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The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A. it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module. may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

The S/5 Anesthesia 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/5 Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Anesthesia Monitor: L-ANE07 and L-ANE07A: L-ANE07A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE07. There are two monitor frame options; the 5-module F-CU5(P) monitor frame and the 8-module F-CU8 module frame which can be extended with an Extension Frame. F-EXT4, via the Extension Module E-EXT. The monitor can be equipped with a Recorder Module, E-REC. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A user several types of plugin measurement modules. Modules (with the exception of E-REC and E-EXT) are the subject of separate 510(k)'s and are not part of this notification. The S/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5 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 Anesthesia Monitor with L-ANE07 and L-ANEO7A can display measurements in the form of numeric values, waveforms and trends. Audible and visual alorms are used to indicate patient status. The alarm priority of an alarm depends on the parameter. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then made easily from the menu using a unique designed pointing device on the keyboard called a ComWheel. The software L-ANE07 and L-ANE07A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation. EEG spectrum analysis evoked potential response averaging and entropy calculations. All the module communication is also handled in . the main software. The software L-ANE07 and L-ANE07A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboard and another is a hand-held Remote Controller (REMCO) which is still directly connected to the S/5 Anesthesia Monitor via a long cord but provides flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper option, patient related care events are documented using the keyboard. The S/5 Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving. The S/5 Anesthesia Monitor can also be uparaded to L-ANEO7(A) software using the CARESCAPE Life Uparade Program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia dating back to 1992 to the last S/5 software level. Upgrading of modular monitors is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and main software components needed to make the monitor compatible with the last main software being delivered.

The provided text is a 510(k) Summary for the Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software. It describes the device, its intended use, and its substantial equivalence to a predicate device.

After reviewing the document, I can confirm that it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

Instead, the document states:

• "Summary of Non-Clinical Tests: Determination of Substantial Equivalence:" The device and its applications comply with voluntary standards as detailed in Section 9 of the premarket submission. Quality assurance measures applied to the development include risk analysis, requirements reviews, design reviews, unit level testing, integration testing, final acceptance testing (validation), performance testing (verification), safety testing (verification), and environmental testing.
• "Summary of Clinical Tests: The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

This indicates that while various non-clinical tests and quality assurance measures were performed, a specific clinical study with defined acceptance criteria and performance metrics (as typically expected for AI/ML device evaluations) was not conducted or not deemed necessary for this particular submission to demonstrate substantial equivalence to its predicate device. This is common for traditional medical devices where equivalence to an existing device is the primary pathway.

Therefore, I cannot populate the requested table or provide details on the study's methodology as the information is not present in the provided text. The device's approval appears to be based on demonstrating equivalence to a previously cleared device through non-clinical testing and adherence to voluntary standards, rather than a prospective clinical study with predefined acceptance criteria.

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The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is intended for multiparameter patient monitoring with optional patient care documentation.

The S/5TM Compact Anesthesia Monitor with L-CANE05 and I -C ANE05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory. ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is indicated for use by qualified medical personnel only.

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L CANE05A uses several types of plug-in measurement modules. Datex-Ohmeda M-series measurement modules or E-series modules are used. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5 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™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A perform some module related tasks like arrhythmia analysis, ST values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis evoked potential response averaging and entropy calculations. All the module communication is also handled in the main software. The software L-CANE05 and L-CANE05A also include the option of creating patient care documentation. The trend informatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (K-CREMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also supported, although the bar code reader is not manufactured anymore. The S/5™ Compact Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving. Networking can be hardwired or wireless. The S/5 Compact Anesthesia Monitor can also be upgraded to L-CANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products upto-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 2000 to the latest S/5 software level. Upgrading of modular monitors and network products is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and software components needed to make the monitor or network product compatible with the latest main software being delivered.

The provided text is a 510(k) Premarket Notification Summary for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A Software. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, ground truth methodologies, or MRMC study results) that would typically be found in an clinical trial report or a comprehensive technical performance study.

Therefore, I cannot extract the requested information. The document states:

• "The device has been thoroughly tested through validation and verification of specifications."
• It lists numerous IEC, EN, CAN/CSA, ISO, UL, and ANSI/AAMI standards against which the device was assessed.

