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The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.

Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).

The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.

The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.

The mainstream gas analyzers are characterized by the following features:

• Low system integration complexity
• Low power consumption
• Fast startup time
• Low weight

The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.

Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.

However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.

1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):

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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it can be mounted in a variety of ways (e.g., shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.

Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.

The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.

This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.

Acceptance Criteria and Device Performance (Non-AI Device)

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

The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.

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The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.
Environment of use – hospital, sub-acute, and pre-hospital settings.
Patient population – Patients requiring expired gas monitoring.

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

The Barbaras Development Inc. CO2 sampling lines are used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled. the gas sampling is exhaust only and there is no gas flow back to patient.

The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates.

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.

The provided FDA 510(k) clearance letter details the clearance of CO2 Sampling lines manufactured by Barbaras Development Inc. The clearance is based on substantial equivalence to a predicate device, Tylenol Medical Instruments Co., Ltd - K181981 - CO2 sampling line, and a reference device, ProMedic – Gas Sampling Lines – K023579.

It's important to note that this document is a 510(k) summary for a medical device that is an accessory (CO2 sampling lines) and not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested elements, such as MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details, are not applicable to this type of device and are not present in the provided text. The evaluation focuses on physical characteristics, material compatibility, and basic performance parameters against established standards.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" and "Performance testing" categories, indicating that these were the acceptance criteria for the device. The reported performance is generally stated as "performed equivalent to the predicate" and "All testing demonstrated that the subject devices are substantially equivalent to the predicate." No specific numerical results are provided in this summary.

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The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables 2 and 3 for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems.

The BD Alaris Infusion System with Guardrails Suite MX includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion and monitoring system designed to provide controlled delivery of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris Infusion System with Guardrails Suite MX has three (3) major components:

1. System Hardware: A core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function.

   • BD Alaris Pump Module (LVP)
   • BD Alaris Syringe Module (SYR)
   • Alaris PCA Module (PCA)
   • BD Alaris EtCO2 Module (EtCO2)
   • Alaris Auto-ID Module (Auto-ID)

2. Guardrails Suite MX Software: Software applications for support and interaction with the system hardware

   • BD Guardrails Editor (GRE)
   • BD Alaris Systems Manager (SM)
   • BD Alaris Systems Maintenance (ASM)

3. Interoperability Software: Software applications for facilitating bi-directional communication between the PCU and attached LVP and SYR modules, and an electronic medical records (EMR) system via BD Alaris Infusion Systems Manager (SM) and Care Coordination Engine (CCE), a non-medical device Medical Device Data System (MDDS).

   • Calculation Services
   • Infusion Adapter (IA)

The PCU is the core of the BD Alaris Infusion System with Guardrails Suite MX and necessary for its operation. It provides a common user interface for programming, and powering and monitoring attached modules. Modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made using inter-unit interface (IUI) connectors built into both sides of the PCU and modules, which also serve to provide power to the modules and communication between the PCU and attached modules. The PCU is powered by AC power and has a rechargeable battery to allow for continued therapy during power interruptions.

The attachable modules are dedicated to controlled delivery of fluids, pharmaceutical drugs, parenteral nutrition, and blood and blood products into patients, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

• The BD Alaris Pump Module (LVP) delivers fluids accurately over programmed times and can detect and notify the user of situations that could impact patient safety, such as improper set loading, occlusion, and air-in-line. It can deliver fluids continuously or intermittently from any compatible container using a dedicated BD Alaris infusion set. Flow rates range from 0.1 to 999 mL/h and bolus doses can be programmed at the start or during continuous infusion.

• BD Alaris Syringe Module (SYR) is designed for injecting fluids from compatible syringes and can detect and notify the user of situations that could impact patient safety, such as an improperly loaded syringe and occlusion. It can deliver continuous or intermittent volumes from 1 to 50 mL syringes at flow rates of 0.01 to 999 mL/hr.

• The Alaris PCA Module (PCA) is designed for patient-controlled analgesia. It shares core components and functionality with the BD Alaris Syringe Module but includes additional features such as: a dose request cord for self-administering pain medication, software with a dose lockout interval, and a locking syringe enclosure door with a key. When configured for use with the BD Alaris EtCO2 Module, it can also trigger a pause of the PCA infusion if the respiratory rate of a patient falls outside the limits.

