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The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age.

The FirstSave STAR Biphasic AED is a biphasic portable battery operated semiautomatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic feature includes: Lithium battery, Single user button for Rescue or Resume, LED diagnostic panel, Non-volatile status indicator, Voice prompts, Biphasic truncated exponential defibrillation waveform, RhythmX ECG analysis algorithm.

The provided 510(k) summary for the FirstSave STAR Biphasic AED (K011901) is a very brief document, typical for a submission from 2002. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general performance standards rather than providing detailed clinical study results with specific acceptance criteria and performance metrics often seen in more recent submissions.

Therefore, much of the requested information cannot be extracted from this document, as a specific "study" proving the device meets "acceptance criteria" with detailed performance outcomes is not described. Instead, the document states that "performance test data is provided in the 510(k) submission" and "Test data demonstrate that the safety and effectiveness... is substantially equivalent to the predicate device," without elaborating on the specific criteria or the exact results.

However, I can extract what is available and highlight what is missing based on your request.

Acceptance Criteria and Device Performance (Limited Information)

The document refers to compliance with industry standards rather than specific quantitative acceptance criteria with reported device performance.

Note: The document states that the "performance test data is provided in the 510(k) submission" and covers "rhythm detection, EMC, charge time, pulse shape, battery capacity, defibrillation recovery, design verification and validation data for hardware and software." However, the specific acceptance criteria for these tests (e.g., "rhythm detection sensitivity must be >X%") and the reported device performance against those criteria are not detailed in this summary.

Study Information (Where available or noted as missing)

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

   • Not specified. The document mentions "rhythm detection" as part of the performance data but does not provide any specifics about a test set (e.g., number of ECGs, patient demographics, or data origin) or the study design (retrospective/prospective).
   • For devices from this era, it was common for rhythm analysis algorithm testing to be done on existing ECG databases, but details are not provided here.

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

   • Not specified. Given the absence of details about a test set, there is no information on expert involvement for ground truth establishment.

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

   • Not specified.

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

   • No, an MRMC comparative effectiveness study is not mentioned. This type of study is typically associated with AI-assisted diagnostic tools that involve human interpretation, which is not the primary function of an AED's rhythm analysis algorithm. AEDs are designed for automated analysis and prompts.

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

   • Yes, implicitly. The "RhythmX ECG analysis algorithm" is described as analyzing the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The mention of "rhythm detection" as part of the performance data implies a standalone evaluation of the algorithm's performance against a known truth (though the details of this evaluation are not provided in this summary). The device is "semi-automatic" meaning the algorithm makes the decision to advise a shock, and the operator manually delivers it.

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

   • Not specified. For rhythm detection in AEDs, ground truth is typically established by expert cardiologists reviewing the ECG tracings.

7. The sample size for the training set:

   • Not specified. Training set details are not included in this summary.

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

   • Not specified.

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The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.

The electrodes are intended for short-term use (

The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.

The provided document is a 510(k) summary for the Survivalink SVL-9630 Disposable Polymer (Hydrogel) Multifunctional Electrode. The document states that the device is substantially equivalent to predicate devices and meets AAMI DF-39 performance standards. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information for AI/algorithm performance studies.

This document describes a medical device, which is an electrode for defibrillators and pacemakers, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested fields (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Based on the provided text, here's what can be extracted:

1. A table of Acceptance Criteria and the Reported Device Performance:

Note: The specific parameters of AAMI DF-39 that were tested (e.g., impedance, adhesion, current distribution) are not detailed in this summary.

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

Not applicable. This is a physical medical device (electrode), not an algorithm. The testing would involve engineering and biocompatibility evaluations, not data sets from patients in the context of AI performance.

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

Not applicable. Ground truth, in the context of expert consensus, is for diagnostic algorithms.

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

Not applicable.

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

Not applicable. This document pertains to a physical electrode, not an AI system designed to assist human readers.

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

Not applicable.

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

Not applicable in the context of diagnostic algorithms. For an electrode, ground truth would relate to its physical and electrical performance against established standards.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

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The FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.

The FirstSave STAR Biphasic AED is a portable battery operated semi-automatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic AED feature includes:

• . Biphasic defibrillation waveform
• . Lithium battery and battery fuel gauge
• Single user button .
• LED diagnostic panel ●
• Non-volatile status indicator ●
• Voice prompts .
  The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.

The provided text describes a 510(k) summary for the SurVivaLink FirstSave™ STAR Biphasic™ AED. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device's diagnostic algorithm.

Here's an breakdown based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantifiable acceptance criteria for rhythm detection (e.g., sensitivity, specificity, accuracy thresholds for shockable vs. non-shockable rhythms).
• Quantifiable performance results for rhythm detection from a specific study. The text only states that the algorithm "analyzes" the rhythm and that the biphasic waveform was "found to be equivalent" in a clinical study for efficacy, not diagnostic accuracy of the rhythm analysis itself.

