Search Results

V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.

V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.

The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.

Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.

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

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

The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.

Ask a specific question about this device

The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.

The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. The vaporizers are available in Sevoflurane and Isoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The output concentration of the Tec 820/850 vaporizer is regulated by the "variable flow-split" method, where a total flow of fresh gas from upstream enters the vaporizer where it is split into two streams. One stream flows into the fresh gas bypass circuit and the other stream flows through the vaporizing chamber where it is saturated with the vapor of the liquid anesthetic agent.
Both gas paths have methods to regulate the flow to achieve desired total output agent concentration. Before exiting the vaporizer through the gas outlet, the split gas streams are joined. The combined total flow then flows out from the vaporizer via the Selectatec circuitry to the anesthesia gas delivery system.

The provided text describes the 510(k) premarket notification for the Tec 820 and Tec 850 anesthetic vaporizers, demonstrating their substantial equivalence to a predicate device (Tec 7). This submission is for medical hardware, not a software-based AI/ML device. Therefore, the questions related to AI/ML device performance (like MRMC studies, standalone AI performance, number of experts, and training/test set details) are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the non-clinical study that proves it meets those criteria.

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

The document refers to "Design Inputs" as the acceptance criteria and "Result" as the reported device performance.

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

The document describes "non-clinical tests" and "functional testing" to verify and validate the performance of the vaporizer. It does not specify a "sample size for the test set" in terms of number of devices tested, but rather indicates that "The Tec 820 and Tec 850 have been fully verified and validated". There's no mention of country of origin for data as this relates to manufactured product testing, not patient data. The testing is retrospective in the sense that it's performed on manufactured devices after design, to prove the design meets specifications.

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

Not applicable. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" here is the design specifications and functional requirements of the vaporizer, established through engineering design and regulatory standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes. The outcomes are objective measurements against engineering specifications ("PASS" or "FAIL").

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 is a hardware device (anesthetic vaporizer), not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is a hardware device. Its performance is inherent to the device itself.

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

The "ground truth" for this device's performance validation is its design inputs and specifications, as established by the manufacturer, and meeting relevant recognized standards for medical devices of this type. The objective tests performed (e.g., concentration accuracy, flow range, temperature compensation) measured the actual device performance against these pre-defined engineering targets.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a hardware device.

Ask a specific question about this device

V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.

The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.

The V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer. Fresh gas enters the vaporizer and is divided into two pathways: carrier gas (through pressure compensation and liquid vaporizing systems) and diluted gas (through bypass and temperature compensation systems). These two pathways mix to form mixed anesthetic gas with a controlled concentration before the outlet. It includes a filling system, can be installed on an anesthetic delivery system, evaporates liquid anesthetic agents to deliver mixed gas of controlled concentration, and provides a mechanism to adjust output concentration.

The provided documentation does not describe a study involving a medical device that uses AI or requires expert adjudication for establishing ground truth, nor does it discuss clinical performance metrics like sensitivity, specificity, or AUC. The submission is for an anesthetic vaporizer, which is a physical device, not a software algorithm.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Studies that prove the device meets acceptance criteria are documented under "7. Performance Data" and "6. Substantial Equivalence Considerations" in the provided text. Functional and system-level tests were conducted to evaluate the performance of each model of the V60 Anesthetic Vaporizer. These tests included measurements for filling rate, filling leakage, volume, output concentration accuracy, flow rates, maximum angles of tilt, temperature range, humidity, maximum atmospheric pressure, pressure difference at outlet, resistance, dial mark calibration, and compatibility. The results of these tests are presented in Appendix H4, H10, G1, and G3 (though the appendices themselves are not included in this document). The document states that all performance of the V60 vaporizer was verified through the successful completion of all tests, demonstrating that the device meets its predetermined specifications and FDA recognized consensus standards, and is equivalent to the predicate.

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

The document does not specify a "sample size" for a test set in terms of patients or independent data points for a diagnostic algorithm. This is a submission for a physical medical device. The "test set" would refer to the anesthetic vaporizers themselves that underwent functional and system-level testing. The document states that "functional and system level testing on the subject devices" was conducted, implying at least one, and likely several, units of the V60 Anesthetic Vaporizer were tested. The provenance of the data is implicitly from Shenzhen Mindray Bio-medical Electronics Co., Ltd, in China, based on the manufacturer's location. The tests are described as non-clinical, indicating lab-based, prospective testing rather than retrospective data analysis.