However, it does not provide:

1. A table of acceptance criteria and reported device performance: This is not available in the document. It only states that the device was "assessed against" and "thoroughly tested through validation and verification of specifications" according to various standards. Specific performance metrics against acceptance criteria are not presented.
2. Sample size used for the test set and data provenance: No information on test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish ground truth and qualifications: No information on experts or ground truth establishment is provided.
4. Adjudication method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The document primarily focuses on demonstrating substantial equivalence based on technical characteristics and general safety standards.
6. Standalone (algorithm only) performance: While the document mentions a "new improved arrhythmia detection and analysis algorithm," it does not provide standalone performance metrics for this algorithm.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The document's primary argument for meeting acceptance criteria implicitly relies on its compliance with known medical device standards and its substantial equivalence to a previously cleared predicate device, rather than presenting a novel clinical performance study with detailed performance metrics.

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The Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE05 and L-ANE05A Software, using F-CU8 or F-CU5(P) Monitor Frame Options and E-EXT Extension Module and E-REC Recorder Module is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.

The S/5™ Anesthesia Monitor with L- L-ANE05and L-ANE05A 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.

The S/5™ Anesthesia Monitor with L- L-ANE05and L-ANE05A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE05and L-ANE05A software is indicated for use by qualified medical personnel only.

The S/5™ Anesthesia 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 care giver can select from a wariety 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/5™ Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/57M Anesthesia Monitor: L-ANE05 and L-ANE05A: L-ANE05A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE05. There are two monitor frame options; the new 5-module F-CU5(P) monitor frame and the 8-module F-CU8 monitor frame which can be extended with an Extension Frame, F-EXT4, via the Extension Module E-EXT. The monitor can be equipped with a Recorder Module, E-REC. The S/5TM Anesthesia Monitor with L-ANE05 and L ANE05A uses several types of plugin measurement modules. Currently, the legacy Datex-Ohmeda M-series measurement modules are used. In the future, the M-series modules will be replaced with the new E series modules, which are basically face-lifted versions of the corresponding M-series modules. Modules (with the exception of E-REC and E-EXT) are the subject of separate 510(k)'s and are not part of this notification. The S/5TM Anesthesia Monitor with L-ANE05and L-ANE05A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5 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™ Anesthesia Monitor with L-ANE05and L-ANE05A 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™ Anesthesia Monitor with L-ANE05and L-ANE05A 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-ANE05and L-ANE05A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, encrgy expenditure calculation, EEG spectrum analysis evoked potential response averaging and cutropy calculations. All the module communication is also handled in the main software. The software L-ANE05and L-ANE05A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. 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/5TM Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also supported, although the bar code reader is not manufactured anymore. The S/5™ Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving. The S/5 Anesthesia monitor can also be upgraded to L-ANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 1992 to the latest S/5 software level. Upgrading of modular monitors and network products is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and software components needed to make the monitor or network product compatible with the latest main software being delivered.

This document (K051400) describes the GE Healthcare Datex-Ohmeda S/5™ Anesthesia Monitor. It's a premarket notification (510(k)) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study report for novel performance claims.

Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth establishment is largely not present in the provided text. The document primarily focuses on regulatory compliance through substantial equivalence.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

• Not present. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's performance, especially for the improved arrhythmia detection algorithm. It states that the "arrhythmia analysis functionality...is the same as the functionality of the predicate device."
• Instead of performance metrics, the document lists compliance with various international and national standards (e.g., IEC 60601-1, EN 60601-1-2, ANSI/AAMI EC57). These standards primarily relate to electrical safety, electromagnetic compatibility, and basic performance rather than specific clinical accuracy or diagnostic performance acceptance criteria.

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

• Not present. The document does not describe a clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
• The non-clinical testing described refers to "validation and verification of specifications" against standards, which typically involves engineering tests, not a clinical data set.

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

• Not present. Since there is no described clinical test set or study evaluating clinical performance, there is no mention of experts or their qualifications for establishing ground truth.

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

• Not present. No clinical test set or adjudication method is described.

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

• Not present. This document predates the widespread use of "AI" in medical devices as understood today (2006). The device is a patient monitor with software for physiological parameter analysis. It does not describe an AI-driven system that would involve human-in-the-loop performance or MRMC studies. The "improved arrhythmia detection and analysis algorithm" is a software change, not necessarily an AI system in the modern sense.

