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The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

• Complete heart block ●
• Sinus bradycardia ●
• Sick sinus syndrome ●
• Bradycardia with congestive heart failure ●
• Atrial and/or ventricular arrhythmias ●
• Cardiac arrest
• o Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• Support during permanent pacemaker replacement ●
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery ●
• Acute myocardial infarction complicated by heart block ●
• Atrial tachyarrhythmias that require high-rate burst pacing for treatment ●

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The provided document is a 510(k) premarket notification letter from the FDA to Medtronic, Inc. regarding a medical device, the Medtronic Model 5392 External Pulse Generator (EPG).

This document does not describe an AI/ML-based medical device or a study involving AI/ML performance.

Instead, it pertains to a traditional medical device (an external pacemaker) and its substantial equivalence to a predicate device. The "study" mentioned refers to bench testing to demonstrate that changes to the device's Instructions for Use (IFU), specifically regarding additional cleaners/disinfectants, do not compromise its design specifications or safety.

Therefore, I cannot extract the information required for an AI/ML-focused performance study because it is not present in the provided text. The questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

• Complete heart block
• Sinus bradycardia
• Sick sinus syndrome
• Bradycardia with congestive heart failure
• Atrial and/or ventricular arrhythmias
• Cardiac arrest
• Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• Support during permanent pacemaker replacement
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery
• Acute myocardial infarction complicated by heart block
• Atrial tachyarrhythmias that require high-rate burst pacing for treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The provided text describes documentation related to the FDA 510(k) clearance for the Medtronic Model 5392 External Pulse Generator (EPG). This document is a premarket notification for a medical device and therefore does not contain information about AI/ML device performance or clinical studies of AI-assisted human readers.

The clearance is for a change in the material of the patient connector in an existing device (predicate device K181973), not a new AI-powered device. Therefore, the questions related to AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable.

However, based on the information provided, here is what can be inferred about the device and its testing, though it does not involve AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The data from this testing showed that the devices could be manufactured with the modified patient connector material and continue to meet the current 5392 design specifications." and "The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues."

While specific numerical acceptance criteria and performance metrics are not detailed in this summary, the general acceptance criterion was that the modified device continued to meet the existing design specifications of the predicate Medtronic Model 5392 EPG.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The studies performed were "bench tests." This indicates the testing was conducted in a laboratory setting, not with patient data.

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

This is not applicable as the testing involved bench tests to verify engineering specifications, not clinical outcomes requiring expert interpretation of ground truth.

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

Not applicable for bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI/ML device, and no human-in-the-loop studies are mentioned.

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

Not applicable. This is a hardware device (external pulse generator) and does not involve a standalone algorithm.

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

The "ground truth" for the bench tests would be the established engineering and performance specifications for the predicate device. Compliance with these specifications was verified.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML device that requires a training set.

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

Not applicable.

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The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

• · Complete heart block
• · Sinus bradycardia
• Sick sinus syndrome
• · Bradycardia with congestive heart failure
• · Atrial and/or ventricular arrhythmias
• · Cardiac arrest
• · Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• · Support during permanent pacemaker replacement
• · Cardiac complications during invasive or surgical procedures
• · Support following cardiac surgery
• · Acute myocardial infarction complicated by heart block
• · Atrial tachyarrhythmias that require high-rate burst pacing for treatment

The Model 5392 EPG is a batterv-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

This document is a 510(k) Premarket Notification from the FDA regarding a Medtronic External Pulse Generator (EPG). It primarily focuses on demonstrating substantial equivalence to a predicate device due to a minor firmware modification. Crucially, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets these criteria.

The 510(k) summary (page 4-5) explicitly states, "The data from the newly verified firmware show that the devices could be manufactured with a new firmware version to mitigate rebooting of the device caused by interrupts in the firmware system." It also mentions "firmware design verification and system verification" and that "The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues."

However, the document does not disclose:

• The specific acceptance criteria for this firmware change.
• The details of the "firmware design verification and system verification" study. This would typically include performance metrics, sample sizes, ground truth establishment, or any human reader studies.

Therefore, based solely on the provided text, I cannot answer the questions as the required information about specific acceptance criteria and the study proving the device meets them (in the context of detailed performance metrics, test sets, expert involvement, etc.) is not present. The document focuses on the regulatory clearance process rather than the technical details of the verification study itself.

Ask a specific question about this device

The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

• Complete heart block
• Sinus bradycardia
• Sick sinus syndrome
• Bradycardia with congestive heart failure
• Atrial and/or ventricular arrhythmias
• Cardiac arrest
• Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• Support during permanent pacemaker replacement
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery
• Acute myocardial infarction complicated by heart block
• Atrial tachyarrhythmias that require high-rate burst pacing for treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The provided document is a 510(k) premarket notification for the Medtronic Model 5392 External Pulse Generator (EPG). This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study of a novel device's performance against specific acceptance criteria for a new clinical application.

