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This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.

PSA™ Series devices are portable pacing system analyzers, which are intended to be used for the evaluation of the integrity and most beneficial placement of stimulation leads. The integrity of a stimulation lead system is characterized by its electrical impedance, the measurement results of which shall meet the specifications of the manufacturer of the lead system. The most beneficial placement of a stimulation lead system is determined by the ability of the PSA Series device to capture the heart rhythm (successful stimulation) and to measure reasonable high amplitudes of P and/or R waves and corresponding slew rates. The PSA™ Series encompasses a single-channel device (PSA 100) and dual-channel device (PSA 200) with each channel employing a differential stimulation output and a differential sensing input. Stimulation leads or extension cables are connected to patented receptacles accommodating pins of 0.9 ... 2 mm or Hypertronics ™ style sockets. In addition to the aforementioned intra-cardiac channels, a PSA Series device offers an additional channel and corresponding terminal for a 5-lead surface ECG. The user interface is divided into a touch screen and an array of four keys dedicated to the functions: On / Off, Emergency, High-Rate, Home. The user monitors device measurements, heart activity and device status through the touch screen and LED indicators. Functions provided by PSA™ series pacing system analyzers are organized into so called applications such as (availability depending on PSA Series model): 1/A (Single-chamber stimulation (Channel 1/A)), 2/RV (Single-chamber stimulation (Channel 2/RV)), DDD (Atrioventricular (dual-chamber) stimulation), UHS (Burst stimulation (Universal Heart Stimulator)). By choosing one application, the (touch) screen displays all functions and information relevant to the specific application. The screen displays with minimal delay a marker signal and up to four signal waveforms all of which a user can select from the group of up to three IEGM signal waveforms (1/A, 2/RV; availability depending on PSA model) and seven surface ECG standard vectors (I, II, III, aVR, aVL, aVF, V). The device provides or facilitates the following measurements: Sensing of intrinsic events of the heart: P/R wave amplitudes and slew rate, Rates (PP, RR interval), Intrinsic AV delay (antegrade conduction time), Retrograde conduction time, Wenckebach point (2:1 conduction). Stimulation of the heart: Capture threshold in up to 2 chambers, Lead impedances, Burst stimulation. During an implantation procedure a PSA™ Series device can temporarily take over the functions of a cardiac pacemaker. Measurement results can be stored to a virtual print-out page, which upon completion of all measurements is transmitted wirelessly to a separate printer or computer. User-configurable settings for general use of the device and individual applications are stored in non-volatile memory. The HIGH-RATE function (dedicated key below the touch screen) provides bust stimulation at rates variable from 70 to 1,000 ppm for terminating atrial and ventricular tachycardia. The (optional) UHS application is special form of the high rate function. Within the UHS application, the user can program a train of burst prior to clinical application, which is also referred to as programmable electrical stimulation (PES). Pressing the EMERGENCY key (dedicated key below the touch screen) immediately initiates an emergency stimulation (VVI, 60 ppm, 7.5 V, 1.0 ms). Pressing the HOME key allows the user to return to the home screen (main menu). The device can operate from line power or the integrated rechargeable battery which provides up to 4 hours of continuous operation. A medical-grade AC power supply is part of the delivery unit. An integrated backup battery maintains stimulation in the unlikely event of a failure of the integrated rechargeable battery or AC power. The robust device enclosure is protected against accidental fluid spill.

1. Acceptance Criteria and Reported Device Performance

The provided document describes both bench testing and a clinical investigation for the Osypka Medical PSA™ Series Pacing System Analyzer (PSA 100™ and PSA 200™).

