this document, as it pertains to a physical cable intended for signal transmission, not an AI-powered diagnostic device.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI device's performance metrics (e.g., sensitivity, specificity). The "Performance Data" section describes categories of testing for a physical cable.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes testing for a physical cable, not a software device that uses a test set of data. The performance section mentions "Design verification and validation (V&V) testing" which refers to laboratory and bench tests for electrical, mechanical, and safety aspects, not a dataset from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic AI.

4. Adjudication method 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 is not an AI device for diagnostic assistance.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" for a cable's performance would be engineering specifications and standards, verified through bench testing, not clinical outcomes or expert consensus on medical images/data.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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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 PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:

• Temporary External Pacing Provides temporary stimulation 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, AV delay, and rate/interval.

The PK-141 patient cable is compatible with the following BIOTRONIK external equipment: ICS 3000 Implant Control System, EDP 20/30 B External Pacemakers, and ERA 300/3000 Pacing System Analyzers. The PK-141 is intended to connect to the patient's sensing and pacing leads. The PK-141 is connected to the Redel connector provided by the external equipment and the alligator clips connect to the electrode. The PK-141 is made up of a 2.8m cable with four touch-proof alligator clips. The alligator clips are clamped directly to the tip or the contact ring of the leads. During its use, the cable is in the sterile field; therefore it must be sterile itself. Skin contact with the patient is not anticipated.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the PK-141 Patient Cable. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device and outlining the device's indications for use.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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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 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, 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, 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 configuration to help prevent hazardous connection between patients and electrical power sources.

The ERA 3000 Pacing System Analyzer (Model: ERA 301.4) underwent a Special 510(k) notification (K042708) to update its software to correct several anomalies. The original predicate device was BIOTRONIK's ERA 3000 Pacing System Analyzer (#K022360, cleared 01-27-03).

The provided text does not contain details of specific acceptance criteria or an explicit study proving the device meets these criteria. The document primarily focuses on the device modification (software update), its general description, indications for use, and regulatory classification.

Therefore, many of the requested details cannot be extracted from the provided text.

However, based on the information provided, here's what can be inferred or stated as not available:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not available.
• Data Provenance: Not available. The document mentions the manufacturing sites (Germany and Switzerland) but provides no information about where any testing or data collection took place.
• Retrospective or Prospective: Not available.

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)

• Number of Experts: Not available.
• Qualifications of Experts: Not available.

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

• Adjudication Method: Not available.

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

• MRMC Study: No. This device is a pacing system analyzer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and not mentioned.

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

• Standalone Performance: The document describes a software update for a "Pacing System Analyzer designed to test the electrical performance of the pulse generator and the pacing lead system." While the device operates automatically, the text does not explicitly detail a "standalone performance" study in the context of a new algorithm's evaluation, but rather refers to corrections of "anomalies" in existing software. The update is for an existing device's functionality.

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

• Type of Ground Truth: Not available. The "anomalies" corrected by the software update would imply that the "ground truth" for the original software's performance (and the corrected version) would relate to the accurate measurement and analysis of pacing parameters (e.g., impedance, capture threshold, pulse amplitude, width, A/V delay, rate/interval). However, the method for verifying these corrections is not described.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a software update to correct anomalies, not a machine learning algorithm requiring a separate training set.

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

• Ground Truth for Training Set: Not applicable. As it's not a machine learning algorithm, there is no training set in the typical sense.

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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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The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers in both the pre-hospital and hospital based environments.

The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide ECG simulation capabilities for applications in clinical training and product demonstration.

The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent performance problems. The SigmaPace 1000 is also intended to be used by training facilities to train medical personnel.

The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

The SigmaPace 1000 is a device used to verify the performance of various parameters of external cardiac pacemakers. This is done by connecting the external leads of the pacemaker to test inputs on the SigmaPace 1000 and selecting the pacemaker to test or by using the press buttons on the front panel display or via appropriate test cables by serial port (RS232). The SigmaPace 1000 can perform a variety of Transcutaneous and Transvenous (Atrial and Ventricular) Pacer tests.

Pulse current, rate, width, and energy
Qualitative demand and async mode tests
Amplitude sensitivity tests
Noise immunity tests
Paced and Sensed Refractory tests
Selectable model specific transcutaneous algorithms
Selectable test loads
DC leakage current (tranvenous)
Current drain test (transvenous)
Long term test for pacer output stability
ECG simulation for training activities

Acceptance criteria and device performance information for the DNI NEVADA INC. SigmaPace 1000 External Pacemaker Analyzer:

This submission document primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail specific quantitative acceptance criteria or a dedicated study report with performance metrics against those criteria. Instead, it describes a more general verification and validation process.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria and corresponding reported device performance values. It outlines the types of tests performed and attests that the device meets the requirements.

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample size used for the test set.
• The data provenance is not specified regarding country of origin or whether the testing was retrospective or prospective. It describes ongoing "verification and validation testing" which implies prospective testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The ground truth for a pacemaker analyzer would typically be established by comparing its measurements to a known, highly accurate reference standard or a golden standard pacemaker. The document does not specify who conducted this comparison or their qualifications.

4. Adjudication method for the test set:

• An adjudication method is not mentioned. Given the nature of a test equipment device, performance would likely be validated against established electrical engineering standards and reference equipment, rather than expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The device is test equipment and is not directly involved in patient diagnosis or treatment by human readers. It analyzes external pacemakers, not medical images or patient data.

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

• Yes, performance testing described is for the standalone device. The SigmaPace 1000 is an automated external pacemaker analyzer. Its "algorithms testing" and other parameter verifications are inherently standalone performance assessments.