• The BD Alaris EtCO2 Module (EtCO2) a capnograph used for continuous, non-invasive monitoring of end-tidal CO2, fractional inspired CO2, and respiratory rate. It can be used to monitor respiratory depression in patients when using the Alaris PCA Module.

• The Alaris Auto-ID Module (Auto-ID) features an internal barcode image scanner and an optional handheld scanner. Scanning a clinician ID unlocks the PCU panel in authorized user mode and links clinical event logs with the clinician. Scanning a patient ID band associates logs with the patient, while scanning IV fluid or medication barcodes selects the specific item from the drug library for infusion modules.

The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, sensor monitoring, motor control, data processing, power control, keypad processing, and communication.

The PCU with its attached modules is designed to be configured to communicate and interact with the Guardrails Suite MX software applications including software for interoperability with Electronic Medical Record (EMR) systems. Communication between the PCU and the software applications is accomplished through either a direct serial connection or through a wireless connection utilize the respective Guardrails Suite MX Software applications.

• The BD Guardrails Editor (GRE) allows for the creation of drug and fluid libraries and guidelines, called 'profiles,' for specific patient populations. GRE also provides a transfer tool to transfer a profile to PCU via serial cable.

• The BD Alaris Systems Manager (SM) manages connectivity and includes a web application, communications server, and database software for managing data, creating reports, connecting with a healthcare facility's network, and storing system configuration, user permissions, and historical data. Use of SM also supports transferring wireless software updates to the PCU during system servicing.

• BD Alaris Systems Maintenance (ASM) is used for standard maintenance tasks, including module calibration and network configurations

• The BD Alaris Interoperable software includes the Infusion Adapter (IA) and Calculation Services to support bi-directional communication between the BD Alaris Infusion System with Guardrails Suite MX and the healthcare facility's EMR. The Infusion Adapter facilitates data exchange ensuring correct message formats and content. Calculation Services performs pre-defined rule-based calculations to obtain infusion duration, body surface area (BSA), and weight-based dose.

It is important to note that interoperability does not include remote control of the BD Alaris Infusion System with Guardrails Suite MX. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician at the bedside before they are activated.

The provided FDA 510(k) clearance letter and summary for the BD Alaris Infusion System with Guardrails Suite MX (K243855) do not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm performance evaluation. Instead, the document focuses on the substantial equivalence of an infusion pump system to a predicate device, with an emphasis on its hardware, software (including safety management and interoperability features), and general electrical and functional safety.

The text does not describe an AI/algorithm in the sense of a diagnostic or assistive AI that requires expert-driven ground truth, MRMC studies, or standalone performance metrics typically associated with AI/ML-based medical devices. The "Guardrails Suite MX" and "Calculation Services" mentioned are primarily about drug library management, dose error reduction, and rule-based calculations, which are more akin to conventional software functionalities rather than adaptive AI algorithms that learn from data.

Therefore, many of the requested categories for describing an AI/algorithm acceptance study are not applicable to the information provided in this document. Given the nature of the device (an infusion pump system), the "acceptance criteria" discussed are related to its functional performance, safety, and compliance with regulations and standards.

However, I can extract the relevant "acceptance criteria" and "performance" data that are presented in the document, framed within the context of a traditional medical device's non-clinical testing.

Reported Device Performance and "Acceptance Criteria" (based on functional and safety requirements):

The document describes non-clinical testing to verify essential performance requirements. These requirements serve as the de facto "acceptance criteria" for the device's main functions.

Since the provided document is a 510(k) clearance letter for an infusion pump system, not an AI/ML-based diagnostic or assistive device, the following points are largely not applicable or not explicitly detailed in the text. I will state if the information is unavailable or implies "None" for the context of this specific device's clearance.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for all performance tests. The document refers to "testing" and "statistical methods in sample size determination and data analysis" but does not provide specific numbers for each test (e.g., how many pumps were tested for flow rate accuracy). This is common for 510(k) summaries where detailed test reports are typically referenced but not fully included.
   • Data Provenance: Not specified regarding country of origin. The testing would generally be conducted by the manufacturer (BD/CareFusion) or their approved test labs. It describes "non-clinical testing" and "simulated clinical conditions," which indicates a prospective validation within a controlled environment.

