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The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.

Breathing circuit that is intended to administer medical gases to a patient. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y piece. The heated wires are intended to minimize condensation in the ventilator tubing.

The provided document is a 510(k) summary for a medical device called the "Hudson RCI Heated Wire Ventilator Circuit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study involving AI or human readers.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. This document outlines the physical and performance characteristics of the proposed device and compares them to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the way a clinical study would for efficacy. Instead, it provides a comparison of specifications and performance tests between the proposed device and its predicate. The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be substantially equivalent to or improve upon.

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

This information is not provided in a 510(k) summary for a physical device. The testing described (e.g., resistance, compliance, leak rate) is laboratory-based performance testing of the device itself, not a clinical study with a "test set" of patient data.

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. There is no concept of "ground truth" or "experts" in the context of this device's performance testing described in the summary. The tests evaluate physical properties against established standards (ISO 5367).

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

Not applicable. See point 3.

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 physical breathing circuit, not an AI-powered diagnostic device.

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

Not applicable. This is a physical breathing circuit, not an AI algorithm.

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

Not applicable. The "ground truth" for this device's performance is derived from standardized physical measurements and engineering specifications, primarily based on the ISO 5367 standard for breathing tubes and connectors.

8. The sample size for the training set

Not applicable. There is no training set for this type of device submission.

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

Not applicable. There is no training set for this type of device submission.

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When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.

When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.

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The provided text is an FDA 510(k) clearance letter for the Hudson Respiratory Care, Inc. HRCI Cat. No. 385-40 Column and HRCI Cat. No. 780-40, 780-41, 780-42, 780-43 Circuit. This document determines substantial equivalence to legally marketed predicate devices, but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

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The Side Draft Neb-U-Mist Nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is for single patient use and is not intended for reprocessing.

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is a non-sterile, single patient use. Disposable Small Volume Nebulizer device designed to be used for intermittent aerosol therapy to deliver hydrating agents or other prescribed inclutions for inhalation. The Hudson RCI Side Draft Neb-U-Mist® Nebulizers intended to treat bronchial spasms, or airway obstruction, associated with diseases such as asthma, chronic bronchitis, and emphysema.

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer employs the Bernoulli Effect in order to transform the solution of liquid medication into tiny particles that can in order to transform the belation on the Bernoulli Effect - the phenomenon be carried in a gad mixture to with increased stream velocity in a fluid – causes the lowering of lateral pressure around the stream of gas to draw liquid up a the lowering of lateral peaches the top of the capillary tube it comes into contact with the stream of gas, it is then shattered into small particles (approximately 3 to 5 microns). These particles are then forced against a baffle (approximately o to o microne) of the particles that will be delivered to the patient that rouses the larger particles. The larger particles settle inside the Nebulizer by removing the largor particles, returning mist to liquid to repeat nebulization process. The smaller particles are then administered as the patient inhales.

The document provided describes a 510(k) submission for the "Side Draft Neb-U-Mist Nebulizer" and its substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed device (predicate device) and demonstrating that it is as safe and effective. It does not typically involve a clinical study in the same way a pre-market approval (PMA) application would for a novel device.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for substantial equivalence in this context is that the new device performs similarly to the predicate device, particularly in critical functions. For a nebulizer, this primarily concerns particle size generation and residual volume.

Study Details

Given this is a 510(k) submission based on substantial equivalence to a predicate device, the "study" is primarily a bench-top comparative test, not a clinical trial with human subjects.

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

   • Sample Size: The document does not specify the exact number of nebulizers tested for particle size and residual volume. It broadly states "Particle Size testing... was performed on both devices" and "Residual testing for both the predicate and proposed devices demonstrated...". Typically, such tests involve multiple units of each device for statistical robustness, but the specific number isn't mentioned.
   • Data Provenance: The tests were conducted internally by Hudson Respiratory Care, Inc. The data is retrospective in the sense that it's a comparison to an existing device, but the tests themselves were likely performed prospectively for the purpose of this 510(k) submission. No country of origin for data is stated, but the company is based in California, USA.

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

   • Not applicable. For technological characteristics like particle size and residual volume, the "ground truth" is established through objective measurement methods using laboratory equipment (e.g., laser diffraction for particle size, gravimetric analysis for residual volume). It does not involve expert consensus in the same way clinical image interpretation or diagnosis would.

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

   • Not applicable. Adjudication methods like 2+1 are used for subjective interpretations (e.g., evaluating medical images) where human experts might disagree. Bench-top performance tests are objective and quantitative; data is analyzed statistically, not adjudicated by experts.

4. 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, an MRMC study was not done. This is a mechanical device (nebulizer) and the submission focuses on its physical performance characteristics, not on diagnostic accuracy involving human readers or AI assistance.

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

   • Not applicable. There is no "algorithm" in this context. This is a medical device, not a software or AI product.

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

   • Objective Measurement Data. The "ground truth" for the performance characteristics (particle size, residual volume) is derived from direct, quantitative measurements obtained in a laboratory setting using standardized testing protocols.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development and testing are based on engineering design and bench-top performance evaluation.

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

   • Not applicable. As there is no training set or AI/ML component, this question does not apply.