Bench Testing Acceptance Criteria (Implicitly, the device 'performs as intended' or 'verified for' the specified ranges):

Clinical Investigation Acceptance Criteria and Reported Performance:

• Effective sensing: Inhibition of atrial/ventricle pacemaker stimulus in the presence of P/R waves, respectively.
• Effective pacing: Effective atrial/ventricle stimulation with their respective time domains.
• Specific quantitative thresholds for effective sensing and pacing were likely part of the methodology, though not explicitly stated as "% of cycles". | - No adverse events occurred while PSA was applied to the patient.
• PSA correctly recognized atrial and ventricular heart activity and inhibited in 364/364 (100%) cardiac cycles recorded.
• PSA correctly caused atrial and/or ventricle capture in 1,621/1,621 (100%) of cardiac cycles recorded.
• Conclusion: PSA is considered safe and effective. |

2. Sample Size and Data Provenance (for test set/clinical study)

• Sample Size: 17 patients were used for the clinical investigation comparing intrinsic measurements.
• Data Provenance: Prospective. The clinical investigations were conducted during routine pacemaker implantation procedures in the operating room at two clinical sites in Hamburg, Germany.

3. Number of Experts and Qualifications (for ground truth in clinical study)

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions:

• "ECG tracings and physician notes will be used to determine whether an adverse event occurred while the PSA was applied to the patient." This implies that qualified physicians (likely cardiologists or electrophysiologists) were involved in reviewing patient data and making clinical judgments.

4. Adjudication Method (for test set)

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for consensus building. The clinical data appears to have been collected and analyzed by "physicians" at the clinical sites. For intrinsic measurements, the comparison was directly between the PSA, the predicate device (ERA 300), and a reference device (M2290); it's a comparison of device readings rather than expert consensus on a singular diagnosis. For stimulation and sensing, effective sensing/pacing and adverse events were determined using "ECG tracings and physician notes," suggesting a medical professional's direct observation and judgment.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the device's performance against a predicate device and direct physiological measurements, not on the improvement of human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, standalone performance was assessed through the "Bench Testing" and "Intrinsic measurement comparisons" portions of the clinical investigation.

• Bench Testing: The device was tested against an "Interstim II heart simulator" and a custom-built computer-assisted test system (Osypka SMS 1000) to verify various stimulation, sensing, and timing parameters. This represents the device's technical performance in a controlled environment.
• Clinical Intrinsic Measurement Comparisons: The PSA's intrinsic measurements were directly compared to those from two other pacing system analyzers (Biotronik ERA 300 and Medtronic Carelink 2290 Analyzer) on the same patients. This evaluates the device's direct measurement capabilities in a real-world setting without human interpretation as an intermediate step.
• Stimulation and Sensing Evaluation: The effectiveness of the PSA's pacing and sensing capabilities was directly observed based on ECG tracings and physician notes, indicating the device's direct performance.

7. Type of Ground Truth Used

The ground truth used was a combination of:

• Bench Test Standards/Known Values: For bench testing, the ground truth was the known or precisely controlled input signals from the test equipment (Interstim II heart simulator, Osypka SMS 1000).
• Predicate Device/Reference Device Measurements: For the intrinsic measurement comparisons in the clinical study, the measurements from the legally marketed predicate device (Biotronik ERA 300) and a reference device (Medtronic Carelink 2290 Analyzer) served as the reference or "ground truth" against which the PSA's measurements were compared for equivalence.
• Clinical Observation/Physician Notes: For determining effective stimulation and sensing, and the occurrence of adverse events, the ground truth was established through direct clinical observation, review of ECG tracings, and physician notes during the procedures. This represents a form of expert clinical judgment based on objective physiological data (ECG).

8. Sample Size for the Training Set

This document describes a premarket notification (510(k)) for a medical device that performs measurements and provides stimulation. It is not an AI/ML-based device that typically requires a "training set" in the machine learning sense. Therefore, there is no mention of a training set or its size. The device's functionality is based on established engineering principles for sensing and delivering electrical signals in cardiac pacing.

9. How Ground Truth for Training Set Was Established

As noted in point 8, this device does not appear to be an AI/ML-based system that uses a discrete "training set" with established ground truth in the context of machine learning. Its validation relies on engineering specifications, comparisons to established devices, and clinical observation.

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The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.

The ICON® is a noninvasive cardiac output monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the ICON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The ICON® determines hemodynamic parameters related to blood flow, contractility and fluid status.

