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The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.

The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.

The device comprises of two main components:

• The ProVu Reinforced Endotracheal tube
• The ProVu Video Stylet (with a removable malleable rod)

The provided FDA 510(k) clearance letter and summary for the ProVu Single Use Video Stylet with Reinforced ET Tube does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance or diagnostic accuracy.

The summary focuses on non-clinical data to demonstrate substantial equivalence to a predicate device. This typically means the device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness. The included sections detail biocompatibility, sterilization, electrical safety, bench performance, and usability, but none of these address how well the device performs its intended clinical function (e.g., successful intubation, accurate verification of tube placement) against specific performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.

Here's an analysis of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The summary lists standards the device complies with (e.g., ISO 5361, IEC 60601-1), which are design and safety standards, not clinical performance acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. No test set for clinical performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth for clinical performance is mentioned.
4. Adjudication method for the test set: Not provided. No clinical test set is mentioned.
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 not an AI-assisted diagnostic tool for "human readers" in the sense of image interpretation. It's a video stylet for direct visualization during intubation. The concept of "AI assistance" and "effect size of human readers" doesn't apply to the reported information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a physical medical device that assists human operators in a procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No clinical ground truth is mentioned.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of what was reported in the 510(k) information:

• Non-clinical data provided:
  • Biocompatibility testing: Evaluated per ISO 10993-1 and ISO 18562 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Subcutaneous Implantation, Chemical Characterisation, Toxicological Risk Assessment, Gas Pathway Testing).
  • Sterilization and shelf-life testing: Validated according to ISO 11135:2014, EO/ECH residual test per ISO 10993-7:2008. Shelf-life of 0.5 year.
  • Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC60601-2-18, and IEC 60601-1-2.
  • Bench performance testing: Complies with ISO 5361, ISO 5356-1.
  • Usability validation: Conducted according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
• Clinical Study: Explicitly stated as "Not applicable."

This is characteristic of a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and technological comparison, rather than requiring new clinical efficacy or effectiveness data.

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Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.

Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.

The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration

Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.

The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.

All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.

Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).

The provided text describes the acceptance criteria and study results for the Flexicare HepaShield Bacterial Viral Breathing System Filter, which is a medical device.

1. Table of acceptance criteria and the reported device performance:

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Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.

Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.

Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.

The provided text describes the acceptance criteria and a study demonstrating the Flexicare Single Use Resuscitator Bags meet these criteria by showing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting recognized standards and performance characteristics comparable to the predicate devices. The "Outcome" column in the table below indicates that the Flexicare device "Passed" each test, implying that it met the respective criteria.

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

The document does not explicitly state the sample size (number of devices) used for each specific test in the "test set". However, it mentions "Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single Use Resuscitator Bag." and similarly for Pediatric and Infant versions. The tests would likely involve a statistically relevant number of devices to ensure reliability.

The data provenance is from Flexicare Medical Limited, United Kingdom. The study is retrospective in the sense that it compares the newly developed Flexicare device against existing, legally marketed predicate devices (Ambu SPUR II Adult, Pediatric, and Infant Single Patient Use Resuscitators) that have already been cleared by the FDA. The performance testing itself would be prospective for the Flexicare device.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. Instead, the ground truth is established by objective measurements against recognized international standards and direct comparison of performance characteristics with legally marketed predicate devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method involving human reviewers for the test set. The validation relies on objective laboratory testing against predefined criteria and standards, and direct comparison of measured characteristics with those of predicate devices.

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. This type of study is typically associated with AI/CAD systems for image interpretation, which is not applicable to a manual resuscitator bag. The study is a non-clinical performance and biocompatibility evaluation.

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

No, a standalone (algorithm-only) study was not done. This device is a manual medical device and does not involve any algorithms or AI for its operation.