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

   • Not Applicable in the AI/ML sense. Ground truth for an infusion pump's performance (e.g., flow rate accuracy, alarm function) is established through engineering measurements and adherence to international standards (like AAMI TIR 101, ISO 80601-2-55). It doesn't involve expert consensus on medical images or clinical outcomes in the way an AI diagnostic would. The "Human Factors evaluation" mentions "clinical assessment" and "biomedical engineering use," implying input from relevant experts, but not for "ground truth" labeling of data.

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

   • Not Applicable. This is a method for resolving discrepancies in expert labeling of data, which is not relevant for the type of objective functional performance testing described for an infusion pump.

4. 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 infusion pump system, not an AI for human reader assistance in diagnostic tasks.

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

   • Partially Applicable / Different Context. The document details extensive "essential performance" testing of the device (hardware and embedded software) in a standalone capacity, demonstrating its accuracy, safety mechanisms, and compliance with standards. This constitutes "algorithm only" performance in the sense of the pump's control algorithms (e.g., for flow rate, pressure detection). However, it's not an "AI algorithm" in the typical understanding of machine learning where a "human-in-the-loop" interaction for clinical decision-making is assessed.

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

   • Engineering Measurements and Compliance with Standards. The "ground truth" for this device's performance is derived from precise engineering measurements, calibration standards, and adherence to established medical device performance standards (e.g., AAMI TIR 101 for flow rate accuracy requires specific test methods and reference measurements). For the EtCO2 module, it's based on accuracy against known gas concentrations.

7. The sample size for the training set:

   • Not Applicable (in the AI/ML sense). This device is not described as utilizing machine learning that requires a "training set" of data for algorithm development. Its software functionalities (e.g., Guardrails Suite MX) are rule-based systems or deterministic algorithms, developed through traditional software engineering and verification processes.

8. How the ground truth for the training set was established:

   • Not Applicable. As no AI/ML training set is indicated, this question is not relevant.

In summary, the provided document meticulously outlines the non-clinical validation of an infusion pump system, demonstrating its safety and effectiveness through adherence to performance specifications and regulatory standards. It does not, however, pertain to the clearance of an AI/ML diagnostic or assistive algorithm, which would involve the specific types of studies and ground truth methodologies requested in the prompt.

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AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

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The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status.

The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.

The MicroTrend System provides a method of assessing the partial pressure of carbon dioxide (PCO2) in the oral mucosa (POMCO2). The MicroTrend System is a device composed of a Monitor, disposable POMCO2 Sensor, and associated connectors. It is designed to be easy to use with minimum training. A single-use disposable POMCO2 sensor is calibrated and then secured against the inside of the patient's cheek. Once the sensor initiates monitoring, the value of POMCO2 is reported on the MicroTrend Monitor instrument display. The MicroTrend Monitor provides trending information on tissue PCO2 readings measured by the disposable sensor every two minutes over a maximum of a 4-hour continuous monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.

The MicroTrend System is intended for use as an adjunct to other standard hemodynamic monitored parameters to help interpret the patient condition, treatment, and action by qualified medical professionals.

This document describes the MicroTrend System, a device for monitoring oral mucosal PCO2 (POMCO2), and its substantial equivalence to the predicate device, CapnoProbe-A, based on performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for a specific performance metric of the device in relation to the predicate. Instead, it states that the performance of the MicroTrend System was "demonstrated to be equivalent to the predicate CapnoProbe-A device" and that "measurements taken from healthy volunteer subjects using the MicroTrend System ... were found to be statistically similar to the historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A." Additionally, it mentions "no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility."

Therefore, the implicit acceptance criterion for the primary clinical performance metric (PoMCO2 measurement accuracy/similarity to predicate) is statistical similarity or equivalence to the predicate device.

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

• Animal Study: The document mentions "A swine animal study was conducted," but does not specify the sample size (number of animals). The data provenance is prospective (study was conducted to demonstrate performance). No country of origin is specified.
• Clinical Study: The document states "A prospective, non-randomized, single-site historically controlled clinical study was performed to evaluate the Microtrend System performance and compared it to published predicate device data." It involved "healthy volunteer subjects," but the sample size (number of subjects) is not specified. The data provenance is prospective for the subject device data, and retrospective/historical for the predicate device data ("published predicate device data" and "historical, combined values"). No country of origin is specified.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the animal or clinical test sets. The ground truth in the animal study appears to be physiological responses to induced hemorrhagic shock and reversal. In the clinical study, the ground truth for "historical, combined values" from the predicate device would presumably have been established previously, but details are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test sets. The clinical study was a "historically controlled clinical study" comparing the subject device's performance to historical predicate data.