The provided text is a 510(k) Summary for the DSYPKA MEDICAL 510(k) K082242 submission, introducing the CARDIOTRONIC® ICON® (also known as OSYPKA MEDICAL® ICON®) hemodynamic monitor. This document explicitly states that the submission is based on demonstrating substantial equivalence to a predicate device, the AESCULON® Type (Version) C2 (K081035).

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical trial where specific numerical thresholds are met by the new device. Instead, the entire submission hinges on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly that the ICON® device performs "as well as" the predicate device, the AESCULON®. The "reported device performance" is a qualitative assessment of equivalence rather than quantitative measurements against predefined targets.

Implicit Acceptance Criteria and Performance (based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable/Not reported. The document explicitly states: "Clinical testing not part of this submission." The demonstration of substantial equivalence was based on non-clinical performance data and a comparison to the predicate device.
• Data Provenance: The document explicitly states: "Demonstration of substantial equivalence between the ICON® (new device) and the AESCULON® (predicate device) was based on an assessment of non-clinical performance data." No specific country of origin for this non-clinical data is provided, nor is it specified if it's retrospective or prospective.

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

• Number of Experts and Qualifications: Not applicable/Not reported. Since clinical testing was not part of the submission and the approach was substantial equivalence based on non-clinical data, there would be no "ground truth" established by experts in the context of clinical performance evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not reported. As no clinical "test set" was used for performance evaluation (only non-clinical data for substantial equivalence), no adjudication method is relevant or described.

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 hemodynamic monitor, not an AI-assisted diagnostic imaging tool with human readers. The concept of an MRMC study and "human readers" is not applicable here.

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

• Standalone Performance Study: The document focuses on demonstrating that the device itself (the ICON® monitor) is substantially equivalent to the predicate device (AESCULON®). It's a medical device, not an AI algorithm in the typical sense that would have "human-in-the-loop performance" as a separate consideration. The comparison is between two complete physical devices. While the device contains algorithms for hemodynamic parameter calculation, a separate "standalone algorithm only" performance study, distinct from the device's overall performance, is not mentioned or implied.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: Not applicable/Not reported for a clinical test set. Given that clinical testing was "not part of this submission," there was no clinical ground truth established for the new device's performance against actual patient conditions. The ground truth, in the context of this 510(k), is implicitly the established safety and effectiveness of the predicate device (AESCULON®), against which the new device (ICON®) is being compared for substantial equivalence using non-clinical data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not reported. This document does not describe the development or training of a new algorithm where a "training set" would be used in the AI sense. It compares a new medical device to a legally marketed predicate device.

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

• Ground Truth for Training Set: Not applicable/Not reported. As there's no mention of a "training set" for an AI algorithm, this information is not relevant to the provided text.

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The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AESCULON® Version C2, including the models CHF Clinic™, Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasive comprehensive cardiovascular monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the AESCULON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The AESCULON® determines hemodynamic parameters with respect to blood flow, vascular system (if the NIBP option is incorporated), contractility and fluid status.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance:

The 510(k) summary for the AESCULON® Version C2 does not explicitly state quantitative acceptance criteria or typical device performance metrics in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AESCULON® Version C1.1). The core of the claim is that the new device "is as safe, as effective, and performs as well as the predicate device."

Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate device, which is considered to meet established safety and effectiveness standards for impedance plethysmographs. The "reported device performance" is framed as being equivalent to the predicate.

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

• Sample Size: Not applicable.
• Data Provenance: Not applicable.

The submission explicitly states: "Summary Clinical testing not part of this submission." This indicates that no new clinical test set was used to directly evaluate the AESCULON® Version C2. The demonstration of substantial equivalence was based on non-clinical performance data and the similarity to the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

Since no clinical testing was performed for this submission, there was no need for experts to establish ground truth for a new test set.

4. Adjudication Method:

• Adjudication method: Not applicable.

As no clinical testing was performed, there was no need for an adjudication method for a test set.

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

• MRMC study: No.

