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Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.

The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients

The provided text describes the "Guardian Neonatal CPAP / Humidification System" and confirms its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include details typically found in performance studies for medical devices like sample sizes, ground truth establishment, or expert involvement.

The document is a "Summary of Safety and Effectiveness" (510(k) summary) and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or detailed study results against specific acceptance criteria. The "Measured Data" section lists ranges for various parameters but doesn't present them as acceptance criteria or performance results from a study.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. I can only report on what is explicitly stated.

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The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.

Here's an analysis of the provided text regarding the OxiCheck device, focusing on acceptance criteria and study information:

The document (K023565) describes the Caradyne OxiCheck, an oxygen analyzer. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the document primarily focuses on technical specifications and similarities to predicate devices, rather than detailed clinical study data typically associated with new medical device approvals.

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

The document does not explicitly state "acceptance criteria" in a separate section. However, the "Design and Specifications" and "Performance Standards" tables effectively serve as the acceptance criteria that the device claims to meet.

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Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.

The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector.

The provided text describes the PROMEDIC INC Criterion 40 Airway Pressure Monitor, a microprocessor-controlled device designed to measure and monitor patient airway pressure. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics.

However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the stated functionalities. The reported device performance is directly drawn from the device's specifications.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria (Inferred from comparison with predicate) and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical or performance data for the Criterion 40. The submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data. The "study" here is a comparison of specifications and intended use.

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 establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set 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 device is an airway pressure monitor, 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
The device itself operates as a standalone monitor of airway pressure. The document describes its functional capabilities and comparison to a predicate device, which implies its direct performance without human interpretation being the primary measure. However, it's not an "algorithm-only" performance study in the AI sense. It's an electro-mechanical device performance evaluation based on specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence is based on:

• Predicate Device Specifications: The established (and legally marketed) characteristics, intended uses, and performance of the Monaghan CM 5000 Airway Pressure Monitor (K871083) and its modifications.
• Engineering and Design Standards: Compliance with electrical safety standards (IEC 601-1-2, UL 260 / IEC 601-1).
• Internal Testing/Validation (Implied): While not detailed, the accuracy claims for pressure alarm and display (+/- (1 + 3% of reading)) would have been established through internal testing against calibrated reference standards.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.

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To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.

The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 140 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube.

The provided text describes a medical device, the Whisperflow Oxygen Flow Generator, and its comparison to predicate devices for FDA 510(k) clearance. However, it does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics typically associated with such studies (like statistical results, sample sizes for test/training sets, expert qualifications, or ground truth establishment).

The document is a "Non-Confidential Summary of Safety and Effectiveness" which focuses on establishing substantial equivalence to previously marketed devices. It primarily details:

• Device Description
• Intended Use
• Comparison of attributes with predicate devices (Vital Signs - Downs Flow Generators - K811393, K83150 and Vital Signs CPAP mask - K801883, EMS Mask - K871851). This comparison involves a qualitative check (Yes/No) for various design and performance attributes.
• Differences between the Whisperflow generators and predicate devices (ribbed cushion vs. air cushion mask design, wider FiO2 range)

Therefore, based solely on the provided text, I cannot complete the requested table and answer many of the questions.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based only on the provided comparison tables, which serve as an implicit set of functional/performance criteria for substantial equivalence)

Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly met if the device performs comparably to the predicate devices across the listed attributes.

Missing Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The document describes a comparison of attributes, not a clinical study with a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No "test set" in the context of expert review is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not relevant. This is not an AI/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This is not an AI/imaging device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of this 510(k) submission. "Ground truth" here is effectively the specifications and functional performance of the predicate devices.
7. The sample size for the training set: Not relevant. This is not an AI device.
8. How the ground truth for the training set was established: Not relevant. This is not an AI device.

Summary of the Study/Comparison:

The document presents a comparison of the Whisperflow Oxygen Flow Generators (WF 8500 and WF 8530 models) to multiple predicate devices (Vital Signs - Downs Flow Generators K811393, K83150 and Vital Signs CPAP mask K801883, EMS Mask K871851). This comparison is qualitative, checking for the presence or absence of various design, functional, and performance attributes. The FDA's letter (K982283) indicates that based on this comparison, the device was found substantially equivalent to legally marketed predicate devices. The study is effectively a desk-based comparison of specifications and intended use rather than a clinical trial or performance test with a specifically defined "acceptance criteria" and "test set" in the manner common for AI-driven diagnostic devices.

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