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, a MRMC comparative effectiveness study was not done. This device is a measurement system and not an AI-assisted diagnostic or interpretive tool that human readers would interact with in a MRMC study context.

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

The device itself is a measurement system. The "clinical study" compares the standalone performance of the MicroTrend System to the standalone performance of the predicate device. Therefore, the clinical study could be considered a form of standalone performance evaluation where the algorithm/device output is directly compared to a reference (the predicate's historical performance). The study "evaluated the Microtrend System performance" directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Animal Study: The ground truth appears to be physiological responses/physiological state (e.g., induction of hemorrhagic shock, systemic lactic acidosis, and reversal of these conditions by reinfusion of blood). The PoMCO2 measurements from the MicroTrend System were expected to reflect these physiological changes similarly to the predicate.
• Clinical Study: The ground truth for comparison appears to be historically established PoMCO2 values obtained from healthy volunteers using the predicate CapnoProbe-A. This implicitly relies on the predicate device's established accuracy. It's a comparison to a known, previously accepted measurement rather than an independent "gold standard" pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a "training set" for an algorithm. The MicroTrend System is described as a measurement device rather than a machine learning/AI algorithm that would typically have a specific training set. The clinical and animal studies described are for validation of the device's performance, not for training.

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

As no training set is described, this information is not applicable/provided.

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The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.

The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.

Here's a breakdown of the acceptance criteria and study information for the Oxy2Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria for the Oxy2Pro mask was that its performance for FiO2 (fraction of inspired oxygen) and EtCO2 (end-tidal carbon dioxide) should not be statistically significantly less than the predicate device (K172365) at the tested flow rates.

The study results demonstrate the following:

The document concludes that the "Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria."

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

• Sample Size for Test Set: Not explicitly stated in terms of a number of masks or subjects. The document mentions "testing was completed under simulated conditions at various flow rates." This implies a series of measurements were taken at different flow rates, but the number of devices tested or repetitions of each test is not specified.
• Data Provenance: The testing was "completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device." It was performed by an "Accredited third-party testing" organization. The location of this organization and whether the data is retrospective or prospective is not specified. Given the context of a 510(k) submission, it is likely prospective testing specifically conducted for this submission.

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

N/A. This information is not relevant or applicable to the type of performance testing described. The "ground truth" (or reference standard) in this context is the measured FiO2 and EtCO2 values under controlled simulated conditions, using calibrated equipment. It does not involve expert interpretation or consensus.

4. Adjudication Method for the Test Set

N/A. As the testing involved objective measurements under simulated conditions, there was no need for an adjudication method by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This type of study is typically performed for AI/image analysis devices where human readers provide interpretations. The Oxy2Pro is a medical device for oxygen delivery and CO2 sampling, and its performance is evaluated objectively through physical measurements, not human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This concept is for software algorithms. The Oxy2Pro is a physical device; its performance is standalone in the sense that it functions physically to deliver oxygen and sample gas.

7. Type of Ground Truth Used

The ground truth used was simulated conditions with true baseline EtCO2 at 5%. This implies a controlled environment where the actual concentration of inspired oxygen and exhaled CO2 was known and measured with high precision using reference instruments.

8. Sample Size for the Training Set

N/A. The Oxy2Pro is a physical medical device, not an AI or machine learning algorithm, so there is no training set in this context.

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

N/A. As there is no training set, this question is not applicable.

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Endure ETCO2/O2 Nasal Cannula has two functions

• 1. It is intended to deliver supplemental Oxygen to patients and

2. to obtain CO2 sampling of exhaled air

Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.

Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.

Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.

The provided text describes the 510(k) premarket notification for the Endure ETCO2/O2 Nasal Cannula (K213767). It indicates that the device is substantially equivalent to a legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The document focuses on demonstrating this equivalence, rather than setting and proving acceptance criteria in the traditional sense of a clinical trial for a new therapeutic or diagnostic device.

