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GE ApexPro CH SpO2 - Nellcor cable: The GE ApexPro CH SpO2 – Nellcor cable is indicated for prescription use only for spot-check or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
GE ApexPro FH SpO2 - Nellcor cable: The GE ApexPro FH SpO2 – Nellcor cable is indicated for prescription use only for spot-check or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

The subject device of this premarket 510(k) notification is composed of two (2) cables as follows: GE ApexPro CH SpO2 Nellcor Cable and GE ApexPro FH SpO2 Nellcor Cable. The GE ApexPro CH/FH SpO2 – Nellcor Cable (subject device) is a that provides an external oximetry-in-a-cable solution when used with the GE ApexPro™ Telemetry System and a Nellcor™ pulse oximetry sensor with Oximax™ technology. The subject device is used as part of the GE ApexPro Telemetry System that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate which is measured by Nellcor pulse oximetry sensors.

The provided text describes the GE ApexPro CH/FH SpO2 - Nellcor Cable, an interface cable designed to work with the GE ApexPro Telemetry System and Nellcor pulse oximetry sensors. The submission primarily focuses on establishing substantial equivalence to a predicate device (The Nellcor Pulse Oximetry Monitor Interface Cable, K172428) through non-clinical evidence and comprehensive verification testing against established standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are primarily based on the accuracy specifications of the existing Nellcor Pulse Oximetry Monitor Interface Cable, which the subject device aims to match or exceed. The listed performance values are for the predicate device, and the subject device is stated to meet these requirements.

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

The text does not specify sample sizes for human subjects in testing. The studies presented are "bench performance testing," "system verification," "software verification," "hardware verification," "compatibility verification," and "compliance testing to standards." This implies the tests were conducted in a controlled laboratory environment without live patient data.
The data provenance is from bench testing and in-house verification and validation studies conducted by Covidien/Medtronic. No country of origin for directly human-derived test data is mentioned as the testing cited is non-clinical.

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

Not applicable. The ground truth for the performance testing cited (SpO2 and Pulse Rate accuracy) was established through simulated inputs (e.g., using a pulse simulator device) and adherence to recognized standards (e.g., ISO 80601-2-61:2017). Human expert consensus was not used as a ground truth for these specific performance metrics.

4. Adjudication Method for the Test Set

Not applicable. The testing described focuses on objective measurement against established simulated inputs and standards rather than subjective assessments requiring adjudication by multiple experts.

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 device is an interface cable for a pulse oximeter, not an AI-powered diagnostic imaging tool or a system that requires human "readers" to interpret output for diagnostic purposes. The submission does not mention any AI components in the context of improving human reader performance.

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

Yes, the studies are essentially standalone, demonstrating the device's ability to accurately measure SpO2 and pulse rate under various simulated conditions (no motion, motion, low perfusion) by comparing its output against known simulated inputs. The various "Verification Test Reports" listed in Table 4 (e.g., "Motion Pulse Rate Accuracy Verification Test Report," "System Performance Verification Test Report," "Benchtop Low Perfusion Accuracy Verification Test Report") describe this type of standalone performance evaluation. The device contains an embedded software that "uses the Nellcor pulse oximetry algorithm to calculate SpO2 ... and PR."

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

The ground truth used for performance testing (SpO2 and Pulse Rate accuracy) appears to be simulated inputs from calibrated devices (e.g., pulse simulator devices) and established measurement criteria defined by international standards (e.g., ISO 80601-2-61:2017). This is a form of objective, often laboratory-controlled, ground truth.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/machine learning model in the sense of requiring a "training set" of data to learn or classify. It utilizes a pre-existing "Nellcor pulse oximetry algorithm" which is embedded in its software. The submission does not refer to any training of this algorithm as part of the new device's development or testing for substantial equivalence. The studies mentioned are focused on verification and validation of the device's performance with this existing algorithm.

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

Not applicable, as there is no mention of a "training set" for an AI or machine learning model developed for this specific device in the provided text. The device incorporates an existing Nellcor algorithm, and the documentation pertains to validating the cable's interface and performance with this algorithm.

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The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

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

• Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
  • Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
• SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
  • Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

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

• Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
• SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

• Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
• SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, standalone performance was assessed for key algorithms:
  • EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
  • TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

• Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
• SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

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

• The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

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The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.

In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.

The provided 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not include specific acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific numerical thresholds in a clinical or analytical study.

Here's an analysis of the available information against your requested points:

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

This information is not provided in the 510(k) summary. The document states that "The following testing of the uSpO2 Pulse Oximetry Cable was performed... to demonstrate substantial equivalence of the modified device to the cleared device," but it does not specify what performance criteria (e.g., accuracy, bias, precision for SpO2 or PR) were used or what the specific test results were.

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 summary lists types of testing conducted (e.g., Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System, System Compatibility), but none of these descriptions include details about sample sizes for a test set or data provenance.

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. Given that the listed tests are primarily engineering and system compatibility tests, it is unlikely that "experts" in the sense of clinical specialists establishing ground truth were involved in these specific tests as described. Clinical performance testing (if performed) for SpO2 devices typically involves arterial blood gas analysis, which is an objective measurement rather than an expert interpretation.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed in the listed 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

This information is not provided. MRMC studies are not relevant for a pulse oximetry cable, which is a sensor and cable connecting to a host system, not an AI-powered diagnostic tool requiring human interpretation.

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

The device itself (the uSpO2 Pulse Oximetry Cable) operates as a standalone component connecting to a host system. The summary implies that "System Compatibility Testing (GE ApexPro Telemetry System)" would assess the cable's performance in conjunction with the host, which is a form of integrated system performance. However, there's no "algorithm only" performance study in the sense of an independent software assessment described. The Masimo SET® technology is inherent to the oximetry process, and its performance characteristics would have been established during the original clearance of Masimo SET® products (e.g., K040259, the predicate device). This submission focuses on the cable's compatibility and functional equivalence when integrated.

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

This information is not provided for the studies listed. For pulse oximeters, the typical ground truth for SpO2 accuracy is arterial blood gas analysis, which is an objective physiological measurement. However, this specific 510(k) emphasizes testing related to the cable's functionality and compatibility, not a de novo clinical accuracy study of the oximetry technology itself.

8. The sample size for the training set

This information is not provided. Training sets are generally associated with machine learning or AI algorithms. This submission is for a medical device (a cable for a pulse oximeter) and does not involve AI/ML technology that would have a "training set" in the conventional sense.

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

This information is not applicable as there is no mention of a training set or AI/ML algorithm in this 510(k) submission.

Summary of Device Performance as Reported:

The 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not provide specific performance data or numerical acceptance criteria. Instead, it concludes:

"The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance."

This statement implies that the device meets performance requirements by being equivalent to a previously cleared device (K040259 - Masimo SET® IntelliVue Pulse Oximeter Module), which itself would have had its performance validated. The tests conducted (Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System Testing, System Compatibility Testing with GE ApexPro Telemetry System) are primarily aimed at demonstrating that the new cable does not introduce new risks or alter the established performance characteristics of the Masimo SET technology when integrated with the specified host system.

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