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The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Portex® BLUxl™ Extra Length Tracheostomy Tube is for the adult patient category that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.
200/710, 720 and 730/xxx are extra proximal length (y measurement) tracheostomy tubes and are indicated for use in patients with excessive skin surface to anterior tracheal wall distance as frequently seen in obesity.
200/715, 725 and 735/xxx are extra distal length (x measurement) tracheostomy tubes and are indicated for use in patients with normal skin surface to anterior tracheal wall distance and require the distal length of the tracheostomy tube to extend more caudally within the trachea.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube for patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.

Portex® BLUxl™ Extra Length Tracheostomy Tubes and BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction.
Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubes and Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes. The inner cannulas are single use only.

The provided FDA 510(k) summary for the Portex® BLUxl™ Extra Length Tracheostomy Tube, BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and BLUxl™ Extra Length Tracheostomy Inner Cannula focuses on establishing substantial equivalence to a predicate device rather than demonstrating the device meets a specific set of primary acceptance criteria through a clinical study.

Therefore, many of the typical elements requested in a description of acceptance criteria and a study proving a device meets them (such as MRMC studies, specific expert qualifications for ground truth, or effect sizes for AI assistance) are not applicable to this type of submission. This document describes a non-clinical performance evaluation to show similarity and safety compared to an already cleared device.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Study Overview and Acceptance Criteria (as applicable for a 510(k) of this nature)

The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating that the subject devices are substantially equivalent (SE) to the predicate devices (Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube, and BLUselect® Inner Cannula) in terms of:

• Intended Use
• Technological Characteristics (materials, design, performance features)
• Safety and Effectiveness (demonstrated through non-clinical testing)

The study proving the device meets these "acceptance criteria" is a non-clinical performance evaluation comparing the subject device to the predicate device. The conclusion states: "The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do not raise any new questions of safety and effectiveness. It is concluded that the information provided in this submission supports substantial equivalence."

1. Table of acceptance criteria and reported device performance

Since this is a substantial equivalence submission based on non-clinical testing, the "acceptance criteria" are implied by successful demonstration of performance similar to the predicate and compliance with relevant standards. The "reported device performance" refers to the successful completion of these tests.

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

• Sample Size: Not specified in terms of clinical patient numbers since this was a non-clinical (bench and lab) performance evaluation. The "sample size" would refer to the number of devices or components tested for each mechanical, biocompatibility, sterilization, and packaging validation. These numbers are typically defined by engineering standards and internal quality procedures.
• Data Provenance: The data is from non-clinical laboratory testing and validation conducted by Smiths Medical ASD, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would typically be where the manufacturer's R&D and testing facilities are located (Minneapolis, MN, USA, based on the address). The data is prospective in the sense that the tests were designed and executed to support this submission.

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

• Not applicable in the typical sense of clinical ground truth. For a non-clinical performance evaluation, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM) and internal design specifications validated by skilled engineers, microbiologists, and other technical experts within the manufacturer's organization or through certified testing labs. These are not "experts" establishing a clinical diagnosis or interpretation but rather technical professionals verifying physical and biological properties against predefined criteria.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., subjective image assessment) to resolve discrepancies. For non-clinical performance testing, the results are typically quantitative and objective (e.g., passing/failing a force test, meeting dimensional specifications, biological assay results). Any discrepancies would be resolved through retesting, root cause analysis, or verification against the defined test methods.

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, not done. This type of study is entirely irrelevant to the submission for a tracheostomy tube. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing AI-assisted performance to unassisted performance.

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

• No, not done. This describes the performance evaluation of an AI algorithm, which is not applicable to a physical medical device like a tracheostomy tube.

7. The type of ground truth used

• The "ground truth" for this device's performance evaluation is based on defined engineering specifications, performance standards (e.g., ISO 11135 for sterilization, ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the predicate device's established safe and effective performance. There is no clinical "ground truth" in terms of disease diagnosis or patient outcomes directly derived for this submission, as clinical testing was not deemed necessary.

8. The sample size for the training set

• Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device and does not involve AI or machine learning algorithms.

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

• Not applicable. As above, no training set for an AI model.

In summary: This 510(k) submission is for a physical medical device and establishes substantial equivalence through a comprehensive non-clinical performance evaluation. It does not involve clinical studies with human subjects, AI algorithms, or subjective interpretations that would necessitate the study design elements typically seen in diagnostic AI/imaging device submissions. The "acceptance criteria" are the successful demonstration of equivalence in intended use, technological characteristics, and safety/effectiveness via robust non-clinical testing against established engineering and regulatory standards.

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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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Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).

It appears there may be a misunderstanding. The document provided is an FDA 510(k) clearance letter and associated summary for a medical device (tracheostomy tube), not a study proving an AI/software device meets acceptance criteria.

