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The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY Modular monitors are capable of monitoring:

• Heart rate
• Respiration rate
• Invasive pressure
• Non-invasive pressure
• Arrhythmia
• Temperature
• Cardiac output
• Arterial oxygen saturation
• Pulse rate
• Apnca
• ST Segment Analysis
• 12-Lead ST Segment Analysis
• tcp02/tcpC02
• EEG signals
• FiO2

With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via an MIB protocol converter.

The modifications implemented with the release of software version VF2 have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF2 software indicates no new issues relative to safety and efficacy. The release of software version VF2 includes the following primary modifications:

• 1. Wireless capability
• Non-invasive blood pressure with step deflation 2.
• 3. MICRO2+(K012770) interface
• Support for Masimo sensors 4.

The INFINITY Modular Monitors (SC 7000 / SC 9000XL) with Wireless Option (a password protected option) allows the monitor to operate in a wireless network configuration. A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.

The Infinity Monitoring System utilizes the oscillometric method to measure noninvasive blood pressure (NIBP). With the SC7000/8000/9000XL VF2 release, the NIBP algorithm has changed from a linear to stepped deflation system.

The INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000XL) VF2 release supports two simultaneous SpO2 measurements. Using a serial port already available on the monitors, the MicrO2+ pulse oximeter (K012770) can communicate with the monitors using a RS232 serial communication and power supply cable connected to the serial port on the monitor. The stand-alone MicrO2+ pulse oximeter transmits SpO2 and Pulse values to the monitor.

The monitor supports the use of Masimo SpO2 sensors via a password protected option and a specific adapter cable.

The provided text describes modifications to the Siemens INFINITY Modular Monitors and makes references to equivalence assessments and clinical accuracy studies. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• "Assessment of non-clinical performance data for equivalence: See Section J"
• "Assessment of clinical performance data for equivalence: See Section J"
• "Clinical accuracy studies referenced to cooximetry (see Section J) were conducted by Masimo using the following sensors in conjunction with the INFINITY Modular monitors"

Since "Section J" is not provided in the input, the specific details of the acceptance criteria and the studies proving the device meets them are unavailable.

Based on the available text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not provided in the given text.
• Reported Device Performance: Not provided in the given text, beyond the general statement that "Testing with VF2 software indicates no new issues relative to safety and efficacy."

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

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). The text only states "clinical accuracy studies referenced to cooximetry... were conducted by Masimo."

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

• Not provided. The text mentions "clinical accuracy studies referenced to cooximetry," implying cooximetry serves as a reference, but it doesn't specify if human experts were involved in establishing ground truth or their qualifications.

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

• Not provided.

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. The described device is a physiological monitor, not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study. The text focuses on the device's ability to measure physiological parameters and its new features (wireless, NIBP, SpO2 interface, Masimo sensor support).

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

• The text implies standalone testing of the device's physiological measurement capabilities through "clinical accuracy studies referenced to cooximetry." However, details of these studies are not provided.

7. The type of ground truth used:

• For SpO2 measurements, the text explicitly states "clinical accuracy studies referenced to cooximetry." Cooximetry is a gold standard for measuring oxygen saturation in blood. For other parameters (Heart rate, Respiration rate, NIBP, etc.), the type of ground truth is not specified in this document.

8. The sample size for the training set:

• Not provided. The document describes modifications to an existing device and refers to "accuracy studies" but does not detail a training set for an AI/algorithm.

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

• Not provided, as details of a training set are not mentioned.

In summary, for a complete answer to your questions, "Section J" of the original 510(k) submission would be required. The provided excerpt only gives a high-level overview of the device modifications and mentions that performance data exists, but not the specifics of that data or the studies.

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The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits.

The INFINITY MICRO2+ is a small, compact battery operated ambulatory pulse oximeter. The hand-held INFINITY MICRO2+ is a redesign of the MICRO2 (K913489) used for the noninvasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate with the use of an oxygen transducer (sensor). The SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance. A range of compatible sensors is available for use with the INFINITY MICRO2+. The INFINITY MICRO2+ can be connected to a Siemens INFINITY Telemetry transmitter (K972714) or to a customer's personal computer for the display and printing of SpO2 trend information. The device is intended to provide continuous. non-invasive SpO2 monitoring for neonatal, pediatric and adult patient populations in health care environments where patient care is provided by licensed health care professionals.

The provided document is a 510(k) summary for the INFINITY MICRO2+ Pulse Oximeter. It does not contain specific acceptance criteria, reported device performance data, sample sizes for test sets, details on ground truth establishment, or information about MRMC studies. The document primarily focuses on demonstrating substantial equivalence to predicate devices.

