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TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.

TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access to the airway via a tracheostoma is required. The flexible tracheostomy tubes are single patient use, individually packaged with an obturator and neckstrap and provided sterile.

The TRACOE® vario Tracheostomy Tubes have an adjustable neck flange with a locking mechanism that allows the length of the tube to be adapted to the anatomical requirements of the individual patient. In addition, the neck flange includes two flexible wings that allow the fastening of a strap around the patients neck for fixation of the tracheostomy tube. These wings can be turned together around the flange or rotated independently within a range of about 60° to 180°. These features are useful for patients with thick necks or with unusual anatomy. The TRACOE® vario Tracheostomy Tubes are available in different models: with or without a high-volume low-pressure cuff, with or without a subglottic suction line which is suitable for Above Cuff Vocalization, fenestrated tube, standard or extended lengths, different diameters, with or without a Minimally Traumatic Insertion System (P series) and can be used within an MR environment.

The TRACOE® vario Tracheostomy Tube is for prescription use only and is applicable for mechanically ventilated or self-breathing patients in hospital (EMS), extended care facilities, outpatient clinics and can be used by individuals trained in tracheostomy care.

This document describes the TRACOE® vario Tracheostomy Tube, a medical device. However, it does not include information about a study proving the device meets specific acceptance criteria in the manner requested (i.e., with a table of reported device performance, sample sizes for test/training sets, expert qualifications, etc.).

The document is a 510(k) summary for a premarket notification to the FDA. It declares the device, TRACOE® vario, to be substantially equivalent to a legally marketed predicate device (TRACOE medical GmbH's vario Tracheostomy Tubes, K051587). This means that the FDA determined the new device is as safe and effective as the predicate device, and it does not require a new Premarket Approval (PMA) application.

Instead of a study with acceptance criteria and measured performance, the document summarizes non-clinical testing and explicitly states "Clinical testing of the TRACOE® vario Tracheostomy Tube was not required to demonstrate substantial equivalence."

Therefore, I cannot provide the requested table and information about a study that proves the device meets acceptance criteria because such a study (with the specified details) is not present in the provided text.

The closest information available is a general statement about bench testing:

"The results of this testing confirm that the TRACOE® vario Tracheostomy Tubes perform as intended, the product information is complete and comprehensive, and the device meets the requirements."

And in the conclusion:

"The TRACOE® vario Tracheostomy Tube has passed all defined criteria. The device has performed as well as the predicate device and is therefore considered substantially equivalent to the cleared predicate device."

While these statements indicate that the device met certain requirements, the provided text does not define those "defined criteria" with specific performance metrics in a table. It also does not detail the methodology of "passing" these criteria as requested in your prompt (e.g., sample sizes, ground truth, expert opinions).

The document focuses on demonstrating substantial equivalence through:

• Comparison to a predicate device: The new device is a modification of an existing, cleared device (K051587). Key differences are listed, primarily adding new models (fenestrated, XL lengths, Minimally Traumatic Insertion System), an expanded intended use statement (29 days), and updated labeling for MR environment and Above Cuff Vocalization.
• Non-clinical testing: This primarily involves testing to recognized standards for:
  • Sterilization and Cleaning (ISO 10993-7, ISO 11737-1, ISO 10993-5:2009)
  • Shelf Life and Transport Testing (ASTM F 1980-16, ASTM 1886/F1886M, ASTM F1929-15, ASTM F2096-11, ASTM F88/88M, ISO 11607-1, ISO 18190, ISO 14644-1, ASTM D4169-16)
  • Biocompatibility Testing (materials confirmed to be the same as legally US marketed devices, and clinical experience is also cited)
  • Bench Testing (ISO 5366, ISO 5356-1, ASTM F640-12, ASTM F2052-15, ASTM F2213-17, ASTM F2119-07, ASTM F2182-11a, ASTM F2503-13). This includes functionality, radiopacity, and MRI compatibility.

Without the specific "acceptance criteria" and "reported device performance" in a quantitative table format mentioned in the prompt, along with the detailed study methodology (sample sizes, ground truth, experts), I cannot fulfill all parts of your request based solely on the provided text.

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The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.

TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents.

The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician.

For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap.

The TRACOE silcosoft® is intended for single-patient use up to 29 days and may be reprocessed 7 times within this period. The device is applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.

The provided text describes the regulatory clearance (510(k)) for the TRACOE silcosoft® tracheostomy tube. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study for device acceptance criteria in the context of an AI/ML powered device.

Therefore, many of the requested fields regarding AI/ML-specific study information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this traditional medical device submission.

