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Intended Use:
The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time.
The monitors are not therapeutic devices.
Caution: The monitors are for prescription use only.

The ECG measurement is indicated to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).
ST segment monitoring is indicated for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is indicated for use with adult patients only.
The derived measurement Pulse Pressure Variation (PPV) is indicated for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Predictive Temperature Module is indicated to provide an accurate prediction of patient temperature using the oral, axillary, or rectal body sites, or to provide an actual temperature reading in the continuous monitor mode to adult and pediatric patients.
The NanoPod capnography module is indicated to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is indicated for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport.
The NanoPod capnography module provides the clinician with an integrated pulmonary index (IPI). The IPI is based on end tidal carbon dioxide, respiration rate, oxygen saturation and heart rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The Integrated Pulmonary Index (IPI) is indicated for use with adult and pediatric (1 to 12 years) patients only.

Warning: The IPI is an adjunct to and not intended to replace vital sign monitoring.

Device Description

The new IntelliVue Patient Monitors 6100 (867311), 6300 (867313) and 6500 (867315) are display units with built-in CPUs. They integrate a TFT LCD flat panel display with dimensions of 10' for model 6100 and 6300 and 15' for the 6500 model). All Monitors are outfitted with a touchscreen interface as a primary input for the device. They also support data input devices such as a dedicated remote control, keyboard and pointing devices such as a mouse.

The new patient monitors have integrated measurements such as ECG/Resp, SpO2, NIBP, IBP and Temperature. In addition to their integrated measurements, these devices can also connect to other external measurement modules through their FlexLink connector. The FlexLink connector serves as an interface between the 6100, 6300 and 6500 Patient Monitors and Medtronic's Microstream™ CO2 NanoPod as well as the Predictive Temperature Module.

The new Patient Monitors run on mains power or on the internal battery. They serve as stationary patient monitors and can also be used as portable patient monitors in hospital transport only.

The new Patient Monitors can communicate with the Philips Central Station (aka Patient Information Center iX, last cleared with K211900) as well as with Philips XDS Software, which is intended for use as an independent display replicating the Patient Monitors screen. They are outfitted with an ECG-Out connector, which may be used to synchronize (via an analog ECG signal output) a connected external device such as a defibrillator, CT scan or Intra-aortic Balloon Pump.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Philips IntelliVue Patient Monitors (6100, 6300, 6500) primarily focus on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical bench testing. However, it explicitly states that no clinical trials were generally required, except for specific Philips initiated laboratory tests for the Philips FAST PicoSAT X SpO2 technology.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, expert involvement, and ground truth for a general "study that proves the device meets the acceptance criteria" in a typical clinical evaluation sense is not present for the overall device clearance. The clearance is based on meeting harmonized standards and non-clinical bench tests for safety and effectiveness, and demonstrating the subject device introduces no new safety or effectiveness issues compared to the predicate.

Here's an attempt to extract and infer the information based on the provided document:

Acceptance Criteria and Device Performance (Primary Device Clearance)

For the overall device, the acceptance criteria are largely implied by compliance with the listed harmonized standards for safety and essential performance. The "reported device performance" is the statement of compliance with these standards and the assertion of substantial equivalence to the predicate, meaning it performs similarly and safely for its intended use.

Acceptance Criteria (Implied by Standards/Equivalence)	Reported Device Performance
Safety and Basic Performance	Compliance with IEC 60601-1:2005 incl. AMD1:2012 and AMD2:2020
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2014 incl. AMD1:2020
Usability	Compliance with IEC 60601-1-6:2010 incl. AMD1:2013 and AMD2:2020
Alarm Systems	Compliance with IEC 60601-1-8:2006 incl. AMD1:2012 and AMD2:2020
Electrocardiographs	Compliance with IEC 60601-2-25:2011
ECG Monitoring Equipment	Compliance with IEC 60601-2-27:2011
Automated Non-Invasive Sphygmomanometers	Compliance with IEC 80601-2-30:2018
Invasive Blood Pressure Monitoring Equipment	Compliance with IEC 60601-2-34:2011
Respiratory Gas Monitors	Compliance with ISO 80601-2-55:2018
Clinical Thermometers for Body Temperature Measurement	Compliance with ISO 80601-2-56:2017 incl. AMD1:2018
Pulse Oximeter Equipment	Compliance with ISO 80601-2-61:2017 incl. COR1:2018
Medical Device Software Life-Cycle Processes	Compliance with IEC 62304:2006 incl. AMD1: 2015
Secondary Cells and Batteries Safety	Compliance with IEC 62133-2:2017 incl. AMD1: 2021
Household and Commercial Batteries	Compliance with UL 2054
Overall Safety and Effectiveness	Substantial equivalence demonstrated to predicate device (IntelliVue Patient Monitor MX550)

