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The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.

The EnduraVent-5 Ventilator is a self-contained, portable ventilator, consisting totally of non-magnetic components which include: (10 a gas inlet connector, (2) a gas inlet filter, (3) two timing valves, (4) a pilot actuator valve, (5) a flow metering valve, and, (6) a pressure-relief valve. During the inspiratory time phase of the system, a small portion of the gas flowing through the system is diverted to the exhalation valve diaphragm, inflating the diaphragm in sequence with the inspiratory time, thereby allowing the main gas flow from the Device to flow to the patient. During the expiratory phase, all ventilator gas flow ceases, the exhalation valve opens and the patients's exhaled gases flow to atmosphere.

The provided 510(k) summary for the EnduraVent-5 Ventilator describes its substantial equivalence to a predicate device, the Magellan Ventilator. It does not detail a study involving specific acceptance criteria or performance metrics for the EnduraVent-5 beyond confirming it operates as designed and functions as intended, with a focus on manufacturing process verification.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results in a table format. It broadly states:

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 mentions "Bench testing" but does not specify the sample size for the tests conducted.
The data provenance is not explicitly stated, but the testing was conducted by Providence Global Medical, Inc. in the context of a US 510(k) submission. It appears to be prospective testing for the EnduraVent-5 against the predicate.

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 mentioned. This type of information is typically relevant for AI/software-based devices assessing medical images or complex data, where human expert review establishes ground truth. For a mechanical ventilator, the "ground truth" is typically defined by engineering specifications and physical measurements, not expert consensus on interpretations.

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

Not applicable/Not mentioned. Adjudication methods are typically used when multiple human readers interpret data, and their disagreements need resolution to establish ground truth. This is not described for the ventilator's performance testing.

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 document describes a comparison between the EnduraVent-5 Ventilator and its predicate, the Magellan Ventilator, based on "exactly duplicated technological characteristics and components, and exactly the same principles of operations." It is a substantial equivalence claim for a physical medical device, not an AI or software-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant or discussed.

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

Not applicable. The EnduraVent-5 is a physical ventilator; the concept of a "standalone algorithm" is not relevant here. The performance testing was of the physical device itself.

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

The "ground truth" for the performance testing of the EnduraVent-5 Ventilator appears to have been established by:

• Engineering specifications and design intent: "confirms that the device operates as designed."
• Comparison to the predicate device: "Bench testing with the Endura-Vent-5 and the predicate Magellan Ventilator was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories." This implies the predicate's known and accepted performance served as a benchmark.
• Physical measurements: Verification of "delivery of the gas volumes, frequencies, and safety devices."

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable. As above, no training set is relevant for this device.

In summary: The 510(k) submission for the EnduraVent-5 Ventilator relies on demonstrating substantial equivalence to a legally marketed predicate device (Magellan Ventilator). The "study" described is primarily bench testing to confirm that the new device replicates the predicate's design and performs as intended, using the same testing protocols. The focus is on verifying manufacturing consistency and functional operation rather than specific quantitative performance metrics against a defined "ground truth" that would be typical for a diagnostic or AI-driven device.

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The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device. Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.

This document is a 510(k) summary for the Atlantis Hyperbaric Ventilator. It is a premarket notification for a medical device seeking substantial equivalence to a predicate device. This type of document generally describes the device, its intended use, and argues for its equivalence to a device already on the market, rather than detailing a clinical study with acceptance criteria and performance data in the way one might expect for a novel device requiring extensive clinical trials.

Based on the provided text, there is no detailed clinical study described that specifically outlines acceptance criteria and then presents study results to prove the device meets those criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through a comparison of intended use, technological characteristics, and principles of operation.

Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted because such a study is not presented in this document.

Here's an analysis based on the available information:

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

• Acceptance Criteria: No specific numerical acceptance criteria are stated in this document. The "acceptance criteria" here is implicitly that the device is "as safe and effective" as the predicate and exhibits "no new issues of safety or effectiveness." This is a regulatory standard for substantial equivalence, not a performance metric.
• Reported Device Performance: No specific performance metrics (e.g., flow rate accuracy, pressure control precision, response time) are reported. The document states that the Atlantis Hyperbaric Ventilator is an "exact duplicate" of the predicate and has "exactly the same technological characteristics" and "exactly the same principles of operations."

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

• Not applicable. No "test set" in the context of a clinical performance study is described. The comparison is based on design and technical specifications against a predicate device.

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

• Not applicable. No "ground truth" or expert review of a test set is described.

4. Adjudication method for the test set

• Not applicable. No "test set" and thus 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 is a ventilator, not an imaging device requiring human reader interpretation or AI assistance.

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

• Not applicable. This is a ventilator, not an algorithm.

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

• Not applicable. The "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" for an algorithm or a clinical trial.

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

• Not applicable.

Summary of Relevant Information from the Document (Reinterpreted for Context):

This 510(k) submission seeks to establish substantial equivalence for the Atlantis Hyperbaric Ventilator (K092264) to the predicate device, the Level-S, Inc.'s Neptune Hyperbaric Ventilator (K082351).

The core of the "proof" that the Atlantis device meets "acceptance criteria" (which in this context means being substantially equivalent to the predicate) is the assertion that:

• "The Atlantis Hyperbaric Ventilator is as safe and effective and is an exact duplicate of the predicate, designed and built by the same person as the predicate Neptune Hyperbaric Ventilator, who is now Vice-President of the Company."
• "The Atlantis Hyperbaric Ventilator has the same intended uses, exactly the same technological characteristics, and exactly the same principles of operations as its predicate device."
• "Any minor technological differences between the Atlantis and its predicated device raise no new issues of safety or effectiveness."

Essentially, the "study" or justification here is a direct comparison of design and specifications to an already approved device, rather than an independent clinical performance study. The FDA's acceptance of the 510(k) implies that they agreed with this assessment of substantial equivalence based on the provided technical documentation and comparisons, rather than requiring a separate clinical trial to establish new performance benchmarks.

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