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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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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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O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring

O2 Nasal cannula with CO2 monitoring that is intended to situate under the patients nose with the prongs of the cannula inserted into patients nostrils where oxygen is administered and CO2 monitored. The O2 Nasal cannula with CO2 monitoring has two co-extruded tubes

This document is a 510(k) Summary for the Flexicare O2 Nasal cannula with CO2 monitoring. It details the device's characteristics and its substantial equivalence to a predicate device, but it does not describe acceptance criteria for an AI/ML powered device nor a study proving performance against such criteria.

The document addresses a medical device that does not incorporate AI/ML. Therefore, much of the requested information regarding AI/ML-specific testing (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable and is not present in the provided text.

Here's an analysis based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The document sets out various physical and functional tests, comparing the Flexicare O2 Nasal cannula with CO2 monitoring to established standards and the predicate device. The "acceptance criteria" here are generally compliance with physical dimensions, material properties, and functional performance as outlined by relevant EN and ISO standards, or as performing "at least as well as" the predicate device.

The study proving the device meets these criteria is described as "Tests Performed" on page 3 and summarized on page 4. It states: "All Samples passed the performance testing when tested against methods House test methods and relevant BS EN standards. The results of this testing show that the O2 Nasal cannula with CO2 monitor...performs at least as well as marketed predicate dev Unomedical."

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

• Sample Size: The document does not specify a numerical sample size for the "test set" (i.e., the number of cannulas tested). It generically refers to "All Samples."
• Data Provenance: Not applicable in the context of device performance testing. The tests are physical and functional evaluations of manufactured units, not data-driven intelligence.

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

This is not applicable as the device is a physical medical device, not an AI/ML system requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is objective measurement against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or classification involved that would require adjudication. Performance is measured objectively.

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, an MRMC study was not done, and this question is not applicable because the device is a physical nasal cannula, not an AI-assisted diagnostic or clinical decision support system.

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, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, dimensional tolerances, and compliance with recognized industry standards (e.g., BS EN 13544-2, ISO 594-1, ISO 594-2). In-house test methods are also used for aspects not covered by specific standards. The implicit ground truth for "at least as well as" is the performance of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML system and does not have a "training set."

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

This information is not applicable as the device is not an AI/ML system and does not have a "training set."

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Classic™ intermittent catheters are intended for use in Mate, Female and Paediatic patients when regular assisted bladder drainage has been instructed by a physician. Classic™ intermittent catheters are indicated for use by individuals whose ablity to void the bladder fully by natural bodily functions is impaired.

Classic ™ Intermittent Catheter is a PVC plastic device that is intended to be inserted through urethra and into bladder of patient to allow drainage of urine. The Classic Intermittent catheter in pouch consists of a tube which is bonded onto a drainage funnel. Classic™ Intermittent Catheter has a round polished finish tip to provide maximum comfort for user. Each catheter features two large evelets in order to drain urine efficiently. Drainage eyelets cut-outs are smooth and rounded to minimize the risk of injury/discomfort when in use. Classic ™ Intermittent Catheters are available in: Adult Male. Available in coude tip or straight tip Adult Female. Available in straight tip Paediatic. Available in straight tip

Here's an analysis of the provided text regarding the acceptance criteria and study for the Classic™ Intermittent Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Classic™ Intermittent Catheter are defined by adherence to specific international and in-house standards, with the reported performance being that "All samples pass" for each test.

2. Sample Size for Test Set and Data Provenance

The document mentions "All samples pass" for each test, implying a test set was used for performance and physical characteristic evaluations. However, the exact sample size used for the test set is not explicitly stated in the provided text.

The data provenance is primarily from in-house testing conducted by Flexicare Medical Limited and evaluations against international standards (BS EN and ASTM). The country of origin of the data is the United Kingdom, where Flexicare Medical Limited is located. The nature of the testing (physical performance, material analysis, biocompatibility) indicates this is prospective data generated specifically for the device's evaluation.

3. Number of Experts and Qualifications for Ground Truth

This device is a physical medical device (intermittent catheter) and the evaluation is based on objective, measurable physical, chemical, and biological properties, not a subjective interpretation like medical imaging. Therefore, there is no concept of "experts establishing ground truth" in the way it applies to diagnostic AI systems. The ground truth is defined by the objective pass/fail criteria of the specified standards and in-house test methods.

4. Adjudication Method

Given the nature of the testing for a physical device, adjudication methods like 2+1 or 3+1 are not applicable. The tests performed have clearly defined pass/fail criteria based on objective measurements and adherence to standards. The "Outcome" column clearly states "All samples pass," indicating a direct evaluation against the established criteria.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for comparing the performance of different human readers (potentially with and without AI assistance) in tasks involving subjective interpretation, such as diagnostic imaging. The Classic™ Intermittent Catheter is a physical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. The device is a physical catheter, not a software algorithm. Therefore, the concept of "algorithm only" performance is not applicable here.