Here's a breakdown of the available information:

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

The document does not explicitly present acceptance criteria in the format typically seen with performance metrics for an AI/ML algorithm. Instead, it demonstrates equivalency to a predicate device through a comparison of technical characteristics and non-clinical testing against recognized standards.

Differences Not Raising New Questions of Safety/Effectiveness:

• Patient population: Predicate offers adult sizes (larger diameters), while TRACOE silcosoft® is for neonates, infants, children, and adolescents. This difference is not considered to raise new safety/effectiveness concerns as the new device falls within a subset of the predicate's population.
• Reprocessing: Predicate allows 5 times for pediatric sizes, TRACOE silcosoft® allows 7 times. This change in reprocessing frequency for pediatric sizes is deemed not to raise different questions of safety and effectiveness.

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

Not applicable. This was a non-clinical evaluation based on device testing and comparison to a predicate, not a study involving human data or an AI/ML algorithm's test set.

3. 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. No ground truth based on expert review was established for a test set in this submission.

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

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable.

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

Not applicable. The "ground truth" for this submission was based on established engineering principles, recognized international standards for medical devices (e.g., ISO standards for tracheostomy tubes, biocompatibility, sterilization), and the performance of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/ML model training was involved.

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

Not applicable.

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The TRACOE® cuff pressure monitor (cpm) is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes.

Patient Population: Adult, pediatic, neonatal patients who have high-volume-low-pressure cuffed endotracheal/ tracheostomy tubes.

The TRACOE® cuff pressure monitor (cpm) inflates or measures the intra-cuff pressure in the range of 20 – 100 cmH2O. It is intended for endotracheal or tracheostomy tubes with high-volume low-pressure (HVLP) cuffs.

The cpm consists of a pressure gauge/manometer and a bulb. Between the manometer and the bulb is a male Luer connector air outlet which is connected to the (pilot balloon valve) of the endotracheal/tracheostomy tube HVLP cuff. Opposite the Luer connector is an integrated air release valve that can be opened and closed with a knurled screw.

To inflate the HVLP cuff, the male Luer connector of the cpm is inserted into the inflation line (pilot balloon valve) of the endotracheal/tracheostomy tube, HVLP cuff and the knurled screw is closed, the bulb is then squeezed to inflate the HVLP cuff. As the pressure increases in the HVLP cuff the pressure value is displayed on the manometer. Once the cuff is inflated to the required cuff pressure the cpm is disconnected from the inflation line (pilot balloon valve).

To measure the HVLP cuff pressure, the knurled screw is closed and the male Luer connector is inserted into the open end of the cuff inflation line. The manometer will display the current HVLP cuff pressure. If the pressure is too low the bulb can be squeezed to inflate the cuff, or if the pressure is too high the knurled screw can be opened to release the cuff pressure. Once the required cuff pressure is achieved the cpm is disconnected from the inflation line (pilot balloon valve).

The TRACOE® cuff pressure monitor can be used for adult, pediatric, and neonatal patients. It is reusable and provided non-sterile. A sterile connection tube (REF 702, 1.0 m) is supplied with the TRACOE® cpm which provides an extension tube for inflating or measuring cuff pressure. The TRACOE® cuff pressure monitor is not suitable for continuous monitoring of HVLP cuff pressure.

The TRACOE® cuff pressure monitor is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes. It is designed for use with adult, pediatric, and neonatal patients.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text for any specific test. The text mentions "Performance and mechanical testing" and "Comparison testing" but doesn't provide the number of units or measurements used for these tests.
• Data Provenance: The testing was conducted by TRACOE Medical GmbH for regulatory submission to the FDA. The nature of the tests indicates they are conducted in a retrospective manner to demonstrate the device meets pre-defined acceptance criteria, likely in a laboratory or testing environment. The country of origin of the data would be Germany, where the company is based.

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 as the studies described are non-clinical, mechanical, and bench testing. These types of tests typically rely on standardized measurement equipment and protocols rather than expert human interpretation for "ground truth."

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

This information is not applicable as the studies described are non-clinical testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to establish a consensus ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a "cuff pressure monitor," a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. The device is a physical, manual instrument and does not involve an algorithm or AI.

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

The ground truth for the non-clinical testing would be derived from calibrated reference standards and objective measurements according to established engineering and medical device testing protocols (e.g., ISO standards for Luer connections, calibrated pressure gauges for accuracy, etc.).

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI or machine learning model that requires training data.

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

This information is not applicable for the same reasons as #8.

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The TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control.

It is for single patient use, and indically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for interor intra-facility transport.