The submission does not mention any MRMC study. The device is a monitor, not an image interpretation or diagnostic aid that typically involves human readers.

6. Standalone (Algorithm Only) Performance Study:

• Standalone study: Yes, implicitly.

The statement "demonstration of substantial equivalence between the AESCULON® Version C2 (new device) and the Version C1.1 (predicate device) was based on an assessment of non-clinical performance data" implies that the new device's core algorithms and engineering performance were evaluated in comparison to the predicate. While not a "standalone performance study" in the sense of a new clinical trial, the assessment of "non-clinical performance data" confirms the algorithm's behavior is consistent with the established predicate's performance characteristics. This is a form of demonstrating algorithmic functionality without human intervention in the loop of the assessment itself.

7. Type of Ground Truth Used:

• Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for the new device's acceptable performance is its substantial equivalence to the predicate device (AESCULON® Version C1.1), which itself would have undergone its own studies to establish its ground truth against recognized physiological measurements or clinical outcomes. The equivalence is established by comparing design, intended use, and principal of operation, as well as the underlying mathematical models and derived parameters.

8. Sample Size for the Training Set:

• Sample Size: Not applicable.

The document does not describe the use of machine learning or AI that would require a distinct "training set" in the conventional sense. The device appears to be based on established biophysical principles and algorithms rather than trained models from a large dataset.

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

• Ground Truth Establishment: Not applicable.

As there is no mention of a dedicated training set, the question of how its ground truth was established is not relevant to this submission. The core "truth" being referred to is the established performance and safety profile of the predicate device, against which the new device is compared for equivalence.

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The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic™ and AESCULON® Pacemaker Clinic™ are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Not Found

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. However, it does provide some information about the device and its claimed performance compared to a predicate device.

Here's an attempt to answer the questions based on the limited information provided, mostly inferring from the comparison to the predicate device:

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

The document doesn't explicitly state quantitative acceptance criteria or a formal performance report with specific metrics. Instead, it focuses on the theoretical differences in how the AESCULON® and its predicate device (BIOZ.COM®) interpret the impedance measurements. The "performance" here is implied by its claim of "substantial equivalence" and its different theoretical interpretation.

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

This information is not provided in the document. There is no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).

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 in the document. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication method for the test set

This information is not provided in the document. The document does not describe any test set or adjudication process.

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 type of study is not applicable to this device. The AESCULON® is a hemodynamic monitoring device, not an AI-assisted diagnostic tool that would involve human readers interpreting images.

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

The device itself is a standalone hemodynamic monitor. Its performance is based on its algorithms for interpreting bioelectrical impedance. There isn't a "human-in-the-loop" aspect described that would necessitate a standalone vs. assisted comparison in the typical sense of AI-driven diagnostic tools. The document describes the core algorithms and their theoretical interpretation of measurements.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for any validation study. Given the nature of a hemodynamic monitor, potential ground truths could involve:

• Invasive direct measurements of cardiac output (e.g., Swan-Ganz catheterization)
• Direct observation of physiological parameters
• Comparison to well-established, validated hemodynamic monitoring methods.

However, none of this is detailed in the provided text. The document primarily focuses on the theoretical interpretation of measurements and comparison to a predicate device.

8. The sample size for the training set

This information is not provided in the document. The document describes the algorithms and their theoretical basis, but not how they were developed or trained on specific datasets.

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

This information is not provided in the document. As there is no mention of a training set, there is also no information on how its ground truth might have been established.

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The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing.

• When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically.
• Specific indications for temporary pacing include, but are not limited to:
• . Complete (third-degree) or intermittent heart block;
• Symptomatic sinus bradycardia; .
• Atrial and/or ventricular ectopic arrhythmia; .
• . Sick Sinus Syndrome (SSS);
• Atrial tachyarrhythmia;
• Acute myocardial infarction-induced heart block; .
• Stimulation during ventricular asystole; ●
• . Use during the replacement of an implantable pulse generator;
• Stimulation and monitoring before the implantation of a cardiac pulse generator; ●
• Stimulation and monitoring following heart surgery. .

