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The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.

The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely. The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.

The information provided describes the acceptance criteria and study proving the device meets those criteria for the Philips Switched Internal Paddles.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Usability Testing: 15 participants (11 sterile processing technicians and 4 surgical technicians).
• Biocompatibility Testing: "Extra Large Switched Internal Paddles with the largest surface area (Model No. M4741A)" were used to simulate a worst-case scenario. The exact number of units tested is not specified, but it implies a single model for testing.
• Other Bench Testing (Hardware, Electrical Safety, Cleaning/Sterilization Validation, Labeling Verification): The sample sizes for these tests are not explicitly stated in the provided text.
• Data Provenance: Not specified, but likely proprietary internal testing given the nature of the submission for product modifications. It's not explicitly stated as retrospective or prospective, but performance testing is inherently prospective for the modified product. No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA.

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

• Usability Testing: The "experts" in this context are the 15 participants in the usability study: 11 sterile processing technicians and 4 surgical technicians. Their qualifications are implied by their roles in a hospital setting (operating room and central processing/sterilization room). No further detail on their specific years of experience or board certification is provided.
• Other Testing: The ground truth for bench tests (biocompatibility, electrical safety, cleaning/sterilization, hardware) is established by adherence to recognized international and national standards (e.g., ISO 10993, IEC 60601, ISO 17665, ANSI AAMI HE75). The "experts" are the engineers and scientists conducting these tests and interpreting results against these standards. Specific numbers or qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Not applicable in the traditional sense for this type of submission. The tests performed are objective measurements against established engineering and biological standards, or observations of user interaction with predefined tasks in usability. There is no mention of a human expert panel adjudicating test results or ground truth in the way it might be done for an AI diagnostic algorithm.

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 MRMC comparative effectiveness study was done. This document describes a K203231 510(k) submission for "Switched Internal Paddles," which is a physical device (defibrillation electrodes) and not an AI diagnostic algorithm or a system requiring human-reader interpretation.

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

• Not applicable. The device is a physical medical device (defibrillation paddles). There is no "algorithm only" component or AI involved. The document explicitly states: "The modified Switched Internal Paddles do not use software for its function nor required any software modifications for compatibility with the HeartStart Defibrillators; therefore, software testing is not applicable for this submission."

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

• Biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) against predefined acceptable limits specified in ISO 10993 standards.
• Electrical Safety & Hardware Performance: Ground truth is established by objective measurements verifying compliance with specified engineering requirements and international safety standards (e.g., IEC 60601 series).
• Cleaning & Sterilization Validation: Ground truth is established by verifying the effectiveness of the reprocessing methods through standardized microbiological and chemical tests to ensure sterility and material integrity after reprocessing, as per ISO 17665-1 and other relevant standards.
• Usability: Ground truth is established by observing user interaction with the device following the modified instructions, assessing their ability to safely and effectively use the device, and identifying any potential use errors, against human factors engineering principles (ANSI AAMI HE75) and FDA guidance.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.

Manual Defibrillation: In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia. Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Cardioversion: The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.

External Pacing: The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology. As a standby when standstill or bradycardia might be expected. External pacing is indicated for adult and pediatric patients.

ECG Display: The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).

CPR Feedback: The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.

The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock. The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.

This is a 510(k) summary for the TEMPUS LS - MANUAL, a multi-function defibrillator. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and non-clinical performance testing. It does not contain information about a clinical study with acceptance criteria in the typical sense of metrics like sensitivity or specificity for an AI algorithm.

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

1. Table of acceptance criteria and the reported device performance

The document describes "pre-established acceptance criteria" but does not explicitly list them or quantify performance metrics in a table. Instead, it states that various tests "met requirements" or "met the requirements of the standard," implying that the acceptance criteria were compliance with specific industry standards and successful operation in bench testing.

