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The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.

ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software.

The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.

The provided text describes a 510(k) submission for the ACIST RXi Mini System, a medical device for measuring intravascular pressure. However, the document focuses on non-clinical tests (bench testing, electrical, software verification) to demonstrate substantial equivalence to a predicate device. It does not present clinical study data or specific acceptance criteria for device performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be populated from the provided information.

Here's a summary based on the available text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing," "electrical testing," "software verification," and "design validation" which are non-clinical and do not typically involve human patient "test sets" in the context of diagnostic accuracy.
• Data Provenance: The tests were non-clinical, likely conducted at the manufacturer's facilities or accredited labs. Country of origin for data is not applicable as it's not patient data. Retrospective/Prospective: Not applicable as it's non-clinical testing.

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

• Not applicable. As this was non-clinical engineering and software testing, there was no "ground truth" established by medical experts in the context of patient diagnosis. Performance was assessed against engineering specifications and regulatory standards.

4. Adjudication method for the test set

• Not applicable. There was no clinical imagery or patient data requiring expert 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

• No. This device is a transducer system for measuring intravascular pressure, not a diagnostic imaging AI system. Therefore, an MRMC study or AI assistance evaluation is not relevant.

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

• Yes, in a sense. The "standalone" performance refers to the device's ability to accurately convert the optical sensor pressure signal into an analog pressure signal. This performance was validated through non-clinical testing (bench testing, electrical testing, software verification, design validation) to show it functions as intended by itself, without human interpretation of its output beyond ensuring it meets specifications.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests would have been engineering specifications, established standards (e.g., IEC 60601-1, IEC 60601-1-2), and design requirements. The device’s output was measured against these predefined technical benchmarks rather than against a medical outcome or expert consensus on clinical data.

8. The sample size for the training set

• Not applicable. This device is a hardware and software system for signal processing, not a machine learning or AI model that requires a "training set" of data in the typical sense.

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

• Not applicable, as there was no training set in the context of machine learning.

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The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.

This document is a 510(k) premarket notification for the CLEARSIGN II Amplifier, which is a Transducer Signal Amplifier and Conditioner. The submission seeks to prove substantial equivalence to a previously cleared device, also named CLEARSIGN II Amplifier (K150235).

The device in question (CLEARSIGN II Amplifier) is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

Acceptance Criteria and Reported Device Performance

The document describes performance data through various verification tests to support a determination of substantial equivalence. While specific quantitative acceptance criteria are not explicitly detailed in a table format, the document states that "No new safety or performance issues were raised during the device testing" and that the testing assures "conformance to the requirements for its intended use."

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is verification testing against design specifications, not a clinical study on patient data.

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

Not applicable. The testing described is design verification (engineering tests), not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set:

Not applicable. This was design verification testing, not a clinical study with subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on identical indications for use and fundamentally similar technological characteristics to a predicate device, with verification testing ensuring no new safety or performance issues. This is not a study comparing human reader performance with and without AI assistance.

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

Yes, in essence, the "Performance Data" section describes standalone testing of the device's hardware and software components. The "CLEARSIGN II ECG Offset Test," "Firmware version 2.09 Verification Testing," and "Software Verification Testing" evaluate the device's intrinsic functions without a human-in-the-loop performance assessment.

7. Type of Ground Truth Used:

The ground truth used for the verification testing would be the engineering specifications and expected output parameters for the device's functions (e.g., specific voltage levels for ECG amplification, correct processing logic for firmware, proper software operation). It does not involve expert consensus, pathology, or outcomes data in the medical sense, but rather conformance to defined technical requirements.

8. Sample Size for the Training Set:

Not applicable. This device is an amplifier and conditioner, not an AI or machine learning algorithm that requires a training set of data. The "firmware" and "software" mentioned are likely traditional programmed logic, not adaptive learning models.

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

Not applicable, as no training set (for machine learning) is relevant to this device's development or regulatory submission.

