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The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.

The Palladium High Flow Therapy System is designed to heat and humidify respiratory gases and deliver high flow respiratory therapy via a small-bore nasal cannula to spontaneously breathing pediatric and adult patients within hospital, sub-acute and homecare settings.

Palladium is portable, self-contained, AC driven or battery powered with high flow therapy driven by an internal blower room air source and supplied with external oxygen or other gas sources, which is the same as the predicate Vapotherm Flowrest® device.

Palladium utilizes similar semi-permeable small-bore tubing technology for humidification and integrity of a closed, single-use water path disposable as the reference Vapotherm Precision Flow® device.

The provided document is a 510(k) premarket notification for the "Palladium High Flow Therapy System". It details the device's indications for use, its comparison to predicate devices, and non-clinical performance testing. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed quantitative results for the Palladium system's performance.

Based on the provided text, a table of acceptance criteria and reported device performance, and details about a specific study proving the device meets these criteria, is not fully available in the requested format. The document describes several non-clinical tests (biocompatibility, electrical safety, software, and bench/performance testing) and states that the "results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate device." However, it does not provide the specific numeric acceptance criteria or the measured performance values for the Palladium device in a clear, quantifiable manner for each test.

Here's a breakdown of what can be extracted based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes general categories of performance testing and states that the outcomes met expectations or demonstrated substantial equivalence. Specific measurable acceptance criteria values and the actual results of the Palladium device (e.g., "Oxygen accuracy: ±X%" and "Measured: Y%") are not provided.

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are non-clinical (bench testing, lab-based safety, and performance evaluations), therefore no patient data or geographical provenance is applicable in the context of the supplied text. The company (Vapotherm, Inc.) is based in Exeter, NH, USA. The testing would have been conducted in a controlled lab environment.

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

• This information is not applicable. The documentation refers to non-clinical (bench) testing, software verification, and compliance with established standards. There is no mention of "ground truth" established by experts in the context of clinical expert review.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple human readers, which is not described here.

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 MRMC study was conducted or mentioned in this document. This is a 510(k) submission for a respiratory gas humidifier, not an AI-assisted diagnostic device.

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 medical device (humidifier), not an algorithm or AI system. Its performance is evaluated through engineering and physiological testing, not AI-centric standalone performance studies.

7. The type of ground truth used:

• For the non-clinical performance and safety tests, the "ground truth" would be the objective measurements against pre-defined engineering specifications and internationally recognized standards (e.g., ISO, IEC). For example, temperature measurements against a calibrated reference, flow rate measurements, or chemical analysis for biocompatibility tests. It's based on technical standards and specifications, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

• Not applicable for the same reason as above.

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Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.

The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:

• Water path: tubing from sterile water supply to vapor transfer cartridge
• . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
• Delivery Tube: triple lumen tubing
• . Nasal Cannula

The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.

Here's a breakdown of the acceptance criteria and the study information for the Precision Flow® HVNI, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Precision Flow® HVNI are primarily non-clinical, focusing on safety, performance standards, software validation, and labeling requirements. The clinical studies establish safety and effectiveness by demonstrating non-inferiority or comparable outcomes to existing treatments.

Study Information

Due to the nature of this particular device (high flow humidified oxygen delivery device) and the provided text, the "studies" are clinical trials and published literature, rather than an AI/ML-specific validation study with test sets, ground truth experts, or training sets in the typical sense. The regulatory submission leverages existing clinical evidence.

For the Adult Clinical Study (Doshi et al.):

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

   • Sample Size: 204 adult patients (104 in HVNI arm, 100 in NIPPV arm).
   • Data Provenance: Multi-center, prospective, randomized clinical trial conducted at 5 sites. Country of origin not explicitly stated but implies US context for FDA submission.

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

   • This is a clinical trial where clinical outcomes (e.g., intubation, failure to tolerate device, physiological parameters like O2 saturation, PaO2, PCO2, relief of respiratory distress, deteriorating medical status) were the ground truth. These outcomes were assessed by treating clinicians (physicians, nurses, respiratory therapists) at the study sites. The "experts" are the medical professionals directly involved in patient care and decision-making within the clinical trial setting. Specific qualifications beyond "physician" are not detailed in the text.

3. Adjudication method for the test set:

   • Not explicitly stated as a formal adjudication panel in the typical AI/ML context. Treatment failure was defined by clear clinical criteria (need for intubation, device intolerance, failure to oxygenate/ventilate, failure to relieve distress, deteriorating medical status). These assessments are inherent to clinical practice and were likely made by the treating clinicians in real-time, within the trial's protocol.

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, this was not an MRMC study comparing human readers with and without AI assistance. It was a comparative effectiveness study between two medical devices/therapies (HVNI vs. NIPPV).

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

   • No, this device is a medical device for patient breathing support; it is not an AI algorithm performing a diagnostic task. Its performance is measured by its clinical impact on patients.

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

   • Outcomes Data: Primary ground truth was clinical outcomes data, specifically "treatment failure rate, defined as the need for intubation, and arm failure rate, defined as the decision for crossover to the alternate therapy, within 72 hours of initiation of assigned therapy." Other outcomes included vital signs, blood gas analysis (e.g., pCO2), physician perception, and adverse events.

7. The sample size for the training set:

   • Not applicable in the context of this device being a medical hardware system, not an AI/ML algorithm requiring a specific training set of patient data.

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

   • Not applicable for the same reason as above.

For the Neonate Patient Population (McQueen et al., Collins et al., Lavizzari et al., Kugelman et al.):

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

   • McQueen et al.: Retrospective cohort study. HFT group: Data from five centers, no specific n given for test set, but stated "used Vapotherm HVNI as their primary and predominant mode." Compared to Vermont Oxford Network (VON) database: 176,599 very low birth weight baby admissions (control/comparison data).
   • Collins et al.: 132 low birth weight infants (< 2500g, <32 weeks gestation). Randomized (67 HFT, 65 nCPAP). Data provenance: Randomized Controlled Trial.
   • Lavizzari et al.: Randomized trial, 298 infants (158 HFT, 158 nCPAP/BiPAP). Data provenance: Prospective, randomized clinical non-inferiority trial.
   • Kugelman et al.: 76 infants (<35 week gestational age, >1000g). Randomized (38 HFT, 38 NIPPV). Data provenance: Randomized Pilot Study.
   • Data Provenance for all neonate studies: Published literature, likely international based on author names and journal types, but not explicitly stated for each study.

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

   • Similar to the adult study, ground truth involved clinical outcomes assessed by treating medical professionals (neonatologists, nurses, etc.) within the context of their respective clinical trials or retrospective data collection. Specific expert qualifications beyond clinical roles are not detailed within the provided text.

3. Adjudication method for the test set:

   • Not explicitly stated as a formal adjudication panel. Outcomes were generally defined by protocol-driven clinical events (e.g., extubation failure, need for intubation, physiological parameters).

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. These are clinical studies comparing therapies, not AI assistance for human readers.

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

   • No.

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

   • Outcomes Data: Primary ground truths included extubation failure rates, rates of intubation/mechanical ventilation, occurrences of pneumothorax, nosocomial infection, ROP surgery, bronchopulmonary dysplasia (BPD), air leaks, IVH, NEC, sepsis, duration of respiratory support, need for surfactant, time to full feeds, length of stay, mortality, and nasal trauma scores.

7. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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