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is used for temporary intensive care pacing of the heart in cases of rhythm disturbances and conduction defects, including:
• Treatment of bradycardia
• Treatment of atrial tachyarrhythmia
• Treatment of special causes of acute myocardial infarction
• Pre-, intra- and postoperative pacing of the heart.
The PACE 101 / PACE 101H / Model 3077 can be used as either an intracardiac signal-inhibited pulse generator or as an asynchronous pulse generator. Pacing rate and amplitude can be adjusted over a wide range, conforming to actual therapeutic requirements. Sensed intrinsic activity and paced pulses are indicated optically by a light-emitting diode (LED). Additionally, acoustic signals for sensing and pacing can be switched on and off.
The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing for the treatment of atrial tachycardia. Pacing frequency can easily doubled or quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in asynchronous mode. An acoustic signal is automatically emitted during high-rate pacing.
Errors that occur during operation are indicated optically and acoustically. A special circuit allows for automatic surveillance of the battery voltage. With the help of an LED and an acoustic signal, complete drainage of the battery can be prevented.
The PACE 101 / PACE 101H / Model 3077 has an additional feature - run-away protection. Run-away protection limits the impulse emission to a maximum of 200 ppm and prevents the delivery of too high a pacing rate in the event of a defect in the frequency generator.
The XI Series™ Extension Cables support proper connection of the PACE 101 / PACE 101H / Model 3077 to various types of pacing lead systems (accessories).
The AS Series™ Arm Straps ensure proper attachment of the PACE 101 / PACE 101H/Model 3077 to the patient's arm (accessory).

The provided text is a 510(k) Summary for the Osypka Medical PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator and its accessories. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device performance evaluation is not available in the provided text.

The document explicitly states:

• "The modifications made do not require additional bench testing." (Page 2, "Summary Bench Testing")
• "The modifications made do not require additional clinical evaluation." (Page 2, "Summary Clinical Evaluation")
• "The modifications made to the device are related to a revision of the Instructions for Use / User’ Manual, without changing the intended use or the fundamental scientific technology." (Page 2, "Conclusion")

This indicates that the submission is based on modifications to an already cleared device, and thus, no new studies demonstrating performance against specific acceptance criteria were conducted or are reported in this 510(k) summary. The basis for clearance is substantial equivalence to predicate devices which presumably met their own performance criteria at the time of their clearance.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document serves as regulatory notification for a modified device, not a report of a new performance study.

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The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing.

When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically.

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

• . Complete (third-degree) or intermittent heart block;
• . Symptomatic sinus bradycardia;
• Atrial and/or ventricular ectopic arrhythmia; .
• . Sick Sinus Syndrome (SSS);
• Atrial tachyarrhythmia; ●
• Acute myocardial infarction-induced heart block; .
• Stimulation during ventricular asystole; ●
• Use during the replacement of an implantable pulse generator; .
• Stimulation and monitoring before the implantation of a cardiac pulse generator: .
• Stimulation and monitoring following heart surgery. .

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is used for temporary intensive care pacing of the heart in cases of rhythm disturbances and conduction defects, including:

• Treatment of bradycardia
• Treatment of atrial tachyarrhythmia
• Treatment of special causes of acute myocardial infarction
• Pre-, intra- and postoperative pacing of the heart.

The PACE 101 / PACE 101H / Model 3077 can be used as either an intracardiac signal-inhibited pulse generator or as an asynchronous pulse generator. Pacing rate and amplitude can be adjusted over a wide range, conforming to actual therapeutic requirements. Sensed intrinsic activity and paced pulses are indicated optically by a light-emitting diode (LED). Additionally, acoustic signals for sensing and pacing can be switched on and off.

