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Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique.
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.

The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.

The provided document is a 510(k) premarket notification summary for medical devices (tracheostomy kits). It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or cannot be extracted from this type of document.

The document primarily demonstrates that the BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kits or Trays are substantially equivalent to existing predicate devices (UltraPerc Percutaneous Dilation Kit and Portex Percutaneous Tracheostomy Kit).

Here's a breakdown of the available information:

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

This document does not present a table of specific performance acceptance criteria in the way it would for a new AI/software device or a device requiring new clinical performance data to demonstrate effectiveness. Instead, the "acceptance criteria" are implied by establishing substantial equivalence to predicate devices. The performance testing conducted (bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, biocompatibility assessment) ensures the device meets its own specifications and is safe and performs as intended, thereby being equivalent to the predicates.

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device.

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

• Sample Size: Not specified for individual tests. The document refers to "applicable components" for bench testing and mentions that tests were "conducted" without providing specific sample numbers for each test.
• Data Provenance: The studies are described as "Non-clinical testing" and include bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, and biocompatibility assessment. These are laboratory/engineering tests rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

This information is not provided. The testing described (bench, packaging, sterilization, biocompatibility, and human factors) relies on engineering and scientific principles and product specifications, not on expert consensus for "ground truth" as might be seen in diagnostic imaging studies. Human factors testing involves users, but their qualifications are not detailed beyond "physician (healthcare staff)".

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple reviewers assess outcomes, which is not the type of study described here.

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

Not applicable. This is a premarket notification for a physical medical device (tracheostomy kit), not an AI/software device. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance testing is adherence to predefined engineering specifications, performance standards (e.g., fluid flow, material strength), and regulatory standards (e.g., ISO for packaging, sterilization, biocompatibility). It is based on objective measurements and compliance with recognized standards, rather than clinical expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is not a study involving machine learning or AI models, so there is no "training set."

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

Not applicable (no training set).

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Portex ® UniPerc™ single use Percutaneous Dilation Tracheostomy (PDT) Kits allows the controlled, elective subcricoid perculaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldings guidewire dilation technique in patients with a large neck and manimum of 50mm of pre-tracheal soft tissue in to the trachea) where standard (up to a maximum of S0mm of pre-tracheal soft tissue anterior to the trached on go noon anatomy (up to a maximum of pre-traches to the trachea) where standard length flange tracheostomy tubes are too short.

Tracheostomy tube maximum period of use 29 days.

The UniPerc™ device has been designed to facilitate percutaneous tracheostomy in patients with a large neck mass and a consequently large skin to anterior trachea depth. The UniPerc™ device is centered on an extra length, wire reinforced, pre-curved, cuffed or uncuffed, tracheostomy tube mounted with an adjustable flange. The tube is supplied with an inner cannula, which can be used to line the internal surface of the tube. Obturators, dilators and other parts are supplied with the various kits.

The UniPerc™ device is designed for insertion using existing, dilating percutaneous or surgical insertion techniques. Care of the device whilst in use also follows existing standards techniques.

The graduated single stage dilator has a lubricious hydrophilic coating when wetted, to improve its ease of insertion.

The provided text does not describe acceptance criteria for a device, nor does it contain a study that proves a device meets those criteria.

Instead, the documents are a 510(k) summary and an FDA clearance letter for the Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit. This type of regulatory submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance against pre-defined acceptance criteria through a specific study.

Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) from the provided text.

The key points from the provided text are:

• Device: Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit
• Purpose: To facilitate percutaneous tracheostomy in patients with a large neck mass and large skin to anterior trachea depth, where standard tracheostomy tubes are too short.
• Regulatory Mechanism: 510(k) submission, seeking substantial equivalence to predicate devices (other Portex tracheostomy kits and tubes).
• Basis of Substantial Equivalence: Comparison of technological characteristics, intended use, and materials of composition with predicate devices.
• Intended Use: In a controlled setting (ICU/operating room) with trained personnel, requiring a minimum of two operators. Specifically for patients with a minimum of 50mm of pre-tracheal soft tissue anterior to the trachea. Maximum period of use is 29 days.
• FDA Clearance: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence, not a performance study against acceptance criteria.

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To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.

Portex Percutaneous Tracheostomy Kit

This document is a FDA 510(k) clearance letter for a medical device called the "Portex Percutaneous Tracheostomy Kit." It does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter primarily:

• Confirms a review of the premarket notification (510(k)).
• Determines substantial equivalence to a legally marketed predicate device.
• States that the device can be marketed subject to general controls and, if applicable, special controls.
• Outlines general responsibilities under the Federal Food, Drug, and Cosmetic Act.
• Includes an "Indications for Use" statement.

Therefore, I cannot provide the requested information about acceptance criteria or a study from the given text.

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The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer and components of these kits that allow for tracheal access for airway management for use in adults only.