7. The Type of Ground Truth Used

The ground truth used for this device's validation is based on:

• Recognized International Standards: Compliance with standards such as BS EN ISO 10651-4:2009, ISO 10993 series, ISO 5356-1:2004, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017, and ASTM F1980.
• Performance Specifications of Legally Marketed Predicate Devices: The performance characteristics (e.g., volume, resistance, force, dead space, stroke volume, pressure relief) of the Flexicare devices are compared directly to those of the Ambu SPUR II predicate devices. The goal is to demonstrate "substantial equivalence," meaning the new device performs as safely and effectively as the predicate.
• Objective Laboratory Measurements: The "Non-clinical Test Results" section explicitly states that "Verification tests were performed to establish the safety and efficacy" including visual inspection, dimensional inspection, internal volume, valve function, drop testing, immersion in water, oxygen concentration, resistances, valve malfunction, tidal volume calculation, O2 tube testing, conical connector compliance, biocompatibility, and particulate emission testing.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device, not an AI or machine learning algorithm.

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

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

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Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.

Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.

Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel.

Expert clinical judgment must be used in assessing patient humidification requirements.

Flexicare's ThermoShield HME Filters are designed to prevent the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration

Flexicare's ThermoShield HME Filters include a HME (Heat and Moisture Exchanger) Media in addition to a filter. The Inclusion of HME media is intended to help prevent complications due to drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT) occlusion. This is achieved by the HME media preventing a large amount of the water vapor from passing through the device.

Flexicare's ThermoShield HME Filters consist of a top/bottom housing, filter pad, HME media and a luer port cap. The Female luer-lock port allows monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.

The patient side of the Flexicare's ThermoShield HME Filters feature a 22mm Male and a 15mm Female conical connector. The machine side features a 22mm Female and a 15mm Male conical connector.

All conical connectors comply with dimensions stated within BS EN ISO 5356-1: 2004

Flexicare's ThermoShield HME Fitters have rounded housing with no sharp edges. This reduces the risk of pressure marks on the patient.

Flexicare's ThermoShield HME Fitters are available in Adult and Mini (Pediatric) sizes.

Flexicare's ThermoShield HME Filters are supplied non sterile in individually sealed polybags.

This document describes the acceptance criteria and the studies performed to demonstrate substantial equivalence for the Flexicare ThermoShield HME Filter (Adult and Mini/Pediatric sizes) to their respective predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document presents separate comparison tables for the Adult and Mini (Pediatric) filters against their respective predicate devices. The "Non-clinical Test Results" section summarizes the primary studies conducted to meet acceptance criteria.

Adult Filters:

Mini (Pediatric) Filters:

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

The document summarizes "non-clinical tests" performed on the Flexicare ThermoShield HME Filter (Adult and Mini sizes). The specific sample sizes for each test are not explicitly stated within the provided text. However, the tests are identified as "Verification tests were performed on Flexicare's Adult/Mini ThermoShield HME Filter." and the results are presented as "All Samples passed the performance testing." This implies that a sufficient number of devices were tested to draw the stated conclusions.

The data provenance is internal to Flexicare Medical Limited, as the studies are described as "Flexicare's ThermoShield HME Filters have been evaluated..." and conducted "against methods and criteria from predetermined acceptance criteria in-house test methods and relevant BS EN & ISO FDA recognized standards." This indicates the data is retrospective internal testing to demonstrate substantial equivalence to previously marketed predicate devices.

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

This is a technical device (breathing circuit filter); therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological images) is not directly applicable. The "ground truth" for the performance characteristics of the device (such as filtration efficiency, moisture output, pressure drop) is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and predefined engineering specifications. The implication is that the tests were conducted by qualified personnel in a laboratory setting, not by "experts" rendering opinions on cases.

4. Adjudication method for the test set:

Not applicable. As described above, this is a technical device evaluated against objective performance criteria and standards, not a diagnostic device requiring expert adjudication of results.

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 filter (breathing circuit bacterial filter) and does not involve AI or human readers for interpretation.