However, based on the information provided, here's what can be inferred and what is missing:

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

This information is not provided in the given text. A 510(k) summary typically includes a summary of performance data in comparison to a predicate device, but specific acceptance criteria (e.g., accuracy +/- X% SpO2) and tables with reported device performance against those criteria are not detailed here. The document mentions "Assessment of non-clinical performance data for equivalence: Section S 7" and "Assessment of clinical performance data for equivalence: Section T 8," suggesting that this information exists in the full 510(k) submission, but it's not present in this summary.

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

This information is not provided. The document states "Clinical and bench testing performed demonstrate that the INFINITY MICRO2+ is as safe and effective as [predicate devices]," but no details about the sample size, type of study (retrospective/prospective), or data provenance are given.

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. For a pulse oximeter, ground truth for SpO2 is typically established through co-oximetry of arterial blood samples. There would likely be a medical professional (e.g., physician, nurse, or clinical researcher) overseeing the blood draws and potentially confirming the patient's physiological state, but the expert qualifications in the context of "ground truth" for a medical imaging or diagnostic device (like radiologist expertise) are not directly applicable here in the same way.

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

This information is not provided. Adjudication methods are typically used when multiple experts are interpreting data and there's a need to resolve disagreements (e.g., in reading medical images). For a pulse oximeter performance study, the ground truth is usually an objective measurement (co-oximetry), so traditional adjudication between multiple human readers or experts is generally not applicable unless there were subjective assessments being made that required resolution.

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

This information is not applicable as the INFINITY MICRO2+ is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. It is a standalone device for measuring physiological parameters.

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

Yes, the device's performance is inherently standalone in nature. A pulse oximeter algorithm processes raw sensor data to output SpO2 and pulse rate. The "SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance." This indicates that the algorithm's performance, operating without human intervention for the primary measurement, was evaluated.

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

While explicitly stated, for pulse oximeters, the ground truth for oxygen saturation (SpO2) measurements in clinical studies is typically arterial blood gas analysis (ABG) measured by a co-oximeter. This provides the true arterial oxygen saturation (SaO2) which is then compared against the SpO2 reading from the device.

8. The sample size for the training set

This information is not provided. The document mentions a redesign and enhancement of the algorithm from a predicate device but does not detail any "training set" in the context of modern machine learning. In 2002, the development process for medical device algorithms like this would likely involve empirical testing and refinement rather than a distinct "training set" as understood in current AI/ML development.

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

This information is not provided and is likely not applicable in the modern sense of an AI "training set" given the device's approval date (2002). Algorithm development at that time would primarily involve physiological modeling, signal processing, and empirical validation against known physiological states (ground truth likely from co-oximetry, similar to for the test/validation).

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This device is capable of monitoring:

• Heart Rate .
• Respiration Rate .
• Invasive Pressure .
• Non-Invasive Pressure ●
• Arrhythmia .
• Temperature .
• Arterial oxygen saturation .
• Pulse rate .
• (central) apnea .
• end-tidal CO2 .
• ST Segment Analysis .

This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, e.g., Physicians, Nurses, and technicians, trained on the use of the devices, who will make the final assessment of the patient's medical condition.

SC 6002XL Wireless Option

A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.

The MultiView WorkStation supports wireless operation by providing information to the SC6002XL allowing the monitor to have a unique network address. Once the SC6002XL has established itself on the network, the MultiView WorkStation has no new functionality. MultiView WorkStation hazards identified with the MVWS support of the wireless functionality have been addressed in MVWS VF2 software.

SC 6002XL with Full Arrhythmia Option

The SC 6002XL VF1 release includes the Full Arrhythmia Option. With this option eight additional arrhythmia calls are enabled. The arrhythmia algorithm is the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632). Previous releases of the SC 6002XL (K993974 DC 900012 (1196002) the same arrhythmia algorithm, however, in the first two releases of the SC and I would the Basic Arrhythmia functionality, with fewer arrhythmia calls was made available.

Fourth Channel Option

In addition, to provide customers with more readily available information, a fourth channel is being made available. The fourth channel is also a locked option.

The provided document is a 510(k) summary for the Siemens INFINITY SC 6002XL Modifications. It details the device, its intended use, and indicates the basis for its substantial equivalence determination to previously marketed predicate devices. However, it does not include detailed information about specific acceptance criteria, a study proving performance against those criteria, or the methodology (like ground truth establishment, sample sizes for training/testing, or expert qualifications) that would typically be found in a clinical or performance study report.

Here's a breakdown of the information that can be extracted and, crucially, what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the given document. The document states "Assessment of non-clinical performance data for equivalence: Section L" but does not elaborate on the specific criteria or the results of this assessment. For clinical performance, it explicitly states "Assessment of clinical performance data for equivalence: Not applicable."

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

This information is not provided. Since no clinical performance study is described, there's no mention of a test set, its sample size, or data provenance.

