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The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.

The CARESCAPE SpO2 – Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended to be used with compatible Philips Intellivue Patient Monitors.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, infant, and neonatal patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of respiratory rate (RRa) for adult and pediatric patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.

The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The purpose of this submission is to add Radius PPG as a compatible accessory to the Carescape SpO2 -Masimo (K221953) and Masimo rainbow SET IntelliVue (K162675). The description of the subject devices is provided below:

Carescape SpO2 - Masimo: The Carescape SpO2 – Masimo is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE, K213234) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

Masimo rainbow SET IntelliVue: The Masimo rainbow SET IntelliVue is a module intended to compatible patient monitors (e.g., Philips IntelliVue, K221348) to provide continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

This FDA premarket notification (K232389) describes the addition of the Radius PPG as a compatible accessory to two existing devices: the Carescape SpO2 - Masimo (K221953) and the Masimo rainbow SET IntelliVue (K162675). The notification states that "there were no hardware or software changes made to the subject devices as part of this submission from the previous clearances." Therefore, the performance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed for the primary devices themselves in this document, but rather for the accessory's clinical performance.

The provided document focuses on demonstrating that the addition of the Radius PPG accessory does not raise new questions of safety and effectiveness, and that the clinical performance of the Radius PPG on patients of different skin pigmentations is equivalent.

Here's an analysis of the provided information, focusing on the Radius PPG accessory's clinical performance criteria as outlined:

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

The document provides clinical performance data for SpO2 monitoring with the Radius PPG across different skin pigmentations. The acceptance criteria for SpO2 accuracy in oximeters are typically expressed as the "Arms" (Accuracy Root Mean Square) value. Although a specific acceptance criterion is not stated as a numerical target in the document for this submission, the reported "Arms" values are compared, implicitly seeking to demonstrate acceptable accuracy across patient populations. Standard SpO2 accuracy for oximeters without motion is usually around 2% Arms.

The reported Arms values of 1.75, 1.79, and 1.75 suggest that the Radius PPG accessory meets or exceeds typical accuracy expectations for pulse oximetry.

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

• Sample Size (for Radius PPG clinical data):
  • Subjects: 22
  • Samples: 762 (Overall)
  • Light Skin Samples: 449
  • Dark Skin Samples: 313
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical data for such devices is typically collected prospectively in controlled settings to assess accuracy.

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 type of device (pulse oximeter) does not rely on expert interpretation for ground truth. The ground truth for SpO2 measurement is typically established using a reference co-oximeter connected to arterial blood samples (invasi

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

Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For pulse oximetry, the ground truth is derived from objective measurements (arterial blood gas analysis with a co-oximeter), so such adjudication methods are not applicable.

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

No, an MRMC comparative effectiveness study was not done. This device is a measurement device (a pulse oximeter accessory), not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, this type of study and effect size are not relevant to this submission.

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

Yes, the clinical data presented (Bias, Precision, Arms) represents the standalone performance of the Radius PPG accessory in measuring SpO2. Pulse oximeters inherently operate in a "standalone" fashion by directly measuring physiological parameters.

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

The ground truth for SpO2 measurements is typically established through arterial blood gas analysis using a laboratory co-oximeter. This provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2), against which the non-invasive SpO2 readings from the device are compared. While not explicitly stated in this summary, this is the standard method for validating pulse oximeter accuracy.

8. The sample size for the training set

The document does not explicitly mention a "training set" for the Radius PPG accessory. For traditional medical devices like pulse oximeters, the device's algorithms are developed and refined using empirical data during the R&D phase. The clinical data presented here is for validation, not training.

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

As noted in point 8, a specific "training set" with ground truth establishment is not detailed in the context of this submission for a pulse oximeter accessory. The device's underlying technology (Masimo SET and rainbow SET Pulse Oximetry) would have been developed and validated with substantial data, and its core principles rely on the physics of light absorption by different hemoglobin species.

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The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patient at a time.

The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.

The Masimo CARESCAPE SpO2 – Masimo with SpHb ("CARESCAPE SpO2 – Masimo") is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 – Masimo is the same module cleared as the GE CARESCAPE SpO2 – Masimo as part of the secondary predicate device (K213234), which provides the Masimo SET and rainbow SET Technology for the measurement and monitoring of pulse oximetry data. The only difference between the two modules is that the subject device is labeled for distribution by Masimo, and the secondary predicate is labeled for distribution by GE Healthcare. The difference between the subject device and primary predicate is the activation of the SpHb feature, the same as what was cleared as part of the secondary predicate (K213234).