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

Not applicable. This device is a mechanical filter and does not involve an algorithm.

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

The "ground truth" for this device's performance is established via objective, quantitative measurements against recognized international standards (e.g., ISO, BS EN, ASTM) and predefined internal acceptance criteria. For example:

• Filtration efficiency: Measured experimentally using a challenge organism/material.
• Moisture output/loss: Measured experimentally under controlled conditions.
• Pressure drop: Measured experimentally at various flow rates.
• Biocompatibility: Evaluated through standard in-vitro and in-vivo tests.
• Dimensional compliance: Measured against ISO standard specifications.

These are empirical measurements, not expert consensus or pathological findings.

8. The sample size for the training set:

Not applicable. This device is a mechanical product and does not involve a training set for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.

The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb.

The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature.

When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature.

The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.

The Flexicare FL-9000U Respiratory Humidifier Base is a respiratory gas humidifier designed to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. The device's performance was evaluated against a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier, to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were primarily established through a "comparison test" against the predicate device, the Fisher & Paykel MR850 Respiratory Humidifier (K073706), and adherence to various recognized standards. The reported device performance is presented as "Substantially equivalent" or "Pass" based on these comparisons and tests.

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

The document does not specify a "test set" in the context of a dataset for AI/ML performance evaluation. Instead, performance was evaluated through non-clinical testing on the physical device and its accessories. This involved:

• Comparison testing: Directly comparing the Flexicare FL-9000U with the predicate device (Fisher & Paykel MR850).
• Adherence to recognized standards: Testing the device against specific criteria outlined in various international standards (e.g., ISO, IEC, EN).

The provenance of this testing data would be from Flexicare's own testing facilities or accredited third-party laboratories performing these tests on the physical device. The information does not state the country of origin of the data explicitly, but Flexicare Medical Limited is based in the United Kingdom.

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

This information is not applicable in the context of this 510(k) summary. The device is a physical medical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or clinical data for performance evaluation in the same way. The "ground truth" for this device's performance is derived from physical measurements, electrical tests, and compliance with established engineering and medical device standards, as well as direct comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. The evaluation of this physical medical device does not involve human readers or a consensus-based adjudication method for a test set of data.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human reader performance is being evaluated, often with and without AI assistance. This device is a respiratory humidifier, a therapeutic device, and its performance evaluation does not involve such studies.

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

No, a standalone (algorithm only) performance evaluation was not done. This concept is specific to AI/ML software devices. The Flexicare FL-9000U is a hardware device with embedded software, and its evaluation focuses on its physical and electrical performance in delivering warmed and humidified gases, not standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Flexicare FL-9000U Respiratory Humidifier Base is primarily established through:

• Engineering specifications and measurements: Direct measurement of physical characteristics (dimensions, weight), electrical parameters (voltage, current, power), temperature control, and sound levels.
• Compliance with international standards: Verification that the device meets the requirements outlined in standards like ISO 8185 for respiratory humidifiers, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC, and IEC 60529 for IP rating.
• Comparative performance to a legally marketed predicate device: Demonstrating that its performance in function is substantially equivalent to the Fisher & Paykel MR850 Respiratory Humidifier, which has an established safety and effectiveness profile. For humidity performance, a specific "Humidity Test Report (NO. HSO-VH-2600A-2015-01,1)" is referenced, implying data derived from specific testing protocols.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense typically used for diagnostic or predictive AI/ML devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device and is not an AI/ML algorithm that requires a "training set" for model development.

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

This information is not applicable for the same reason as point 8.

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Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.

Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Flexicare Neonatal Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.

Flexicare Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source. The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.

Flexicare's Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.

