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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.

In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.

The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

• A table of acceptance criteria with reported device performance values against those criteria.
• Sample sizes used for test sets.
• Information about ground truth establishment, experts, or adjudication methods.
• Details about MRMC studies or effect sizes for AI assistance.
• Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

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

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

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The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.

The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).

This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.

The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.

The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.

Here's an analysis of the provided information, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.

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

The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.

• Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.

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

This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring adjudication.

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 question is not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This question is not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
• International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.

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

This question is not applicable. There is no training set for an AI model.

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The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

• Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs)
• CMV and IMV mode of ventilation with or without PEEP / CPAP
• Provide oxygen or a mixture of medical air and oxygen

The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent. The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device. The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use. The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

The pNeuton mini Ventilator is a device designed for providing ventilatory support to critically ill neonate to pediatric patients. Its acceptance criteria and proof of meeting them are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its specifications, which meet or exceed the requirements of relevant voluntary standards. Below is a summary of key performance characteristics and their specifications:

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

The document explicitly states that "Clinical testing was not performed on this device." Therefore, there is no test set in the context of human patient data. The provenance of the data is from non-clinical bench testing and simulated conditions performed by the manufacturer, Airon Corporation, presumably in the USA (where the company is based). The data is retrospective in the sense that it represents controlled lab measurements and simulations based on predefined specifications and standards.

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

As clinical testing was not performed and the data is non-clinical bench testing, the concept of "ground truth" derived from expert clinical opinion is not applicable here. The "truth" or reference for performance was established by engineering specifications and recognized industry standards (e.g., ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F). The experts involved would be those who developed these standards and the engineers and technicians at Airon Corporation who conducted the tests and verified compliance. Their qualifications would be in engineering, medical device manufacturing, and testing, rather than medical clinical specialties for patient diagnosis.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used. The device's performance was judged against pre-defined engineering specifications and compliance with voluntary standards through measurement and direct verification.

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

No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not performed on this device." The submission relies on substantial equivalence to predicate devices and non-clinical testing.

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

Yes, in essence, the non-clinical testing described represents standalone performance of the device. The pNeuton mini Ventilator is a mechanical, pneumatic device with no electronic controls or software, hence no "algorithm" in the modern AI sense. The testing verified the physical and mechanical performance of the device itself against its specifications in a controlled, simulated environment, without direct human interaction or intervention during the operational tests (e.g., the 2,200 hours of continuous operation).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Engineering specifications: The target performance parameters (e.g., flow rates, pressure ranges, time accuracies) defined by Airon Corporation for the pNeuton mini Ventilator.
• Voluntary industry standards: Specific requirements and test methodologies outlined in standards such as ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F, and CGA V-5:2008. These standards define acceptable ranges and test environments for ventilators.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a mechanical ventilator and does not involve machine learning algorithms that would typically require a training dataset.

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

Not applicable, as there is no training set for this device.

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The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liquid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.

The Sevoflurane Vaporizer 953 is an anesthetic vaporizer used together with Siemens Servo Ventilator 900 in anesthetic applications. It is a modification of the Siemens Vaporizers 950/951/952. The modifications made are: At the knob a scale for Sevoflurane is added. The scale indicates concentration values from 0.2% to 8%. The knob scale, label and filling mechanism, are yellow color coded. To reach the concentration values 8% the inside diameter of a capillary tube is 0.36mm instead of 0.30mm as in the other vaporizers.

The Siemens Sevoflurane Vaporizer SV 953 is an anesthetic vaporizer that has expanded indications compared to the predicate device, the Siemens Vaporizers 950/951/952 (Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952). The acceptance criteria for this device are based on its equivalence to the predicate device in terms of safety and effectiveness, and its compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical or data-driven evaluation. Instead, it refers to "all different settings of the new expanded indications" being tested. The studies described are validation tests on the device itself, rather than a study on a patient population or data set.

The data provenance is not applicable in the traditional sense of clinical data. The tests are presumably conducted internally by Siemens-Elema AB as part of their design validation process.

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

This section is not applicable. The device validation relies on engineering and performance testing against predefined criteria and standards, not on expert adjudication of a test set in a medical imaging or diagnostic sense.

4. Adjudication method for the test set

This section is not applicable, as there is no mention of a test set requiring adjudication in the context of this device's validation.

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. The submission focuses on device equivalence through design and performance testing.

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

This concept is not applicable to the Sevoflurane Vaporizer SV 953, as it is a mechanical medical device, not an AI or software algorithm. Its performance is inherent to its design and functionality, which is tested directly.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• Engineering specifications and design requirements: The device's operation must meet designed functional parameters.
• Compliance with recognized standards: ISO/DIS 8835-1.2 and ISO 5360.
• Comparison to predicate device performance: The device is deemed safe and effective if its performance is equivalent to or better than the previously approved predicate device under equivalent testing conditions.
• Pre-defined acceptance criteria: Set for the tests conducted on the device's various settings.

8. The sample size for the training set

This section is not applicable, as this is a medical device approval based on design validation and performance testing, not a machine learning model requiring a training set.

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

This section is not applicable, as there is no training set mentioned in the context of this device's approval.

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The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.

The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer. Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water. The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face. The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.

The provided 510(k) summary for the "Stealth/Pilot (Final Name to Be Determined) MDI Spacer with Facemask" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and addressing technological characteristics with "no testing required" for most points.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "There were no specific studies completed in association with this submission."

Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable, as no studies involving a test set and ground truth establishment were described.

4. Adjudication method for the test set

Not applicable, as no studies involving a test set were 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 device is a mechanical medical device (MDI spacer with a facemask), not an AI-powered diagnostic or assistive technology.

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

Not applicable, as this is a mechanical device, not an algorithm.

7. The type of ground truth used

Not applicable, as no studies involving ground truth were described.

8. The sample size for the training set

Not applicable, as no training set was used (e.g., for an AI algorithm).

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

Not applicable, as no training set was used.

Summary of the Study and Device Acceptance:

The submission for the "Stealth/Pilot" facemask does not include any performance studies or clinical trials with acceptance criteria and measured device performance in the traditional sense. Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices ("ACE" MDI Spacer and "Stealth" MDI Spacer) and confirming that its technological characteristics meet basic design requirements without interfering with the primary function of the MDI spacer.

The "Summary of Studies" section explicitly states, "There were no specific studies completed in association with this submission," and the "Conclusions Drawn from Studies" section states "None."

The acceptance criteria listed in Section 6 ("Technological Information") are essentially design requirements that the manufacturer asserts are met by the Pilot mask's design, materials, and intended function. The FDA's 510(k) clearance process often allows for substantial equivalence determinations without new clinical or performance data if the new device is sufficiently similar to legally marketed predicate devices. In this case, the Pilot mask is an accessory that interfaces with an already cleared MDI spacer, and the manufacturer argued successfully that its design characteristics inherently met the stated requirements, thus "no testing is required."

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