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The HeartSine samaritan® PAD 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• . Unconscious
• Not breathing .
• . Without circulation

The samaritan® PAD 450P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program.

The samaritan® PAD 450P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 450P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

Like the SAM 350P predicate device, the SAM 450P is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The SAM 450P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device.

Like the SAM 350P predicate device, the SAM 450P incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation quidelines. However, in addition to the metronome provided in the SAM 350P, the SAM 450P also includes a proprietary impedance cardiogram (ICG) analysis algorithm to determine the rate at which CPR compressions are being administered. The SAM 450P uses the measured CPR compression rate to provide both audible and visual feedback prompts to the user to quide them to administer compressions at a rate within the current AHA resuscitation quidelines (i.e., 100-120 compressions per minute). The SAM 450P's audible and visual feedback prompts take the form of voice prompts such as "Push Faster", "Push Slower", and "Good Speed" and LEDs in red, amber and green being lit on the device cover to indicate if the speed at which the compressions are being delivered is too fast, too slow or within the guideline recommendations.

Like the SAM 350P predicate device, the proprietary SAM 450P ECG analysis algorithm automatically determines whether a victim has a shockable or nonshockable rhythm and advises a shock when appropriate. If a shock is required, the SAM 450P will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.

Like the SAM 350P predicate device, an escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation quidelines.

After initial analysis and shock delivery (if appropriate), the SAM 450P will advise that CPR may be commenced via a number of voice prompts such as "Begin CPR" and "It is safe to touch the patient" in addition to emitting an audible metronome.

Like the SAM 350P predicate device, the SAM 450P records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.

The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the SAM 450P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a paediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft. The Pad-Paks are identical to those cleared under K123881 for the SAM 350P.

Like the SAM 350P predicate device, the SAM 450P incorporates the following features:

• . Controls for Power ON/OFF and Shock
• Automated charging at escalating energies of 150J, 150J, 200J ●
• Automated self-tests and LED status indicator ●
• Combined, disposable battery and electrodes (Pad-Pak™)
• Electrode placement guidance voice prompts and LED/icon indicators
• CPR voice prompts and metronome ●
• Paediatric function for victims between the ages of 1 and 8 years at non-● escalating energy of 50 J
• Integral event data recording .

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HeartSine samaritan® PAD 450P, formatted as requested:

Acceptance Criteria and Device Performance

Study Details

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

• Arrhythmia Diagnostic Algorithm Validation: Standardized AHA, MIT, and CU databases were used. The document does not specify the sample size (number of ECGs) from these databases or their specific provenance.
• CPR Rate Feedback (Animal Study): The document does not specify the sample size (number of animals or data points). It was a GLP (Good Laboratory Practice) animal study, implying prospective data collection under controlled conditions. The country of origin for the data is not specified.
• Usability Study: The document does not specify the sample size (number of participants/users). It was a usability study, implying prospective data collection. The country of origin for the data is not specified.

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):

• Arrhythmia Diagnostic Algorithm: For standardized databases like AHA, MIT, and CU, ground truth is typically established by multiple cardiologists or experts in electrophysiology through consensus based on detailed ECG review, sometimes supplemented by clinical outcomes. The document does not specify the number or qualifications of experts involved in the creation of these databases, only that the databases were used.
• CPR Rate Feedback (Animal Study): Ground truth for actual CPR compression rate was determined by "video recordings." The document does not mention human experts establishing this ground truth, implying direct measurement from video.
• Usability Study: Ground truth for time to first shock and usability of CPR feedback prompts would be based on observational data and potentially user feedback/surveys. The document does not specify experts establishing ground truth, rather it's data collected during the study.

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

• The document does not describe a specific adjudication method for any of the studies, particularly concerning expert review of data. Ground truth for the algorithm validation relied on pre-existing standard databases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance was not explicitly described or performed based on the provided text.
• The usability study assessed the "usability of the new CPR feedback prompts," which implies assessing human performance with the device's feedback guidance, but it's not described as a formal MRMC study comparing performance with and without AI (or the device's specific CPR feedback).

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

• Yes, a standalone evaluation of the arrhythmia diagnostic algorithm was done. The document states it was "extensively validate[d]... using standardised AHA, MIT and CU databases." This is a validation of the algorithm's performance independent of a human user.
• The CPR rate feedback algorithm component's accuracy was also evaluated in the animal study by comparing its output to actual compression rates determined by video recordings, suggesting a standalone assessment of its accuracy.