Specifics regarding the Philips FAST PicoSAT X SpO2 Technology Clinical Data:

The document mentions: "The 510(k) included clinical data from Philips initiated laboratory tests with the intent to demonstrate the accuracy performance of the Philips FAST PicoSAT X SpO2 technology." This is the only explicit mention of "clinical data" related to a performance study. Given the limited information, assumptions are made where details are not provided.

Information Category	Details from Document (or inferred as N/A/Unknown)
1. Acceptance Criteria & Device Performance (for SpO2)	Acceptance Criteria: Not explicitly stated in the provided text. For SpO2 technology, typical accuracy acceptance criteria are defined in standards like ISO 80601-2-61 (which the overall device claims compliance with), often involving a root mean square difference (ARMS) between the device's SpO2 readings and a reference method (e.g., co-oximetry of arterial blood). This performance is usually evaluated under various conditions (e.g., motion, low perfusion, varying oxygen saturation levels). Reported Device Performance: The document only states the clinical data was to "demonstrate the accuracy performance." It does not explicitly list the achieved accuracy metrics (e.g., ARMS value) or state that specific numerical acceptance criteria were met. However, the clearance implies that the performance was deemed acceptable by the FDA for substantial equivalence.
2. Sample Size (Test Set) & Data Provenance (for SpO2)	Sample Size: Not specified in the provided text. Data Provenance: "Philips initiated laboratory tests." This suggests the data was collected in a controlled laboratory environment, likely in Germany where Philips Medizin Systeme Böblingen GmbH is located, or another Philips facility. It is likely prospective data collected specifically for this validation.
3. Number of Experts & Qualifications (for SpO2)	Not applicable/Not mentioned for establishing ground truth as the "clinical data" refers to objective measurements for SpO2 accuracy, not expert consensus on qualitative assessment. The ground truth (reference method) for SpO2 accuracy would typically be an established medical device (e.g., a co-oximeter).
4. Adjudication Method (for SpO2)	Not applicable/Not mentioned. Adjudication is typically for subjective expert review, not for objective measurement comparisons like SpO2 accuracy.
5. MRMC Comparative Effectiveness Study (for SpO2)	No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it mention any human reader improvement with or without AI assistance for this SpO2 technology. This type of study is more common for diagnostic imaging or interpretation tasks.
6. Standalone Performance Study (for SpO2)	Yes. The "Philips initiated laboratory tests with the intent to demonstrate the accuracy performance of the Philips FAST PicoSAT X SpO2 technology" would represent a standalone (algorithm-only) performance evaluation against a reference standard. The study's focus was on the performance of the SpO2 technology itself.
7. Type of Ground Truth Used (for SpO2)	Not explicitly stated but for SpO2 accuracy, the ground truth is almost universally reference measurements from a validated co-oximeter of arterial blood samples, taken while the pulse oximeter is monitoring the subject.
8. Sample Size for Training Set (for SpO2)	Not mentioned. The document describes a performance evaluation ("clinical data...to demonstrate accuracy performance"), which typically uses a test set, not a training set. If machine learning was involved in developing the SpO2 algorithm, training data would have been used, but details are not provided.
9. How Ground Truth for Training Set was Established (for SpO2)	Not applicable/Not mentioned as no training set details are provided. If a training set was used, its ground truth would likely be established in the same manner as the test set: through reference measurements from a co-oximeter.

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