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The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

This document is a 510(k) summary for the Capnostream™ 35 Portable Respiratory Monitor. It details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

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

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, precision, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through validation of software functions, usability testing, and wireless connectivity.

• Software Validation: "to ensure that all modified software functions as intended."
  • Reported Performance: Passed. Implicitly, the software performed as expected and intended.
• Cybersecurity Documentation: "identified cybersecurity risks and summarized how they were mitigated."
  • Reported Performance: Cybersecurity risks were identified and mitigated.
• Usability Testing (per IEC 60601-1-6): "assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display."
  • Reported Performance: Passed.
• Wireless Connectivity Testing: "The wireless communication testing passed for all wireless key types compatible with the device."
  • Reported Performance: Passed.

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

• Usability Testing:

  • Sample Size: 15 intended users.
  • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. It's implied to be prospective testing specific to this device.

• Other tests (Software, Cybersecurity, Wireless Connectivity): Sample sizes for data points are not specified, as these are typically functional or engineering tests rather than studies on a "test set" of patients or data records.

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 in the document. The listed tests (software validation, usability, wireless connectivity) do not typically involve establishing a clinical "ground truth" derived from expert consensus in the same way a diagnostic algorithm might. Usability testing relies on user feedback, and software/connectivity validation relies on engineering specifications.

4. Adjudication method for the test set

This information is not provided as it's not applicable to the types of tests described. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation, which is not what was performed for these non-clinical tests.

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

There is no indication that an MRMC comparative effectiveness study was done. The device description and performance data focus on device functionality and its equivalence to predicates, not on AI assistance to human readers or effect sizes of such assistance. The device is a monitor, not an AI diagnostic tool.

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

The performance data listed (software validation, usability, wireless connectivity) are for the device as a standalone product in terms of its functions. There is no mention of an "algorithm only" performance study separate from the device's integrated operation. The device itself performs continuous non-invasive monitoring and provides specific parameters and alerts.

7. The type of ground truth used

• Software Validation: The "ground truth" is adherence to predefined software requirements and specifications.
• Usability Testing: The "ground truth" is the successful and easy completion of key tasks by users and their understanding of the display, measured against usability objectives.
• Wireless Connectivity Testing: The "ground truth" is successful connection and data transmission/reception according to wireless communication standards and protocols.

These are functional and engineering "ground truths," not clinical ones like pathology or expert consensus on patient conditions.

8. The sample size for the training set

This information is not provided. The document describes non-clinical performance tests of a medical monitor, not the development or training of a machine learning algorithm.

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

This information is not provided, as there is no mention of a training set or ground truth establishment for algorithm training in the context of this device's K200594 submission.

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The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.

For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.

For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

This document describes the premarket notification (510(k)) for the Nonin Onyx 3, Model 9591 Finger Pulse Oximeter. The device measures functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, and also provides a non-invasive measurement of respiration rate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nonin Onyx 3, Model 9591 are primarily based on demonstrating substantial equivalence to predicate devices and compliance with recognized standards such as ISO 80601-2-61:2011 for pulse oximeters. The performance values are compared against those of the predicate devices.

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

• Respiration Rate Accuracy Verification Clinical (QATR10912):
  • Sample Size: A total of 30 subjects were enrolled.
  • Data Provenance: Single-center, randomized study. The country of origin is not specified, but given the FDA submission, it is likely the US. The study is described as "clinical," implying a prospective data collection approach for this specific test.
• SpO2 Accuracy Testing:
  • Sample Size: Healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older. The exact number of subjects is not specified beyond "all subjects" when referring to ARMS calculation.
  • Data Provenance: Conducted at an independent research laboratory. The country of origin is not specified, but likely the US. This also implies a prospective clinical study where arterial blood samples were taken.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.

• Respiration Rate: Ground truth was established by Capnography based respiratory rate. This is an objective measurement, not directly relying on human expert interpretation for ground truth.
• SpO2 Accuracy: Ground truth was established by co-oximetry analysis of simultaneous arterial blood samples. This is a gold standard, objective measurement and does not involve human expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth for both Respiration Rate and SpO2 accuracy was established through objective, clinical gold standard measurements (Capnography and co-oximetry), rather than subjective expert consensus requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance assessment focused on the device's accuracy against recognized clinical standards/predicate devices, not on how human readers' performance might improve with or without AI assistance from this device. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for image interpretation.

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

Yes, the studies described (Respiration Rate Accuracy, SpO2 Accuracy) evaluate the standalone performance of the device itself (the Model 9591 Pulse Oximeter) against established ground truth methods. It measures and displays the parameters, and its accuracy is assessed in isolation from human interpretation.