Therefore, the requested information about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/human comparative effectiveness study, ground truth establishment, and training/test set details, is not fully applicable or directly provided in this document. This submission is for a minor modification to an already cleared device.

However, I can extract the relevant information from the document regarding the modifications and the qualification that addresses those changes.

Here's an analysis based on the provided text, addressing what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for the entire device or specific performance metrics in a clinical sense. Instead, it refers to acceptance criteria for the qualification of manufacturing process changes.

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

• Sample Size: Not specified. The document states "devices manufactured with the updated cables and new routing" were evaluated. This likely refers to a manufacturing batch or a specific number of units undergoing testing related to the physical changes.
• Data Provenance: Not explicitly stated, but implicitly derived from an internal manufacturing qualification process by Medtronic, Inc. This would be considered retrospective in the sense that it's an internal validation of manufacturing changes, not new clinical data collection.

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

• Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" here is compliance with manufacturing specifications and ensuring the physical changes do not introduce new safety or performance issues. This would typically be assessed by engineering and quality assurance personnel against established internal standards, rather than clinical experts establishing a medical "ground truth."

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/not specified. The evaluation involved "qualification of the manufacturing process," which implies adherence to predefined manufacturing and quality control standards, rather than a subjective adjudication process by multiple individuals.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic imaging devices or AI algorithms used in clinical decision-making, often comparing human performance with and without AI assistance. The Medtronic Model 5392 EPG is a temporary pacemaker, and this submission is for a minor modification to its manufacturing.

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

• Standalone Performance Study: No. This device is not an AI algorithm. Its performance is inherent to its electromechanical function as a pacemaker, not a software algorithm providing independent analysis.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" related to this submission is primarily adherence to engineering specifications, manufacturing quality standards, and safety requirements for the physical changes (cable routing and length). It's about ensuring the modified device functions as intended and meets established design and quality parameters, not a clinical ground truth like pathology or patient outcomes.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of the K162550 Submission:

This 510(k) submission is for minor modifications to the Medtronic Model 5392 External Pulse Generator (EPG). The modifications are specifically related to the "routing and length of three internal cables." The purpose of the submission is to demonstrate that these minor changes do not alter the device's fundamental safety or effectiveness and that it remains substantially equivalent to the previously cleared version (K150246).

The "study" referenced is a qualification of the manufacturing process, which included "new fixtures." The key finding is that this qualification "met the specified acceptance criteria and did not raise new safety or performance issues," leading to the conclusion of substantial equivalence. This is a common type of submission for non-significant device changes and not a clinical performance study.

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The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

• Complete heart block
• Sinus bradycardia
• Sick sinus syndrome
• Bradycardia with congestive heart failure
• Atrial and/or ventricular arrhythmias
• Cardiac arrest
• Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• Support during permanent pacemaker replacement
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery
• Acute myocardial infarction complicated by heart block
• Atrial tachyarrhythmias that require high-rate burst pacing for treatment

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

This FDA 510(k) premarket notification is for a Medtronic Model 5392 External Pulse Generator (EPG). This document establishes substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a clinical study for a new device. Therefore, many of the requested categories for a new device's performance study are not directly applicable or are not detailed in this document.

The core of this submission is to demonstrate that the modified Medtronic Model 5392 EPG is substantially equivalent to its predicate device (Medtronic Model 5392 EPG K132924), despite a minor design modification.

Here's the information presented, framed within your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are primarily based on demonstrating that the modified device performs equivalently to the predicate device, especially considering the minor "modified negative battery contact design." Performance is implicitly accepted if it aligns with the predicate and passes standard engineering verification.

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

This document describes bench testing for verification, not clinical studies with human participants. Therefore:

• Sample Size: Not explicitly stated in terms of patient numbers or clinical test cases. The testing was "regression bench testing to product level performance requirements." This implies engineering test units.
• Data Provenance: Not applicable. This refers to engineering bench test data, not patient data.

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 clinical outcomes or diagnoses is not established in this type of submission focused on substantial equivalence through bench testing. The "truth" is whether the device meets its engineered specifications and performs consistently with the predicate.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies to resolve discrepancies among human readers/experts. This submission focuses on engineering verification.

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 a medical device for providing temporary cardiac pacing, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is an external pulse generator, not an algorithm. Its operation inherently involves "trained personnel" in a "clinical environment where the patient is monitored continuously."

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is based on engineering specifications and performance characteristics of the predicate device, as confirmed through bench testing. It's about demonstrating that the modified device's performance aligns with established engineering standards and the known performance of the predicate, not clinical outcomes derived from expert consensus, pathology, or long-term patient follow-up.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an algorithm, as this is a hardware device.

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

Not applicable, as there is no training set for an algorithm described in this document.

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