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

• Arrhythmia Diagnostic Algorithm: Ground truth was established by the standardized AHA, MIT, and CU databases, which typically rely on expert consensus over detailed ECG analysis and sometimes clinical correlation.
• CPR Rate Feedback (Animal Study): Ground truth for the actual CPR compression rate was determined by "video recordings" of the compressions.
• Usability Study: Ground truth for "time to first shock" and "usability" would be directly observable metrics and subjective feedback from participants.

8. The sample size for the training set:

• The document does not specify the sample size for any training set. It refers to validation of an algorithm (arrhythmia detection) that is "unchanged from the predicate device," implying its development and training (if any) occurred previously. For the CPR feedback algorithm, training specifics are not provided.

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

• The document does not provide details on how the ground truth for any training set was established, as it does not explicitly describe a training phase for a new algorithm in detail. The arrhythmia diagnostic algorithm was carried over from the predicate device, implying its ground truth establishment (if it was a machine learning algorithm) occurred during the development of the predicate device or a previous iteration. The CPR feedback algorithm is described as a "proprietary impedance cardiogram (ICG) analysis algorithm" but details on its training and ground truth establishment are absent.

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The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• . Unconscious
• . Not breathing
• Without circulation

The samaritan® PAD 350P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The samaritan® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

The HeartSine samaritan® PAD (Public Access Defibrillator) 350P (also called the SAM 350P) is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The samaritan® PAD 350P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. The samaritan® PAD 350P also incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation guidelines.

A proprietary ECG analysis algorithm automatically determines whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. If a shock is required, the samaritan will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.

An escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines.

After initial analysis and shock delivery (if appropriate), the PAD 350P will advise that CPR (cardiopulmonary resuscitation) may be commenced via a number of voice prompts such as "It is safe to touch the patient" and "Begin CPR" in addition to emitting an audible metronome.

The defibrillator records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.

The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the samaritan® PAD 350P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a pediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft.

The samaritan® PAD 350P incorporates the following features:

• . Controls for Power ON/OFF and Shock
• Automated charging at escalating energies of 150J, 150J, 200J .
• Automated self-tests and LED status indicator .
• Combined, disposable battery and electrodes (Pad-Pak™) .
• Electrode placement guidance voice prompts and LED/icon indicators .
• CPR voice prompts and metronome .
• Pediatric function for victims between the ages of 1 and 8 years at non-. escalating energy of 50 J
• . Integral event data recording

This document describes the HeartSine samaritan® PAD 350P, an Automated External Defibrillator (AED). The acceptance criteria for the device's arrhythmia analysis algorithm are not explicitly stated in numerical terms within the provided text. However, the document does mention the use of "Standardised AHA, MIT and CU databases" to extensively validate the algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions the use of "Standardised AHA, MIT and CU databases" for algorithm validation, but the number of cases or recordings within these databases used for testing is not provided.
• Data Provenance: The data comes from "Standardised AHA, MIT and CU databases." These are recognized, publicly available databases of ECG signals often used for arrhythmia analysis research and defibrillator algorithm testing. The document does not specify the country of origin for these specific databases but they are generally international in scope. It is not stated whether the data is retrospective or prospective, but data from such established databases is typically retrospective for validation purposes.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For "Standardised AHA, MIT and CU databases," the ground truth (e.g., shockable vs. non-shockable rhythms) would have been established by experts, likely cardiologists or electrophysiologists, during the creation of these databases. However, the specific details for this device's validation are not provided.

4. Adjudication Method for the Test Set

• Not specified. Given the use of "Standardised" databases, the ground truth would have been predetermined within those databases through an adjudication process during their initial creation, but the specific method (e.g., 2+1, 3+1) is not detailed for this device's validation.

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 comparative effectiveness study involving human readers with and without AI assistance was not done. The document focuses on the automated external defibrillator's algorithm and overall device performance, not on aiding human interpretation of ECGs. The device itself is an "automated" external defibrillator, where the algorithm makes the primary decision regarding shock delivery.

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

• Yes, a standalone algorithm performance evaluation was done. The statement "Standardised AHA, MIT and CU databases were used to extensively validate the HeartSine samaritari® PAD 350P algorithm" directly indicates standalone validation of the algorithm's performance against these established datasets. The device automatically determines shockable rhythm, implying standalone capability.

7. The Type of Ground Truth Used

• Expert Consensus / Reference Databases: The ground truth for the algorithm validation was based on the classifications (shockable/non-shockable rhythms) established within the "Standardised AHA, MIT and CU databases." These databases are curated with expert-adjudicated diagnoses.

8. The Sample Size for the Training Set

• Not explicitly stated within the provided text. The document only mentions the use of "Standardised AHA, MIT and CU databases" for validation of the algorithm. It does not provide information about a distinct training set or its size. It's possible the algorithm was developed using other datasets or iterative refinement, but this is not detailed.

