Search Results

The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator 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 pacing include, but are not limited to:

• · Complete heart block
• · Sinus bradycardia
• Sick sinus syndrome
• · Bradycardia with congestive heart failure
• · Cardiac complications during invasive or surgical procedures
• · Support, management, and evaluation of a patient before permanent pacemaker implantation
• · Support during permanent pacemaker replacement
• · Interventional cardiology procedures where pacing is required

The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)

The provided document is a 510(k) premarket notification letter from the FDA to Solo Pace, Inc. regarding their device, Solo Pace Control. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

• Specific acceptance criteria and reported device performance in a table format. It mentions "performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents," and "The results of the above performance testing met the specified acceptance criteria." However, it does not detail what those criteria were or the specific performance results.
• Sample sizes used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on regulatory aspects, such as the device's classification, indications for use, comparison to a predicate device, and a high-level summary of performance testing categories (e.g., electrical safety, EMC, software verification, cybersecurity). It confirms that testing was done and met acceptance criteria, but it does not provide the granular detail required to answer your specific questions about the study design, ground truth establishment, or specific performance metrics.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested detail. The document confirms that such studies were performed and met criteria, but it does not include the specifics of those studies.

Ask a specific question about this device

The intended uses of Lifetech Cardio Temporary Pacemaker are

1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance.
   Lifetech Cardio Temporary Pacemaker is only intended to be operated
3. in a clinical setting, and
4. by trained professionals.
   Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
5. results from an acute and reversible cause and will likely not require permanent pacing, and
6. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
   Examples of specific indications for temporary pacing may include:
   a) Sick sinus syndrome
   b) Sinus bradycardia
   c) Atrial and/or ventricular arrhythmias
   d) Complete atrioventricular block
   e) Asystole
   f) Bradycardia accompanied by congestive heart failure
   g) Patient support, management and evaluation before the implantation of implantable pacemaker
   h) Support during the replacement of implantable pacemaker
   i) Cardiac complications occurring during intervention or surgery
   j) Support after the cardiac surgery
   k) Acute myocardial infarction complicated with cardiac conduction block
   l) High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The Lifetech Cardio Temporary Pacemaker (hereinafter called "TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. The TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.

This document is a 510(k) Premarket Notification from the FDA, focusing on substantial equivalence for a medical device. It does not contain the kind of detailed information about acceptance criteria, study methodologies (like sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, or specific ground truths) that would be present in a clinical performance study report for an AI/ML-based device.

The document discusses a temporary pacemaker and its modifications, primarily focusing on manufacturing specifications, intended use, and comparison to a predicate device. The "Performance Tests" section lists high-level tests like "Analysis Cable test," "Pacing Percentage Statistics test," "Rapid Atrial Pacing function test," and "Software verification and validation." These are engineering/bench tests to verify hardware and software functionalities against design specifications, not clinical performance studies with patient data and ground truth as typically understood for an AI/ML diagnostic or prognostic device.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types) because it is not present in the provided text. The document is about a hardware medical device (pacemaker), not an AI/ML algorithm.

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
• 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.

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 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.

Ask a specific question about this device

The intended uses of Lifetech Cardio Model 8301 Temporary Pacemaker are

1. to provide temporary single chamber synchronous or asynchronous anti-brady pacing therapy, and
2. to test electrical performance of an implanted lead system, including pacing threshold, sensing sensitivity and impedance.
   Lifetech Cardio Model 8301 Temporary Pacemaker is only intended to be operated
3. in a clinical setting, and
4. by trained professionals.
   Indications for anti-brady pacing therapy may be based on symptomatic bradycardia conditions that:
5. results from an acute and reversible cause and will likely not require permanent pacing, and
6. causes symptoms and/or severe hemodynamic impairment and when permanent cardiac pacing is not immediately indicated or available.
   Examples of specific indications for temporary pacing may include:
   a) Sick sinus syndrome
   b) Sinus bradycardia
   c) Atrial and/or ventricular arrhythmias
   d) Complete atrioventricular block
   e) Asystole
   f) Bradycardia accompanied by congestive heart failure
   g) Patient support, management and evaluation before the implantable pacemaker
   h) Support during the replacement of implantable pacemaker
   i) Cardiac complications occurring during intervention or surgery
   j) Support after the cardiac surgery
   k) Acute myocardial infarction complicated with cardiac conduction block

Lifetech Cardio Model 8301 Temporary Pacemaker (hereinafter called "8301 TPM") is a handheld device powered by two common size AA 1.5V Alkaline (LR6) batteries, which is intended for temporary single chamber anti-brady pacing therapy and implanted system analysis. 8301 TPM offers a complete set of pacing and sensing controls and supports either SSI (synchronous) or SOO (asynchronous) pacing modes. Its analysis features enable pacing threshold, sensing sensitivity and impedance measurement.
Patient Cable is an accessory provided along with 8301 TPM and is designed to connect a pacing lead system to 8301 TPM.