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

This information is not provided. As no clinical performance study is described with a test set, there is no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set:

This information is not provided. Since no test set is described, there is no adjudication method mentioned.

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

This information is not provided. The document makes no mention of an MRMC study or any AI assistance. The device is a physiological monitor, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

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

This information is not explicitly stated as a standalone performance study in the document. The document refers to the arrhythmia algorithm being "the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632)." This implies that the algorithm's performance was evaluated in the context of those previous submissions, but documentation for that specific evaluation is not part of this 510(k) summary.

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

This information is not provided for any specific study in this document.

8. The sample size for the training set:

This information is not provided. The document does not describe a training set as it pertains to an AI/ML algorithm being developed or refined.

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

This information is not provided.

Summary of what the document does provide regarding the device's basis for market clearance:

The document focuses on demonstrating substantial equivalence to previously cleared devices (predicates) rather than providing a detailed de novo clinical performance study report.

• Predicate Device: Siemens INFINITY SC 6002XL (K993974, K002105) and the arrhythmia algorithm from Siemens MVWS INFINITY Telemetry (K003179) and other Siemens patient monitors (SC 7000/SC 9000XL K980882, SC 8000 K983632).
• Modifications: The 510(k) submission addresses modifications to the existing INFINITY SC 6002XL, specifically:
  • Wireless Option: Adding a wireless ethernet adapter for network connectivity. The functionality is stated to be "the same functionality as a hardwired system."
  • Full Arrhythmia Option: Enabling eight additional arrhythmia calls using an existing, previously cleared arrhythmia algorithm found in other Siemens devices.
  • Fourth Channel Option: Providing a fourth channel of information.
• Assessment of Equivalence:
  • Non-clinical performance data: Referenced as "Section L," but details are not provided in this summary.
  • Clinical performance data: Stated as "Not applicable," indicating that for these specific modifications, new clinical data was not deemed necessary by the submitter to demonstrate substantial equivalence, likely due to the use of a previously cleared algorithm and the nature of the wireless and fourth-channel additions.
• Standards: IEEE 802.11 Standard for Wireless Medium Access Method (MAC) and Physical Layer (PHY) is listed, suggesting that the wireless component's performance would be evaluated against this standard.

In essence, the document asserts that the modified device is substantially equivalent to existing, legally marketed devices based on the inclusion of proven components (like the arrhythmia algorithm) and standard compliant technologies (like wireless networking), without presenting new, detailed performance study outcomes for these specific modifications.

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This device is capable of monitoring:

• Heart Rate .
• Respiration Rate ●
• Invasive Pressure .
• Non-Invasive Pressure ●
• Arrhythmia ●
• Temperature .
• Arterial oxygen saturation .
• Pulse rate .
• (central) apnea .
• end-tidal CO2 .

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

The devices are intended to be used on Adult. Pediatric and Neonatal populations, with the exception of Arrhythmia which is not intended for the neonatal population.

The INFINITY SC 6002XL is an addition to Siemens INFINITY patient monitoring series that has combined the technologies of two predicate devices: the INFINITY SC 600X and the INFINITY SC 7000. Like the SC 600X the INFINITY SC 6002XL is a compact, configured monitor whose small size allows for ease of portability. Modifications have been made to the SC 600X software to make it more analogous to the SC 7000 platform. The front panel display is similar in design to the SC 7000 for a more uniform look to the INFINITY product line. In addition to A/B clinical performance tests that compared the new INFINITY SC 6002XL to the SC 7000, in-house verification and validation tests were performed. All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices.

The provided text is a 510(k) Notification for the Siemens INFINITY SC 6002XL Portable Patient Monitor. This type of submission is for medical devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and efficacy. Therefore, the document primarily focuses on comparing the new device against existing ones.

As such, detailed acceptance criteria and a study proving the device meets them in the way modern clinical trials would are not present in this type of submission. This document highlights that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." However, it does not provide the specific metrics, methodologies, or results of these tests in detail.

Thus, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

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

This information is not explicitly provided in the 510(k) summary. The document states that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." This implies that the acceptance criteria were likely based on matching the performance of the predicate devices for each monitored parameter (Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse Rate, (central) Apnea, and end-tidal CO2). However, specific numerical acceptance thresholds or detailed performance metrics are not given.

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

This information is not provided. The document mentions "A/B clinical performance tests" and "in-house verification and validation tests" but gives no details on sample size, data source (country), or whether it was retrospective or prospective.

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

This information is not provided.

4. Adjudication method for the test set:

This information is not provided.

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:

This is irrelevant for a patient monitor and certainly not mentioned. Patient monitors like this do not involve "human readers" or "AI assistance" in the way an imaging diagnostic device might.