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

The document does not detail a "test set" in the context of an AI algorithm's performance. The closest analogous information is for the Human Factors validation testing:

• Sample size: 15 participants
• Data provenance: Not specified, but given the manufacturer is UK-based and the test was for usability, it's likely the participants were located in a similar context. It was a prospective study to evaluate usability.

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 as the document describes non-clinical testing and human factors usability, not a clinical study requiring expert-established ground truth for diagnostic accuracy.

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

This information is not provided as the document does not describe a process that would involve expert adjudication of a test set for diagnostic performance.

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 MRMC comparative effectiveness study was not done with human readers and AI assistance. This document describes a medical device (defibrillator) primarily relying on hardware and embedded software functionality, not an AI-powered diagnostic tool that assists human readers.

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

This concept is not directly applicable to the device described. The "algorithm" here refers to the device's operational functions (defibrillation waveform generation, pacing parameters, CPR metronome, etc.) rather than a diagnostic algorithm generating an output for review. Bench testing was performed for these functionalities, which could be considered "standalone" in the sense that the device's technical specifications were verified against standards.

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

For the non-clinical performance testing, the "ground truth" was the pre-established acceptance criteria derived from recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-4). For the human factors study, the ground truth was the successful and safe use of the device by participants, evaluated against predefined usability metrics.

8. The sample size for the training set

The document does not mention a "training set" as it is not for an AI/ML algorithm that undergoes a training phase with a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.

Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.

The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.

The provided text describes a 510(k) premarket notification for Sterilizable Internal Defibrillation Paddles. It's important to clarify that this document is for a medical device (hardware), not an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training/test set sizes) are not directly applicable in the same way.

Instead, the acceptance criteria for such a device typically revolve around demonstrating substantial equivalence to a predicate device, as well as meeting established safety and performance standards through design verification and validation.

However, I will extract the information that is comparable or relevant to your questions, and specify where the requested information is not applicable for this type of device.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting design specifications related to safety and performance.

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

Non-Applicable / General Information for Hardware Devices

The following questions are primarily relevant to AI/ML software performance studies and are not directly applicable to this hardware device's 510(k) submission as described.

• 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 for a hardware device in the context of AI/ML test sets. Performance testing for hardware involves laboratory, animal, and simulated use testing, not "test sets" of data in the AI/ML sense. Data sources for such tests are internal (e.g., test benches, animal studies).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML test set is not a concept used for this type of hardware device's testing.
• 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 is a hardware device, not an AI assistance tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory to a defibrillator and requires a highly-trained medical professional for use. It is a human-operated device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a hardware device means meeting its engineering and safety specifications, and performing its intended function.
• 8. The sample size for the training set: Not applicable for hardware.
• 9. How the ground truth for the training set was established: Not applicable for hardware.

Summary of Device-Specific Study Information (Performance Data)

The submission highlights that no human clinical studies were submitted as part of this 510(k) Premarket Notification. This is typical for devices seeking substantial equivalence where predicate device experience or non-clinical data is deemed sufficient.

The performance data that supports the acceptance criteria for this hardware device includes:

• Design Verification Testing: To ensure the device meets established design specifications.
• Biocompatibility Testing: To ensure materials are safe for biological contact.
• Electrical Safety and Electromagnetic Compatibility Testing: To ensure the device operates safely within electrical and electromagnetic parameters.
• Design Validation Testing: Which encompassed:
  • Animal Testing: To evaluate performance in a living biological system.
  • Simulated Use Testing: To assess performance under conditions mimicking clinical use.

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To remove excessive hair prior to placement of defibrillator electrodes.

The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment.

To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.

The provided document describes the FDA 510(k) premarket notification for the "Rapid Hair Removal Pads" (RHRP) and its substantial equivalence determination to a predicate device. The document details performance testing conducted to support this claim, which includes Human Factors/Usability testing, Impedance testing, and Biocompatibility studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with numerical targets, but rather describes the successful outcomes of the tests. Based on the reported findings, we can infer the implicit acceptance criteria met by the device.