The document details the equivalence of a new tracheostomy tube (Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff) to previously cleared predicate devices, based on similar technological characteristics, intended use, and performance data from bench testing, biocompatibility, sterilization, and human factors. It does not involve AI or software, and therefore, it does not contain the information you requested about acceptance criteria and a study proving an AI device's performance.

To answer your request, I would need a document describing an AI/software medical device's performance study, including its acceptance criteria and the results of that study.

The document you provided is about a conventional medical device.

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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator, and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access.

The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.

This document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of medical devices. It primarily compares new devices to previously cleared predicate devices. Therefore, the information typically requested about acceptance criteria and detailed study designs for performance evaluation of AI/ML-based medical devices (like training/test set sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present for this specific type of device and submission.

The document states that the safety and/or effectiveness of the subject device for modifications (new sizes, OD changes, package/labeling changes) are supported by performance testing and biocompatibility testing. However, it does not provide the detailed acceptance criteria and study results in the format requested for an AI/ML device.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists several tests performed and states that "The pre-determined acceptance criteria were met" for some mechanical tests. However, it does not provide specific numerical acceptance criteria or the reported performance data.

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

Not provided. The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for detailed clinical or AI/ML performance studies, not for the manufacturing and material changes of a device like this.

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

Not applicable/Not provided. This information is relevant for studies involving human interpretation or clinical outcomes used as ground truth, particularly in AI/ML performance evaluations. For physical medical devices undergoing performance and biocompatibility testing for manufacturing changes, this concept of "ground truth" established by experts in a test set is not directly relevant in the same way.

4. Adjudication method for the test set

Not applicable/Not provided. Similar to point 3, adjudication methods are used in studies where there's variability in interpretation (e.g., expert readers reviewing medical images). This is not applicable to the types of performance and biocompatibility tests described for this device.

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 is not mentioned. This type of study is specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This submission is for a physical medical device (tracheostomy introducer/exchange set) and does not involve AI assistance.

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

No. This is not applicable as the submission is for a physical medical device, not an algorithm.

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

Not explicitly provided in specific detail for each test. For the physical performance tests (like security of attachment, compression force, tensile strength, verification of outer diameter), the "ground truth" would be the engineering specifications and established standards (e.g., BS EN ISO 5366:2016 for security of attachment). For biocompatibility, the ground truth is defined by the biological response assays and limits set by ISO standards (ISO 10993-5, -7, -10, -11, -12). The document states compliance with these standards, implying that the results met the requirements dictated by these standards for safety.

8. The sample size for the training set

Not applicable/Not provided. This concept is specific to AI/ML models. The devices here are physical medical devices, not AI algorithms, so there is no training set in this context.

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

Not applicable/Not provided. As there is no training set for an AI/ML model, this question is not applicable.

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The device is intended for use in providing tracheal access for airway management.

The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.

The provided text is a 510(k) summary for a medical device, the Shiley™ Neonatal/Pediatric Tracheostomy Tube. It details the device's characteristics, intended use, and comparisons to predicate devices, along with the performance testing conducted to demonstrate substantial equivalence.

However, the document specifically states "N/A - Clinical evidence was not necessary to show substantial equivalence." This means that the submission did not include a clinical study in the traditional sense, especially not one involving human subjects that would typically require the establishment of an AI model's performance against human readers or a ground truth derived from expert consensus or pathology for a diagnostic or AI-driven device.

Therefore, many of the requested elements for AI model evaluation (like multi-reader multi-case studies, expert adjudication, training set details, etc.) are not applicable to this 510(k) submission as it concerns a physical medical device (tracheostomy tube) and not an AI/software device.

I can, however, extract information regarding the acceptance criteria and the studies that were performed to prove the device met those criteria for this type of medical device.

Acceptance Criteria and Device Performance for the Shiley™ Neonatal/Pediatric Tracheostomy Tube

This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (tracheostomy tube) to existing predicate devices based on design, materials, and performance through non-clinical testing. It does not involve an AI model or diagnostic performance evaluation that would necessitate clinical studies, multi-reader analyses, or expert ground truth establishment in the way described in the prompt's questions.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Tests Performed) and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated for each test, but standard for medical device bench testing and biocompatibility involves a sufficient number of samples to ensure statistical validity and representativeness of the manufacturing process. These are typically small, controlled batches for verification.
• Data Provenance: Laboratory test results from internal or contracted testing facilities for the subject device. These are prospective tests performed specifically for this 510(k) submission, not retrospective patient data. The country of origin for the testing itself is not specified, but the applicant (Covidien) is based in Boulder, CO, USA.