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

The device is a patient monitor, which inherently operates in a standalone manner by continuously measuring and displaying physiological parameters. The "algorithm only" aspect would refer to the internal signal processing of the monitor. The document confirms that "in-house verification and validation tests were performed," which would include testing the accuracy and reliability of these internal algorithms. However, a separate "standalone" study in the context of an AI algorithm is not applicable here given the device's function as a physiological monitor.

7. The type of ground truth used:

This information is not provided. For a patient monitor, ground truth would typically be established using validated reference measurement devices or established clinical standards for each physiological parameter.

8. The sample size for the training set:

This information is not provided. For a device like this, there isn't a "training set" in the machine learning sense. The device's algorithms are developed through engineering and validated against known physiological signals and simulated conditions.

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

This information is not provided. As noted above, the concept of a "training set" with established ground truth as in machine learning is not directly applicable to this type of device development as described in the 510(k) notice.

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This device is capable of monitoring Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, End-tidal carbon dioxide, (central) apnea, ST segment analysis. With the MultiGas™ and MultiGas+™ modules the SC9000/SC9015 is capable of measuring: Respiration rate, Inspired and expired Carbon Dioxide (CO2), Inspired and expired Oxygen (MultiGas+TM only), Average inspired Oxygen (MultiGas™ only), Inspired and expired concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis. This device can be connected to third party devices: Siemens SV 300™ ventilator, the Baxter Vigilance™ blood gas system, the Puritan Bennett 7200™, Draeger Evita IV™, & Babylog™, and Siemens SV900™ ventilators. The device is intended to be used in the environment where patient care is provided by Healthcare professionals, and use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the 12-Lead ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only.

The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is an updated version of the Siemens SC9000/SC9015 Bedside Monitoring System. The system is comprised of the following components: MultiMed-12™ ECG pod, SC9000 with a new, optional processing board and enhanced software, MultiView WorkStation with enhanced software, Cardiology Review Station (optional). A new 12-lead ECG patient cable, the MultiMed-12™ "pod', collects data from the patient and transmits it to the SC9000 unit. To enable 12-lead ST processing, the new, optional processing board must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unit receives the signals from the MultiMed-12™ ECG pod, downsamples them to 500 samples/s and performs QRS detection. The SC9000 then performs 12-lead ST analysis on the ECG leads provided, using the same algorithm as the predicate device (Siemens Megacart™, K915225) with minor modifications to generate ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector. The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). If connected to a commercially available LaserPrinter™, ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to enable printing of 12-lead reports. This requires no hardware modifications. The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST data from the SC9000, and collects and archives the trend data for review by the user.

The provided 510(k) summary for the Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis includes limited information regarding acceptance criteria and study details. Based on the document, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "Currently there are no FDA standards for this device." and "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." However, it does not list specific quantitative acceptance criteria for ST segment analysis or the reported performance metrics against those criteria. It only mentions that the device uses "the same algorithm as the predicate device" for 12-lead ST analysis.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "a standard clinical database per AAMI recommendations," but the size of this database is not provided.
• Data Provenance: Not explicitly stated. It refers to "a standard clinical database," which implies a collection of existing data, likely retrospective. The country of origin is not mentioned.

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

Not explicitly stated. The document mentions "testing versus a standard clinical database," but it does not describe how the ground truth within this database was established or the number and qualifications of experts involved.

4. Adjudication Method for the Test Set

Not explicitly stated. Given the reference to a "standard clinical database," it's possible that the ground truth within that database was already established through some form of expert consensus or adjudication, but the method is not detailed here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or indicated in the document. The study described focuses on the device's performance against a clinical database, not on its impact on human reader performance.

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

Yes, a standalone performance evaluation of the algorithm appears to have been done. The document states, "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." This implies the algorithm's output was compared directly against the ground truth of the database, without human intervention in the analysis process being explicitly mentioned as part of this qualification.

7. The Type of Ground Truth Used

The ground truth used was based on a "standard clinical database per AAMI recommendations." This suggests that the ground truth for ST segment analysis within this database would typically be derived from expert consensus by cardiologists or other qualified medical professionals, often using established criteria for ST segment evaluation. However, the exact nature (e.g., pathology, outcomes data) is not specified beyond "standard clinical database."

8. The Sample Size for the Training Set

Not applicable. This device is an updated version of a previously cleared device (Siemens MEGACART™ K915225 and SC9000/SC9015 K946306). The document mentions the new device uses "the same algorithm as the predicate device" for ST analysis. This suggests that the algorithm was developed and validated prior to this submission, likely using training data, but the details of that training set and its size are not provided in this 510(k) summary. The current submission focuses on demonstrating substantial equivalence, not re-training a new algorithm.

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

Not applicable, as details about a training set for this specific submission are not provided. The algorithm is stated to be the "same as the predicate device," implying its ground truth establishment would have occurred during the development of the original algorithm, which is not described here.

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