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

• Not applicable/Not present in a clinical sense. The device itself is a standalone monitor. However, the document does not describe a standalone clinical performance study of the algorithm in isolation. The "validation and verification of specifications" would include testing of the algorithm's functionality as part of the system, but not necessarily a separate performance study against a clinical ground truth.

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

• Not present. Given the absence of a described clinical performance study, there is no mention of the type of ground truth used. For a device like an arrhythmia detector, ground truth would typically come from adjudicated ECG recordings.

8. The sample size for the training set

• Not present. As this document does not describe a machine learning or AI algorithm development, there is no discussion of a training set or its sample size. The "improved arrhythmia detection and analysis algorithm" is presented as a software change, likely developed through traditional signal processing and algorithm design, not necessarily machine learning requiring a "training set."

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

• Not present. (See point 8).

Summary of what the document does provide regarding "the study":

The "study" or rather, the basis for regulatory clearance, is a non-clinical testing program that assessed the device against a list of international and national standards:

• Type of Study: Verification and validation of specifications against recognized consensus standards.
• Purpose: To demonstrate that the device is safe and effective and substantially equivalent to its predicate device, primarily through compliance with engineering and safety standards.
• Nature of Testing: Primarily electrical safety, electromagnetic compatibility, and basic functional performance checks as dictated by the listed standards (e.g., IEC 60601 series, ISO 9918, ANSI/AAMI EC57).
• Conclusion: "The device has been thoroughly tested through validation and verification of specifications. ... there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE05 and L-ANE05A Software... as compared to the predicate device."

In essence, for this 510(k) submission, the "study" demonstrating adherence to acceptance criteria is the comprehensive non-clinical testing for compliance with established safety and performance standards for patient monitoring equipment, rather than a clinical performance study with specific diagnostic accuracy metrics. The improvement in the arrhythmia algorithm is noted as a change, but its specific performance metrics against clinical data are not detailed in this summary.

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The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.
The S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A 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.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for use by qualified medical personnel only.

The S/5™ Compact Anesthesia 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 Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Compact Anesthesia Monitor: L-CANE03 and L-CANE03A. L-CANE03A is equipped with extended arthythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CANE03.

The provided text describes modifications to an existing patient monitor, the Datex-Ohmeda S/5™ Compact Anesthesia Monitor, with new software versions L-CANE03 and L-CANE03A. The primary focus of the submission is to demonstrate substantial equivalence to the predicate device and ensure continued safety and effectiveness after the modifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the device's monitoring functions, nor does it report specific numerical performance data against such criteria.

Instead, the acceptance criteria are implicitly linked to compliance with recognized medical device standards and demonstrating substantial equivalence to the predicate device. The performance is indirectly "reported" by affirming compliance with these standards and stating that the device is "safe and effective for the intended use."

The key modifications that would typically have performance implications are:

• Improvement in QRS detection with low QRS amplitude ECG, to avoid false Asystole alarms.
• Modification of Ventricular Tachycardia definition: now 6 beats at a heart rate of 120 bpm (previously 5 beats at 100 bpm).
• L-CANE03A equipped with extended arrhythmia analysis capability (though stated to be substantially equivalent to the predicate's arrhythmia analysis).

However, specific quantitative acceptance criteria or performance metrics for these changes are not provided in the summary. The document states: "Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for validating the device's performance after modifications. The evaluation seems to be focused on nonclinical testing and compliance with industry standards.

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

The document does not mention using experts to establish ground truth for a test set. This type of detail is typically found in clinical validation studies, which are not explicitly detailed here.

4. Adjudication Method

Since there's no mention of experts or a test set requiring ground truth adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or mentioned in the provided summary. The submission focuses on substantial equivalence through design and software changes, and compliance with standards, rather than a clinical human-in-the-loop comparison.