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

• N/A. The testing conducted for this device is physical and material performance testing, not a diagnostic or AI evaluation requiring expert-established ground truth from clinical images or patient data. The "ground truth" here is compliance with engineering specifications, material standards, and regulatory guidelines, verified by laboratory measurements.

4. Adjudication Method for the Test Set:

• N/A. This concept applies to human reader studies or AI performance evaluations, not to the bench and material testing performed for this device. Test results are objective measurements against pre-defined specifications.

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

• No. As explicitly stated in the summary, "N/A - Clinical evidence was not necessary to show substantial equivalence." An MRMC study is a type of clinical study used for diagnostic devices, particularly those involving image interpretation by human readers.

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

• No. This device is a physical tracheostomy tube, not a software algorithm.

7. The Type of Ground Truth Used:

• For this device, the "ground truth" is defined by engineering specifications, international consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ISO 5366, ISO 5356), and FDA guidance documents. Compliance with these established objective criteria serves as the basis for performance evaluation and substantial equivalence determination.

8. The Sample Size for the Training Set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. As no training set for an AI model was used, this question is not applicable.

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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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The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject device, the Weinmann Tracheostomy Exchange Set, includes a Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator (cleared under K133597), five Ciaglia loading dilators (21-, 24-, 26-, 27-, and 28-Fr; cleared under K133597), an 8-Fr Cook Airway Exchange Catheter (cleared under K162729), and two Rapi-Fit Adapters (cleared under K162729).

The Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator is designed to be advanced over an airway exchange catheter into an existing tracheostomy tube to dilate the stoma, to be prepared for replacement of a new tracheostomy tube. The dilator is 38.0-Fr in outer diameter and 20 centimeters long. This dilator has a depth marking to indicate the skin level, which is placed 11 centimeters from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 centimeters of the device.

The Ciaglia loading dilators are designed to be inserted into a new tracheostomy tube to facilitate dilation of the stoma and placement of the tube in the airway. The dilators are available in outer diameter of 21 to 28 Fr; all dilators are 20 centimeters long and curved at the distal end.

The airway exchange catheter is designed to be inserted into the previously existing tracheostomy tube in patients prior to removal. The airway exchange catheter keeps the airway open during dilation and placement of a new tracheostomy tube. The airway exchange catheter is 8.0 Fr in outer diameter and 45 centimeters long. The distal end of the airway exchange is a blunt tip with rounded edges.

Two Rapi-Fit adapters (one with a 15-mm connector, and one with a Luer lock connector) are provided to be used with the airway exchange catheter for oxygenation when the requirement for oxygen is high in patients but the tracheostomy tube is not in place. The 15 mm Rapi-Fit adapter is designed for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a highpressure jet ventilation oxygen source. The Luer Lock connection is a male Luer Lock that is compatible with the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Weinmann Tracheostomy Exchange Set (K180034), structured to answer your specific questions:

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

The document does not explicitly present a table of quantitative acceptance criteria for the Weinmann Tracheostomy Exchange Set, nor does it provide specific numerical performance metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:

• Identical intended use and similar indications for use.
• Similar technological characteristics, method of operation, and materials of construction.
• Satisfactory results from non-clinical testing.

Based on the available text, here's a conceptual table:

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

The document describes non-clinical testing, which typically does not involve human subjects. The testing described includes:

• Dimensional and Compatibility Evaluation of the subject device (Accelerated/Real Time Aged).
• Biocompatibility testing.

The document does not specify a "sample size" in terms of number of patients or cases. For non-clinical device testing, sample size would refer to the number of devices or components tested. This information is not provided in the document.

The data provenance is from Cook Incorporated's internal non-clinical testing, as implied by the reference to "applicable non-clinical testing to ensure reliable design and performance under the specified design requirements." There is no mention of country of origin of data, or if it was retrospective or prospective in the clinical sense, as it refers to device testing, not human trials.

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 or not provided. Since the study is a non-clinical device performance and substantial equivalence assessment, it does not involve establishing ground truth from expert consensus on patient cases. Decisions are based on engineering and material science testing standards and comparison to a predicate device.

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

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where multiple experts independently assess cases and discrepancies are resolved. This document details non-clinical device component testing.

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

There was no MRMC comparative effectiveness study done. This device is a physical medical device (tracheostomy exchange set), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" does not apply.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm, so an "algorithm only" performance study is irrelevant.

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

The "ground truth" for this regulatory submission is established through:

• Engineering specifications and standards: For dimensional, compatibility, and material properties.
• Biocompatibility standards: Often ISO 10993 series.
• Comparison to a legally marketed predicate device: The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Sets (K133597). The predicate device's safety and effectiveness implicitly serve as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable or not provided. There is no "training set" in the context of this device's non-clinical testing. Training sets are typically associated with machine learning or AI development.

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

This information is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

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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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Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.

