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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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The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are 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 .
• 12-Lead ST Segment Analysis .
• Transcutaneous Oxygen and Transcutaneous Carbon Dioxide (tpO2/CO2) .

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are 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 gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, . and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia.

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

The provided text describes the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors and their intended use, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. While it lists various monitoring capabilities and specifications, it does not detail performance metrics, study designs, or results that would demonstrate the device meets specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered from the provided text.

Here's what can be extracted based on the information given, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document lists the types of parameters the monitors are capable of measuring (e.g., heart rate, respiration rate, invasive pressure, etc.), but it does not specify performance metrics (e.g., accuracy, precision, response time, false alarm rates) or compare them against predefined acceptance criteria.

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

Not provided. The document does not describe any specific test set or clinical study data.

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

Not provided. The document does not describe any test set or ground truth establishment process.

4. Adjudication Method for the Test Set

Not provided. The document does not describe any test set or adjudication process.

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 document describes a medical device (patient monitor), not an AI algorithm for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study or AI assistance is not relevant to the information provided.

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

Not applicable. The device is a patient monitor, which by its nature is an "algorithm only" type of device in terms of measuring and displaying parameters. However, the document does not contain details of standalone performance studies for its various algorithms (e.g., arrhythmia detection, ST segment analysis). It relies on substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not provided. As no specific performance studies are detailed, the type of ground truth is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is a hardware and software system for patient monitoring, not a machine learning model that undergoes "training" in the conventional sense for AI. If there were internal algorithm development or validation, the sample sizes for such activities are not mentioned.

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

Not applicable/Not provided (see #8).

Summary of Device and Regulatory Status:

• Device Name: Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors
• Predicate Device: Siemens SC9000/SC9015 Patient Monitoring System (K946306)
• Regulatory Pathway: 510(k) premarket notification to establish substantial equivalence.
• Date of Submission: August 13, 1998
• FDA Clearance Date: August 24, 1998
• Intended Use: To monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & transcutaneous carbon dioxide. Also includes measurement of various gas concentrations with add-on modules. The device provides visual and audible alarms.
• Intended Population: Adult, Pediatric, and Neonatal (with specific parameter restrictions for different populations).
• Intended Environment: Healthcare environment where patient care is provided by healthcare professionals.
• Evidence for Equivalence: The document indicates an "Assessment of non-clinical performance data for equivalence: See Section U" and "Assessment of clinical performance data for equivalence: See Section V". However, these sections are not provided in the given text, so the specific details of the data reviewed by the FDA for substantial equivalence are missing. The primary argument in the provided text for equivalence is the similarity in manufacturer, intended use, population, environment, display, waveforms, arrhythmia detection, modularity, networking, NBP, MIB, MultiGas, ST, and IBP features to the predicate device.

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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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Olympus Communications Network: To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers.
SC 3000 Workstation: To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network.
SC 3000 Remote Display: To act as a Slave Display for the SC 3000 Workstation.

Not Found

This document describes the safety and effectiveness information for the Siemens Olympus Communications Network, SC 3000 Workstation, and SC 3000 Remote Display. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• General Information: Device classification, common names, trade names, intended uses, and establishment details.
• Safety and Effectiveness Information II: Compliance with electrical standards (IEC 601-1, UL 544, UL 433, EN 60950, UL 1950, CSA 22.2 No. 950, CE Mark), operational instructions, and adherence to a product development process for design and testing.
• Substantial Equivalence III: Comparison to previously cleared predicate devices from Siemens (SIRENET Communications Network, SIRECUST 120/121C Central Station, SIRECUST 120/121S Slave Display) and Marquette (Unity Network, CentralScope™ 12 Central Station, Remote Color Display).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the given text.

To answer your request, the input document would need to include sections detailing:

• Specific performance metrics (e.g., accuracy, reliability, latency for communication networks; display resolution, refresh rates for workstations/displays).
• Quantitative acceptance thresholds for these metrics.
• Protocols and results of a study (e.g., validation testing, clinical trials) designed to demonstrate that the device meets these thresholds.

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