• RHRP labeling effectively directs users.
• Application and removal of RHRP can be completed within a reasonable timeframe (implied performance goal).
• No user confusion or error identified. | - Training of ALS personnel and RHRP labeling effectively directed users on proper application and removal.
• Proposed labeling changes will further enhance the user interface.
• Timed simulation: ALS personnel were able to properly place and remove RHRP in under 15 seconds.
• No user confusion or user error identified based on simulation and questionnaire responses. |
  | Impedance Testing | - RHRP application should substantially decrease impedance at electrode placement sites.
• This decrease in impedance should optimize electrode-to-skin contact and aid defibrillation therapy. | - The hair removal accomplished by the RHRP adhesive substantially decreases impedance, thereby optimizing the electrode pad-to-skin contact and aiding defibrillation therapy.
• Impedance readings were taken before and after RHRP application to demonstrate this effect. |
  | Biocompatibility | - No detectable interaction with human cells (cytotoxicity).
• Minimal or temporary skin irritation (human use testing).
• No chemical irritation of the skin.
• The adhesive materials coming into contact with the skin are non-toxic, do not contain color additives, and have no adverse environmental effects (based on manufacturer records). | - Cytotoxicity test results show no detectable interaction between RHRP and human cells, with a reactivity grade of "O".
• Human Use Testing showed only minor and temporary mechanical irritation of the skin.
• No chemical irritation of the skin was experienced after application and removal.
• Analysis of the RHRP adhesive material (based on manufacturer records) deemed them non-toxic, free of color additives, and with no adverse environmental effects. |

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

• Human Factors/Usability Testing:
  • Sample Size: 15 Advanced Life Safety (ALS) trained professionals.
  • Data Provenance: Prospective, conducted in a simulated emergency setting with live human subjects. The country of origin is not specified but is implied to be within the jurisdiction of the FDA submission (USA).
• Impedance Testing:
  • Sample Size: 26 total chest pulls (implying the RHRP was used 26 times, likely on different subjects or areas).
  • Data Provenance: Prospective, as impedance readings were taken before and after RHRP application. Country of origin not specified (implied USA).
• Biocompatibility Studies:
  • Cytotoxicity Test: Sample size not explicitly stated for the test itself, but performed on the device material.
  • Human Use Testing: Sample size not explicitly stated, but implies observation on human subjects.
  • Adhesive Material Analysis: Based on manufacturer records (no specific sample size for a test set provided here).
  • Data Provenance: Assumed prospective for cytotoxicity and human use testing, retrospective/document review for adhesive material analysis. Country of origin for tests not specified (implied USA).

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

• Human Factors/Usability Testing: The "ground truth" here is the ability of ALS personnel to correctly and efficiently use the device without confusion or error. This was established through observation and questionnaire responses from 15 ALS trained professionals. Their specific qualifications are stated as "Advanced Life Safety trained professionals (ALS personnel)".
• Impedance Testing: The "ground truth" is the change in impedance. This was measured objectively using a "CheckTrode Ohm meter" by presumably study personnel, not through expert consensus on images or outcomes.
• Biocompatibility Studies:
  • Cytotoxicity: Measured objectively in a lab setting by trained personnel following established protocols.
  • Human Use Testing: Based on observation of skin reactions, likely by trained medical observers.
  • Adhesive Material Analysis: Based on manufacturer records, implying expert analysis of material composition and safety data by the manufacturer's qualified personnel.

The document does not detail a process of using a specific number of "experts" to establish ground truth in the sense of image interpretation or medical diagnosis for these types of tests.

4. Adjudication Method for the Test Set

• Human Factors/Usability Testing: No explicit adjudication method (like 2+1 or 3+1) is mentioned. User performance was assessed through direct observation during a simulated environment and through post-testing questionnaire responses from the 15 ALS personnel. "No user confusion or user error was identified" suggests a consensus or clear determination from the observed data.
• Impedance Testing: No adjudication method. It relies on objective meter readings.
• Biocompatibility Studies: No adjudication method. Based on laboratory test results and observations.