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The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARSIGN II Amplifier:

This document is a 510(k) Premarket Notification submission for a medical device called the CLEARSIGN II Amplifier. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel studies. Therefore, the information provided focuses on comparative testing and adherence to standards rather than traditional clinical trial-style data.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance metrics in the way one might expect for a new, breakthrough device. Instead, the "acceptance criteria" are implied by adherence to established industry standards and successful completion of specific functional tests. The reported "performance" is that the device met these predefined acceptance criteria.

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

   • Sample Size:
     • For bench testing: Not specified in terms of number of units or test iterations beyond "testing per standards."
     • For in vivo testing: "In vivo animal testing" is mentioned, implying a biological sample, but the number of animals or specific experimental design is not detailed.
   • Data Provenance: The standard tests (IEC, ISO, etc.) are generally conducted in a controlled laboratory environment. The in vivo animal testing would also be laboratory-based and prospective within the context of the study. The document does not specify a country of origin for the data, but given it's a submission to the FDA (USA), it's likely the testing was conducted in the US or by a facility adhering to US/international standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The studies described are primarily engineering and bench tests against known standards, which typically do not involve human expert adjudication for "ground truth" in the same way clinical image analysis would. For functional tests, "ground truth" is defined by the physical or electrical standards themselves.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the type of testing described. Adjudication methods are typically used for subjective assessments or when there is ambiguity in defining a "ground truth" from complex clinical data, which is not the nature of the engineering and functional tests reported here.

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:

   • No, an MRMC comparative effectiveness study was not done.
   • This device is an amplifier for physiological signals (ECG, pressure transducers), transmitting data to a recording system. It is not an AI-powered diagnostic tool that assists human readers in interpreting complex images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

   • The "performance" of the device is inherently standalone in the sense that its functional capabilities (amplification, conditioning, signal transmission) are tested against engineering specifications. The device itself is an electromechanical component of a larger system (LabSystem PRO EP Recording System). Its performance in isolation (e.g., signal fidelity, noise reduction) is what would be tested, as described by the various IEC and ISO standards. However, it's not an "algorithm-only" device; it's hardware with embedded software.
   • The document implies standalone testing of the amplifier's functionality and its software's performance, but it's within the context of hardware.

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

   • The "ground truth" for these tests is generally defined by established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). For functional tests (like invasive blood pressure or ECG monitoring), the 'truth' would be a precisely known input signal that the device is expected to accurately amplify and condition according to its specifications. For electrical safety, the 'truth' is compliance with safety limits. In a sense, the "ground truth" is the specification itself and the ability of the device to meet it.
   • The "in vivo animal testing" would likely establish safety and basic physiological signal acquisition capability, with "ground truth" being in vivo physiological signals and the absence of adverse events, observed by qualified veterinary or medical staff.

7. The sample size for the training set:

   • Not applicable and not mentioned. This device is not an AI/ML device that requires a "training set." It is an amplifier, and its design is based on engineering principles and standards, not on learning from a dataset.

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

   • Not applicable. As stated above, there is no training set for this type of device.

Summary of Device and Study Context:

The CLEARSIGN II Amplifier is an electromedical device intended to amplify and condition physiological signals (ECG and pressure). The regulatory submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (CLEARSIGN Amplifier, K050006). This means the focus of the studies is to show that the new device has "fundamentally the same technological characteristics" and performs in a safe and effective manner, compliant with current (updated) standards, and does not raise new safety or effectiveness concerns compared to the predicate.

The "studies" performed are primarily:

• Bench testing: Verifying compliance with various electrical, electromagnetic, software, functional, and environmental standards (IEC, ISO, ISTA).
• In vivo animal testing: Likely for general safety and initial physiological data acquisition demonstration.

These types of studies are standard for regulatory clearance of updates or minor modifications to existing device types and are distinct from multi-center clinical trials or AI validation studies that require extensive human expert review or large annotated datasets.

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The Bard Borealis (CLEARSIGN) Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the Bard LabSystem III EP Laboratory) that can record and display the information.