This document is a 510(k) premarket notification for the "Masimo CARESCAPE SpO2 - Masimo with SpHb" device. The submission claims substantial equivalence to previously cleared predicate devices (K212876 and K213234). The primary change in the subject device is the activation of the SpHb (total hemoglobin concentration) feature, which was already cleared as part of the secondary predicate (K213234).

Therefore, the performance data presented is largely a restatement of the specifications of the equivalent devices, rather than new testing specific to this submission.

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 acceptance criteria are the performance specifications for accuracy (Arms - Accuracy Root Mean Squared) listed in Table 1 and Table 4-1. The reported device performance is indicated as meeting these specifications by virtue of being the same device as the predicates.

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

The document states, "As there were no performance changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no performance bench testing was included in this submission." This indicates that no new performance testing was conducted for this specific submission (K221953) to establish the device's performance directly. The performance specifications are derived from previous clearances of essentially the same device. Therefore, the sample size and data provenance for the original studies that established these specifications are not detailed in this document.

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 available in the provided text, as no new performance testing was conducted for this submission. The performance claims rely on prior clearances.

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

This information is not available in the provided text, as no new performance testing was conducted for this submission.

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

The device is an oximeter for continuous non-invasive monitoring of SpO2, PR, and SpHb. It is not an AI-assisted diagnostic device, nor does it involve human "readers" or image interpretation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.

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

The device's performance specifications (e.g., Arms accuracy) are akin to a "standalone" performance, in the sense that they describe the accuracy of the device's measurements compared to a reference standard, without human interpretation as part of the primary measurement. The document states that the physical module and its underlying Masimo SET and rainbow SET Technology are the same as previously cleared. So, the stated performance specifications are effectively the standalone performance of the device's algorithms for SpO2, PR, and SpHb. No new standalone testing was conducted for this submission, relying on previous clearances.

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

For oximeters, the ground truth for SpO2 and SpHb measurements is typically established through direct blood gas analysis (e.g., co-oximetry) from arterial blood samples. The document does not explicitly state the ground truth method but this is the standard for such devices. This information also would have been detailed in the original submissions for the predicate devices.

8. The sample size for the training set

This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context. The device relies on established physiological principles and signal processing techniques (Masimo SET and rainbow SET Technology).

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

This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context.

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The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 - Masimo is equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.

The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).

The provided text describes the CARESCAPE SpO2 - Masimo device, whose 510(k) submission (K212876) is for a labeling update and to market the device under its own 510(k). The device itself is identical to the primary predicate device, GE CARESCAPE SpO2 – Masimo (part of K200494), with no changes to hardware, software, or performance. Therefore, new performance data was not generated for this submission.

The acceptance criteria provided in the document are the performance specifications of the device as previously cleared with the predicate device.

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

Since this submission is for a device that is identical to a previously cleared predicate, the "reported device performance" refers to the previously established performance specifications which are considered met, as there are no changes to the device itself.

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

The document explicitly states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence."

Therefore, no new test set was used for this particular submission. The performance data is derived from the testing conducted for the primary predicate device (K200494), but the details of that testing (sample size, data provenance) are not provided in this document.

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

Not applicable for this submission as no new testing was performed to establish ground truth.

4. Adjudication method for the test set

Not applicable for this submission as no new testing was performed to establish ground truth that would require adjudication.

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 oximeter, not an AI-assisted diagnostic tool.

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

The performance specifications listed are standalone performance metrics of the oximeter device. Details of the studies establishing these specifications were conducted for the predicate device, but are not described in this document.

7. The type of ground truth used

For an oximeter measuring SpO2 and Pulse Rate, the ground truth typically involves invasive blood gas analysis (for SpO2) and ECG or simultaneous direct measurement (for Pulse Rate) against which the device's measurements are compared. These methods would have been used during the original testing of the predicate device.

8. The sample size for the training set

Not applicable. This document is for a medical device (oximeter), not an AI model requiring a training set. The device operates on physical principles, not machine learning.

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

Not applicable.

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