7. The type of ground truth used:

• The document implies the use of established engineering and functional specifications as the ground truth. The device "is tested to ensure it meets the requirements as defined in the product specification and advertising." This suggests the ground truth is derived from design specifications and established standards for pacemaker performance.

8. The sample size for the training set:

• This information is not applicable and not provided. The SigmaPace 1000 is a measurement device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its "algorithms" refer to specific testing protocols for different pacemaker models, not learned models.

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

• This information is not applicable and not provided for the reasons stated above (not an AI/ML algorithm requiring a training set). The "algorithms" are likely deterministic test sequences and calculation methods programmed into the device based on pacemaker manufacturer specifications and industry standards.

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The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes.

Specific indications for temporary cardiac pacing include, but are not limited to, the following:

• Sick sinus syndrome
• Sinus bradycardia
• Atrial and/or ventricular arrhythmias
• Complete heart block
• Cardiac arrest
• Bradycardia with congestive heart failure
• Support, management, and evaluation of a patient before implantable pacemaker implantation
• Support during implantable pacemaker replacement
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery
• Acute myocardial infarction complicated by heart block

The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation.

The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is a hand-held, temporary, battery-powered, external, single chamber pacemaker designed for antibradycardia pacing therapy in asynchronous or synchronous (demand) pacing modes and to test the electrical performance of implanted lead systems. The Model 5318 Temporary Pacemaker / Implant Tool can be used with transvenous or myocardial lead systems in either a bipolar or unipolar lead configuration. In addition, the Model 5318 Temporary Pacemaker/ Implant Tool can be used to determine stimulation and sensing thresholds for temporary pacing. The device is connected to commercially available temporary or permanent pacing leads with patient cables.

The device incorporates the following features:

• Output Rate, Amplitude and Sensitivity control and display on base level screen
• Lead impedance measurement and display capability
• Adjustable Pulse Width from .06 2.0 ms (0.06-0.6 ms in 0.06 ms increments; 0.6-2.0 in 0.1 ms increments)
• Ouput Range: 0.1 V 10.0 V
• Base Rate: 30 to 200 ppm (30-50 ppm in 5 ppm increments; 50-100 ppm in 2 ppm increments; 100-200 ppm in 5 ppm increments)
• Sensitivity Range: 0.5 mV - 20 mV in synchronous pacing modes
• Pacing mode determined by manual adjustments to output amplitude and sensitivity parameter settings
• Battery polarity reversal capability
• 10 second continuous operation at nominal values during battery replacement
• Self-test capability
• Pin-protected cables (no exposed pins)
• Pace and Sense indicators
• On-Screen messages
• Screen backlighting for adjustment in low-light level situations
• Control lock function which prevents the dials from being changed inadvertently
• Low battery indicator
• EMERGENCY key
• Reversion circuitry
• Pause capability

The Model 5318 Temporary Pacemaker / Implant Tool allows pacing parameter adjustments and pacing mode selections to be made with four dials and seven membrane keys located on the front side of the device. The dials are for RATE, OUTPUT, SENSITIVITY, and PULSE WIDTH. The seven membrane keys are: LOCK/UNLOCK, MEASURE, PULSE WIDTH, PAUSE, OFF, ON and EMERGENCY.

Device parameter setting information is provided to the user with two liquid crystal display (LCD) screens on the front of the device. The upper screen displays the parameters for basic pacing (rate, output and sensitivity) and device status. The lower screen displays: warnings and instructions to the user; pulse width setting; and impedance measurements. A light source aids visibility for the LCD display under low-light conditions. Bails on the case allow the device to be hung from an IV pole or strapped to the mounting position of choice.

The provided text describes the Medtronic Model 5318 Temporary Pacemaker / Implant Tool and its 510(k) submission. It details the device's features, intended use, and a comparison to a predicate device (Medtronic Model 5311B Pacing System Analyzer). It also includes a summary of "non-clinical testing" (bench testing) performed on the device.

However, the document does not describe a study involving human subjects or AI. The tests performed are for hardware performance, electrical conformance, and environmental requirements, aligning with a traditional medical device submission for a physical device, not an AI/ML-based software device.

Therefore, many of the requested points, such as sample size for test sets (human data), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this document.

Here's a breakdown of what can be extracted based on the provided text, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "Medtronic specifications" as the acceptance criteria, and states that tests "showed that the device operated to Medtronic specification" for various characteristics. However, specific numerical acceptance criteria values are not provided. The reported performance is a general statement of compliance rather than quantitative results for each parameter.

Information Not Applicable or Not Provided in the Document:

Due to the nature of the device (a physical temporary pacemaker, not an AI/ML software), most of the requested information for an AI/ML device study is not present. The document focuses on in-vitro (bench) testing of hardware performance and software functionality rather than clinical performance with human data.

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML study. The document refers to "Medtronic Model 5318 Temporary Pacemaker / Implant Tool devices" and "test assemblies" for in-vitro testing, but does not specify a sample size for these. Data provenance is not relevant as it's not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's electrical, mechanical, and environmental performance is typically established by engineering specifications and objective measurements, not expert consensus on patient data.
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 document describes a physical medical device, not an AI-assisted diagnostic tool.
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.): The ground truth for this device's performance is objective engineering specifications and measurements (e.g., specific voltage outputs, pulse widths, impedance readings, resistance to environmental factors) verified through "in-vitro testing."
8. The sample size for the training set: Not applicable in the context of an AI/ML study. The document mentions "Software Development and Testing" and verification against specifications but does not detail a "training set" for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. For software verification, the "ground truth" would be the specified functional and performance requirements defined in the "Software Requirements Specification" and "Software Description."

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