The Borealis Amplifier is a medical device intended to collect, amplify, filter and format physiological signals for transfer to a host computer system (Bard Electrophysiologic LabSystem III Laboratory) capable of recording and display of such information. The physiologic signal information is acquired from diagnostic and therapeutic electrophysiology (EP) catheters, surface electrocardiographic (ECG) electrodes, intravascular pressure transducers, intracardiac stimulators and RF ablation generators.

The provided text describes the "Borealis Amplifier" and states that "Software qualification is performed on the system according to specific acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the Borealis Amplifier" and "The testing demonstrates that the Borealis Amplifier meets the established performance requirements." However, the document does not explicitly list the acceptance criteria or the specific device performance outcomes for these criteria. It focuses on demonstrating substantial equivalence to a predicate device (STAMP Amplifier) through adherence to various electrical safety and compatibility standards, and general software quality assurance.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's what can be answered and what information is missing:

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

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 Test Set: Not specified. The document mentions "testing conducted in support of the Borealis Amplifier" and reports in Volume II (appendices), but does not detail sample sizes for specific functional tests.
• Data Provenance: Not specified. The document does not indicate the country of origin of testing data, nor whether it was retrospective or prospective. The testing appears to be primarily laboratory-based to meet engineering and safety standards, rather than clinical trial data.

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)

• Not applicable. The document discusses non-clinical tests (electrical safety, EMC, software qualification) for an amplifier device. These types of tests typically rely on engineering specifications and measurement equipment, not expert consensus for ground truth on clinical images or diagnoses.

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

• Not applicable. As noted above, the tests are primarily engineering and technical, not clinical evaluations requiring adjudication of ground truth by multiple experts.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an amplifier for physiological signals, not an AI-assisted diagnostic tool for human readers.

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

• The document describes the device as collecting, amplifying, filtering, and formatting physiological signals for transfer to a host computer for recording and display. It explicitly states: "The system does not control the delivery of therapy, it does not administer drugs, it does not perform any life-supporting or life-sustaining functions, and it does not analyze data acquired during an EP procedure." Therefore, its performance is inherently standalone in its function as an amplifier, without a "human-in-the-loop" component for its primary operation. The testing conducted focused on its technical compliance to standards (electrical safety, EMC, software verification) rather than an assessment of diagnostic performance.

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

• For the non-clinical tests described, the "ground truth" would be the engineering specifications and compliance requirements outlined in the various international standards (e.g., EN 60601-1, IEEE standards for software). For instance, for electrical safety, the ground truth is whether the device's electrical leakage or insulation meets the specified limits in the standard.

8. The sample size for the training set

• Not applicable. This document describes a medical device (an amplifier) and its compliance testing, not a machine learning or AI model that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, 11 & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Draeger Infinity Modular Monitor for display. Such devices include:

Maquet SV 300 ventilator
Maquet Servoi Ventilator
Maquet SV900 ventilator
Draeger Evita 2 ventilator
Draeger Evita 4 ventilator
Draeger EvitaXL ventilator
Draeger Savina ventilator
Draeger Babylog ventilator
Draeger FabiusGS Anesthesia System
Draeger Narkomed 2 Anesthesia System
Draeger Narkomed 4 Anesthesia System
Draeger Narkomed 6000 / 6400 Anesthesia Systems
Draeger Julian Anesthesia Machine
Puritan Bennett 7200 ventilator
Puritan Bennett 840 ventilator
Hamilton Galileo ventilator
Ohmeda 7900 Anesthesia Machine
Abbott Oximetrix 3 Blood Gas Analyzer
Abbott Q2 CCO monitor
AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer
Baxter Vigilance blood gas/continuous cardiac output monitor
Optical Sensors Inc .: OSI - Optical CAM
VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor*
Sensormedics Micro Gas 7650
Draeger Fabius Tiro
Draeger Primus
Viasys Bear 1000

Note: * The SC 9000 does not support communication with the Aspect BIS Monitor

Draeger's Infinity Medical Information Bus Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB VF5.1 software enables connectivity of the Viasys Bear 1000 ventilator to the Infinity modular monitors.