The provided text describes the Flexicare Neonatal Heated Wire Breathing Systems and Autofill Humidification Chamber seeking clearance via a 510(k) pathway, asserting substantial equivalence to predicate devices (Fisher & Paykel RT235 Heated Breathing Circuit and MR290 Autofill Humidification Chamber).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• Substantial Equivalence Study: The entire document is a 510(k) summary, which is a submission to the FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. The "study" here is thus a comprehensive comparison and verification testing program, often referred to as non-clinical performance testing.
• No AI Component: The devices described (heated wire breathing systems and humidification chambers) are hardware-based medical devices. There is no mention of algorithms, artificial intelligence (AI), machine learning (ML), or software with diagnostic or therapeutic capabilities. Therefore, questions related to expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable.
• Ground Truth for Testing: The "ground truth" for the non-clinical tests is based on established engineering principles, recognized international standards (ISO, ASTM, IEC, BS EN), and pre-determined acceptance criteria derived from the predicate device's performance or general medical device safety and efficacy requirements.

1. Table of Acceptance Criteria and the Reported Device Performance

The document provides two comparison tables (one for the breathing system and one for the humidification chamber) listing characteristics between the Flexicare device and its predicate. Additionally, a "Summary of performance Testing" table (page 10) outlines specific tests, their standards/acceptance criteria, and the outcome.

Flexicare Neonatal Heated Wire Breathing Systems

Flexicare Autofill Humidification Chamber

Performance Testing Summary (Page 10)

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

• Sample Size for Test Set: The document does not specify the exact number of units/samples used for each non-clinical test (e.g., how many systems were visually inspected, or how many were subjected to drop testing). It generally states "Verification tests were performed" or "Testing demonstrated."
• Data Provenance: The tests are explicitly referred to as "Non-clinical Test Results" and "Verification tests." These are laboratory-based engineering and performance tests conducted on the physical devices. The country of origin for the data is implicitly the UK, where Flexicare Medical Limited is located. The nature of testing is prospective in the sense that the new Flexicare devices were manufactured and then specifically tested against established standards and in comparison to a predicate device.

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

• Not Applicable. This is a non-clinical device clearance, not an AI/clinical diagnostic study. The "ground truth" for the test set is determined by the specifications in recognized international standards (ISO, ASTM, IEC, BS EN) and the pre-determined acceptance criteria established by the manufacturer, which are based on engineering requirements and predicate device performance. There are no "experts" establishing a clinical "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical device testing, there is no need for adjudication as typically understood in clinical or AI performance studies involving human readers. Test results are objectively measured against predefined criteria.

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. The device is not an AI-powered diagnostic tool, and no human-reader study was conducted or is relevant for this type of device clearance.

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

• Not Applicable. The device is a physical medical device (breathing systems and humidification chambers), not an algorithm or software. No standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

• The "ground truth" for these tests is based on:
  • Recognized International Standards: Such as ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556, ASTM F1886-09, ASTM F88-09, ASTM F1929-12. These standards define the expected performance metrics, safety requirements, and test methodologies for medical devices of this type.
  • Predicate Device Performance: Direct comparison to the Fisher & Paykel RT235 and MR290 devices forms a key basis for establishing substantial equivalence.
  • Pre-Determined Acceptance Criteria: For tests not covered by specific standards, Flexicare established internal "Pre-Determined Acceptance Criteria" based on engineering specifications and ensuring safety and effectiveness comparable to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This refers to machine learning models, which are not part of this submission. There is no "training set" in the context of this traditional medical device clearance. The development of the device itself would involve engineering design and iterative prototyping, but not a dataset for training an algorithm.

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

• Not Applicable. As there is no training set, this question is not relevant.

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Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.

Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.

Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source.

The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.

Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for Flexicare Heated Wire Breathing Systems and Autofill Humidification Chambers.

