Search Results

The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is designed to enrich the fresh gas flow of a continuous flow anaesthesia machine, when the vaporizer is connected directly between the flowmeter and the common gas outlet of the machine. The device has been developed in close co-operation with clinicians and the anaesthetic agent manufacturer.

This document is a 510(k) summary for the Sigma Alpha Vaporizer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML-based medical devices.

Therefore, many of the requested items related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not present in this document.

Here’s an analysis based on the provided text, addressing what can be extracted:

Acceptance Criteria and Device Performance Study for Sigma Alpha Vaporizer

This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a detailed clinical study with quantifiable metrics as one would expect for a novel AI/ML device.

The "study" in this context refers to the comparison of the Sigma Alpha Vaporizer's technological characteristics, intended use, and indications for use against predicate devices. The implicit acceptance criterion is that the new device is "as safe and effective" as the predicates, and that its technological characteristics are "very similar" without any "minor differences" making it "any less safe and effective."

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implicit)	Reported Device Performance (as per 510(k))
   Substantial Equivalence (Overall Safety & Effectiveness to Predicates): The device must be "as safe and effective" as analogous legally marketed predicate devices. This implies meeting performance standards for anesthetic vaporizers in terms of vaporizing specific agents and delivering controlled concentrations.	The document concludes: "From the above information it is concluded that the Penlon Sigma Alpha Vaporizer is substantially equivalent to the above named predicate devices." It explicitly states that "any minor differences do not make the Sigma Alpha any less safe and effective than the predicate devices."
   Intended Use & Indications for Use Match Predicates: The device's intended use and indications for use should align with the predicate devices.	"The intended use and indications for use apply equally to the above named predicate devices." The device is intended to vaporize Suprane® (Desflurane) and deliver controlled concentrations to patients (adult and pediatric).
   Technological Characteristics Similarity: The device's technological characteristics must be very similar to predicate devices.	"The technological characteristics of the Sigma Alpha and the predicate Devices... are very similar."

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

   • N/A. This is a 510(k) for a medical device (anesthetic vaporizer), not an AI/ML diagnostic or predictive tool. There is no "test set" of observational data in the AI/ML sense mentioned in this document. The evaluation is based on device design, engineering specifications, and comparison to predicate devices.

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

   • N/A. No "ground truth" establishment in the AI/ML sense. The approval process relies on regulatory review by FDA experts based on the device's documentation and demonstrated substantial equivalence, rather than expert consensus on a dataset.

4. Adjudication method for the test set:

   • N/A.

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:

   • N/A. This device is an anesthetic vaporizer, not an AI-assisted diagnostic tool.

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

   • N/A. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used:

   • N/A. For this type of device, "ground truth" would relate to engineering measurements verifying the vaporizer's output accuracy against its calibrated settings under various operating conditions. Such detailed test results are typically presented in the full 510(k) submission, but only the summary is provided here, which focuses on substantial equivalence. The summary does not provide specific performance data beyond the claim of substantial equivalence.

8. The sample size for the training set:

   • N/A. There is no "training set" in the AI/ML sense for this device.

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

   • N/A.

Ask a specific question about this device

The Keyed Filler Bottle Adaptor is intended to be used to enable the bottle, in which the anaesthetic agent is supplied by the pharmaceutical company, to be connected to the keyed filler port of an anaesthetic vaporizer. The Keyed Filler Bottle Adaptor provides a flexible connection that allows the liquid agent to be filled into, and drained from, the vaporizer by gravity.

It is indicated for use with bottles of Halothane, Enflurane, Isoflurane and Sevoflurane that provide anaesthesia, via a vaporizer, to a patient connected to an anaesthetic machine.

The Keyed Filler Bottle Adaptor is an accessory to a restricted medical device and is intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The Keyed Filler Bottle Adaptor enables users to connect the bottle, in which the pharmaceutical company supplies specific liquid anaesthetic agents (Halothane, Enflurane, Isoflurane and Sevoflurane), to a compatible filling receptacle provided on an anaesthetic vaporizer, that is attached to an anaesthetic machine. Four versions of the adaptor are available, each one with a colour coded bottle connector and male adaptor (for connecting to the vaporizer). Each adaptor is specific to one of the anaesthetic agents named above and is considered to be an accessory to a vaporizer.

The provided text is a 510(k) summary for the Penlon Limited Keyed Filler Bottle Adaptor, which aims to demonstrate substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for AI/ML-based diagnostic devices.

Therefore, many of the requested categories of information are not applicable to this document. The document describes the device, its intended use, and claims substantial equivalence based on technological characteristics similar to the predicate device. It does not contain information about studies with specific acceptance criteria, sample sizes for test or training sets, expert adjudication methods, or MRMC comparative effectiveness studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary for this device focuses on demonstrating substantial equivalence to a predicate device (Southmedic, Inc. Vapofil Keyed Agent adaptor K945993) rather than presenting a study with specific performance metrics against pre-defined acceptance criteria. The claim is that "any minor differences do not make the Penlon Keyed Filler Bottle Adaptor any less safe and any less effective than the predicate device."

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

This information is not provided in the document as it doesn't describe a clinical or performance study with a test set.

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

This information is not provided in the document as it doesn't describe a study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in this document. This type of study is typically conducted for diagnostic devices (especially those involving AI/ML) to assess reader performance with and without AI assistance, which is not relevant to a mechanical accessory like a keyed filler bottle adaptor.

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

No, a standalone performance study was not done and is not applicable to this device. This concept is relevant for AI/ML algorithms.

7. The Type of Ground Truth Used

This information is not provided as there is no study described that requires establishing ground truth. The device is a mechanical adaptor, and its performance is assessed through its mechanical characteristics and compatibility with other components, rather than against a "ground truth" in a clinical diagnostic sense.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a training set; this concept is relevant for AI/ML algorithms.

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

This information is not provided as there is no mention of a training set.

Ask a specific question about this device

The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Respiratory Therapists and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.

The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. In addition, in spontaneous mode, it can be used to monitor anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.

The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.

The provided document is a 510(k) summary for the AV-S Anaesthesia Ventilator. It focuses on demonstrating substantial equivalence to predicate devices and outlines the device's technical characteristics and intended use. Crucially, this document does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication for performance evaluation studies.

The text consistently refers to the device as an "Anaesthesia Ventilator" and its purpose is for "continuous mechanical ventilatory support during general anaesthesia." It emphasizes the similarities with predicate devices (Penlon Limited AV800 Anaesthesia Ventilator and Datex-Ohmeda 7900 Anaesthesia Ventilator) in terms of software control, multi-mode functionality, and indications for use. The only noted technological differences are the incorporation of the Prima Oxygen monitor and additional software for advanced spontaneous breathing support modes.

Since the document does not contain the requested information about acceptance criteria and performance studies, I am unable to populate the table or provide details for points 2 through 9.

Therefore, the response for the requested information is that it is not present in the provided text.

Ask a specific question about this device