This connection enables the display of device specific data on an Infinity modular monitor. Data from the Viasys Bear 1000 ventilator can also be displayed and alarms annunciated on the VentCentral application (K003246) of the MultiView.

The provided text is a 510(k) Summary for a medical device (Draeger's Infinity Medical Information Bus Protocol Converter). This summary outlines device information, intended use, and substantial equivalence, but it does not contain details about acceptance criteria, device performance studies, or clinical trial data.

Specifically, the document states:

• "Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5.1 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates that some non-clinical testing was done to confirm the software update didn't change the core functionality or safety, but it doesn't provide specific criteria or results.
• "Assessment of clinical performance data for equivalence: Not applicable" This explicitly states that clinical performance data was not required for this 510(k) submission.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, and for this particular device (a protocol converter for medical data display), extensive clinical performance studies or specific acceptance criteria for diagnostic accuracy (as would be seen in an AI/diagnostic imaging device) were deemed "not applicable."

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The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, II & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Draeger INFENTTY Modular Monitor for display. Such devices include:

Maquet SV 300 ventilator Maquet Servoi Ventilator Maquet SV900 ventilator Draeger Evita 2 ventilator Draeger Evita 4 ventilator Draeger EvitaXL ventilator Draeger Savina ventilator Draeger Babylog ventilator Draeger FabiusGS Anesthesia System Draeger Narkomed 2 Anesthesia System Draeger Narkomed 4 Anesthesia System Draeger Narkomed 6000 / 6400 Anesthesia Systems Draeger Julian Anesthesia Machine Puritan Bennett 7200 ventilator Puritan Bennett 840 ventilator Hamilton Galileo ventilator Ohmeda 7900 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer Abbott Q2 CCO monitor AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Baxter Vigilance blood gas/continuous cardiac output monitor Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650

Note: * The SC 9000 does nor support communication with the Aspect BIS Monitor

Draeger's Infinity Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB/MIBII VF4 software enables MIB connectivity of the following Draeger devices to the INFINITY modular monitors:

Narkomed 6000 & 6400 Fabius GS Savina Evita XL

These connections enable the display of device specific data on an INFINITY modular monitor. Data from the devices can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation and alarms received from the Evita XL and Savina ventilators annunciated.

This submission, K033807, describes a modification to the Draeger Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters. The primary change is the enablement of MIB connectivity for new Draeger devices (Narkomed 6000 & 6400, Fabius GS, Savina, Evita XL) to the INFINITY modular monitors through VF4 software. The key takeaway from the document is that no new clinical or non-clinical performance data was deemed necessary to establish substantial equivalence for this modification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication and ground truth establishment is not applicable to this specific 510(k) submission, as it relies on the predicate device's established performance without introducing new performance claims that would require new and extensive testing.

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

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

Since this is a modification to an already cleared device and the submission states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," specific acceptance criteria and detailed reported performance for the modified aspects are not explicitly defined in this document. The implicit acceptance criterion is that the modified device maintains the fundamental technology, intended use, and safety/effectiveness of the predicate device.

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

• Sample size for test set: Not applicable (no new testing for this modification was deemed necessary beyond demonstrating functionality of the new connections).
• Data provenance: Not applicable.

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):

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: 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:

• MRMC study: Not applicable. The device is a protocol converter, not an AI-driven diagnostic system.

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

• Standalone performance study: Not applicable. The device is a hardware/software protocol converter for data display, not an algorithm with standalone performance metrics in the typical sense.

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

• Type of ground truth: Not applicable for new testing specific to this modification. The "ground truth" for the predicate device would have been the accurate transmission and display of physiological data, which, for a protocol converter, relies on functional verification rather than clinical outcomes or expert consensus in the same way a diagnostic imaging device would.

8. The sample size for the training set:

• Sample size for training set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground truth establishment: Not applicable.

In summary, this 510(k) submission is for a device modification that extends connectivity, and it leverages the substantial equivalence of its predicate devices without requiring new, extensive performance studies for clearance.