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The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure.

The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a "back-up" ventilation system in the event of mechanical ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.

The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical device which temporarily augments ventilation in patients during ventilatory insufficiency or ventilatory failure. As is the case with the device in the original submission, this modified resuscitator may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport. The only difference between the original device and this modified version is the presence of a pressure monitoring port located on the non-rebreathing valve component of the finished device assembly.

This document does not contain an AI/ML device. It describes a manual resuscitator. Therefore, the requested information about acceptance criteria for an AI/ML device and the study proving it meets those criteria cannot be extracted.

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The Hudson RCI Gas Sampling Oxygen Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.

The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery through both nasal prongs while allowing sampling of the patient's exhaled gas from both nasal prongs. Oxygen is delivered to the Cannula during all phases of ventilation through the base of the cannula and is directed through the lower halves of each nasal pronq into the nasal pharynx. During exhalation, oxygen continues to flow into the nasal pharynx through these lower pronq halves. When the gas sampling line is connected to an expiratory gas monitor, a small amount of gas is continuously withdrawn from the nasal pharynx through the upper halves of both nasal prongs. Part of this gas exits one side of the cannula and is routed via a small-bore gas sampling line to the expired gas monitor.

The provided document is a 510(k) summary for the Hudson RCI CO2, Oxygen Nasal Cannula, which is a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. Therefore, it focuses on comparing the new device to existing devices rather than presenting extensive new study data to establish performance criteria against a set benchmark in the way you might find for a novel device.

The document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met for the Hudson RCI CO2, Oxygen Nasal Cannula itself.

Specifically, the document lacks the following information for the Hudson RCI device:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics and acceptance thresholds for the new device.
2. Sample size used for the test set and the data provenance: Not applicable, as no specific performance test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device for gas sampling and oxygen delivery, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Predicate Device: SALTLER LABS Oxygen Delivery - CO2 Sampling Nasal Cannula (K892406 and K863883).
• Device Description: The Hudson RCI cannula provides bifurcated nares for oxygen delivery through both nasal prongs and simultaneous sampling of exhaled gas from both nasal prongs. Oxygen flows through the lower halves of each prong, and gas is sampled through the upper halves.
• Intended Use: Adjunct to oxygen therapy, delivering low flow oxygen while providing a means to sample expired gas, for monitoring ventilatory rate. No difference in intended use from the predicate device.
• Patient Population: Infant to adult patients requiring low flow oxygen therapy and expired gas monitoring. No difference in patient population from the predicate device.
• Comparison of Technological Characteristics: The main difference from the predicate device is that the Hudson RCI cannula performs both oxygen delivery and CO2 sampling through each nasal prong, whereas the predicate delivers oxygen through one and samples CO2 from the other. However, both operate in a similar manner. The document asserts no difference in technological characteristics that would affect safety or effectiveness compared to the predicate.
• Conclusion: Hudson RCI believes the device is substantially equivalent to the SALTER LABS Oxygen Delivery CO2 Sampling Cannula.

In essence, this document demonstrates substantial equivalence to an existing legally marketed device, which is the primary "acceptance criterion" for a 510(k) submission. It relies on the assumption that if the new device is substantially equivalent to one previously cleared, it is by extension "safe and effective." It does not present new performance data in the structured way implied by your questions, which are more relevant to a novel device or a device with new performance claims.

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For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisting of a gas-permeable filter medium captured between two clear plastic housings. When the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter medium within the filter. The medium traps bacteria and viruses carried within the airstream.

This document describes a medical device, the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter, and its comparison to a predicate device, the Gibeck product no. 1910 Iso-Gard Depth Filter. The provided text is a non-confidential 510(k) Summary of Safety and Effectiveness submission and does not detail an AI/ML device or a study involving human readers or AI assistance. Therefore, it is impossible to extract information related to AI-specific criteria, such as multi-reader multi-case (MRMC) studies, effect size of AI improvement, standalone algorithm performance, or ground truth establishment for training sets.

However, based on the provided text, I can infer the acceptance criteria (performance of the predicate device) and the reported device performance for the physical filter.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "The Hudson RCI Bacteria/Viral Filter and the Gibeck filter have been tested by an independent laboratory for bacterial and viral filtration performance." This implies a test set was used for each filter, but the number of samples is not provided.
• Data Provenance: The testing was conducted by an "independent laboratory." No country of origin is specified. The study appears to be retrospective in the sense that the performance data for both devices was collected and then compared.

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

This is not applicable as the device is a physical filter, not an AI/ML diagnostic tool. The "ground truth" for filter performance is based on laboratory testing against established bacterial and viral challenges.

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

This is not applicable for a physical filter performance study. The reported efficiency values are likely direct measurements from laboratory tests.

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 is not applicable as the device is a physical filter. This document does not describe an AI/ML device or a study involving human readers.

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

This is not applicable as the device is a physical filter. This document does not describe an AI/ML device.

7. The type of ground truth used:

The ground truth for the performance metrics (BFE, VFE, Dead Space) was established through laboratory testing using standardized methods for bacterial and viral challenge, and dead space measurement.

8. The sample size for the training set:

This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.

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

This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.

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