The TRACOE® smart Cuff Manager is an accessory device for high volume low pressure (HVLP) cuffed endotracheal/tracheostomy tubes to maintain the cuff pressure within a range of 20 cm H₂O to 30 cm H₂O. This device includes a spherical, hard shell (transparent) outer casing with an elastic inner balloon (blue), that is attached to a base housing with both a male and female luer connector. The male connector is inserted into the inflation line (pilot balloon valve of the endotracheal/tracheostomy tube HVLP cuff) and the female connector is attached to a cuff inflation device (syringe or cuff pressure monitor). When the TRACOE® smart Cuff Manager is connected to the cuff inflation line the inner balloon is inflated with a cuff inflation device until the balloon diameter is between 2/3 - 3/4 of the outer casing. The cuff inflation device is then removed from the TRACOE® smart Cuff Manager, and after a few minutes the cuff pressure is rechecked to confirm the cuff is properly inflated inner balloon of the TRACOE® smart Cuff Manager will act as a pressure reservoir, allowing the air to flow between the balloon and the endotracheal/tracheostomy cuff, through passive control, in order to maintain the pressure range.

When the endotracheal/tracheostomy tube cuff pressure increases, due to compression through patient motion, coughing etc., the surplus air flows slowly into the inner balloon of the TRACOE® smart Cuff Manager through the integrated damping function. The damping function prevents sudden changes in cuff pressure which could result in a gap between the trachea. When the cuff pressure is reduced (following the patient motion) the inner balloon will allow the stored air to freely flow (without damping) back into the endotracheal/tracheostomy tube cuff in order to reinstate the cuff pressure to the prescribed range of 20 cm H₂O to 30 cm H₂O.

The TRACOE® smart Cuff Manager is for single patient use, and provided sterile for ease of use when connecting in a sterile environment. The device is applicable for mechanically ventilated or spontaneously breathing patients under medical supervision in hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

The provided text describes the 510(k) premarket notification for the TRACOE® smart Cuff Manager. It details the device's intended use, its technical characteristics compared to predicate devices, and a summary of non-clinical testing performed to establish substantial equivalence.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

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

The document doesn't explicitly present a table of acceptance criteria and reported device performance in a numerical format. However, it states the key performance objective and describes how testing confirmed it.

The primary performance criterion for the TRACOE® smart Cuff Manager is to maintain the High Volume Low Pressure (HVLP) cuff pressure of an endotracheal tube or tracheostomy tube within the range of 20 to 30 cm H2O through passive control.

The reported device performance, demonstrated through non-clinical testing, is that the device successfully meets this criterion. The document states:

• "Mechanical testing confirmed luer connections, pressure reservoir filling, damping function and maintaining the cuff pressure range (20 cm H2O to 30 cm H2O) under multiple situations (e.g., extended time periods, cuff compression)."
• "Comparison testing with the predicate devices PressureEasy (K833327) and Lanz (K791045) included maintaining the cuff pressure during volume/pressure changes and over an extended period of time."
• "The results of this testing demonstrated that the TRACOE® smart Cuff Manager is substantially equivalent to the legally cleared predicate devices."
• "The TRACOE® smart Cuff Manager has passed all defined criteria."

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

The document describes non-clinical performance and mechanical testing, as well as comparison testing with predicate devices. However, it does not specify the sample size for these tests (e.g., how many devices were tested, how many testing cycles). The tests are performed on the device itself (TRACOE® smart Cuff Manager) and in comparison with predicate devices.

The data provenance is from non-clinical testing performed by the manufacturer, TRACOE medical GmbH, in Germany. The tests are inherently prospective as they are conducted specifically to validate the device's performance against predefined criteria.

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 as the described study is a non-clinical performance and mechanical testing, not a study evaluating expert interpretation or clinical decision-making. The "ground truth" here is the physical measurement of cuff pressure and the device's ability to maintain it within a specified range, as measured by instruments.

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

This information is not applicable for non-clinical performance and mechanical testing. Adjudication methods are typically used in clinical studies involving expert reviews or subjective assessments, which is not the nature of the described tests.

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 comparative effectiveness study was not done. The device (TRACOE® smart Cuff Manager) is a passive mechanical device for maintaining cuff pressure, not an AI-assisted diagnostic or interpretive tool that would involve human readers. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence."

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

The described testing is essentially standalone performance testing of the mechanical device. The device operates through "passive control" without active human intervention once set up, making the non-clinical tests akin to standalone performance evaluations in a controlled environment.

7. The type of ground truth used:

The ground truth used for this device is physical measurement of cuff pressure. This is a quantitative, objective measurement taken by instruments to determine if the device successfully maintains the pressure within the specified range (20-30 cm H2O).

8. The sample size for the training set:

There is no training set mentioned or implied because this is a mechanical device, not a machine learning or AI algorithm that requires training data.

