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Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients.

Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation.

The provided document is a 510(k) clearance letter and summary for a physical medical device (tracheostomy tube), not a software-based AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies proving performance for an AI/ML device.

The questions asked pertain specifically to the validation of AI/ML models in medical devices, which typically involve metrics like accuracy, sensitivity, specificity, and detailed study designs (test sets, ground truth, expert adjudication, MRMC studies, etc.).

Since the document describes a Class II physical medical device (Tracheostomy Tube and Tube Cuff), the information regarding acceptance criteria and performance data is related to its physical and biological safety and efficacy, not AI/ML performance.

Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML device or its validation.

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Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.

The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo).

Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.

Here's a breakdown of the acceptance criteria and study information for the Pilling™ Tracheostomy Tubes, based on the provided FDA 510(k) summary:

It's important to note that this document is a 510(k) summary for a medical device, not an AI or software device. Therefore, many of the typical questions related to AI acceptance criteria, ground truth, and reader studies are not applicable. The focus here is on demonstrating equivalence to a predicate conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of tubes tested for biocompatibility, locking mechanism, or separation). This is common for traditional medical device bench testing where the focus is on design verification against established standards and predicate characteristics, rather than statistical significance across a large patient dataset as seen in AI/Clinical studies.
• Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical performance testing (bench testing and biocompatibility analysis) of the manufactured device. These tests are inherently prospective, conducted by the manufacturer. There is no mention of country of origin for "data" in a patient/clinical sense.

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

• This question is not applicable for this type of medical device submission. Ground truth, in the AI/clinical sense, typically refers to expert annotations or diagnoses on medical images/data. For a physical device like a tracheostomy tube, "ground truth" is established by adherence to engineering specifications, recognized international standards (like ISO 10993 and ISO 5366), and direct physical measurements or functional tests of the device itself. Experts involved would be engineers, materials scientists, and quality control professionals, ensuring the device meets its design requirements and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for AI, to resolve discrepancies in expert opinions on ground truth. For the described non-clinical bench testing, results are typically objective (e.g., does it lock, does it separate at a certain force, are materials biocompatible). Any discrepancies would be handled through standard engineering and quality control procedures (e.g., re-testing, root cause analysis), not through expert adjudication in the medical sense.

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

• No. An MRMC study is designed to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of an AI tool on a set of cases. This submission is for a physical medical device (tracheostomy tube), not an AI system. Therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This question is specific to AI algorithms. The Pilling™ Tracheostomy Tube is a physical medical device. There is no algorithm involved to perform a standalone study.

7. The Type of Ground Truth Used

• Engineering Specifications and International Standards: For this device, the "ground truth" is primarily based on:
  • Biocompatibility: Confirmation by laboratory testing that materials meet the requirements of ISO 10993-1:2018.
  • Functional Performance: Verification through bench tests that the device components (locking mechanism, connector fit, obturator) operate as designed according to internal engineering specifications.
  • Security of Attachment: Demonstration of compliance with ISO 5366:2016 related to the physical integrity and attachment strength of specific components.
  • Comparison to Predicate: The ultimate "ground truth" for a 510(k) is demonstrating that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness, based on its characteristics and performance.

8. The Sample Size for the Training Set

• Not applicable. This question refers to the training data for an AI algorithm. As established, this is a physical medical device, not an AI product.

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

• Not applicable. This question pertains to AI algorithm development.

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The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.

The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631.

The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube.

The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation.

A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.

The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.

The Venner PneuX™ TT (Tracheostomy Tube) is a medical device. The provided text outlines the performance data to establish its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Venner PneuX™ TT are primarily based on established ISO standards for medical devices and specific performance tests, as well as biocompatibility assessments. The reported device performance indicates that the device passed all conducted tests.