The Portex® Blue Line Ultra® Paediatric Tracheostomy Tube (Blue Paeds) is designed for the paediatric population who require an artificial airway due to trauma or medical condition. It is indicated for patients who require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. The subject device package consists of a paediatric tracheostomy tube and cotton tape (neck strap) and a maximum recommended period of use is 29 days.

The tube is manufactured with a flange, blue line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for use when in-contact with patient tissue/bodily fluids/secretions.

This document describes the Portex Blue Line Ultra Paediatric Tracheostomy Tube (BLU PAEDS) and asserts its substantial equivalence to predicate devices, thus demonstrating that it meets acceptance criteria for its intended use. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BLU PAEDS are established by demonstrating compliance with relevant ISO standards and comparable performance to the predicate devices. The document frames this as "substantial equivalence" rather than explicit numeric acceptance criteria for each characteristic.

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

The document does not specify exact sample sizes for each bench test conducted. Instead, it states: "Non-clinical testing of the components comprising each configuration of the subject BLUE PAEDS were assessed and tested appropriately to design controls; i.e. design verification, design validations." This implies sufficient samples were used to meet the requirements of the standards cited.

The data provenance is prospective, non-clinical bench testing performed by the manufacturer, Smiths Medical. The "country of origin of the data" is not explicitly stated but would typically be the location of Smith Medical's testing facilities, likely within the USA given the FDA submission.

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

This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by the specifications and criteria outlined in the relevant ISO standards and internal design requirements, rather than expert consensus on a test set in the way one might see for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided. As "ground truth" for non-clinical bench testing is based on device specifications and standard compliance, a formal adjudication method by external experts (like 2+1 or 3+1) is not typically applicable or described in this context.

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. This device is a medical instrument (tracheostomy tube), not a diagnostic AI system or an assistive technology that improves human "reading" performance. Therefore, this type of study is not relevant to its clearance.

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

This question is not applicable to the Portex Blue Line Ultra Paediatric Tracheostomy Tube. It is a physical medical device, not an algorithm, and does not have "standalone" performance in the context of AI. Its performance is inherent to its design and material properties.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of this device is primarily based on:

• Compliance with established international standards (e.g., ISO 5366-3, ISO 5366, ISO 5356-1, ISO 18190, ISO 10993-1, ISO 11135, ISO 11747, ASTM F2503-13).
• Engineering specifications and design controls to ensure the device performs as intended for airway maintenance in paediatric patients.
• Comparison to legally marketed predicate devices to establish substantial equivalence in safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI or machine learning model, so there is no "training set."

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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ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.

In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.

By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.

The entire device is for single patient use and the HME-part is for single use.

Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.

Environment of Use: Hospitals, ICU, sub-acute care institutions and home.

The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices".

Speaking Valve and HME 15 / 22

The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus.

The Speaking Valve has two modes: speaking mode and HME mode.

In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.

In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.

HME DigiTop and HME DigiTop O2

The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.

The provided text is a Premarket Notification (510(k)) for a medical device called "ProTrach DualCare." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device to existing ones and presenting non-clinical studies to support safety and performance.

The document does not contain information about studies involving human subjects, clinical efficacy, or the statistical metrics often associated with AI/ML device performance (like sensitivity, specificity, AUC) from a test set with corresponding ground truth established by experts. Therefore, many of the requested items cannot be directly extracted from this document.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its performance and substantial equivalence.

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

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

The document provides a comparison table between the ProTrach DualCare and its predicate device (SPIRO Speaking Valve) for several performance attributes. While explicit "acceptance criteria" (numerical thresholds) are not always stated, the comparison implies that "same" or "better" performance is the acceptance criterion for substantial equivalence.

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 provided in the document. The studies mentioned are primarily non-clinical engineering and biocompatibility tests. There is no mention of "test sets" in the context of clinical data or human subjects.

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 provided as the document does not describe studies involving expert-established ground truth for a clinical test set. The ground truth for the non-clinical tests (e.g., moisture loss, dead space) would be established by the measurement instruments and methodology prescribed by relevant engineering standards.

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

This information is not provided as there is no mention of a human-reviewed "test set" and thus no need for an adjudication method.

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

An MRMC comparative effectiveness study was not done. This submission is for a physical medical device (speaking valve/HME) and does not involve AI or human readers.

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

This is not applicable as the device is not an AI algorithm.

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

For the non-clinical tests: The "ground truth" for reported performance metrics like moisture loss, airflow resistance, leakage, and dead space would be derived from standardized physical measurements using laboratory equipment, following recognized testing standards (e.g., those related to HMEs and tracheostomy accessories). For biocompatibility, the ground truth is established by the results of biological tests according to ISO 10993 series.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use a "training set" in the context of AI/ML.

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

This information is not applicable/not provided.

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