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This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

The monitored parameters are:

1. ECG
2. Noninvasive Blood Pressure (NIBP)
3. Invasive Blood Pressure (IBP)
4. Temperature
5. Respiratory Gases
6. Anesthetic Agent Gases
7. Respiratory Rate
8. Pulse Oximetry (SpO2)
9. Arrhythmia and ST Analysis of the ECG waveforms

The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

The provided text does not contain specific acceptance criteria or a study detailing the device's numerical performance against such criteria. The document is a 510(k) summary for the Criticare Systems Inc. Model 9100 Family Vital Signs Monitor, which primarily asserts substantial equivalence to predicate devices and compliance with various performance and safety standards.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not present in this document.

Here's an overview of what can be extracted and what is missing:

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

The document does not provide a table with specific numerical acceptance criteria and reported device performance. Instead, it broadly states: "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device." It also lists various performance standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.

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

This information is not provided in the document. The filing focuses on substantial equivalence and standard compliance rather than detailed study results.

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

This information is not provided in the document. Given that the main claim is equivalence to predicate devices and compliance with engineering standards, direct human interpretation of a test set with expert ground truth establishment is not described.

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

This information is not provided in the document.

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

An MRMC comparative effectiveness study is not mentioned in the document. The device is a vital signs monitor, and the filing describes its standalone performance and equivalence, not its role in assisting human interpretation or diagnostic efficacy in a reader study. There is no AI component mentioned.

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

Yes, the filing implicitly describes a standalone performance evaluation by stating "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device" and listing compliance with various performance standards (e.g., for NIBP, oximetry, ECG, etc.). These standards typically involve objective testing of the device's accuracy and functionality without human intervention in the loop of the measurement and display process.

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

For the performance evaluations mentioned (compliance with standards like AAMI SP-10 for NIBP or ISO 9919 for Oximetry), the ground truth would typically be established through scientific reference methods, calibrated instruments, and standardized test protocols as defined by those specific engineering and performance standards. It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather "technical ground truth" established by the standards themselves.

8. The sample size for the training set

This information is not provided in the document. The document references "existing core technologies from the predicate 8100 monitor" and "CSI's field experience with these modalities in the predicate devices has been satisfactory." This suggests that the development likely leveraged historical data and experience from previous products, but specific training set sizes are not disclosed.

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

This information is not explicitly provided. Given the reliance on "existing core technologies" and "field experience," the ground truth for any underlying algorithms (e.g., for arrhythmia detection or ST segment analysis) would have been established during the development and validation of those predicate technologies, likely through a combination of clinical data and expert review, but the specifics are not detailed here.

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Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias, and produce events/s] prms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagrosis of those measurements.

The modification is a software-based change that adds the following features: - Atrial Fibrillation alarm - Heart Rate configuration to short or yellow long alarm - Addition of messages indicating causes of invalid OT measurement

The provided document is a 510(k) premarket notification for the Philips ST/AR ST and Arrhythmia Software, Release J.0. It states that the device is substantially equivalent to previously cleared devices and outlines the new features, such as Atrial Fibrillation alarm. However, the document does not contain specific acceptance criteria or detailed study results with the requested information (sample sizes, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details). It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate," and that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The document is a regulatory submission summary, not the full study report.

To address your request, I will explain what would be expected in such a study for a device like this and how the information would typically be presented, acknowledging that the specifics are missing from the provided text.

Based on the provided text (K080461 - Philips ST/AR ST and Arrhythmia Software, Release J.0), the following information is available or can be inferred:

• Device Name: Philips ST/AR ST and Arrhythmia Software, Release J.0
• New Features: Atrial Fibrillation alarm, Heart Rate configuration, messages for invalid QT measurement causes.
• Predicate Devices: K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 (Philips ST/AR ST and Arrhythmia Software), K073462 (GE Dash monitor), K031320 (GE EK-Pro Arrhythmia Detection Algorithm).
• General Statement on Testing: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."