However, based on the information provided, we can infer the "acceptance criteria" through the comparative performance testing and the "study" that proves the device meets (or is equivalent to) those criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Endure ETCO2/O2 Nasal Cannula performs similarly or identically to the predicate device (Oridion K010024) in key functional areas.

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The performance testing appears to be primarily laboratory-based comparisons between the proposed device and the predicate.

• Test Set Sample Size: Not explicitly stated for performance tests. The comparison of physical measurements, CO2 sampling, and O2 flow rates implies a limited number of devices were tested against each other.
• Data Provenance: Not applicable in the context of patient data for the performance comparison. The tests were likely conducted in a controlled lab environment. The document states "Age testing done with cannulas manufactured in 2019" which suggests a retrospective analysis of previously manufactured devices for aging studies.

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

Not applicable. This is not a study requiring expert clinical assessment for ground truth. The performance testing involves objective measurements (e.g., CO2 levels, O2 flow, physical dimensions) and adherence to standards (e.g., ISO 10993, ISO 18562).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical imaging or diagnostic interpretation involved that would require an adjudication method like 2+1 or 3+1.

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 a medical accessory for delivering oxygen and sampling CO2, not an AI-powered diagnostic tool.

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

Not applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Compliance with international standard ISO 10993-1 and ISO 18562. This represents established biological safety standards.
• For Performance Testing (CO2, O2, Physical): Comparison against the performance of the legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The predicate device's performance established the "ground truth" or benchmark for equivalence.
• For Age Testing/Shelf Life: Laboratory-based aging studies where the performance of aged devices is compared to new devices (and found equivalent to "cannulas manufactured in 2022").

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable.

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The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris System is an interoperable of communicating and exchanging data with compatible information technology systems.

The BD Alaris System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, End-Tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. The EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

The BD Alaris Pump Module, and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

The BD Alaris System with Guardrails Suite MX v12 is a modular infusion and monitoring system designed to provide accurate, automated infusion of a broad range of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris System with Guardrails Suite MX v12 has three major components:

• System Hardware: a core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with . a distinct function.
• . Guardrails Suite MX Software: software applications for support and interaction with the system hardware (BD Alaris System Manager, BD Alaris Guardrails Editor, and BD Alaris System Maintenance).
• Interoperability Software: applications for bi-directional communication between the PCU/attached modules and an . electronic medical records (EMR) system. (Care Coordination Engine, Infusion Adapter, and Calculation Services).

The PCU is the core of the BD Alaris System with Guardrails Suite MX v12 and powers, programs, and monitors the attached modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made inter-unit interface connectors built into both sides of the PCU and modules.

The attachable modules are dedicated to infusion of fluids/medication, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

Each system must include a PCU. The rules for attachment of the modules are as follows:

• · The PCU is designed to operate a maximum of four infusion or monitoring modules. Modules added in excess of four are not recognized, with the exception of the Auto-ID Module that can be included as a fifth module.
• · Up to four Pump or Syringe Modules may be attached to a PCU at one time
• Only one PCA and one EtCO2 module can be included within the four attached influsion or monitoring modules, since each BD Alaris System v12 is dedicated to a single patient.
• In order to keep the PCU with attached modules well balanced when attached to a pole, it is important to distribute the . modules as evenly as possible on both sides of the PCU unit.

The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, motor control, data processing, power control, keypad processing, and communication.

Communication occurs within the PCU or modules, and between the PCU and attached modules. Communication between the units is by direct electrical connection through the mechanical supports on each side of the PCU and modules.

The PCU with its attached modules is designed to communicate and interact with the BD Alaris System with Guardrails Suite MX v12 software applications including software for interoperability with electronic medical records (EMR) systems. Communication between the PCU and the software application is accomplished through either a direct serial connection with the PCU or through a wireless connection with the PCU. If communication is interrupted, the PCU and modules will continue to function as programmed, but clinicians will need to make changes or inputs manually.

It is important to note that interoperability of the BD Alaris System v12 does not include remote control of the BD Alaris System v12 components. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician before they are activated.

The provided FDA 510(k) summary for the BD Alaris System with Guardrails Suite MX v12 explicitly states a "Summary of Non-Clinical Testing" and "No animal data was generated", and "No clinical data was generated". Therefore, the device performance is reported from non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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