The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing for the treatment of atrial tachycardia. Pacing frequency can easily doubled or quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in asynchronous mode. An acoustic signal is automatically emitted during highrate pacing. Errors that occur during operation are indicated optically and acoustically. A special circuit allows for automatic surveillance of the battery voltage. With the help of an LED and an acoustic signal, complete drainage of the battery can be prevented. The PACE 101 / PACE 101H / Model 3077 has an additional feature - runaway protection. Run-away protection limits the impulse emission to a maximum of 200 ppm and prevents the delivery of too high a pacing rate in the event of a defect in the frequency generator. The Series XI Extension Cables support proper connection of the PACE 101 / PACE 101H / Model 3077 to various types of pacing lead systems (accessories). The Series AS Arm Straps ensure proper attachment of the PACE 101 / PACE 101H / Model 3077 to the patient's arm (accessory).

The aforementioned devices are stand-alone devices that provide temporary atrial or ventricular demand or asynchronous pacing therapy. The aforementioned devices are battery powered. Indicator lights flash to show atrial and ventricular sensing and atrial and ventricular pacing functions.

The PACE 101 / PACE 101H / Model 3077 is equipped with insulated connector terminals matching the protected pins of the Series XI Extension Cables and meets the 21 CFR Part 898 performance standard.

This is a 510(k) summary for a temporary pulse generator (pacemaker) and its accessories, not a study that proves device meets acceptance criteria. The document explicitly states that modifications made to the device did not require additional bench testing or clinical evaluation. Therefore, the information typically requested regarding acceptance criteria and a study proving device performance is not present in this document.

The document focuses on demonstrating substantial equivalence to predicate devices based on modifications primarily related to the Instructions for Use/User's Manual and the previous market release of accessories in combination with another device.

Based on the provided information, I cannot fulfill your request for the following reasons:

1. No Acceptance Criteria or Reported Device Performance: This document does not specify any quantitative acceptance criteria or provide performance data from a study for the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator. The filing states that the modifications did not require additional testing or evaluation.
2. No Study Conducted (for the current submission): The 510(k) summary explicitly states: "The modifications made do not require additional bench testing," and "The modifications made do not require additional clinical evaluation." This means a new study to prove the device meets acceptance criteria was not conducted for this particular submission.
3. No information on sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth, or training set: Because no new study was conducted for this submission, there is no information available regarding these elements. The submission relies on the substantial equivalence to previously cleared predicate devices.

Summary of Device and its Equivalence Claim:

The document describes the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator and its accessories (extension cables and arm straps). It claims substantial equivalence to several predicate devices (K970497, K923621, K020896). The basis for this 510(k) submission is "modifications related to a revision of the Instructions for Use / User's Manual, without changing the intended use or the fundamental scientific technology." The accessories had also been previously market-released with another pulse generator.

Conclusion stated in the document:
"Based on the limited impact of the modifications made, it is concluded that the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is as safe, as effective, and performs as well as the predicate devices."

Therefore, the provided text does not contain the information necessary to complete your detailed request regarding acceptance criteria and a study proving device performance.

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The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

Specific indications include, but are not limited to, the following:

• Sick Sinus Syndrome;
• Bradycardia with congestive heart failure;
• Complete heart block;
• Acute myocardial infarction complicated by heart block;
• Sinus bradycardia;
• Cardiac arrest with ventricular asystole;
• Atrial and/or ventricular ectopic arrhythmia;
• Postoperatively after cardiac surgery;
• Temporary application during implantation or exchange of permanent pacemaker.

Indication for atrial overdrive stimulation (rapid atrial pacing):

• Supra-ventricular tachycardia.
  The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes.

The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.

The PACE 203 / PACE 203H / MODEL 3085 is a dual-chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation. Synchronous and asynchronous modes of atrial, ventricular and A-V sequential stimulation are available for treatment of acute brady-arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The stimulation parameters are easily adjustable by rotating dials through a wide range of values.

The PACE 203 / PACE 203H / MODEL 3085 offers the possibility for atrial overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular tachycardia. The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate. The overdrive rate can be determined before and changed during overdrive therapy. If required, overdrive stimulation can be initiated with the touch of a button. The overdrive stimulation is indicated optically and acoustically.

The battery operated device can be affixed to the patient's arm by the arm strap included. The housing is protected against accidental liquid spills.