Missing Information (Not present in the provided document):

• Specific numerical acceptance criteria for each performance metric.
• Reported device performance values against these criteria.
• Sample sizes for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study (effect size, improvement with AI assistance).
• Details of standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• Method for establishing ground truth for the training set.

Hypothetical Example of Acceptance Criteria and Study Design (What would typically be found in a more detailed submission for an arrhythmia detection algorithm, not based on the provided text directly):

Given the device includes an "Atrial Fibrillation alarm" as a new feature, a study validating this specific feature would typically involve comparing the algorithm's detection of Atrial Fibrillation (AFib) against a ground truth established by expert cardiologists.

Hypothetical Table of Acceptance Criteria and Reported Device Performance (Illustrative, not from the provided text):

Detailed Study Information (Illustrative, not from the provided text):

1. Sample Size for Test Set and Data Provenance:

   • Sample Size: 2,500 hours of continuous ECG recordings.
   • Data Provenance: Retrospective, collected from five major hospitals across the United States, Europe (Germany, UK), and Japan. The dataset included a diverse patient population (age, gender, comorbidities) representing the intended use population (adults).

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Number of Experts: 3 independent electrophysiologists.
   • Qualifications: All experts were board-certified cardiologists with sub-specialty certification in electrophysiology, each with a minimum of 10 years of experience in ECG interpretation and arrhythmia diagnosis.

3. Adjudication Method for the Test Set:

   • Method: 2+1 Adjudication.
     • Each ECG recording segment was independently reviewed by two electrophysiologists.
     • If the two initial reviewers agreed on the presence or absence of AFib, that consensus became the ground truth.
     • If the two initial reviewers disagreed, a third, senior electrophysiologist (the "tie-breaker") reviewed the segment, and their decision established the ground truth.

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

   • Was it done?: No, an MRMC study was not performed for this 510(k) submission, as the focus was on the performance of the algorithm itself in detecting new features like AFib in a standalone manner, with comparison to predicate algorithms, rather than comparing human reader performance with and without AI assistance for this specific feature. (However, for image-based AI or diagnostic AI, MRMC studies are common).

5. Standalone (Algorithm Only) Performance:

   • Was it done?: Yes. The performance metrics presented in the hypothetical table above represent the standalone performance of the Philips ST/AR ST and Arrhythmia Software, Release J.0 algorithm in detecting AFib based on the ECG input, without human intervention in the detection process.

6. Type of Ground Truth Used:

   • Type: Expert Consensus. The ground truth for the presence or absence of Atrial Fibrillation was established by the independent review and adjudication of the electrophysiologists as described in section 3.

7. Sample Size for the Training Set:

   • Sample Size: 15,000 hours of continuous ECG recordings. This dataset was distinct from the test set to ensure independent evaluation.

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

   • Method: The ground truth for the training set was established through a combination of automated pre-annotation followed by expert review and correction. An initial algorithmic pass provided preliminary annotations for various arrhythmias, including AFib. These annotations were then meticulously reviewed and corrected by a team of experienced ECG technicians under the supervision of a lead electrophysiologist. For ambiguous cases, adjudication by two independent electrophysiologists ensured accuracy, similar to the test set ground truth establishment process, but with a higher throughput focus.

Conclusion from the provided K080461 document:

The provided 510(k) summary (K080461) indicates that the device underwent "Verification, validation, and testing activities" and that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This is a general statement required for a 510(k) summary and does not include the detailed performance data, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications that you requested. Such detailed information would typically be found in the full submission, which is not publicly available under the 510(k) summary.

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The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A is intended for multiparameter patient monitoring.

The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/57M Compact Critical Care Monitor with L-CICU02 and L-CICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*. (*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for use by qualified medical personnel only.

The S/5TM Compact Critical Care Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Critical Care Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5™ Compact Critical Care Monitor: L-CICU02 and L-CICU02A. L-CICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CICU02.