It's important to note that this document is a 510(k) summary for a medical device cleared in 2015. It focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a de novo application with extensive clinical trials. Therefore, the information provided is geared towards proving equivalence through performance testing against established standards and predicate device characteristics, rather than detailing a study that "proves the device meets the acceptance criteria" in the sense of a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Device 1: Flexicare Heated Wire Breathing Systems

Device 2: Flexicare Autofill Humidification Chamber

Study Information (Based on provided 510(k) Summary)

The document describes non-clinical performance testing rather than a clinical study as would be typical for proving effectiveness for new technology. The primary study presented is a substantial equivalence comparison with predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a numerical count of individual units for each test, but it refers to "All Samples" passing performance testing. The provenance is internal company testing (Flexicare Medical Limited, UK). The tests are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance.
• Data Provenance: The testing was conducted by Flexicare Medical Limited, located in the United Kingdom.

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

• This is not applicable as the "ground truth" for these tests are objective, measurable physical properties and compliance with engineering standards (e.g., resistance values, leakage rates, dimensional properties). These are not subjective interpretations requiring human experts for ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. The tests involve objective measurements and comparisons against pre-defined acceptance criteria or industry standards. There is no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a technical device and not an AI or diagnostic imaging device that would typically involve human readers for interpretation. Therefore, a MRMC study is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in a sense. The performance tests ("Non-clinical Test Results") are standalone evaluations of the device's physical and functional properties against predefined criteria and standards. There is no "human-in-the-loop" component in evaluating the device's technical specifications. The devices themselves do not incorporate AI or complex algorithms requiring such evaluation.

7. Type of Ground Truth Used

• The "ground truth" for these tests is based on:
  • Objective physical measurements: (e.g., volume, length, resistance, weight, flow rates).
  • Compliance with international standards: (e.g., ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, ISO 10993, ASTM F1886, ASTM F88, ASTM F1929, BS EN 556).
  • Comparison to a legally marketed predicate device: The characteristics and performance of the predicate device (Fisher & Paykel RT380 and MR290) serve as a benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

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

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

• Not applicable. As this device does not involve AI/ML, there is no training set or associated ground truth for it.

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CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.

Flexicare's CO2 monitoring line is single patient use, small diameter tubing intended to be connected to a luer lock connector on a patient interface to allow for gas sampling from a patients exhaled breath by gas sampling equipment. The Gas monitoring/analysing device will feature a pump, which draws expired breath from the patient through the monitoring line and into the gas analyser. Flexicare's CO2 monitoring line is available with or without a 0.45um hydrophobic filter, which prevents the transfer of water vapour down the monitoring line and into the gas sampling equipment. Flexicare's CO2 monitoring lines feature clear construction to aid visual inspection of the device. The CO2 monitoring line is a single patient use device, designed for use with one patient over a single course of treatment. The CO2 monitoring line is supplied in a sealed poly bag in a non sterile state and is not to be sterilized. The Flexicare CO2 monitoring lines feature 2M & 3M length tubes.

Here's a breakdown of the acceptance criteria and study information for the Flexicare CO2 monitoring line, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Resistance to Flow Performance Details:

• CO2 monitoring line (without filter):
  • Flexicare: 8.8 mbar at 100ml/min flow, 30.2 mbar at 300ml/min flow
  • Predicate: 15.2 mbar at 100ml/min flow, 51.2 mbar at 300ml/min flow
• CO2 monitoring line (with filter):
  • Flexicare: 30.0 mbar at 100ml/min flow, 95.7 mbar at 300ml/min flow
  • Predicate: 33.4 mbar at 100ml/min flow, 114.5 mbar at 300ml/min flow

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

The document does not explicitly state the specific number of samples used for each test (the sample size). However, it consistently states "All samples pass" for each test.

The data provenance is from Flexicare Medical Limited, United Kingdom, as indicated by the manufacturer's details and the report being dated in the UK. The tests described are part of a premarket notification (510(k)) submission, meaning they were conducted specifically for this regulatory purpose. The nature of these tests (performance, dimensional, biocompatibility etc.) implies they are prospective in the sense that they were designed and executed to evaluate the new device against established criteria and a predicate device.