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 MRMC comparative effectiveness study was done or reported. The device is a physical hair removal pad, not an AI or digital diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• Not applicable. As the device is a physical hair removal pad, there is no "algorithm only" performance separate from its interaction with a human user applying it.

7. The Type of Ground Truth Used

• Human Factors/Usability Testing: Observational data (user performance, task completion time) and self-reported feedback (questionnaire responses) from trained professionals.
• Impedance Testing: Objective quantitative measurements (impedance readings in ohms) from a testing device (CheckTrode Ohm meter).
• Biocompatibility Studies: Laboratory assay results (cytotoxicity grade), clinical observation of skin reactions (human use testing), and material composition analysis (manufacturer records).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the context of data. The "training" mentioned in the Human Factors study refers to training the ALS personnel on how to use the device.

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

• Not applicable. (See point 8).

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Defibrillator Function: The E Series ALS products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series ALS products must be prescribed for use by a physician or medical advisor of an emergency response team.

Intended Use — Manual Operation: Use of the E Series ALS products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series ALS unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate.

Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradvcardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.

Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.

This document is a 510(k) premarket notification for the "Zoll E Series ALS" device. The manufacturer is seeking clearance for a specific configuration of an existing device (Zoll E Series cleared under K111594 and K092598) as a standalone Class II device. The key aspect is that this new configuration, E Series ALS, disables the ECG rhythm analysis (advisory) option and removes the "analyze" button, making it a manual-only/non-AED configuration.

Based on the provided text, there are no specific acceptance criteria or a dedicated study described to demonstrate the device meets acceptance criteria as typically found for new device functionality or performance claims. The fundamental argument for clearance in this submission is that no new device functionality or performance is being introduced.

Here's an analysis based on the structure of your request:

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

   • Acceptance Criteria: Not explicitly stated as new criteria. The device is leveraging the performance and safety established for its predicate device (Zoll E Series, K111594 and K092598). The central "acceptance" is that the removal of the AED/advisory functionality does not introduce new risks or modify existing performance.
   • Reported Device Performance: No new performance metrics are reported in this particular submission. The device's performance characteristics (defibrillation energy delivery, pacing, monitoring vital signs, CPR feedback) are presumed to be the same as the cleared predicate device.

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

   • No new test set was used for this submission. The submission explicitly states: "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary." This implies reliance on the testing performed for the predicate device.

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

   • Not applicable. No new test set requiring expert ground truth establishment for novel functionality was used in this submission.

4. Adjudication method for the test set

   • Not applicable. No new test set.

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

   • Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted or referenced in this document.

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

   • Not applicable. This device is a medical device with various monitoring and therapeutic functions, not an algorithm. The 510(k) submission itself is for a "standalone Class II clearance" in the regulatory sense, but not for a standalone algorithm performance study. In fact, the removal of an "algorithm-like" function (ECG rhythm analysis/advisory) is a key aspect of this submission.

7. The type of ground truth used

   • Not applicable for this submission. For the predicate device, the ground truth would have been established through a combination of engineering testing, clinical studies, and compliance with performance standards typical for defibrillators, pacemakers, and patient monitors.

8. The sample size for the training set

   • Not applicable. This submission does not involve a machine learning algorithm or a specific training set.

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

   • Not applicable.

Summary of the document's argument regarding acceptance criteria and testing:

The core of this 510(k) submission for the Zoll E Series ALS is that it is a configuration of an already cleared device (Zoll E Series, K111594). The key modification is the disabling of the ECG rhythm analysis (advisory) option and the removal of the "analyze" button, effectively creating a manual-only defibrillator for use by ACLS qualified personnel.