6. Standalone Performance Study

The document implies a standalone (algorithm only) performance evaluation through "validation and verification of specifications" and compliance with standards like "FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are not quantitatively presented. The focus is on the process of testing against standards rather than reporting the results of such tests in a summarized form.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the context of nonclinical testing and compliance with standards for a patient monitor, the ground truth would likely be established by:

• Reference measurements/simulations: Using calibrated equipment to generate known physiological signals (e.g., ECG waveforms with specific arrhythmias, varying QRS amplitudes) to test the device's ability to accurately detect and classify them.
• Expert consensus (implied for standards): The standards themselves (e.g., IEC 60601-2-27 for ECG monitoring) are often built upon expert consensus regarding acceptable performance limits.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning algorithms, which are not explicitly detailed as a core component of this submission beyond general "data processing" and "arrhythmia analysis capability."

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through description of modifications, affirmation of similar intended use and indications, and compliance with a comprehensive list of nonclinical safety and performance standards. It does not contain detailed quantitative performance data or descriptions of clinical validation studies often associated with diagnostic AI devices.

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The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is intended for multiparameter patient monitoring with optional patient care documentation.

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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. The S/5TM Anesthesia Monitor with L-ANE03 A software is also indicated for documenting patient care related information. The S/57M Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.

The S/5™ Anesthesia 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 care giver 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/5™ Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Anesthesia Monitor: L-ANE03 and L-ANE03A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE03.

The modifications to the device are:

• Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance.
• Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole alarms.
• The definition for Ventricular Tachycardia have been modified: now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
• Invasive pressure cursor added to the inv.bp waveform field. The cursor is used for marking the reference pressure levels during a monitoring period.
• MAC (Mean Alveolar Concentration) age calculation added. User can select the calculation of age-dependent MAC values.
• Invasive pressure Mean Arterial Pressure (Art mean) value added to vital parameters numerical trend page.
• New catheter types added to the selection list for the Cardiac Output measurement.
• Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode.
• Messages related to the communication between S/5 monitor and D-O Central have been modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
• Menu and Data Card symbols and Network symbol have been modified. Layout changes have been done so that the same symbols can be displayed with all of the different display resolutions.
• A 19" LCD display and a 43″ plasma display secondary display option have been added along with a display controller specific for the 19" LCD (B-DISP19).

The provided text describes a Premarket Notification (510(k)) for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software. This document primarily focuses on establishing substantial equivalence to a predicate device (Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279)) and outlines the device's intended use and the results of nonclinical testing.

The document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study with detailed metrics like sensitivity, specificity, or reader agreement. Instead, it focuses on compliance with recognized safety and performance standards and affirms the device's substantial equivalence to a legally marketed predicate.

Therefore, many of the requested details (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not explicitly provided in this type of regulatory submission. The "study" proving the device meets acceptance criteria, in this context, refers to the nonclinical testing and compliance with standards.

Here's an attempt to extract and interpret the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to "nonclinical testing" and "software validation and verifications," which would involve testing, but details on sample size (e.g., number of ECG recordings, duration of tests) are not provided.
• Data Provenance: Not specified, but given the nature of the testing described (electrical safety, EMC, mechanical, software validation), it would involve internal laboratory testing and simulations rather than patient data in the context of clinical trials. The improvements mentioned (QRS detection, VT definition) would have been validated using internal test datasets, likely derived from various sources where such events occur.

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

• Not specified. For performance improvements like QRS detection and VT definition, internal experts (e.g., biomedical engineers, cardiologists/anesthesiologists involved in medical device development or review) would establish reference or "ground truth" data, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not specified. Given the compliance testing nature, formal adjudication by a panel is unlikely for most of the listed tests. For specific software algorithm changes (like QRS detection improvement or VT definition), internal processes for verifying correctness would be in place, but a specific "adjudication method" like 2+1 or 3+1 is not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance and is typically associated with AI/CAD systems that interpret images or complex data for diagnostic purposes. This device is a patient monitor, which provides raw and processed physiological data directly to medical personnel, rather than an AI interpreting images for a reader.

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

• Yes, standalone performance was implicitly done for the algorithm components, particularly for the "Improvement in the QRS detection" and the "modified... Ventricular Tachycardia" definition. The "software validation and verifications" would encompass testing the algorithms' performance against defined specifications (e.g., accuracy of QRS detection, correct classification of arrhythmias based on the new definition). However, specific performance metrics (e.g., sensitivity, specificity, accuracy) from such standalone tests are not detailed in this summary.