This document is a 510(k) premarket notification for the "Lifetech Cardio Model 8301 Temporary Pacemaker." It describes the device's intended use, technological characteristics, and performance compared to a predicate device, the "Medtronic Model 5318 Temporary Pacemaker / Implant Tool."

Here's an analysis of the provided information to answer your questions regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., "pacing rate accuracy within X%") alongside reported performance values. Instead, it makes a general statement of compliance with standards and successful verification and validation.

However, based on the Summary of Testing section and the Conclusion, we can infer the acceptance criteria categories and the high-level assessment of performance:

2. Sample sized 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 details on specific sample sizes for particular tests (e.g., number of devices tested for electrical safety, number of software test cases). It broadly states that "Design verification and validation was performed."

• Sample Size: Not explicitly stated for any specific test. It implies adequate samples were used to demonstrate compliance with the cited standards and internal criteria.
• Data Provenance: The testing was conducted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. (based in China) as part of their design verification and validation process. The data would therefore originate from their internal testing activities.
• Retrospective or Prospective: These would be prospective tests conducted as part of the device's development and regulatory submission.

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)

This question is not applicable to the type of device and testing described. The "Lifetech Cardio Model 8301 Temporary Pacemaker" is a hardware medical device with embedded software. Its performance is evaluated against engineering specifications, international standards (IEC), and its ability to replicate the functions of a predicate device.

Ground truth, in the context of expert consensus, pathology, or outcomes data, is typically relevant for diagnostic AI/ML devices or devices whose output requires subjective interpretation. For this pacemaker, ground truth is established by objective measurements against established engineering principles and medical device standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations, primarily in studies involving human readers or subjective assessments (e.g., image analysis, clinical diagnoses). The testing of this pacemaker involves objective, measurable electrical and mechanical performance parameters, and compliance with standards, not subjective expert judgment requiring adjudication.

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

Not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where the device's output influences human readers' performance (e.g., radiologists interpreting images). The Lifetech Cardio Model 8301 Temporary Pacemaker is a therapeutic and diagnostic tool for direct patient intervention (pacing) and objective measurements (threshold, sensitivity, impedance), not an AI-powered diagnostic aide that assists human readers in making interpretations.

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

The device itself is a "standalone" medical device in the sense that its core functions (pacing, sensing, measurement) are performed by the device and its embedded software. The software verification and validation testing described in the document is essentially evaluating the "algorithm only" performance within the device's complete system. The device is intended to be operated "by trained professionals," meaning there's always a human in the loop for clinical application and decision-making, but the internal functions and measurements are automated by the device's algorithms and hardware.

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

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: These define the expected performance metrics (e.g., pacing rate range, output current accuracy, sensing sensitivity limits).
• International standards: Specifically cited are IEC 60601-1, IEC 60601-2-31, and IEC 60601-1-2. Compliance with these standards indicates adherence to generally accepted safety and performance criteria for external pacemakers.
• Equivalence to a predicate device: The fundamental claim is substantial equivalence to the Medtronic Model 5318. This implies that the performance (pacing parameters, analysis features, safety, etc.) of the Lifetech device should be comparable to or meet the established performance of the predicate.
• FDA guidance: For software, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" served as the basis for software verification and validation.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional machine learning sense. The software it contains is traditional embedded software, developed using standard software engineering principles and verified against specifications, not trained on a dataset.

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

Not applicable for the same reason as point 8.

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 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 Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It 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 indications:

• Complete heart block
• Sinus bradycardia
• Sick Sinus Syndrome
• Bradycardia with congestive heart failure
• Atrial and/or ventricular arrhythmias
• Cardiac arrest
• Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
• Support during permanent pacemaker replacement
• Cardiac complications during invasive or surgical procedures
• Temporary support of a patient following cardiac surgery
• Acute myocardial infarction complicated by heart block
• High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.

The Medtronic Model 53401 External Pulse Generator (EPG) (K180873) is found to be substantially equivalent to its predicate device (K162054) based on verification testing that met specified acceptance criteria.

1. Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Firmware Verification: Ensure the updated firmware (Version 1.03) operates as intended.	Data from the newly verified firmware (Version 1.03) showed that the devices could be manufactured with this new version to mitigate rebooting of the device caused by interrupts in the firmware system.
   System Verification: Confirm overall system functionality and safety with the updated firmware.	The results of system verification testing met the specified acceptance criteria and did not raise new safety or performance issues.
   Maintain Substantial Equivalence in intended use/indications, operating principle, design, functionality, biological safety, packaging, and shelf life compared to the predicate device.	The modified device has the same intended use/indications for use, operating principle, design features, device functionality, biological safety, packaging materials, and shelf life as the predicate.

2. Sample size used for the test set and the data provenance: Not applicable. The submission focuses on firmware and system verification rather than performance with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved engineering verification of firmware and system, not expert-based ground truth establishment for clinical outcomes.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This was not an MRMC study for AI assistance; it was a verification study for a hardware/firmware update to an existing medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The study focused on the standalone performance of the updated firmware and the overall system according to engineering specifications. While not explicitly framed as "algorithm only," it evaluates the device's functional performance in isolation of a human operator, outside of standard operating parameters.

7. The type of ground truth used: The ground truth for this verification study was based on engineering specifications and expected functional behavior of the device and its firmware. The objective was to confirm that the updated firmware addressed a known issue (rebooting due to interrupts) and that the system continued to function according to its established design requirements.

8. The sample size for the training set: Not applicable. This was a verification study of a firmware update for an existing device, not a machine learning model requiring a training set.

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

Ask a specific question about this device

The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes.

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

• · Complete heart block
• · Sinus bradycardia
• · Sick Sinus Syndrome
• · Bradycardia with congestive heart failure
• · Atrial and/or ventricular arrhythmias
• · Cardiac arrest
• · Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
• · Support during permanent pacemaker replacement
• · Cardiac complications during invasive or surgical procedures
• · Temporary support of a patient following cardiac surgery
• · Acute myocardial infarction complicated by heart block
• · High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.

The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.

The provided FDA 510(k) summary for the Medtronic Temporary External Pacemaker Model 53401 does not include acceptance criteria or a study that clearly demonstrates the device meets specific performance metrics in the way a clinical study would for an AI/ML device.

This document describes a medical device, specifically an external pacemaker, not an AI/ML powered diagnostic device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and type of ground truth) is not applicable or present in this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with various medical device standards.

Here's an analysis of the provided text in the context of the requested information, with specific notes on why certain categories are not applicable:

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

The document does not present a table of specific acceptance criteria with corresponding device performance metrics in the format typically seen for AI/ML performance. Instead, it states that "Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria." It refers to compliance with various standards.

Implicit Acceptance Criteria (based on standards compliance):

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

This information is not provided as the submission describes non-clinical bench testing and human factors evaluation of a physical device, not an AI/ML algorithm processing medical data. There is no "test set" in the sense of a dataset of medical cases.

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)

This is not applicable. Ground truth for medical data is not relevant to the testing described for this physical pacemaker device. Human factors evaluations would involve users, but they are assessing usability, not establishing ground truth for diagnostic accuracy.

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

This is not applicable as there is no "test set" of medical cases requiring adjudication.

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

This is not applicable. MRMC studies are used for diagnostic algorithms involving human readers interpreting outputs. This document is for a physical pacemaker device.

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

This is not applicable. This is a physical device, not an algorithm. Performance testing (e.g., electrical output, battery life, physical durability) would be "standalone" in the sense that the device is tested by itself, but this is a different context than standalone AI algorithm performance.

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

This is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The ground truth for device performance would be the specifications and requirements defined by the manufacturer and relevant medical device standards.

8. The sample size for the training set

This is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable.

Summary of the Study:

The "study" presented here is a design verification and validation process for a traditional medical device (an external pacemaker). It primarily relies on non-clinical bench testing and human factors evaluation testing to demonstrate compliance with various international and national standards (e.g., IEC 60601 series, ISO 10993, ASTM D4169, ANSI/AAMI HE75). The key "proof" of meeting acceptance criteria is the documentation of compliance with these established safety, performance, usability, and manufacturing standards for medical devices. The ultimate goal of this submission is to establish substantial equivalence to an existing legally marketed predicate device (Medtronic Model 5392).

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.

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.

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.

Ask a specific question about this device