The manufacturer explicitly states:

• "No software modifications were needed to produce the E Series ALS..."
• "The capability to configure the device as E Series ALS during the manufacturing process by disabling the ECG rhythm analysis already existed in the predicate device cleared under K111594."
• "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary."
• "Removal of the 'Analyze' button from the front panel... did not introduce any new risks, or raise any usability issues or concerns..."

Therefore, the "acceptance criteria" discussed in this document are implicitly the safety and effectiveness criteria established and met by the predicate device (K111594/K092598). The "study that proves the device meets the acceptance criteria" is essentially the original testing and clearance data for the predicate device, combined with the argument that removing a feature does not negatively impact the device's substantial equivalence or safety profile. The FDA's issuance of the clearance letter (Pages 0-1) indicates their agreement with this assessment for regulatory purposes.

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The Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (30 joule maximum).

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The provided text describes a 510(k) premarket notification for Cardio Med Pediatric Radiotranslucent Multifunction Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device through nonclinical bench testing. It does not contain information typically found in studies for AI/machine learning medical devices, such as those related to reader performance, clinical outcomes, or large-scale data analysis for algorithm development.

Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) cannot be addressed from the given text.

Here's a summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. The exact number of samples or lots is not specified.
• Data Provenance: Not applicable in the context of this device. The testing was nonclinical bench testing, not involving human data.

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

• Not applicable. This was bench testing against engineering standards, not diagnostic device validation requiring expert-established ground truth.

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

• Not applicable. This was bench testing against engineering standards. Results would be pass/fail based on direct measurement and comparison to thresholds rather than expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a passive electrode, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

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

• The "ground truth" for the bench testing was defined by the quantitative limits specified in the AAMI Standard ANSI/AAMI DF80:2003 and the FDA performance standard for touch-proof ECG connectors. Biocompatibility was assessed against standard biological safety test protocols.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an algorithm.

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

• Not applicable. There is no training set for an algorithm.

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EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications:

• external defibrillation
• synchronized cardioversion
• cardiac stimulation
• ECG monitoring
  EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.
  The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule.
  The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule.
  The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

FIAB EURO DEFI PADS series of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type electrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market.
The products are packaged in pairs inside water-vapor proof, heat sealed, non-transparent, aluminum/PE pouches.
FIAB EURO DEFI PADS series of disposable multi-function electrodes are available in the following versions: adult, adult radiotransparent, pediatric.

This submission is for a medical device that is substantially equivalent to existing predicate devices, rather than a diagnostic AI algorithm. Therefore, the questions related to AI performance metrics, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies are not applicable in this context. The acceptance criteria and study detailed below refer to the substantial equivalence requirements for traditional medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The submission does not specify a "test set" in the context of an AI algorithm or a clinical trial with a defined patient population. Rather, the "tests" refer to engineering and biological evaluations performed on the device itself.

• Sample size: Not explicitly stated for each test, but standard procedures for medical device testing within ISO and AAMI standards would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., adequate electrodes for biocompatibility, multiple units for electrical or compatibility testing).
• Data provenance: The testing was conducted by NAMSA (for biocompatibility) and likely by FIAB SpA or a contracted laboratory for other tests. The manufacturer is FIAB SpA, located in Florence, Italy. The data is prospective for these specific tests as they were performed to validate the device for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI diagnostic device where expert ground truth is established for image/data interpretation. Ground truth for device performance is established by adherence to recognized national and international standards (e.g., AAMI/ANSI, ISO) and laboratory testing protocols.

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

Not applicable. This is not an AI diagnostic device requiring human adjudication of performance outcomes. Device performance is determined by meeting predefined technical specifications and standards (e.g., passing electrical tests, biocompatibility results).

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

Not applicable. This is not an AI diagnostic device. No human-in-the-loop performance or MRMC study was conducted.

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

Not applicable. This is not an AI algorithm. The device, when used, is always "human-in-the-loop" as it requires a medical professional to apply and operate it with a defibrillator.