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

• Not explicitly stated within the provided text because the training set itself is not detailed. If the "Standardised AHA, MIT and CU databases" were also used for training (which is less common for validation datasets after development), then the ground truth would have been established by expert consensus within those databases.

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The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.

The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.

Here's an analysis of the provided text regarding the acceptance criteria and study for the samaritan® Pediatric-Pak (Model SPP 351).

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings and conclusions of studies and does not typically contain exhaustive details about the methodologies of those studies. Therefore, some information requested may not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and a detailed performance table for the new device's efficacy. The core acceptance criteria appear to be implicit in the comparison to the predicate device's established safety and effectiveness.

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

• Sample Size: Not explicitly stated for the "pediatric heart rhythm database" used for validation. The summary only mentions "validation against a pediatric heart rhythm database."
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as a "pediatric heart rhythm database," implying it contains recorded heart rhythms from pediatric patients.
• Retrospective or Prospective: Not explicitly stated, however, the phrase "validation against a pediatric heart rhythm database" strongly suggests a retrospective analysis of existing recorded data.

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

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a "heart rhythm database," it's likely that established medical criteria or a consensus of cardiologists previously annotated the rhythms within the database, but this is not detailed in the summary.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The comparison is between the new device's technology and performance (as evaluated via bench testing and database validation) against a predicate device, not typically involving human readers.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study involving human readers and AI assistance was reported.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Standalone Study Done: Yes, a standalone evaluation of the device's performance was conducted. The summary states: "The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices." This implies that the device's ability to appropriately identify and deliver a shock (or withhold if not required, though the focus is on reduced energy delivery) was evaluated without a human-in-the-loop, against pre-recorded rhythms.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the standalone performance was based on a "pediatric heart rhythm database." This implies that the rhythms in the database were classified according to their clinical significance (e.g., shockable vs. non-shockable rhythms for pediatric patients, or specific energy requirements for different rhythm types). This would typically be established by expert medical consensus or established diagnostic criteria.

8. Sample Size for the Training Set

• Sample Size: The provided 510(k) summary does not mention a training set or its sample size. This device appears to rely on a fixed resistive attenuation and a "pediatric look-up table" for energy delivery, rather than an adaptive algorithm that would typically require a training set. The "pediatric heart rhythm database" was used for validation, not training.

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

• How Ground Truth Established: Not applicable, as no training set is mentioned for an adaptive algorithm. The device's operation is described as a "purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software," indicating a deterministic rather than machine-learning-based approach requiring a training set. The "pediatric look-up table" itself would have been developed based on established medical guidelines for pediatric defibrillation.

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The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, nonsterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

The HeartSine Samaritan® PAD PAK pads are single use, non-sterile, hydrogel polymer self-adhesive electrode pads. The Samaritan® PAD PAK pads will be used in conjunction with Samaritan® PAD low energy semi-automatic external defibrillator (AED). The pads are sealed in a pouch to prevent drying out and to maintain their integrity throughout the duration of the shelf life.

The provided text describes the 510(k) summary for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes. It focuses on the device's substantial equivalence to predicate devices and its intended use, rather than presenting detailed acceptance criteria and a specific study proving device performance against those criteria in a format with numerical targets and reported outcomes.

Here's an analysis based on the information provided, highlighting what can be extracted and what is missing for a comprehensive answer to your request:

Acceptance Criteria and Study Details for HeartSine Samaritan® PAD PAK Defibrillation Electrodes

The provided document (510(k) Summary) describes the general performance and biocompatibility testing undertaken for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes, but it does not specify quantitative acceptance criteria or detailed study results in a table format. Instead, it makes general statements about compliance with standards and internal specifications.

Based on the information, the following can be inferred and what is missing is noted:

1. Table of Acceptance Criteria and Reported Device Performance

A specific table with quantitative acceptance criteria and corresponding reported device performance values is not provided in the document. The document states:

• "The PAD PAK pads comply with the requirements of AAMI/ANSI DF80. ISO 10993, and FDA Memorandum G95-1, and with HeartSine Technologies, Inc. internal specifications for a single use, ECG monitoring & defibrillation pad."
• "The testing of the PAD PAK pads demonstrate that the PAD PAK Pads function as intended."
• "The results of the testing have also shown the Samaritan® PAD PAK pads do not raise any new questions of safety or effectiveness."

To create the requested table, one would need to refer to the specific standards (AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1) and the manufacturer's internal specifications, which are not detailed in this summary.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally mentions "Testing and performance documentation has been submitted with the 510(k) submission."