7. The type of ground truth used

• For the nonclinical testing described, the ground truth would likely be based on:
  • Defined Standards: For electrical, EMC, mechanical, and environmental tests, the "ground truth" is compliance with the limits and methodologies specified in the respective international and national standards (e.g., IEC 60601 series).
  • Reference Devices/Simulators: For physiological parameter measurement accuracy, calibrated reference devices or patient simulators would likely be used.
  • Expert Definitions/Reference Annotations: For algorithm improvements like QRS detection and VT definition, the ground truth would be based on expertly annotated ECG waveforms or established physiological criteria for these events.

8. The sample size for the training set

• Not specified. As this is a 510(k) submission primarily focused on hardware and software updates to an existing monitor, and not a de novo AI/Machine Learning device where "training sets" are explicitly described, information on training set size is not provided. The development and refinement of algorithms (like QRS detection) would have involved internal datasets, but these are not quantified here as "training sets."

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

• Not specified. Similar to point 8, the concept of a formally defined "training set" with ground truth established by external experts (as might be seen in advanced AI submissions) is not explicitly discussed in this type of 510(k). For algorithmic development, internal R&D processes would involve creating or acquiring data where the correct physiological events are identified (e.g., by manual review against established clinical criteria or by using highly accurate reference systems), but the specifics are not disclosed.

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The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, Sevoflurane, and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.

The device will be available for use by medical personnel on patients within a medical facility including adults, children and infants.

The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

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Common names for the BSM-5130A device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia monitor. The device has been classified as Class III per Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, "Physiological Patient Monitor with Arrhytmia Detection and Alarms" as MHX and under 21 CFR 870.2340. "ECG Analysis System" as LOS. Functions of the device have also been classified as Class II by the Anesthesiology Device Classification Panel and the General Hospital and Personal Use Classification Panel as follows: under 21 CFR 870.2300, "Cardiac Monitor (including cardiotachometer and rate alarms)" per DRT: under 21 CFR 870.2700, "Oximeter" per DQA; under 21 CFR 870.1130, "Noninvasive Blood Pressure Measurement System" per DXN; under 21 CFR 870.1110 and 21 CFR 870.1100, "Blood Pressure Computer and Alarm" per DSK and DSJ; under 21 CFR 880.2910, "Thermometer. Electronic, Clinical" per FLL; under 21 CFR 868.2375, "Breathing Frequency Monitor" per BZQ; under 21 CFR 868.1720, "Oxygen Gas Analyzer" per CCL; under 21 CFR 868.1400, "Carbon Dioxide Gas Analyzer" per CCK; under 21 CFR 870.2910, "Radio Frequency Physiological Signal Transmitter" per DRG.

The provided text is a 510(k) premarket notification for the NIHON KOHDEN AMERICA, INC. BSM-5130A Series Bedside Monitor. It includes information about the device's indications for use, classification, and predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

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

The text does state: "The BSM-5130A series Bedside Monitor was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications."

This indicates that internal performance testing and software validation were conducted, but no details about the specific acceptance criteria or the results of these tests are provided.

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The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A is intended for multiparameter patient monitoring with optional patient care documentation.

The S/57M Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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 Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.

The S/5™ Compact Anesthesia 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 Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Compact Anesthesia Monitor: L-CANE02 and L-CANE02A. L-CANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities. this software option is identical to L-CANE02.

The S/5TM CAM 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™ CAM is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5TM 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™ CAM 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™ CAM is operated by a keyboard. Typically pressing a kev 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-CANE02 and L-CANE02A perform some module-related tasks like arrhythmia analysis. ST-values 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. The software L-CANE02 and L-CANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthesia record, and the related events and medication can be easily entered with the same user interface as the monitor itself. 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/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Compact Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving.

The provided document describes a Premarket Notification 510(k) for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of specific device performance studies against acceptance criteria.

The document states that the device was thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation, and verification of specifications, reporting compliance with safety standards. However, it does not explicitly define acceptance criteria or report specific performance metrics for the device's functions (e.g., arrhythmia detection accuracy, ST-segment analysis sensitivity/specificity) using a defined test set.

Therefore, many of the requested details, especially those related to a clinical study establishing device performance against acceptance criteria, cannot be extracted from this 510(k) summary. The document focuses on regulatory compliance through substantial equivalence to a predicate device and adherence to recognized standards.

