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The BB-613 Watch Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

The BB-613 device is a wrist-worn device consisting of a light source (LEDs) and sensor array on the backside of the device, with a user interface on the front side of the device. The LEDs transmit light into the subject's skin at their wrist, and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation and pulse rate results. It also displays symbols that show if there was no signal or a weak signal. The device is powered by a rechargeable battery.

Here's an analysis of the acceptance criteria and study data for the BB-613 Watch Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Oximeter Clinical Validation: 10 patients
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study involved "patients with varying Fitzpatrick skin types (I – V)" and their ages ranged from 18 to 40, with 6 males and 4 females. It is a prospective clinical validation.
• Sample Size for Pulse Rate Validation: Not explicitly stated beyond "a custom built simulator." This implies it was a laboratory-based validation rather than human subjects for this specific test.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical validation. It only states that the clinical validation showed "equivalence to simultaneous measurements from the predicate oximeter." This implies the predicate oximeter itself served as the reference for ground truth in this comparison, rather than independent expert adjudicated measurements.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense of multiple human readers or experts reviewing data for ground truth establishment. For the clinical validation, the BB-613's readings were compared to a "predicate oximeter" simultaneously. For pulse rate, a "custom built simulator" was used.

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 involving human readers and AI assistance was not performed or described in this document. This device is an oximeter, which provides direct physiological measurements, not interpretations that would typically involve human readers or AI assistance in the way a diagnostic imaging device might.

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

Yes, the studies described are essentially standalone performance evaluations of the device. The clinical validation compares the device's output to a predicate, and the pulse rate validation uses a simulator. These tests assess the algorithm and hardware's ability to accurately measure and display SpO2 and pulse rate without user interpretation or interaction being a variable in the performance metric. However, it's important to note that the device's intended use is "spot-checking," implying a user still reads the display.

7. The Type of Ground Truth Used

• For SpO2 Clinical Validation: The "simultaneous measurements from the predicate oximeter" served as the reference or ground truth.
• For Pulse Rate Validation: A "custom built simulator" provided the reference for pulse rate.
• Other tests (biocompatibility, software, electrical safety, home use) relied on adherence to specified international standards and guidances, where the ground truth is defined by the criteria within those standards.

8. The Sample Size for the Training Set

The document does not explicitly reference or provide details for a "training set" in the context of the device's algorithms. If there was machine learning involved in developing the device's algorithms, the training data used is not disclosed here. The performance data focuses on validation/testing.

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

Since a training set is not described, the method for establishing its ground truth is also not provided.

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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

This is a 510(k) summary for Philips SureSigns VS3 and VS4 vital signs monitors, describing modifications to add additional measurement capabilities. The provided text, however, does not contain information about specific acceptance criteria or a detailed study proving the device meets said acceptance criteria with numerical performance data. It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

Therefore, I cannot fulfill all parts of your request with the provided information.

However, based on the information available, here's what can be extracted:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table or numerical format. The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence," implying that the devices met pre-defined specifications. However, the exact criteria and corresponding performance metrics are not detailed.

• Sample Size for Test Set and Data Provenance: This information is not explicitly stated in the provided text.

• Number of Experts and Qualifications: This information is not mentioned in the provided text.

• Adjudication Method: This information is not mentioned in the provided text.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was done. The device is a vital signs monitor, which typically involves direct measurement rather than interpretation by multiple human readers in the way an AI-assisted diagnostic tool might.

• Standalone (Algorithm Only) Performance Study: The document mentions that the new features are achieved by using OEM modules that are "FDA cleared under Kxxxxxx." This implies that the performance of these modules as standalone components was already established in their respective clearances. For instance, for CO2 measurement, the Oridion microMediCO2 OEM module was cleared under K094012; for SpHb, RRa, and Masimo SpO2, the Masimo Rainbow SET Radical 7R CO-Oximeter was cleared under K100428; and for Temporal Temperature, the Exergen TemporalScanner Thermometer was cleared under K011291. The QuickNBP mode is described as based on the "same algorithm that provides the regular NBP measurements" in the existing devices. Therefore, while not explicitly called a "standalone study," the reliance on previously cleared, established technologies suggests that their standalone performance has been demonstrated.

• Type of Ground Truth Used: Not explicitly stated for the overall device's performance. However, for the OEM modules incorporated, their original clearances would have involved appropriate ground truth methods for each physiological parameter (e.g., direct measurement for temperature, arterial blood gas analysis for SpO2 calibration, etc.).