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. This is for a physical medical device (anesthetic vaporizer), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for the performance tests would be the established scientific and engineering principles and the specifications of the predicate device, against which the V60's physical performance was measured.

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

Not applicable. This is for a physical medical device, not a diagnostic device requiring adjudication of interpretations.

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 is for a physical anesthetic vaporizer, not an AI-powered diagnostic tool involving human readers.

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

Not applicable. This is for a physical anesthetic vaporizer, not a software algorithm.

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

The "ground truth" for the device's performance is established by the functional specifications and international standards (e.g., ISO, IEC, ANSI/AAMI) that define the expected output concentration accuracy, flow rates, resistance, and other physical properties of an anesthetic vaporizer. The predicate device's performance also serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a submission for a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As this is not a machine learning algorithm, there is no "training set" or establishment of ground truth for it in that context.

Ask a specific question about this device

The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.

The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.

The provided text is a 510(k) summary for a Sevoflurane Vaporizer Adaptor, which is a medical device for filling anesthetic vaporizers. This document does not contain information about acceptance criteria, device performance, a study design, or ground truth establishment typically associated with an AI/ML medical device. The device described is a physical adaptor, not a software algorithm.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details as it pertains to AI/ML device validation.

Instead, the document details the device's classification, intended use, and its substantial equivalence to a predicate device (Keyed Filler Bottle Adaptor K053564). The evidence provided for its safety and effectiveness relies on its similarity to the predicate device and compliance with ISO 5360:2006 for anesthetic vaporizers.

The relevant information from the provided text is:

Device Name: Sevoflurane Vaporizer Adaptor
Intended Use: To be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
Predicate Device: Keyed Filler Bottle Adaptor (K053564)
Key Statement for Equivalence: "The general design and materials of the Sevoflurane Vaporizer Adaptor is very similar to the predicate device. The only differences are the connection into the vaporizer and the model types... These differences do not make the Sevoflurane Vaporizer Adaptor any less safe or less effective than the predicate device."
Standard Compliance: "The device complies with the requirements of ISO 5360:2006."

To reiterate, the original request is designed for AI/ML device submissions, and this document does not contain any information relevant to those specific criteria.

Ask a specific question about this device

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 GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane.

The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.

The provided document is a 510(k) summary for the GAV – General Anaesthetic Vaporizer. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device (Tec 5 Continuous Flow Vaporizer) based on clinical and technical comparisons. However, it does not include detailed information regarding acceptance criteria, a specific study proving those criteria, or the methodology (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) typically associated with such studies for AI/ML-based devices.

The document primarily focuses on demonstrating equivalence to an existing device through comparison of features and performance characteristics, rather than establishing performance against specific, quantifiable acceptance criteria through an independent study as one might expect for a novel AI/ML medical device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in this summary. The document discusses "similar relevant performance according to expected clinical effect" and "similar specifications and properties (Accuracy, temperature range, flow range, pressures and output matches the set concentration and remains constant over a number of changing/changeable variables)." However, it doesn't provide specific numerical acceptance criteria.
• Reported Device Performance: The document states that the device's output "matches the set concentration and remains constant over a number of changing/changeable variables." This is a qualitative statement of performance, but specific numerical performance results (e.g., ±X% accuracy) are not provided in this summary. It mentions "non-clinical tests the results of which are detailed in Section 4," but Section 4 itself is not provided in the input.

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

• Not provided. This document is for a mechanical vaporizer, not a data-driven AI/ML device. Therefore, a "test set" in the context of data for AI/ML is not applicable here.

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/Not provided. As above, this is not an AI/ML device, and no ground truth establishment through expert review of data is described. The equivalency claim is based on engineering design, materials, and expected functional performance likened to the predicate device.

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

• Not applicable/Not provided.

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/Not provided. This is a mechanical vaporizer, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable/Not provided. This is a mechanical device, not an algorithm.