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

As there is no training set, this question is not applicable.

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TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management in patients with unusual anatomy or thick neck patients.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding Tracoe-Vario Tracheostomy Tubes. It states that the device is substantially equivalent to a legally marketed predicate device (Bivona TTS Adjustable Neck Flange Tracheostomy Tube).

However, this document does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for training was established.

Therefore, I cannot fulfill your request using the provided input. The document is solely an FDA clearance letter based on substantial equivalence, not a detailed study report.

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The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth. Tracoe Phon Assist I (Ref Models 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy tubes or cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of:

• Mild Tracheal Stenosis
• Laryngeal Tumors
• Bilateral Vocal Cord Paralysis
• Trachealmalacia
• Head Trauma
• Broncheopulmonary Dysplasia
• Amyotrophic Lateral Scierosis
• Chronic Obstructive Pulmonary Disease

The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Tracoe Phon Assist I. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies with specific acceptance criteria like those often seen for novel or high-risk devices. For devices deemed substantially equivalent, the performance is generally considered acceptable if it is comparable to the predicate device.

Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether standalone algorithm performance was done.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This information would typically be found in detailed performance studies submitted as part of the 510(k) application, but it is not summarized in the FDA's decision letter.

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Model 301: device is intended for providing tracheal access for airway management including artificial ventilation.

Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to sately wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve".
Model 303: device is intended for providing tracheal access for airway management.

Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve".
Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy.

Model 401: device is intended for use in patients with the larynx intact in combination with TRACOES-FLEX model 302 and 304.

The TRACOE -FLEX tracheostomy tubes, the accessories as well as the replacement parts (inner cannulas and plugs) are sterile products for single patient use only. They essentially consist of a neck plate, an outer and an inner cannula. Outer and inner cannulas consists of thin walled relatively soft plastic material, which gets even softer at body temperature. The special feature of the TRACOE -FLEX tracheostomy tubes is, that the neck flange is movable in a horizontal as well as in a vertical axis, so that the cannula inside the trachea does not move, when the patient either bends or turns his head. The outer cannula can carry an inflatable low pressure high volume cuff (models 301 and 302) and/or can be perforated (models 302 and 304). Inner cannulas with a twist-lock 15 mm adapter are non fenestrated (models 301, 302, 303 and 304); additional inner cannulas with a short blue twist-lock adapter (models 302 and 304) are fenestrated. Fenestrated inner cannulas with an integrated "speaking valve" for models 302 and 304 are available as accessories (model 401) for all sizes.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of typical AI/ML medical device submissions. Instead, it describes a traditional medical device (tracheostomy tubes) and its comparison to predicate devices for 510(K) clearance.

Therefore, I cannot fulfill your request for the following sections:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, I can provide information based on the "Assessment of Substantial Equivalence based on non-clinical Performance Data" section:

Summary of Device Performance and Equivalence

The TRACOE®-FLEX tracheostomy tubes, including the "speaking valves," were tested in comparison to Shiley/Mallinckrodt tubes. The assessment aimed to demonstrate substantial equivalence, focusing on physical characteristics and performance rather than a clinical study with patients or AI-driven analysis.

Non-Clinical Performance Data Overview:

• Tests Conducted: Measurements of dimensions, resistance to airflow, kink resistance, and connection between cannula and neck plate.
• Results: All tested parameters were "at least as good as those of the predicate devices." Some features showed improvement, specifically:
  • Resistance to airflow
  • Softness of the wall
  • Flexibility between cannula and neck plate

Key Technological Characteristics and Improvements (compared to predicate devices):

• Neck Plate Flexibility: TRACOE®-FLEX tubes have a neck plate that allows movement in both horizontal and vertical axes, enhancing cannula stability during patient head movements, unlike Shiley/Mallinckrodt tubes which only move horizontally, and other tubes with fixed neck plates.
• Thinner Cannulas: TRACOE®-FLEX tubes have thinner cannulas, which at a given tracheostoma size, provide comparatively higher airflow.
• Softer Material: Made from a softer plastic (polyurethane) than Shiley products, resulting in greater softness and flexibility.
• Integrated Speaking Valve: The Tracoe "speaking valves" are constructed as an integral part of the inner cannulas, making them less bulky than predicate devices from Shiley/Mallinckrodt and Passy-Muir.

Biocompatibility Assessment:

• All materials are medical grade with certificates of compliance.
• Elution tests according to USP23 on final sterilized products were negative.

This information describes the evidence provided for a traditional medical device's 510(k) submission, confirming its equivalence to existing devices based on non-clinical performance and material biocompatibility. It does not fit the structure of an AI/ML device study.

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