• Sample Size for Training Set: This information is not applicable as the document describes hardware modifications incorporating existing, cleared OEM modules and leveraging existing algorithms. It does not mention the development or training of new algorithms that would require a distinct training set.

• How Ground Truth for Training Set Was Established: Not applicable given the nature of the device modifications.

In summary, the provided text primarily focuses on the substantial equivalence argument for modifications to existing vital signs monitors by integrating previously cleared OEM modules and leveraging existing algorithms. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, expert involvement, or adjudication methods that your request entails for a newly developed AI/diagnostic device.

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The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied.

The device is not to be used in the presence of flammable anesthetic agents or other iqnition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate intra-hospital transport. The HAMILTON-G5's pneumatics deliver gas -- while its electrical systems controls pneumatics, monitors alarms and distributes power. The user interface consists of a LCD-display with touch screen, keys, and a press-and- turn knob.

The HAMILTON-G5's new software version 2.30, includes a pulse oximetry function for continuous, non-invasive oxygen saturation monitoring (SpO2).

Volume targeting in the HAMILTON-G5 is now supported by a new ventilation mode, called the Volume Support mode (VS). It is a flow-cycled, volume targeted, and pressure-regulated mode.

The Volume Support (VS) mode is designed for spontaneously breathing patients. It provides support to patient-initiated breaths so as to deliver the desired tidal volume (V+), at a level appropriate to the patient's efforts. This mode allows the ventilator to change the support in response to changing patient conditions and inspiratory effort levels. To achieve this volume, the device decreases support when the patient's breathing activity increases or, conversely, increases support when the patient's inspiratory effort decreases.

Here's an analysis of the acceptance criteria and study information for the HAMILTON-G5 device, based on the provided document:

The document is a 510(k) summary for the HAMILTON-G5 ventilator, specifically for an updated version (SW 2.30) that includes a pulse oximetry function and a new Volume Support (VS) ventilation mode. It focuses on demonstrating substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it describes compliance with recognized standards and uses qualitative statements of "substantial equivalence" for the new features.

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or a number of test cases. The testing appears to be primarily bench testing (waveform performance, communication integrity) and compliance with standards rather than clinical trials with patient populations.
• Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing mentioned (waveform testing per ASTM F1100-90, software V&V) is likely performed in a lab or simulate environment. The country of origin of the device manufacturer is Switzerland.

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

• This information is not provided in the document. The document describes compliance with engineered performance standards and internal verification/validation, not the establishment of ground truth by human experts for a test set.

4. Adjudication Method for the Test Set:

• This information is not provided as the testing described does not involve expert adjudication of a test set in the way a clinical study or diagnostic imaging study would.

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

• No, an MRMC comparative effectiveness study was not done. This document is for a medical device (ventilator) seeking 510(k) clearance, which typically relies on
  bench testing and substantial equivalence to predicates, not comparative effectiveness studies of human readers with vs. without AI assistance. The device itself is not an AI diagnostic tool.

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

• This question is not directly applicable in the context of this device. The HAMILTON-G5 is a ventilator, a physical device with embedded software and functions. The new features (VS mode, SpO2) are integrated functionalities of the device. The "standalone performance" of these functions (e.g., the SpO2 calculation itself) is established by using previously cleared OEM components and by verifying their integration into the HAMILTON-G5, not as a separate, algorithm-only performance assessment like that for a diagnostic AI.

7. The Type of Ground Truth Used:

• The "ground truth" for the new functionalities would be established by:
  • Engineering Specifications / Reference Devices: For the Volume Support mode, the "ground truth" for its performance is derived from the established performance characteristics and waveforms defined by the ASTM F1100-90 standard and comparison to the MAQUET Servo-i predicate device.
  • Calibration & Known Standards: For the SpO2 function, the "ground truth" for oxygen saturation and pulse rate values would come from the calibrated performance of the OEM pulse oximeter systems (Masimo, Nihon Kohden) and ensuring these values are accurately transmitted and displayed by the HAMILTON-G5.
  • Regulatory Standards: Overall safety and electromagnetic compatibility ("ground truth" for compliance) are established by fulfilling the requirements of the cited IEC standards.

8. The Sample Size for the Training Set:

• Not applicable. This document describes a medical device undergoing 510(k) clearance, not an AI or machine learning model that requires a "training set" in the conventional sense. The device's software (SW 2.30) is developed and verified through engineering processes, not by training on a dataset.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no "training set." The software development and verification process would involve testing against validated specifications and expected outputs based on engineering principles and regulatory standards.

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