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

This information is not applicable and not provided. The device is an electrode for monitoring and defibrillation, not an interpretative AI device that requires expert ground truth for its core function. Testing would involve electrical performance, biocompatibility, and physical integrity, not diagnostic accuracy based on expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3.

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

A MRMC comparative effectiveness study is not applicable to this device. This type of study is typically done for diagnostic imaging or interpretation devices where human readers are involved in assessing cases. The device here is an electrode, and its performance would be assessed through technical, electrical, and biological testing, not by comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to this device. As an electrode, there is no "algorithm only" performance or "human-in-the-loop" concept in the way it applies to AI-driven diagnostic devices. The device's function is physical and electrical.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus) is not applicable here. For an electrode, "ground truth" would refer to established electrical measurement standards, biological safety standards, and physical performance specifications. The document states the device complies with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and internal specifications. These standards define the "ground truth" for electrical performance, biocompatibility, and physical characteristics.

8. Sample Size for the Training Set

This information is not applicable and not provided. The Samaritan® PAD PAK electrodes are a hardware device, not an AI/ML algorithm that requires a "training set" in the computational sense.

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

This information is not applicable and not provided for the same reasons as #8.

Summary of what can be extracted from the provided text for acceptance criteria and study:

• Acceptance Criteria (General): Compliance with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and HeartSine Technologies, Inc. internal specifications. The device should "function as intended" and "not raise any new questions of safety or effectiveness."
• Study (General): "Testing and performance documentation has been submitted with the 510(k) submission." This testing demonstrated compliance with the aforementioned standards and internal specifications.
• Device Function: Single use, non-sterile, self-adhesive hydrogel pads, intended for ECG monitoring and external defibrillation, to be used with the Samaritan® PAD Automated External Defibrillator on patients 8 years and older.

Missing Information:
Crucially, the document lacks the specific quantitative acceptance criteria, the detailed results from the performance and biocompatibility tests, and any sample sizes used for these tests. The 510(k) summary is a high-level overview, not the detailed technical report of the studies themselves.

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The HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• Unconscious .
• Not breathing
• Without circulation .

The Samaritan® PAD is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samantan® PAD is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® PAD is a small, lightweight portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® PAD incorporates a simple user interface of voice prompts and visual graphic prompts to guide the user. A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model Samaritan® AED. If a shock is required, the Samaritan® PAD will automatically charge to the appropriate energy level and prompt the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® PAD will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® PAD uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's heart rhythm and, if required, deliver the defibrillation pulse to the patient.

The Samaritan® PAD incorporates the following features:

• An LED graphic display providing visual graphic prompting to the . user
• Automated self tests with an LED flashing status indicator .
• Integral event data recording

The Samaritan® PAD uses a disposable, non-rechargeable lithium manganese dioxide battery to operate the Samaritan® PAD for a minimum of 3 hours of continuous operation or provide a minimum of 30 - 200 Joule shocks. The disposable battery is housed in a plastic tray with the disposable defibrillation pads. By housing the battery in the same rigid plastic tray as the electrodes, this will greatly assist the end user in keeping the device in a state of readiness. This will also help eliminate the chance that the end user would respond to an incident with a good battery but expired electrodes, as could happen with many other AEDs currently.

Event details are recorded internally in the Samaritan® PAD for later retrieval on a computer. 1.5 hours of continuous ECG as well as incident events time stamped are recorded. Event and incident data can be viewed, printed, annotated and forwarded using the HeartSine SAVER software program. The Samaritan® PAD incorporates a USB communication port that allows for downloading event details to the SAVER software program. This USB port also allows for changing language settings for the Samaritan® PAD voice prompts and allows for customizing the factory settings.

Samaritan® PAD also incorporates a training module which converts the Samaritan® PAD into a training device. The training module will automatically disable the Samaritan® PAD energy delivery capability. This training module will allow the user to select training scripts, which simulate different rescue and demonstration scenarios.

The provided text outlines the acceptance criteria and study information for the HeartSine Samaritan® PAD, an Automated External Defibrillator (AED).

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Samaritan® PAD's analysis algorithm is identical to the Samaritan® AED (K023854) which is already in commercial distribution. Therefore, the acceptance criteria and performance are implicitly aligned with the previously cleared device. The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials, implying that the device meets the established safety and efficacy standards for defibrillation. While specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds for arrhythmia detection) are not explicitly detailed in the provided text, the core performance is tied to its predicate device.