The functional design of the PACE 203 / PACE 203H / MODEL 3085 allows safe and easy operation with regards to all requirements of DDD stimulation.

The PACE 203 / PACE 203H / MODEL 3085 further offers the following features:
• During battery changes, stimulation will be maintained for at least 30 s.
• A non-volatile memory keeps any desired stand-by program ready for use, even if the device is shut off.
• A standard program, which can be individualized, is available for each primary pacing mode.
• An emergency program can be "called up" by pressing an emergency key.
• A burst- and a ramp function are available for atrial overdrive-stimulation.
• An Unlock/Lock button protects against accidental change of the set parameters.
• The set parameters and (error) messages are shown on a liquid crystal display.
• The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown separately by blinking LEDs for both atrium and ventricle. Additionally, a beep-tone can be switched on whenever desired.
• System malfunctions that occur are indicated optically and acoustically.
• A lead surveillance system indicates interruptions and short circuits.
• When a battery change is required, optical and acoustic alerts are provided.
• During dual chamber pacing, an automatic mode for adapting A-V delay, maximum tracking rate (MTR), and PVARP is available.
• An automatic mode for adjusting the sensitivity in both the atrium and ventricle may be chosen.
• A Pause function is available for easy determination and measurement of the patient's intrinsic heart activity.

The Series XI Extension Cables support proper connection of the PACE 203 / PACE 203H / Model 3085 to various types of pacing lead systems (accessories).

The Series AS Arm Straps ensure proper attachment of the PACE 203 / PACE 203H / Model 3085 to the patient's arm (optional accessory).

Here's a summary of the acceptance criteria and study information for the Osypka Medical PACE 203 / PACE 203H / MODEL 3085 external cardiac pacemaker, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state a specific sample size for a "test set" in the context of a prospective clinical trial with individual patient data.

• Bench Testing: The "sample" would be the devices themselves (PACE 203 / PACE 203H / MODEL 3085 and MEDTRONIC MODEL 5330) and possibly various components during testing with a simulator. No specific number is given for how many devices or test runs. Data provenance is not specified beyond "bench testing using a simulator."
• Clinical Evaluation: The document mentions "the course of the investigation" and "recordings obtained," implying a clinical study with patients. However, no sample size (number of patients) or data provenance (e.g., country of origin, retrospective/prospective) and type of data (e.g. number of electrodes, number of leads etc.) is explicitly detailed in the provided text. It is described as a "clinical evaluation," which typically implies a prospective study.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

Not applicable in the provided summary. The clinical evaluation implicitly relies on observation of device performance in patients, likely by medical professionals, but it does not describe a process of expert consensus for establishing ground truth for evaluating reader performance or diagnostic accuracy of the device. The device is a pacemaker, not a diagnostic imaging AI.

4. Adjudication Method for the Test Set:

Not applicable in the provided summary. There is no mention of an adjudication process as would be used for multi-reviewer assessments of diagnostic output.

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 an external pacemaker, and the evaluation focuses on its functional performance and safety, not on the diagnostic effectiveness of human readers with or without AI assistance.

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

Yes, a standalone evaluation of the device's performance was performed through:

• Bench Testing: The device (and its predicate) were "subject to bench testing using a simulator" to compare performance against specifications. This is an algorithm/device-only evaluation.
• Clinical Evaluation: The "clinical evaluation validated safety and effectiveness" and observed that the device "provided correct sensing, pacing and A-V sequential demand pacing (DDD) performance without failure." While used with humans, the focus is on the device's autonomous function.

7. The Type of Ground Truth Used:

• Bench Testing: The ground truth was based on the specifications of the devices being tested and the expected outputs from the simulator.
• Clinical Evaluation: The ground truth would be the physiological response of the patients and the observed functional performance of the pacemaker as determined by clinical assessment and recordings, confirming correct sensing, pacing, and A-V sequential demand pacing without failure.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on established engineering principles for cardiac pacing.

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

Not applicable, as there is no training set for this type of medical device.

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