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

The "ground truth" for this medical device's performance is its adherence to established engineering, safety, and biocompatibility standards, and its functional equivalence to legally marketed predicate devices. This includes:

• Standard adherence: Compliance with 21 CFR 898.12, ANSI/AAMI DF80:2003, and ISO 10993 (biocompatibility).
• Predicate device comparison: Demonstrating that the device has the "same intended use," "no technical differences in the design, materials, packaging, and labeling" to the predicate, and performs as expected for its clinical applications.
• Laboratory testing results: Objective measurements from tests like biocompatibility, component compatibility (e.g., insertion/extraction forces, energy delivery), and electrical standards compliance.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm that requires a training set.

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

Not applicable. This is a medical device, not an AI algorithm that requires a training set.

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The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104 cm² (16.1 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ECG ELECTRODES) was tested against the AAMI Standard ANSI/AAMI DF80:2003.

Additionally, the device was subjected to an accelerated age shelf life test:

• Acceptance Criteria: Maintain compliance with the above AAMI tests after 36 months of accelerated aging.
• Reported Device Performance: All units passed the tests after the accelerated age shelf life test.

Furthermore, Biocompatibility testing was performed on the patient contact material Hydrogel, and the material passed.
Finally, Compliance with the FDA performance standard for touch-proof ECG connectors was verified by inspection.

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

• Sample Size for Test Set:
  • For the AAMI electrical performance tests: Three different lots, with six samples each (total of 18 samples).
  • For the 36-month accelerated age shelf life test: Three different lots, with two samples each (total of 6 samples).
  • For Biocompatibility testing: Not specified, but performed on the patient contact material (hydrogel).
  • For Connector compliance: Verified by inspection of the connectors (number of units not specified).
• Data Provenance: The nature of these tests (bench testing, accelerated aging, biocompatibility) indicates that the data is prospective and generated in a laboratory setting, rather than being collected from patients. The country of origin for the data is not explicitly stated in the provided text.

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

This type of submission is for a medical device (defibrillator electrodes) and primarily relies on bench testing against established industry standards (AAMI Standard ANSI/AAMI DF80:2003) and conformance to FDA performance standards for connectors.

• Experts for Ground Truth: There is no mention of human expert consensus being used to establish a "ground truth" for the performance of these basic electrical and material properties tests. The "ground truth" is defined by the objective, quantifiable limits set forth in the AAMI standard itself and FDA regulations for connectors. The testing would be conducted by qualified laboratory personnel, but their role is to measure and report, not to interpret complex clinical data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As described above, the determination of "passing" is based on objective measurements against pre-defined numerical limits in a standard, not on the subjective interpretation of expert reviewers that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No. This submission is for a physical medical device (defibrillator electrodes), not an AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on:

• Industry Standards: Specifically, the AAMI Standard ANSI/AAMI DF80:2003 for electrical performance characteristics of defibrillator electrodes.
• FDA Regulations/Performance Standards: For "touch-proof" ECG connectors and biocompatibility.
• Objective Measurements: These standards define quantifiable limits (e.g., ≤100 mV for DC Offset, ≤3,000 Ohms for AC Small Signal Impedance) against which the device's measured performance is compared.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.

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

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

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The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIOCONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

Acceptance Criteria and Device Performance Study for Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes (K103154)

1. Table of Acceptance Criteria and Reported Device Performance

The Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes were tested against the AAMI Standard ANSI/AAMI DF80:2003 for defibrillator pads.

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

Sample Size: For the AAMI bench tests, three different lots were used, with six samples from each lot subjected to the tests. Additionally, the same testing routine (three lots, two samples each) was applied to a 36-month accelerated age shelf life test.
Data Provenance: The data is reported from nonclinical bench testing performed by the manufacturer, Cardio Medical Products, Inc. This is prospective data generated specifically for the premarket notification. The country of origin of the data is not explicitly stated in the provided text but is implied to be within the United States, given the FDA submission.