The S/5™ CCCM uses several types of plug-in measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification. The S/5™ CCCM is typically furnished with a module that measures ECG, invasive and noninvasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5™ Compact Monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5™ CCCM can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5™ CCCM is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-CICU02 and L-CICU02A perform some module-related tasks like arrhythmia analysis. ST-value calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5™ Compact Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The S/5™ Compact Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor viewing. Trends can be sent via a network to a central computer for archiving.

This document describes the Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed device performance metrics in the way one might expect for a diagnostic or AI-based device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

The document concludes that "there are no new questions of safety and effectiveness" compared to the predicate, indicating that the device meets the implied performance and safety levels established by the predicate.

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

The document describes nonclinical testing and compliance with standards rather than a clinical study with a "test set" of patient data in the context of typical AI/diagnostic device validation.

• Test set sample size: Not applicable in the context of a prospective clinical data cohort. The testing involved verification against engineering and safety standards.
• Data provenance: Not explicitly stated as clinical data. The studies performed are compliance-based (electrical safety, EMC, mechanical, environmental, software validation), which would typically use test equipment and simulated scenarios rather than patient data.

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

This information is not provided in the document as it focuses on engineering and regulatory compliance rather than a clinical performance study requiring expert adjudication of ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the clinical sense (e.g., for diagnostic accuracy).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

No. The document does not describe an MRMC study. The device is a patient monitor with software enhancements for existing functionalities (like arrhythmia analysis), not an AI-assisted diagnostic tool designed to directly improve human reader performance on a specific task.

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

The document primarily describes the standalone performance of the device's enhanced software features (e.g., arrhythmia analysis, ST-segment analysis) against established engineering standards and substantial equivalence to a predicate device. However, this is not in the context of an "AI algorithm" in the modern sense but rather software functions within a patient monitor. The testing implicitly verifies the algorithm's performance in these specific areas (e.g., heart rate calculation, arrhythmia analysis capability) without direct human intervention in its processing, but the device is designed for use by qualified medical personnel (human-in-the-loop).

7. The Type of Ground Truth Used

For the nonclinical testing described:

• Engineering specifications and regulatory standards: The "ground truth" for the tests mentioned (electrical safety, EMC, mechanical, software validation) is the successful adherence to the defined parameters and limits within these international and national standards.
• Predicate device's established performance: The core of the 510(k) submission relies on demonstrating that the updated device is "substantially equivalent" to the previously cleared predicate device. This means the predicate's performance and safety effectively served as a benchmark for what is acceptable.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of AI/machine learning models in the contemporary sense. The software functions appear to be based on established algorithms in critical care monitoring, rather than data-driven models requiring a specific "training set."

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

Not applicable. As the document does not describe an AI/machine learning training process, there is no mention of a training set or how its ground truth would be established.

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The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients.

With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions.

Impedance Respiration measurement is indicated for patients ages 3 years and older.

Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more.

The monitor is indicated for use by qualified medical personnel only.

The Cardiocap 5 monitor is a multi-parameter monitor that is factory configured. The monitor provides basic hemodynamic monitoring of ECG, SpO2, Temp, NIBP and Invasive provides outs addition to the hemodynamic monitoring it can be configured with Gas monitoring which are: CO2, N2O, O2, Anesthetic Agents with agent identification and Patient Spirometry TM .

The Cardiocap 5 monitor software available is for Anesthesia or Critical Care. The customer upon purchase for optimized use of monitor can select the software for application.

In addition the Cardiocap 5 rev. B will offer other options and enhanced features. These features are the following:

OSAT - Enhanced D-O Oximetry (SpO2) performance NSAT - Nellcor Oximetry XP w/2 temp - Invasive pressure with 2 temp feature Rec. w/2 key - Recorder with 2 direct key function

Because the Cardiocap 5 monitor is factory-configured for cost-effectiveness and compactness, the parameters and optional thermal array recorder cannot be upgraded later. Software is upgradeable.

Cardiocap 5 is based on the same state-of-the-art monitoring and user interface technology, including menu logic and alarm philosophy, as the S/5 monitors. The Cardiocap 5 can also be networked to the Datex-Ohmeda Network.

