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The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The provided text describes the A5 Anesthesia Delivery System and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested.

The document indicates:

• Summary of Performance Testing: "The A5 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards." It then lists numerous IEC, ISO, CGA, and ASTM standards.
• User Evaluation: "The A5 has been evaluated by end-users and found to meets performed within its intended use and met their specific needs."

However, it does not provide:

• A table of specific acceptance criteria (e.g., accuracy +/- X%, sensitivity, specificity) with reported device performance metrics against those criteria.
• Details on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or specific ground truth establishment methods for a training set.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, because this information is not present in the provided text. The document focuses on regulatory compliance through adherence to standards and user evaluations rather than detailed performance metrics.

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The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (ECG, SpO2, IBP)
• Pulse Oximetry (SpO2 )
• ST Segment Analysis derived from 3 or 5 lead measurements
• Arrhythmia Detection derived from 3 or 5 lead measurements
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) up to two (2) channels .
• Carbon Dioxide (CO2)
• Respiration Rate derived from ECG or CO2
• Temperature
• IV Drug Calculations

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

The provided 510(k) summary for the Passport V Monitor does not contain specific acceptance criteria or a dedicated study section with detailed performance metrics. It generally states:

"The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements."

This indicates that various performance tests were conducted to demonstrate compliance with relevant standards, but the summary does not explicitly list the acceptance criteria or the reported device performance in a table format.

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

Here's a breakdown of what can be inferred or stated as not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with "recognized safety, performance and electromagnetic compatibility standards" and "appropriate test requirements" for software verification and validation, but specific numerical or qualitative criteria for each parameter (e.g., accuracy for heart rate, SpO2) are not provided.
• Reported Device Performance: Not explicitly stated in the document. The document confirms that the device was tested and found to be in compliance, but it does not present the results of those tests (e.g., measured accuracy, bias, or precision of physiological parameters).

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: Not specified.
• Data Provenance: Not specified.

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 specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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:

• This device is a patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or expected for this type of device and is not mentioned.

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

• The Passport V monitor is a standalone device with algorithms for various physiological measurements (ECG, SpO2, NIBP, etc.). The statement "The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" implies that its standalone performance was evaluated against these standards. However, specific details of these standalone performance tests (e.g., how accuracy of Heart Rate was measured without human intervention) are not provided.

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

• For a patient monitor, ground truth would typically involve reference measurement devices (e.g., a calibrated ECG simulator for heart rate accuracy, a reference oximeter for SpO2, a calibrated pressure transducer for blood pressure). The document does not specify the exact methods or reference standards used to establish ground truth for its performance tests.

8. The sample size for the training set:

• This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for an AI model learning from data). It is a traditional patient monitor. Therefore, this information is not applicable and not provided.

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

• As a traditional patient monitor, the concept of a "training set" and its associated ground truth establishment is not applicable.

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The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), pulse rate and temperature.

The Accutorr V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Accutorr V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Accutor V may be powered by a rechargeable Lithium ion battery or through line-power. The Accutorr V may be equipped with optional infrared or predictive temperature and recorder modules and may be mounted on an optional rolling stand for easy portability.

The provided text K091068 is a 510(k) Summary for the Accutorr V Monitor. This document does not contain the detailed study information regarding acceptance criteria and performance as requested. It states that "The Accutorr V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" and that a "risk analysis has been developed... The device's software has been verified and validated in accordance with the appropriate test requirements." However, it does not provide the specific acceptance criteria, reported device performance metrics, study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot populate the requested table and answer the study-related questions based on the information provided in K091068. The document serves as a summary for regulatory submission, rather than a detailed report of the performance studies.

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The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

The Navigator Anesthesia Delivery System is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The Navigator System is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the Navigator provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the Navigator System with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional anesthesia system along with dual flow tubes which display the gas flows at all times. The Navigator contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.

The provided text describes the 510(k) summary for the Navigator Anesthesia Delivery System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the information required to fully answer your request (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not provided in the given text.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as specific performance thresholds. The document generally states compliance with "recognized safety, performance and electromagnetic compatibility standards."
• Reported Device Performance: Not quantified. The document states it has been "tested and found to be in compliance" with these standards.

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: Not mentioned.
• Data Provenance: Not mentioned.

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. The "testing" mentioned refers to compliance with engineering/safety standards, not clinical ground truth established by experts.
• 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: No, this is an anesthesia delivery system, not an AI-assisted diagnostic tool for human readers.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable as it's not an algorithm, but a medical device. The "software has been validated" refers to internal software validation, not a standalone performance evaluation in the context of AI.

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

• Type of Ground Truth: Not applicable in the traditional sense of diagnostic AI. The "ground truth" for this device would be established by validated engineering tests and compliance with recognized standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a training set.

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

• How Ground Truth was established: Not applicable.

Summary of available information regarding the "study" (Performance Testing):

The document mentions a "Summary of Performance Testing" which states:

• "The Navigator System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards."
• "A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards."
• "The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)."
• The conclusion states that based on this performance testing, the device is "safe, effective and substantially equivalent to the predicate device."

In essence, the "study" proving the device meets acceptance criteria is a series of engineering and software validation tests demonstrated to comply with established medical device standards and FDA guidance for substantial equivalence, rather than a clinical study with detailed performance metrics, patient cohorts, or expert ground truth.

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