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

This information is not provided in the document. The tests performed are primarily engineering and laboratory-based assessments of physical and functional characteristics against defined standards and criteria, rather than expert-driven clinical evaluations requiring ground truth establishment by medical experts.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The tests are objective measurements against standards or functional comparisons, not subjective clinical assessments requiring adjudication. The results are reported as "All samples pass," indicating direct conformance to acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. The device is a CO2 monitoring line, which is a passive tubing device. The comparison studies focused on physical and functional equivalence to a predicate device, not on human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. The device does not involve any software or electronic components, therefore no algorithm is present to be evaluated.

7. The Type of Ground Truth Used

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

• Pre-determined Acceptance Criteria: These are internal specifications or performance targets set by Flexicare.
• International Standards: e.g., ISO 594-1, ISO 594-2, ASTM F1980, BS EN ISO 10993-3, -5, -10.
• Comparison to a Predicate Device: The performance of the Flexicare device (e.g., resistance to flow, CO2 detection capability, leakage, tensile strength) was directly compared to the Intersurgical predicate device (K122075) to demonstrate similar or better performance.

For the CO2 monitoring performance, the ground truth was whether the device could consistently detect CO2 from beneath the nostrils, similar to the predicate device. The document states: "Both manufacturers' devices detected CO2 consistently, proving substantial equivalence."

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a simple mechanical tubing product and does not involve machine learning or AI, thus there is no "training set."

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

This information is not applicable/not provided, as there is no training set.

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DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.

The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.

DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure.

DualGuard™ consists of a bite block with a removable oxygen delivering/ CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth.

When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2.

DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit.

The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading.

DualGuard™ is available in adult size only.

Here's an analysis of the acceptance criteria and study findings for the DualGuard™ device based on the provided document:

Acceptance Criteria and Device Performance

The document states that "All Samples passed the performance testing when tested against methods and criteria from pre-determined acceptance criteria In-House test methods and relevant BS EN, ISO & ASTM FDA recognized standards." and that "The results of this testing show that DualGuard™ passes all performance tests and performs at least as well as the marketed predicate device 'TwinGuard' by Trawax."

Study Information:

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

   • Sample size: The document consistently states "All Samples" passed testing, but it does not specify the numerical sample size for each test or for the overall test set.
   • Data provenance: The document is from Flexicare Medical Limited, located in the UK. The standards referenced (BS EN, ISO, ASTM) are international. The document does not specify if the testing was performed in the UK or elsewhere. No information on retrospective or prospective data is provided, as the tests appear to be laboratory performance tests of the device itself rather than clinical data from human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable to the type of testing described. The document describes non-clinical performance and design verification testing against established engineering standards and pre-determined acceptance criteria. There is no mention of human expert evaluation to establish ground truth for the device's technical performance.

3. Adjudication method for the test set:
   This information is not applicable. As mentioned above, the testing described is technical performance testing against objective standards, not interpretation by human adjudicators.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory (bite block, cannula for O2 delivery and CO2 monitoring), not an AI-powered diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is irrelevant and not mentioned.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   No, a standalone (algorithm only) performance study was not done. This device does not involve an algorithm for performance, as it is a physical medical device for oxygen delivery and CO2 sampling. It is intended for use with other medical devices (like a capnograph machine) and by humans during procedures.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for the non-clinical performance testing was the established engineering standards (e.g., BS EN13544-2, ISO 594-1, ISO 594-2, ASTM F1980, BS EN ISO 10993-10, BS EN ISO 10993-5) and pre-determined acceptance criteria specific to the device's design and intended function. For attributes like "Dead Space," the "ground truth" or benchmark was the performance of the legally marketed predicate device.

7. The sample size for the training set:
   This information is not applicable. The DualGuard™ is a physical medical device and does not involve AI or machine learning algorithms that would require a "training set."

8. How the ground truth for the training set was established:
   This information is not applicable, as there is no training set for this device.

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