7. The Type of Ground Truth Used

• Respiration Rate: Capnography based respiratory rate. (Objective, physiological measurement)
• SpO2 Accuracy: Co-oximetry of simultaneous arterial blood samples. (Objective, laboratory gold standard)

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For a device like a pulse oximeter that relies on physiological principles and signal processing, a distinct "training set" in the context of machine learning (where algorithms learn from large datasets) is typically not applicable in the same way as it would be for an AI-based image analysis tool. The device's algorithms are likely developed and validated through engineering design, signal processing, and testing against known physiological responses, rather than deep learning from a "training set" of patient data.

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

Not applicable, as a distinct "training set" in the context of machine learning is not mentioned or implied for this device's development as described. The performance validation relies on the clinical studies mentioned above, comparing the device's output to objective physiological measurements.

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The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (information systems) it is connected to.

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors.

The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

This document primarily describes a 510(k) premarket notification for the GE Healthcare Unity Network ID, focusing on its substantial equivalence to a predicate device, Unity Network ID V8 (K170199). It does not contain information about acceptance criteria for device performance with specific metrics or detailed study results where a device's performance is measured against those criteria.

The information provided describes the device's function (data collection and clinical information management), its intended use, and the changes made from the predicate device (primarily software updates to support new third-party devices).

However, it explicitly states:
"The Unity Network ID V9 was tested to assure that the device meets its design specifications. Testing included all new or modified features."
and
"The subject of this premarket submission, Unity Network ID V9, did not require clinical studies to support substantial equivalence."

Therefore, based on the provided text, I cannot describe the acceptance criteria and study as requested, because specific performance acceptance criteria and a study demonstrating the device meets those criteria are not detailed.

The document only states that non-clinical tests were performed to ensure compliance with voluntary standards and design specifications. It lists general quality assurance measures applied during development and testing but does not provide specific performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical performance study for AI/machine learning devices.

Here's a breakdown of the specific points you requested, noting what is and isn't available in the provided text:

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

   • Not Available: The document does not provide a table of acceptance criteria nor reported device performance metrics against such criteria. It states the device "meets its design specifications" and "comply with, applicable voluntary standards," but no specifics are given.

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

   • Not Available: No test set sample sizes or data provenance are mentioned as no clinical studies were performed. The testing described is non-clinical verification and validation of design specifications.

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

   • Not Applicable/Not Available: Since no clinical studies were required and no test sets with ground truth are described, there is no information about experts establishing ground truth.

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

   • Not Applicable/Not Available: 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 Applicable/Not Available: This device is a data collection and management system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

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

   • Not Applicable/Not Available: This device is not an algorithm for diagnostic or prognostic purposes, but rather an interface for data transmission. Standalone performance in the context of an algorithm is not relevant here.

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

   • Not Applicable/Not Available: No ground truth in the context of a clinical performance study is mentioned.

8. The sample size for the training set

   • Not Applicable/Not Available: This device is not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would involve configuring it to correctly interpret and transmit data from specific third-party devices, which is part of its design and verification process, not a machine learning training process.

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

   • Not Applicable/Not Available: See point 8.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.

The provided document is a 510(k) summary for the SmartLinx Vitals Plus Patient Monitoring System. It outlines changes to an already cleared device, primarily the addition of Nellcor SpO2 pulse oximetry solution and software upgrades.

The document explicitly states that "clinical studies to support substantial equivalence" were not required. Therefore, there is no information in this document regarding:

• Acceptance criteria expressed as performance metrics or targets.
• A specific study proving the device met such acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing sets.

Instead, the submission relies on:

1. Comparison to a legally marketed predicate device (SmartLinx Vitals Plus Patient Monitoring System, K171751) and a reference device (Zoe Medical's 740 Select, K130411). The core argument is that the modifications (primarily the addition of Nellcor SpO2) do not raise new questions of safety and effectiveness, as the reference device already supports Nellcor SpO2.
2. Performance testing: This is described as "hardware and software verification and validation, as well as testing to FDA recognized consensus standards."
3. Conformance with FDA recognized consensus standards: A table of standards (such as ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304, etc.) is provided to demonstrate adherence to established safety and performance requirements for medical electrical equipment, including pulse oximeters and software.

Therefore, the tables and information requested cannot be derived from the provided text, as this 510(k) relies on substantial equivalence through design and standards conformance, rather than new clinical performance data for the specific changes.

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