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The Penlon Prima Anaesthesia Machine is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will deliver this fresh gas to the patient.
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.

The Prima Anaesthesia Machine is a continuous flow anaesthesia gas delivery device that enables the anesthetist to deliver mixtures of oxygen, air, nitrous oxide and volatile anaesthetic agents to a patient. Although the device has no direct contact with the patient it has an important role to play in a system that delivers anaesthesia gases to a patient.
The device comprises a trolley, a gas delivery system, gas control system. safety systems and facilities to mount and interface other modules of an anaesthesia delivery system, e.g. ventilators, vaporizers, absorbers plus other accessories. The design of the device conforms to all relevant national and international standards covering the safety of anesthesia systems.

This FDA submission focuses on a modification to an Anesthesia Machine, not an AI/ML powered device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device approval (which involve metrics like sensitivity, specificity, reader studies, etc.) are not applicable here.

The document describes a Special 510(k) for a device modification, which emphasizes demonstrating that the modified device is substantially equivalent to a legally marketed predicate device. The information provided is primarily administrative and descriptive, outlining the device's function, intended use, and technological characteristics. There is no mention of a study involving clinical performance metrics, reader studies, or explicit acceptance criteria in the format you've requested for an AI/ML device.

Here's why the requested information cannot be fully provided based on the given document:

• No AI/ML Component: The device is an "Anaesthesia Machine," a hardware medical device. There's no indication of any AI or machine learning algorithms involved.
• Focus on Substantial Equivalence: For this type of device modification submission, the "study" is often a demonstration through engineering analysis, design documentation, and testing (e.g., electrical safety, mechanical integrity, gas delivery accuracy) that the modified device performs as intended and is as safe and effective as the predicate. These are typically internal validation activities, not public "studies" with performance metrics like those for diagnostic AI.
• Lack of Specific Quantitative Performance Data: The document does not contain tables of performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, expert ground truth establishment, or details about reader studies.

If this were an AI/ML powered device submission, the requested information would be crucial. However, for a traditional hardware device modification, the content of the provided 510(k) summary is typical.

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The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.

Anaesthetic Vaporizer

This document is a 510(k) premarket notification decision letter from the FDA for an "Anaesthetic Vaporizer." It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics. The device described is a traditional medical device (anesthetic vaporizer), not a software device that would typically have performance metrics like sensitivity, specificity, and a ground truth study.

Therefore, I cannot provide the requested information.

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Penlon PPV Vaporizers

This document is a summary of safety and effectiveness for Penlon PPV Vaporizers, submitted in accordance with SMDA 1990. It describes compliance with "ASTM F1161:1988 Clause 12" and "Clause 4" of the same standard. It also mentions a hazard analysis and user manual improvements.

However, the provided text does not contain the specific information required to complete your request, which focuses on:

• Acceptance Criteria Table and Device Performance: The document states compliance with a standard but doesn't list specific acceptance criteria (e.g., performance metrics, thresholds) or reported device performance against those criteria. It only mentions general compliance.
• Sample size and data provenance for test set: No information.
• Number of experts and qualifications for ground truth: No information.
• Adjudication method for test set: No information.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No information on human reader improvement with/without AI.
• Standalone algorithm performance: This document describes a medical device (vaporizer), not an AI algorithm, so standalone performance is not applicable in the requested context.
• Type of ground truth used: Not applicable as it's not a diagnostic AI study.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document is purely a regulatory submission summary for a physical medical device, not a study report for an AI/software-as-medical-device (SaMD) that would typically involve the requested performance evaluation details.

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