The hemodynamic frame (F-MX) and hemodynamic with gases frame (F-MXG) both include ECG with ST analysis and impedance respiration, SpO2, 1 temperature, and noninvasive blood pressure. Invasive blood pressures (2 channels) and second temperature is an option for both models. Airway gas options are for hemodynamic with gases frame .

The Cardiocap 5 monitor now extends its feature sets to allow flexibility of customerpreferred oximetry options. These new oximetry features replace the functionality of the original oximetry offering. (Only one oximetry option is available at a time.

The Datex-Ohmeda Cardiocap 5 (Rev B) and its accessories, including the N-XOSAT option, are patient monitoring devices. The provided text outlines the declaration of substantial equivalence to a predicate device (Datex-Ohmeda Cardiocap 5 Rev A, K992323) rather than a direct study demonstrating acceptance criteria met for a novel device. The basis for acceptance is demonstrating that the new device is as safe and effective as the predicate device by showing identical intended use, substantially identical indications for use, and similar technological characteristics, with any differences not raising new questions of safety or effectiveness.

Here's an analysis based on the provided text, focusing on how the new device's equivalence and safety/effectiveness were established:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by the predicate device's performance and compliance with relevant standards. The "reported device performance" is implicitly that it meets or maintains these standards.

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

The document describes non-clinical testing for compliance with standards rather than a clinical study with a "test set" of patients. The evaluations are primarily engineering and bench testing, software validation, and verification against established performance specifications and regulatory standards. There is no mention of a patient-based test set or data provenance (e.g., country of origin, retrospective/prospective). The N-XOSAT option mentions "monitoring hospital patients under clinical motion conditions," implying some level of testing for this specific feature, but no details on sample size or study design are provided in this summary.

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

Not applicable. This is not a study requiring expert-established ground truth for patient outcomes or diagnoses. The "ground truth" for non-clinical testing refers to compliance with predefined engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a human-read test set requiring adjudication in the context of this 510(k) submission.

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

No MRMC study was mentioned or performed as described in the provided text. The submission focuses on substantial equivalence to an existing device, not on demonstrating an improvement in human reader performance with AI assistance.

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

Not explicitly detailed as a separate study. The device itself is a patient monitor, which inherently provides information to a human operator. The "software validation and verification of specifications" would constitute an assessment of the algorithm's performance in its specific functions (e.g., ST analysis, gas analysis, NIBP measurement) in a standalone capacity against its own internal specifications and relevant standards.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" refers to:

• Engineering Specifications: The device's performance parameters (e.g., accuracy of ECG, SpO2, NIBP measurements) are verified against internal design specifications derived from industry standards and clinical requirements.
• Regulatory Standards: Compliance with the listed mandatory and voluntary standards (e.g., IEC 601-1, AAMI SP10-92) serves as a "ground truth" for safety and basic performance acceptance.
• Predicate Device Performance: The predicate device itself acts as a "ground truth" benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This document does not describe the development or validation of machine learning algorithms that typically require training sets. The "software validation" mentioned would refer to traditional software engineering quality assurance.

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

Not applicable, as there is no mention of a training set for machine learning.

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The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.

Impedance Respiration measurement is indicated for patients ages 3 and up.

Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up.

The monitor is indicated for usc by qualified medical personnel only.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Cardiocap 5". It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed information about the specific acceptance criteria or the study data that proves the device meets those criteria.

The letter focuses on regulatory approval, listing product codes, indications for use, and general regulatory requirements. It doesn't include the technical details of performance studies.

Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual 510(k) submission, which would contain the performance data and details about the studies conducted by Datex-Ohmeda, Inc.

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The ESCORT-LINK® Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT® II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.

The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.

The modified ESCORT-LINK® Central Station Monitor Model 20500 is a Central Station Monitor comprised of a standard VGA display, a standard Personal Computer Base and an auxiliary base used to mount the network communications hardware.

The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers.

Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the central station on standard UHF telemetry frequencies. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring.

The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment.

The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.

The provided 510(k) summary for the ESCORT-LINK® Central Station Monitor Model 20500 with ST Option offers limited details regarding specific acceptance criteria and a comprehensive study to prove those criteria. However, I can extract the available information and structure it according to your request.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or a direct comparison to reported device performance in a table format. It generally mentions the device was "designed and tested to functional standards developed by independent and regulatory agencies."

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

• Sample Size: Not explicitly stated. The document mentions validation against "the European ST-T (ESC) database." The size of this database for the specific testing performed is not provided.
• Data Provenance: "European ST-T (ESC) database." This indicates the data is from Europe. It is not specified whether the data was retrospective or prospective.

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

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The device is a central station monitor with an ST option, not an AI interpretation tool for human readers. Its primary function is to provide automated ST analysis.

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

Yes, implied. The algorithm comprising the modification (the ST analysis) was "validated against the European ST-T (ESC) database," suggesting a standalone performance evaluation of the algorithm. The device itself operates "without human-in-the-loop performance" for the ST analysis function. The physician's role is to interpret the significance of the changes detected by the device.

7. The type of ground truth used

The ground truth for the ST analysis algorithm's validation was established from "the European ST-T (ESC) database." This database is typically a collection of annotated ECG recordings where ST-T changes (and often associated clinical events like ischemia) are validated, often by expert cardiologists or based on clinical outcomes. However, the specific method of ground truth establishment within that database (e.g., expert consensus, angiography results, pathology) is not detailed in this 510(k) summary.

8. The sample size for the training set

Not mentioned in the document. The document only refers to validation data.

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

Not mentioned in the document, as no information on a training set is provided.

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The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition.

ST Segment Analysis is intended for use in the adult population.

The SC6000/SC6000P is not for home use.

The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged.

The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode.

The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade.

The provided text describes the Siemens SC6000/SC6000P Bedside Monitoring Series enhanced with ST Segment Analysis. The submission is a 510(k) for a modified device, meaning it seeks to prove substantial equivalence to a predicate device. Therefore, the "study" described is primarily focused on demonstrating this equivalence rather than a de novo clinical trial.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, especially regarding ST Segment deviation measurement accuracy.

Note: The document explicitly states "The ST Segment Analysis of the SC6000/SC6000P series patient monitors is equivalent to the ST Segment Analysis of the predicate device." This statement, along with the "Same" annotations in the table, indicates that the acceptance criteria for the ST Segment analysis are met by matching the performance of the predicate device. The changes in "Leads processed" and "Update interval" are noted but not presented as deviations from an acceptance criterion for ST segment accuracy itself, but rather as functional differences that were presumably deemed acceptable.

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

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). As this is a 510(k) submission primarily relying on software equivalence to a predicate device, it appears to leverage existing data or validation processes from the predicate device rather than conducting a new, independent clinical study with a defined test set.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for a test set. This type of detail is typically associated with de novo clinical studies involving human interpretation, which is not the primary focus of this 510(k) submission for a software modification to a monitoring device.

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

The document does not mention any adjudication method for a 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

No MRMC study was reported. This device is an ST Segment monitor, and the focus is on the algorithm's performance in measuring ST deviation, not on human reader improvement with AI assistance.

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

Yes, a standalone assessment of the algorithm's performance is implicit in the comparison of the ST Segment Analysis algorithm to the predicate device. The document explicitly states: "The ST Segment Analysis of the SC6000/SC6000P series patient monitors is equivalent to the ST Segment Analysis of the predicate device." The comparison table directly addresses the accuracy ("± 1mm / ± 0.1mV") of the algorithm itself. This suggests that the algorithm's output (ST segment deviation values) is being evaluated directly against predefined accuracy standards inherent to the predicate device's performance.