7. Type of Ground Truth Used

The ground truth used for evaluating the Classic™ Intermittent Catheter is based on:

• Objective Measurement against Standards: Adherence to established international standards (e.g., BS EN 1616, ASTM F623-99, ISO 10993-7) for physical dimensions, flow rates, tensile strength, leak integrity, and biocompatibility.
• In-house Test Methods and Specifications: Specific internal tests developed by Flexicare Medical Limited for properties like tensile testing, tube hardness, and connection forces.

Essentially, the ground truth is defined by the pass/fail criteria stipulated within these standards and documented test methods.

8. Sample Size for Training Set

No "training set" is applicable or mentioned. This device does not use an AI algorithm that requires training data. The "samples" referenced in the "Summary of Testing" are test units of the manufactured catheter used for performance verification.

9. How Ground Truth for Training Set Was Established

Since there is no AI algorithm or training set, this question is not applicable.

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For use with ventilators, anaesthesia machines and open flow systems where filtration of inspired and expired gases is required. The filter may be located at the machine end of expiratory and/or inspiratory limb of the circuit or at the patient end of the circuit Single patient use up to 24 hours.

Breathing Filters Bacterial

This describes a 510(k) premarket notification for a breathing filter. The document indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this type of regulatory submission (510(k)) and the provided text do not contain the kind of detailed study information you are asking for (acceptance criteria, specific performance metrics, sample sizes for test/training, expert adjudication, MRMC studies, standalone performance, or ground truth details).

510(k) submissions typically demonstrate substantial equivalence through comparison to an existing device, and while performance data is often included, it's not structured in the way you've outlined for an AI/ML medical device. The document is a clearance letter and an "Indications for Use" statement, not a scientific study report.

Therefore, for your request, I must state that the provided text does not contain the information requested for acceptance criteria, study details, sample sizes, expert involvement, or AI/ML specific performance metrics. This is a traditional medical device clearance, not an AI/ML driven device submission.

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The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

The Flexicare Endotracheal tube is a single lumen tube with or without a cuff. The device is used for airway management / gas transport and is connected to a ventilator or resuscitation devices via a connector and breathing tubing. Cuffed variants have an inflatable Cuff, a narrow inflation lumen and pilot balloon with valve permitting inflation and deflation using a suitable syringe fitted with a tapered luer connector. All variants (less reinforced) have a radio opaque marker consisting of an axial line embedded into the tube which enables identification the device when patient is x-ray viewed. All variants have a Murphy eye. All variants are supplied sterile and are single use/disposable.

The provided FDA 510(k) summary for the Flexicare Endotracheal Tube does not contain the kind of detailed information about acceptance criteria and study design that would typically be found in a submission for an AI/ML medical device. This document describes a traditional medical device (an endotracheal tube) and its substantial equivalence to a predicate device based primarily on meeting an international standard and having similar design and materials.

Therefore, for aspects related to AI/ML device evaluation, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, the answer will be that this information is not applicable or not provided in the given document because the device is not an AI/ML product.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Study Details (for a Non-AI/ML Device)

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

   • Not applicable / Not provided. The summary indicates testing against ISO 5361, which is a performance standard for the physical characteristics and safety of tracheal tubes, not a clinical study requiring test sets of patient data. The standard covers aspects like dimensions, strength, cuff integrity, material biocompatibility, and sterilization. Actual "sample sizes" would refer to the number of tubes tested for these physical and material properties, but this specific detail is not given.
   • The manufacturer is from the United Kingdom.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable / Not provided. For a traditional physical medical device like an endotracheal tube, "ground truth" as relevant to clinical data or expert interpretation is not established in the same way as for an AI/ML diagnostic device. The "truth" for this device resides in its adherence to engineering specifications and performance standards (like ISO 5361).

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

   • Not applicable / Not provided. This concept is for resolving disagreements among multiple experts in clinical data labeling, which is not relevant here.

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 applicable. This device is an endotracheal tube, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

   • Not applicable. There is no algorithm for this device.

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

   • Not applicable in the typical sense for AI/ML. The "ground truth" for this device's safety and effectiveness is its compliance with the technical specifications and performance requirements outlined in the ISO 5361 standard. This involves objective measurements of physical properties, material analysis, and sterilization validation, rather than clinical outcomes or expert interpretation of patient data.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML product and does not have a training set.

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

   • Not applicable. This device is not an AI/ML product and does not have a training set or associated ground truth.

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