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

This study involved bench testing against established engineering standards (AAMI, FDA performance standard). It did not involve human interpretation or subjective assessment of medical images or patient data. Therefore, there were no experts used to establish ground truth in the context of medical diagnosis or interpretation for this specific type of device testing. The "ground truth" was the objective measurement against the specified engineering limits.

4. Adjudication method for the test set

Not applicable. As this was bench testing against objective engineering standards, there was no subjective judgment or adjudication required. Each test result was either within the specified limits ("Passed") or not.

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 was not done. This device is a defibrillator electrode and does not involve AI or human interpretation of medical data in its primary function.

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

Not applicable. This device is a physical medical device (defibrillator electrode), not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.

7. The type of ground truth used

The ground truth used was based on objective engineering and performance standards established by the Association for the Advancement of Medical Instrumentation (AAMI Standard ANSI/AAMI DF80:2003) and FDA performance standards for ECG connectors. For biocompatibility, the ground truth was meeting established biocompatibility testing protocols for patient contact materials.

8. The sample size for the training set

Not applicable. This is a physical medical device. There was no machine learning or AI algorithm that required a "training set."

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

Not applicable, as there was no training set for this device.

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The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propag MD unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The Propag MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

Sp02 Monitoring: The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc.

Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

The ZOLL Propaq MD was cleared by the agency under 510(k) application K100654 as a multi-parameter monitor / defibrillator / external transcutaneous pacer with the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures, CO2, temperature, data recording and printing. The device is designed for use by trained medical personnel in both out-of-hospital and inhospital applications. The proposed modification adds a filter (SmartCuf) to the existing NIBP algorithm that uses the existing ECG QRS detection to qualify the pressure pulses used in the device NIBP measurement.

The provided 510(k) summary for the ZOLL Propaq MD (K102468) describes a modification to an existing device (K100654), specifically the addition of a filter (SmartCuf) to the Non-Invasive Blood Pressure (NIBP) algorithm. The summary does not include detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance data. Instead, it relies on substantial equivalence and compliance with a recognized industry standard for the NIBP feature.

Here's an analysis based on the information given, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Comments: The document states that the NIBP with SmartCuf feature continues to comply with AAMI SP10. It does not provide specific numerical criteria from AAMI SP10 (e.g., mean difference, standard deviation) or the actual measured performance data against those criteria. For other functionalities, the claim is substantial equivalence to the predicate, implying they meet the same (unspecified in this document) performance criteria as the predicate.

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

This information is not provided in the document. The general statement "Extensive performance testing" does not include details on sample size, data type (retrospective/prospective), or country of origin for any test data.

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

This information is not provided in the document. Given that the primary performance claim relates to an NIBP algorithm's compliance with a standard, it's less likely to involve expert reviewers in the same way an image analysis device would. The "ground truth" for NIBP standards typically involves direct arterial measurements.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when combining expert opinions, which is not indicated here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI, comparing human performance with and without AI assistance. The described modification is a filter for an NIBP algorithm.

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

Yes, implicitly. The context of "AAMI SP10 testing" for an NIBP algorithm suggests a standalone evaluation of the algorithm's accuracy against a reference standard, without direct human-in-the-loop intervention during the measurement process. The SmartCuf filter modifies the NIBP algorithm itself.

7. The Type of Ground Truth Used

For the NIBP algorithm, the ground truth would typically be invasive arterial blood pressure measurements. While not explicitly stated as "invasive arterial measurements," compliance with AAMI SP10 for NIBP inherently requires comparison against such a gold standard. For predicate equivalence claims, the ground truth would be that established for the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the document. As the SmartCuf is described as a "filter" added to an existing NIBP algorithm, it's unclear if "training data" in the machine learning sense was used, or if it's a rule-based or signal processing modification. If it's a rule-based filter, a distinct training set might not apply in the same way.

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

This information is not provided in the document. If a training set was used, the method for establishing its ground truth (e.g., against invasive arterial measurements) is not detailed.

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