The Portex "Ultra Perc" single use Percutaneous Dilation Tracheostomy Kits allow the percutaneous insertion of the Police Sublic Fere "Single discriptions of the stage) circumferencial dilatational Seldinger guidewire technique. Kits are supplied with a Portex Blue Line Ultra Tracheostomy Tube and introducer. The kits are intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel. A minimum of 2 operators are required - one to maintain the patient's airway, anaesthesia, breathing and circulation, and the other to perform the procedure. The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra The Forex Forealizer, are available in sizes 7.0, 8.0 and 9.0mm only.

The provided text is a 510(k) summary for a medical device (Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit). It aims to demonstrate substantial equivalence to previously marketed predicate devices, not primarily to prove device performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, for many of the requested points, the information is not present in the provided document. This is typical for a 510(k) submission that relies on substantial equivalence rather than new clinical effectiveness trials.

Here's an analysis based on the provided text, addressing each point where possible:

Acceptance Criteria and Device Performance Study for Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit

The provided document does not contain explicit acceptance criteria in the typical sense of numerical thresholds for a new clinical study. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.

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

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

The document mentions "Performance data for the proposed device is shown in section 8.0 Performance. Clinical data is provided in Appendix 2." However, Section 8.0 and Appendix 2 are not provided in the excerpt. Therefore, the sample size or provenance of any direct test data for the proposed device is unknown from the given text.

The primary "evidence" for this 510(k) is based on the equivalence to predicate devices which have established clinical use. This is not a study that uses a "test set" in the traditional sense of a clinical trial for a novel device.

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. This is not a study requiring expert-established ground truth for a test set. The focus is on demonstrating substantial equivalence to predicate devices, which are already in clinical practice.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.

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 medical kit for a surgical procedure, not a diagnostic AI device. Therefore, an MRMC study and effects on human readers are irrelevant to this submission.

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

Not applicable. This is a physical medical device kit, not an algorithm.

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

Not applicable. The "ground truth" in a 510(k) submission based on substantial equivalence is the safety and effectiveness profile of the predicate devices as established by their prior marketing and clinical use. No new ground truth needed to be established for the proposed device, beyond demonstrating its similarity to these predicates.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable. There is no training set for this device.

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To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management.

The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. It employs the well understood and established procedure for dilating a stoma and introducing the tracheostomy tube using the Seldinger over a guide wire system. The kit contains all of the standard components to which the user are accustomed: scalpel, needle and cannula, syringe, guidewire, guiding catheter, Gauze pads, short pre-dilator, dilator system, and tracheostomy tube introducers. The kit differs from the above two kits in that it employs a single tapered dilator to replace the multiple serial dilators. The packaging is the same as that used in K022212. It is designed with an outer blister, which contains an inner tray. The tray layout is designed to present the user with the components in the order of use. Each pack is EO sterilised and individually packed in a carton together with the directions for use.

The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) and a letter of substantial equivalence from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as typically found in an AI/ML device submission.

The document describes a physical medical device and its equivalence to predicate devices, focusing on its design, intended use, and regulatory classification. It does not involve any AI/ML components or performance metrics related to diagnostic accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested table and study details based on the input text.

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The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing Luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The manufacturer, Portex, Inc., submitted a 510(k) premarket notification (K031057) for their PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. The submission includes a summary of nonclinical and clinical tests that support the device's substantial equivalence to predicate devices and its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The clinical user evaluation involved 28 subjects in the control group and 26 subjects in the two study groups. This totals 54 subjects for the clinical test set.
• Data Provenance: The study was a prospective clinical user evaluation conducted at St. John's Mercy Medical Center. The country of origin is not explicitly stated but can be inferred as the United States (given the submission to the FDA and the U.S. location of the manufacturer and study site).

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

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to a "clinical user evaluation," which implies participation from medical professionals. The study was conducted at "St. John's Mercy Medical Center," suggesting that the evaluation was carried out by healthcare professionals at that institution who are experienced in performing tracheostomies and managing tracheostomy patients.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical user evaluation. It presents the findings as conclusions from the evaluation without detailing the consensus or disagreement resolution process.

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 conducted, nor is this device an AI-assisted device. The study was a clinical user evaluation comparing a new medical device to existing (predicate) devices, focusing on clinical outcomes directly related to the device itself, not AI interpretation or human reader performance with or without AI.

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. This device is a physical medical device (tracheostomy kit), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be based on clinical observation and assessment of patient outcomes. This would include:

• Clinical Assessment: Direct observation by healthcare professionals during tube insertion for "trauma or difficulty."
• Patient Outcomes/Monitoring: Data collected on the "incidence of occlusion of the tracheostomy tube" over time for the study subjects.
• Expert Clinical Judgement: The expertise of the clinicians performing the procedures and evaluating the patients would form the basis of the "ground truth" for success or failure regarding safety and effectiveness.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this device. As a physical medical device, there isn't a "training set" in the sense of data used to train a machine learning model. Instead, the design and development of the device would have involved internal testing and refinement (e.g., engineering tests, bench testing, animal studies, or earlier human factors analysis) which are not detailed as a "training set" in this summary.