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

The text mentions "Clinical studies was performed to test the efficacy of the biphasic waveform." However, it does not provide any details regarding:

• The sample size (number of patients) used in this clinical study.
• The data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The text does not mention the number of experts used or their qualifications for establishing ground truth, particularly for the rhythm detection algorithm. The clinical study mentioned was for the efficacy of the biphasic waveform, not explicitly for validating the diagnostic algorithm's accuracy with expert-established ground truth.

4. Adjudication Method for the Test Set

The text does not provide any information about the adjudication method used for any test set or clinical study.

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

The text does not report on an MRMC comparative effectiveness study or any effect size indicating how much human readers improve with AI vs. without AI assistance. The device is described as a "semi-automatic" AED, meaning the device makes a recommendation, and the operator presses a button to deliver the shock. The focus here is on the device's diagnostic algorithm itself, not on assisting human readers in interpreting data.

6. Standalone (Algorithm Only) Performance

The device is described as having a "diagnostic algorithm that analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm." This implies a standalone algorithm's performance is central to the device's function. However, the document does not present a standalone performance study with specific metrics (like sensitivity, specificity, or accuracy) for this algorithm against a defined ground truth. Instead, it relies on demonstrating compliance with standards and equivalence to predicate devices. The clinical study mentioned focuses on the efficacy of the biphasic waveform, which is about the treatment's outcome, not necessarily the diagnostic accuracy of the rhythm analysis.

7. Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for validating the rhythm detection algorithm. For the "efficacy of the biphasic waveform" study, the ground truth would likely be patient outcomes in response to defibrillation. For the diagnostic algorithm, ideal ground truth would be expert consensus on ECG rhythms, but this is not mentioned.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for training the device's diagnostic algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how ground truth was established for the training set.

Summary of Device Performance Claim:

The SurVivaLink FirstSave™ STAR Biphasic™ AED is positioned as substantially equivalent to its predicate devices (SurVivaLink's FirstSave and HeartStream Forerunner AEDs). The primary performance claims regarding the device's diagnostic algorithm are that it "analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm" and that the "biphasic waveform...was found to be equivalent to the monophasic truncated exponential waveform in the FirstSave." The submission emphasizes compliance with AAMI standards and various technical tests (EMC, charge time, etc.) rather than specific, quantified performance metrics for the diagnostic algorithm itself.

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The V2 semi-automatic external defibrillator is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The V2 is intended to be used on patients who weighs more than 90 lbs.

FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR (formerly V2) Models 9100/9110

This document is a 510(k) clearance letter for the FirstSave™ Automated External Defibrillator. It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This document does NOT contain information about acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the provided input.

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The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.

The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.

The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.

The provided document is a 510(k) summary for a medical device called the SVL-9130 Defibrillation Electrode. It details the device's administrative information, predicate devices, intended use, and a brief statement about its performance.

However, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance. Specifically, it states:

"The SVL-9130 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and SurVivaLink's internal specifications. In all instances, the SVL-9130 electrodes functioned as intended."

This is a general statement of compliance, but it does not provide:

• Specific acceptance criteria: The document refers to "AAMI DF-39 specifications" and "SurVivaLink's internal specifications" but does not list or describe them.
• Reported device performance: It doesn't present any quantitative results (e.g., impedance measurements, defibrillation efficacy rates, adhesion strength, etc.) that would demonstrate how the device "functioned as intended" against those specifications.
• Details about the study: There is no information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or any form of comparative effectiveness study (MRMC) or standalone performance study.

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to existing standards rather than presenting detailed study results.

Here's what I can extract from the document regarding studies and performance, but it's very limited:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified.
• Data provenance: Not specified.

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

• Not specified. The document indicates adherence to technical specifications, not human interpretation-based ground truth.

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

• Not applicable/Not specified. This typically applies to studies where human interpretation of data (like medical images) is involved, which is not the case described here.

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:

• No, an MRMC study was not done or reported. This device is an electrode, not an AI-powered diagnostic tool.

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

• Not applicable in the context of an algorithm. The "standalone" performance here would refer to the physical and electrical performance of the electrode itself, which they state "met all the specifications" but provide no specific data.

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

• The "ground truth" for the electrodes appears to be defined by the technical specifications of AAMI DF-39 and SurVivaLink's internal specifications, which likely include physical, electrical, and biocompatibility standards. No biological or clinical ground truth (like pathology or outcomes) is mentioned in relation to specific performance data.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not an AI algorithm that undergoes "training."

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

• Not applicable.

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