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

• Not applicable/Not provided in the traditional sense. The "ground truth" for a mechanical device like this would typically be established through engineering specifications, reference standards, and performance testing against those standards (e.g., flow meters, gas analyzers, temperature sensors). This summary does not detail the specific ground truth methodologies for the non-clinical tests it references.

8. The sample size for the training set

• Not applicable/Not provided. This is a mechanical device, not an AI/ML device that uses a training set.

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

• Not applicable/Not provided.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device that is a mechanical anesthesia vaporizer. It does not contain the type of AI/ML-specific study information requested. The "proof" of the device meeting its intended function relies on non-clinical tests (results not detailed here) and a comparison to a legally marketed predicate device with similar design, materials, and clinical/technical performance characteristics.

Ask a specific question about this device

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.

The provided document is a 510(k) premarket notification for a medical device called "D-Vapor," an anesthetic vaporizer. This type of regulatory submission in 2004 did not typically include detailed performance studies with acceptance criteria in the format requested, as it relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical trial data.

Therefore, many of the requested data points (like sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable (N/A) or not provided in this type of document for this class of device at this time.

Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes features and functionalities that demonstrate substantial equivalence to predicate devices (Tec 6 Plus and Vapor 2000). The "performance" is implied by matching or having similar characteristics to these existing devices.

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

• Sample Size: Not specified. The submission focuses on device description and comparison to predicates, not a clinical test set.
• Data Provenance: Not applicable for a traditional "test set" in this context. The data provided describes the device's features and its relation to predicate devices.

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

• Number of Experts: Not specified. The submission does not describe a process of establishing ground truth with experts for a test set.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not applicable. No test set requiring expert adjudication 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

• MRMC Study: No. This device is an anesthetic vaporizer, not an AI-powered diagnostic device, so an MRMC study with human readers assisting AI is not relevant or described.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable in the context of an algorithm. The device's performance is described in terms of its mechanical and electronic functions. The device is a standalone functional unit within an anesthesia delivery system.

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

• Type of Ground Truth: Not applicable in the sense of a diagnostic or predictive algorithm. The "truth" for this device lies in its ability to accurately deliver a controlled concentration of Desflurane, as verified through engineering tests and comparison to established predicate devices. The document implies that the predicate devices' long-standing safe and effective use serves as a form of "ground truth" for the overall device category's functionality.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.

The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.

Here's an analysis of the provided text to fulfill your request.

Based on the provided documents, there is no specific study described that proves the device meets particular acceptance criteria in the format you've requested.

The documents are a 510(k) Summary of Safety and Effectiveness and an FDA clearance letter for the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer. These types of documents assert substantial equivalence to previously cleared devices rather than providing detailed clinical or performance studies with acceptance criteria in the way you might find for novel AI/ML medical devices.

Instead, the submission relies on:

• Substantial Equivalence: The key argument is that the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer is substantially equivalent to existing Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers.
• Compliance with Voluntary Standards: The device was designed to comply with applicable portions of EN 740, ISO 5358, and ASTM F1161.
• Engineering Tests/Validation: The document states, "The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizers have been validated through testing that, in part, support the compliance of the current and predicate device to the above mentioned standards." However, it does not detail these tests, their acceptance criteria, or their results.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies for a performance study.

Here's how I would answer your request based on the lack of this specific information in the provided text:

1. Table of Acceptance Criteria and 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)

• Not applicable/Not specified. The provided document does not describe a test set or data provenance in the context of a performance study for this device. The submission focuses on substantial equivalence and compliance with engineering standards.

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/Not specified. This pertains to clinical or diagnostic performance studies, which are not detailed in the provided documents.

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

• Not applicable/Not specified. This information is relevant for studies involving human interpretation or expert consensus on ground truth, which is not 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

• No. The device described is an anesthesia vaporizer, a hardware medical device, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable/Not specified. This is a hardware device; the concept of a standalone "algorithm only" performance is not relevant.

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

• Not applicable/Not specified. For a hardware device like an anesthesia vaporizer, "ground truth" typically refers to engineering specifications, calibrated measurements, and adherence to safety and performance standards, rather than clinical outcomes or diagnostic interpretations. The document refers to compliance with voluntary standards (EN 740, ISO 5358, ASTM F1161).

8. The sample size for the training set

• Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.

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

• Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.

Ask a specific question about this device