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

Since there is no "training set" in the context of an algorithm or machine learning for this device, the concept of establishing ground truth for a training set does not apply. The development process for the physical device would have involved standard medical device design control procedures, where design inputs are translated into design outputs, and verification/validation activities ensure the device meets its requirements. Any "ground truth" during development would stem from engineering specifications, material testing standards, and preclinical (e.g., animal, bench) study results.

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To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.

The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.

The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) seeking market clearance. In 510(k) submissions, the primary "acceptance criterion" is often substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through controlled studies with explicit acceptance criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technical characteristics and indications for use, and sometimes through performance testing if the device introduces new technology or significantly different characteristics.

Based on the provided text, here's an analysis structured around your request:

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

The submission does not explicitly list quantitative "acceptance criteria" in the way one might expect for an AI/algorithm-based device (e.g., AUC > X, sensitivity > Y). Instead, the core acceptance criterion is substantial equivalence to predicate devices. The "reported device performance" is essentially the claim of having similar technical characteristics and safety/effectiveness as the predicates.

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

The document does not describe a clinical "test set" in the context of an algorithm or diagnostic device. For this type of physical medical device, "testing" likely refers to bench testing, biocompatibility testing, material testing, and potentially limited cadaver or animal testing (though not explicitly detailed here). There is no mention of a "test set" in terms of patient data.

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 to the provided 510(k) summary. The submission focuses on product design, materials, and comparison to predicates, not on establishing ground truth for a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable, as no test set in the diagnostic sense is described.

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

This is not applicable. The device is a physical tracheostomy kit, not an AI or imaging-related device that would be subject to such a study design.

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

Not applicable, as the device is a physical kit, not an algorithm.

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

Not applicable. For this device, the "ground truth" to be demonstrated is largely based on the established safety and performance of its predicate devices and the physical characteristics/materials meeting design specifications.

8. The sample size for the training set

Not applicable, as there is no "training set" for an algorithm described.

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

Not applicable.

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The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The provided text describes a 510(k) summary for the PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed clinical study with performance metrics.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this text:

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

This information is not available in the provided text. The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than setting or meeting specific performance acceptance criteria with detailed metrics like sensitivity, specificity, or inter-reader agreement. The "Conclusion" section states: "The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices." This implies that the device meets the safety and effectiveness standards derived from the predicate, but it doesn't quantify specific performance metrics or acceptance criteria as you would find in a clinical trial report.

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

This information is not available in the provided text. The document refers to "testing performed and comparison to the predicate devices" but does not detail any specific human subject test sets, their sample sizes, or data provenance. It's highly probable that the testing referred to was primarily bench testing and material compatibility assessments, rather than a clinical study requiring human subject data provenance.

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)

This information is not available in the provided text. Since there's no mention of a clinical test set with human data requiring ground truth establishment by experts, this detail is not relevant to the content provided.

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

This information is not available in the provided text. Again, without a clinical test set for human readers, adjudication methods are not discussed.

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 available in the provided text. The device described is a medical instrument (tracheostomy kit) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected for this type of device.

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

This information is not available and not applicable to the device described. This question typically relates to the performance of artificial intelligence algorithms. The PER-FIT™ Percutaneous Dilational Tracheostomy Kit is a physical medical device.

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

This information is not available in the provided text. As explained above, the submission claims substantial equivalence through testing and comparison to predicates, which likely involved engineering and material testing rather than clinical ground truth establishment in the traditional sense for diagnostic tools.

8. The sample size for the training set

This information is not available in the provided text. This question is typically relevant for machine learning algorithms, which is not what this device is.

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

This information is not available in the provided text and is not applicable to this device.

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The Rusch UltraTracheoflex®Tracheoflex® Tracheostomy Tube Kits are intended for use in airway management of tracheostomized patients.

Tracheoflex® Fenestrated Tracheostomy Set-Cuffed, Tracheoflex® The Ultra Tracheostomy Set-Uncuffed, Tracheoflex® Fenestrated Tracheostomy Set-Uncuffed, are sterile, disposable, single use cuffed, or uncuffed fenestrated fixed length fenestrated tracheostomy tubes with a fixed flange. The kit may include a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, phonation value, a sealing cap, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.

The provided text describes medical device submission for tracheostomy tube kits, not an AI/ML device. Therefore, it does not contain information about acceptance criteria or study data for an AI/ML device.

Specifically, the document states: "No clinical testing was completed." This directly indicates that no study was performed to assess the device's performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to already marketed devices based on features, materials, and dimensions.

Therefore, I cannot provide the requested information.

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