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The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel

The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pressure Control Unit PCU-2000" and an "Indications for Use Statement" attachment.

This document describes a medical device (transducer signal amplifier and conditioner) and its intended use, rather than an AI/algorithm-driven device that would undergo significant performance evaluation with acceptance criteria, ground truth, and studies like MRMC or standalone performance.

Therefore, the requested information about acceptance criteria and studies (including sample sizes, ground truth establishment, expert involvement, adjudication methods, and AI-specific studies) cannot be extracted from this document because:

• The device is a hardware component: The PCU-2000 is described as a "two-channel electrically isolated amplifier" intended to provide an "electrical interface" between a pressure transducer and a data acquisition module or medical monitor. It conditions analog signals, not processes complex image or sensor data with AI.
• The 510(k) clearance process for this type of device focuses on substantial equivalence: The letter confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is different from the extensive performance validation required for AI/ML devices.
• No mention of AI, algorithms, or complex data analysis: The entire document refers to basic signal amplification and conditioning for physiological pressure measurements. There is no indication of any AI component, predictive modeling, or diagnostic algorithms that would necessitate the type of detailed performance studies you're asking about.

In summary, the provided text does not contain the information requested because the device described is not an AI/algorithm-driven device that would typically undergo such studies and evaluations.

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The Siemens Medical Information Bus (MIB/MIB II and MIB Duo) Protocol Converters are intended for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that a third party medical device that provides data, such as: Siemens SV 300 ventilator, Siemens Servoi Ventilator, Baxter Vigilance blood gas/continuous cardiac output monitor, Siemens SV900 ventilator, Draeger Evita II ventilator, Draeger Evita IV ventilator, Draeger Babylog ventilator, Puritan Bennett 7200 ventilator, Draeger Narkomed II Anesthesia System, Draeger Narkomed IV Anesthesia System, Draeger Julian Anesthesia Machine, Ohmeda 7900 Anesthesia Machine, Abbott Oximetrix 3 Blood Gas Analyzer, AVL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer, Optical Sensors Inc.: OSI - Optical CAM, VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor; Aspect A-2000 BIS Monitor should be connected to a Siemens INFINITY Modular Monitor for display.

The Medical Information Bus (MIB) Protocol Converters have received six 510(k) clearances for connectivity with third party devices. Minor software modifications have been implemented in the MIB/MIB II and MIB Duo protocol converters, and a device specific accessory cable is now available that allows an interface connection for Siemens Servoi Ventilator (K010925) to the INFINITY modular moritors (SC 9000/SC7000/SC9000XL/SC8000). This connection enables the display of Servoi Ventilator data on an INFINITY modular monitor and on the VentCentral display (K003246) of the MultiView WorkStation.

This document is a 510(k) summary for the Siemens Medical Information Bus (MIB, MIB II, MIB Duo) Protocol Converter. It outlines the device's purpose, previous clearances, and intended use. The content focuses on regulatory compliance and equivalence to predicate devices, rather than a detailed study demonstrating performance against specific medical acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted or inferred from this document.

Here's an assessment based on the provided text:

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

The document does not specify quantitative acceptance criteria or detailed device performance metrics in the way a clinical study would for diagnostic accuracy or treatment efficacy. The assessment for equivalence is based on "non-clinical performance data" without explicit criteria or results mentioned.

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

Not applicable. This document is a regulatory submission for a protocol converter, not a clinical study involving patient data or a test set in the traditional sense for evaluating diagnostic or therapeutic efficacy. The "non-clinical performance data for equivalence" refers to technical characteristics and functionality.

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)

Not applicable. No ground truth establishment by medical experts is described, as this is a device for data integration, not for making clinical diagnoses or treatment decisions itself.

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

Not applicable. No adjudication method is described.

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 protocol converter, not an AI-assisted diagnostic or therapeutic tool. No MRMC study or AI-related performance improvements are mentioned.

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

Not applicable. This device is not an algorithm for standalone performance. Its function is to facilitate data display for human healthcare professionals.

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

Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this device's function as a protocol converter.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no training set mentioned.

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