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

The document states, "The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials." However, it does not specify the sample size for these clinical trials used to demonstrate the algorithm's efficacy, nor does it explicitly state the country of origin of the data or whether the data was retrospective or prospective. It implies that these studies were conducted for the original Samaritan® AED (K023854) and are being referenced for the PAD model's substantial equivalence.

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

This information is not provided in the given text. While it mentions "human clinical trials," it does not detail the process of establishing ground truth for the test sets with experts.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

An MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned in the provided text. The device is an Automated External Defibrillator (AED), which is primarily an automated device designed to be used by trained personnel, not a diagnostic aid for human readers in the traditional sense of an MRMC study.

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

Yes, a standalone performance assessment of the algorithm was implicitly done. The document states, "A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854." It also mentions "The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials." This suggests that the algorithm's ability to accurately detect arrhythmias and make shock/no-shock decisions independent of continuous human interpretation was evaluated in the context of the previous clearances.

7. The Type of Ground Truth Used

Based on the nature of AEDs, the ground truth for their algorithms is typically established through a combination of:

• Expert Consensus (Cardiologists/Electrophysiologists): For highly ambiguous ECG rhythms, expert cardiologists would classify rhythms as shockable or non-shockable.
• Outcomes Data: The ultimate ground truth for an AED is its ability to successfully defibrillate a patient in cardiac arrest, leading to a return of spontaneous circulation. This can be derived from clinical trial outcomes.
• Pathology/Physiology during animal/human clinical trials: Evaluation of the waveform's impact on cardiac tissue and rhythm during trials would contribute to establishing efficacy.

The provided text generally refers to "animal and human clinical trials" for waveform efficacy, which would typically involve these types of ground truth.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the algorithm. Since the algorithm is "identical" to a previously cleared device, the training would have occurred prior to that clearance (K023854).

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

The document does not provide specific details on how the ground truth for the training set was established. However, for AED algorithms, it typically involves:

• Large databases of annotated ECGs: These databases are usually curated by expert cardiologists who classify rhythms (e.g., ventricular fibrillation, asystole, normal sinus rhythm, other non-shockable rhythms).
• Data from real-world cardiac arrest events: Retrospective or prospective collection of ECG data from actual cardiac arrest victims, where the outcome (resuscitation, no resuscitation, presence of shockable rhythm) is known and often confirmed by medical professionals.

The general statement about "animal and human clinical trials" for the "efficacy of the HeartSine SCOPE biphasic waveform" implies a robust process of data collection and ground truth establishment for both development and testing of the algorithm.

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The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• Unconscious .
• Not breathing .
• Without circulation .
  The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.
The Samaritan® AED incorporates the following features:

• . Backlight LCD display providing text prompts and ECG display
• Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
• Automated self tests with a separate status indicator display .
• . Controls for Power On/Off, Shock, Backlight, Contrast & manual override
• Integral event data recording incorporated in the removable battery .
  A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.

Here's an analysis of the provided text regarding the HeartSine Samaritan® AED, structured to answer your questions about acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the device complies with industry standards. The reported performance is framed in terms of this compliance.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "animal and human clinical trials" mentioned.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in any clinical trials.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The device is an AED, which is primarily an automated diagnostic and therapeutic device, rather than an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was conducted for the device's core function. The document states: "A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision." This implies that the algorithm performs its analysis and makes a decision independently. The overall device then guides the user to press a shock button if a shock is indicated, but the initial "shock or no-shock decision" is algorithmic.

7. The Type of Ground Truth Used

The document refers to "animal and human clinical trials" to demonstrate the efficacy of the biphasic waveform. For AEDs, the ground truth for efficacy would typically be:

• Clinical Outcomes Data: Such as successful defibrillation, return of spontaneous circulation (ROSC), and patient survival, observed in human trials.
• Physiological Response Data: In animal trials, this would involve observing the cessation of ventricular fibrillation and return to a perfusing rhythm.

For the shock/no-shock decision, the ground truth would typically be:

• Expert Consensus on ECG Interpretation: A panel of cardiologists or electrophysiologists independently reviewing ECGs and determining the presence or absence of a shockable rhythm (e.g., ventricular fibrillation, pulseless ventricular tachycardia). This is inferred, not explicitly stated in this document.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the "proprietary ECG analysis algorithm."

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

The document does not explicitly state how the ground truth for the training set was established. However, for an ECG analysis algorithm in an AED, it would typically involve:

• Annotated ECG Databases: Large databases of ECG recordings from patients in cardiac arrest, with each recording meticulously labeled by expert cardiologists or electrophysiologists as either a shockable rhythm (e.g., VF, pulseless VT) or a non-shockable rhythm (e.g., asystole, PEA, normal sinus rhythm).

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