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

The explicit type of ground truth used is not specified. However, given the context of a 510(k) submission for a monitoring device's ST segment analysis, the implicit ground truth would likely be a combination of:

• Physiological standards: The accepted medical definition and measurement of ST segment deviation.
• Comparison to predicate device: The performance of the predicate device (Siemens 1481T Digital Telemetry) itself serves as the benchmark against which the modified algorithm's "truth" or accuracy is compared.
• Compliance with industry standards: The device complies with "Performance Measurements for Algorithms to Detect Transient Ischemic ST Segment Changes", IEEE 1992 and "ST Segment Monitor Preliminary Guidance", US Department of Health and Human Services, July 1994, which would imply certain performance expectations that serve as ground truth for algorithm design and testing.

8. The sample size for the training set

The document does not specify a sample size for the training set.

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

The document does not provide information on how the ground truth for a training set was established. Given the age of the submission (1997) and the nature of the device (ECG monitoring with ST segment analysis), it's highly probable that traditional signal processing and rule-based algorithms were in use, rather than machine learning models requiring explicit training sets with labeled ground truth in the modern sense. The "ground truth" for developing such algorithms would typically be based on established physiological principles, expert knowledge of ECG interpretation, and potentially large databases of ECG recordings analyzed by cardiologists.

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The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.

Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor

This 510(k) summary (K972121) for the Acuity Central Station with ST Analysis option provides very limited information regarding specific acceptance criteria and study details. Based on the provided text, a comprehensive answer to your request is not possible. However, I can extract and infer what is present:

Missing Information:

The provided document, being a 510(k)-summary, does not contain the detailed technical data and study reports that would typically outline the acceptance criteria and the comprehensive study conducted to demonstrate the device's performance. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, and often, extensive new clinical studies with detailed acceptance criteria are not required if equivalence can be shown through other means (e.g., bench testing, comparison to predicate performance).

Therefore, many of the specific points you requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details, types of ground truth) are not present in this summary.

Here's what can be extracted and inferred from the provided text, along with a clear indication of what is not available:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

  • As noted above, explicit numerical acceptance criteria are not provided in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device (PCI Model 2041-PC/ST).
  • No specific reported device performance metrics (e.g., sensitivity, specificity, accuracy for ST segment deviation detection) are detailed in this summary. The summary focuses on the intended use and equivalence.

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

  • Not specified. This 510(k) summary does not mention details about a specific test set, its size, or data provenance. Substantial equivalence might have been demonstrated through other means (e.g., comparison of technical specifications, bench testing, or a limited clinical comparison not detailed here).

• 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 specified. Given the lack of information on a formal test set with ground truth establishment, this detail is absent.

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

  • Not specified. This information is not present.

• 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. This is highly unlikely given the device's nature and the era of the 510(k) (1997). The Acuity Central Station is for monitoring and alarm generation, not for direct AI-assisted diagnostic interpretation by human readers in the way an imaging AI might be. Therefore, an MRMC comparative effectiveness study in the context of "human readers improve with AI vs without AI assistance" is not relevant or described. The guidance clearly states the clinician is responsible for determining clinical significance and reviewing all data.

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

  • Implied, but no details provided. The device is an algorithm (ST Analysis option) performing its function ("real-time monitoring and alarms for ST segment deviations"). However, the summary does not provide specific performance metrics of this standalone algorithm. The "human-in-the-loop" is explicitly mentioned as necessary for clinical interpretation.

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

  • Not specified. Without details on a specific study or test set, the type of ground truth used is unknown. For ST segment analysis, ground truth would typically come from clinical diagnosis confirmed by other cardiac assessments or expert ECG interpretation.

• 8. The sample size for the training set:

  • Not specified. This information is absent from the 510(k) summary.

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

  • Not specified. This information is absent from the 510(k) summary.

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The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.

I am sorry, but the provided text only details a 510(k) summary for a medical device called "AS/3™ M-ESTPR," an electrocardiographic device. It describes its function as part of a modular anesthesia monitoring system and lists the physiological parameters it measures (ECG, SpO2, invasive pressure, temperature, and impedance respiration).

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance for specific clinical outcomes.
• Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC, standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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