Here's a breakdown of the information that can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any performance testing. The document refers to "thorough testing" and "verification of specifications" but provides no details on test set sizes for evaluating specific clinical functionalities.
• Data Provenance: Not specified.

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

• Not applicable as no specific clinical performance study with a test set and ground truth establishment is described.

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 patient monitor, not an AI-based diagnostic tool requiring human reader studies.

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

• While the software performs tasks like "arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging," the document does not detail specific standalone performance studies for these algorithms. Its focus is on general compliance and substantial equivalence to the predicate device, which inherently implies that these functions perform as expected for such a device type.

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

• Not specified for any algorithmic performance. For overall safety and compliance, the "ground truth" is adherence to various international and national safety and performance standards (e.g., IEC, EN, ANSI/AAMI).

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a medical device with embedded software, not a machine learning model where a distinct "training set" would typically be discussed in this context. The software is preloaded and performs specific known physiological calculations and analyses based on established algorithms in patient monitoring.

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

• Not applicable/Not specified, for the reasons above.

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The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is intended for multiparameter patient monitoring with optional patient care documentation.

Indications for use:

The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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 *.

The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is indicated for use by qualified medical personnel only.

The S/5TM Anesthesia 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 care giver 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 Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing.

There are two software options available for the S/57M Anesthesia Monitor: L-ANE02 and L-ANE02A.

L-ANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE02.

The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A uses several types of plugin measurement modules are the subject of separate 510(k)'s and are not part of this notification. The S/5TM Anesthesia Monitor with L-ANE02 and L-ANE02A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures. pulse oximetry and temperature. Modules are placed in the S/57M 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/57M Anesthesia Monitor with L-ANE02 and L-ANE02A 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™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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-ANE02 and L-ANE02A perform some module related tasks like arrhythmia analysis, ST-values 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. The software L-ANE02 and L-ANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. 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/5TM Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving.

I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a specific study proving the device directly meets acceptance criteria for improved arrhythmia analysis (L-ANE02A software). The document focuses on regulatory approval (510(k) submission) for a modified patient monitor by demonstrating substantial equivalence to a predicate device.

Here's a breakdown of why I cannot fulfill your request with the given information:

1. Acceptance Criteria and Reported Device Performance: The document lists several recognized safety and performance standards (like IEC, EN, CAN/CSA, ISO, UL, ANSI/AAMI, FDA 21 CFR 898.12) that the device complies with. These are general standards, not specific acceptance criteria for a particular feature like arrhythmia detection. There are no reported performance metrics for the device (e.g., sensitivity, specificity, accuracy) in relation to arrhythmia detection or any other specific physiological parameter.

2. Sample Size and Data Provenance: This information is completely absent. The document discusses device modifications and compliance with standards, but not the methodology of a study involving a test set, its size, or its origin.

3. Number and Qualifications of Experts: Not mentioned.

4. Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. The document describes a "standalone" device (patient monitor) and its software, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance Study: The document states, "Uses an arrhythmia analysis version which has an improved vfib algorithm compared to arrhythmia analysis version submitted in the predicate 510(k)." This implies an improvement in algorithmic performance. However, there is no detailed standalone study presented with performance metrics (e.g., sensitivity, specificity for vfib detection), sample sizes, or ground truth methodology to quantify this improvement. The focus is on demonstrating overall safety and effectiveness through compliance with general standards and substantial equivalence, rather than a detailed performance study of a specific algorithm.

7. Type of Ground Truth: Not specified. If an arrhythmia study were conducted, the ground truth would likely be expert-adjudicated ECGs, but this is not detailed in the provided text.

8. Sample Size for Training Set: Not applicable/not mentioned. This isn't a machine learning algorithm where a distinct "training set" would be referenced in this context. While the software has an "improved vfib algorithm," the development and validation data for this algorithm are not disclosed here.

9. Ground Truth for Training Set: Not applicable/not mentioned.

In summary: The provided 510(k) summary focuses on demonstrating that the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is substantially equivalent to a predicate device and complies with various safety and performance standards. It does not contain the details of a specific clinical or technical study that defines acceptance criteria for its arrhythmia analysis capability and then presents data to show those criteria were met. The claim of an "improved vfib algorithm" is stated, but without supporting study data in this document.

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