• Ethylene oxide residue levels meeting Tolerable Contact Limit (TCL) for prolonged exposure devices (patient contact > 24 hours up to 30 days) according to ISO 10993-7.
• Packaging integrity supporting proposed shelf life through accelerated and real-time aging studies. | Passed (device is provided sterile, met SAL, EO residue levels met TCL, aging studies supported shelf life including packaging integrity). |
  | Biocompatibility | - MEM Elution Assay (Cytotoxicity) per ISO 10993-5:2009 & ISO 10993-12:2012.
• Intracutaneous Reactivity per ISO 10993-10:2010 & ISO 10993-12:2012.
• Guinea Pig Maximum Sensitization per ISO 10993-10:2010 & ISO 10993-12:2012.
• Acute Systemic Toxicity per ISO 10993-11:2006 & ISO 10993-12:2012.
• Subacute/subchronic Toxicity (14-day) per ISO 10993-11:2006 & ISO 10993-12:2012.
• Genotoxicity – Ames and Mouse Lymphoma Assay per ISO 10993-3:2014 & ISO 10993-12:2012.
• Implantation (4-week) per ISO 10993-6:2007.
• Material-Mediated Pyrogenicity per ISO 10993-11:2006 & ISO 10993-12:2012. | Passed for all listed tests. |
  | Performance Testing (Mechanical & Functional) | - Conformance to ISO 5366:2016 (Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors) for dimensions, curvature, cuff diameter, and connectors.
• Conformance to ISO 5361:2016 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors).
• Mechanical and functional requirements, including: cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage and seal pressure leakage (tested on terminally sterilized unaged and aged samples).
• Cuff inflation, leakage and function.
• Lumen function.
• Pull tests for all joints and connections.
• Bite block resistance.
• Meeting the same acceptance criteria as the predicate device (K100950). | Passed (met all standards and requirements, both unaged and aged, and met predicate device's acceptance criteria). |
  | MRI Compatibility | - Magnetically induced displacement force per FDA guidance.
• Magnetically induced torque per FDA guidance.
• Heating by radiofrequency fields per FDA guidance.
• Image artifact per FDA guidance.
  (Evaluated per FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued December 11, 2014). | Passed (demonstrated MR compatible under specified conditions in labeling). |

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

The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "Terminally sterilized unaged and aged samples were tested" for mechanical and functional assessments. The various biocompatibility tests would have their own sample size requirements as per the specified ISO standards, but these details are not provided in this summary.

The data provenance is from in-vitro (laboratory) and potentially in-vivo (animal for some biocompatibility tests like sensitization, toxicity, implantation) studies conducted by the manufacturer or contracted labs to demonstrate compliance with recognized standards. There is no mention of human clinical trial 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 in the context of this device and testing. The "ground truth" for these tests (sterilization, biocompatibility, mechanical performance, MRI compatibility) is established by adherence to pre-defined international standards and scientific methodology, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be the qualified personnel performing and interpreting the laboratory tests and analyses according to those standards (e.g., microbiologists for sterility, toxicologists for biocompatibility, engineers for mechanical testing).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results (e.g., imaging) is involved and a consensus among multiple readers is needed to establish ground truth. For the physical and chemical testing performed for this device, results are objective (e.g., pass/fail for a cytotoxicity assay, numerical values within a specified range for dimensions, etc.) and do not require expert adjudication as 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

There was no MRMC comparative effectiveness study done. This device is a tracheostomy tube, 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

There was no standalone (algorithm only) performance study done. This device is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

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

• International Standards: Adherence to established ISO standards (e.g., ISO 11135, ISO 10993, ISO 5366, ISO 5361) that define acceptable parameters and test methods for tracheostomy tubes, sterilization, and biocompatibility.
• Predicate Device Equivalence: The new device met the same acceptance criteria as the legally marketed predicate device (K100950), implying that the predicate's established safety and effectiveness forms a basis for comparison.
• FDA Guidance: Compliance with specific FDA guidance documents, particularly for MRI compatibility.
• Pre-defined Specifications: The device successfully passed tests against its own performance specifications (e.g., regarding cuff inflation, leakage, lumen function, pull tests, bite block resistance).

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

This information is not applicable. As there is no training set, there is no "ground truth for the training set."

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Smiths Medical Portex® BLUselect® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid® allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

The Smiths Medical Portex® BLUselect and BLUselect Suctionaid 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. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use.

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

This document, K173384, is a 510(k) Summary for medical tracheostomy tubes and inner cannulas. It asserts substantial equivalence to predicate devices, focusing on design, materials, and performance testing rather than clinical study data with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent if it meets the criteria of the predicate device and relevant international standards. The criteria are based on physical and functional characteristics, and the reported performance indicates compliance with these.

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

The document does not explicitly state sample sizes for specific tests. The tests were bench tests conducted on the physical device components. Data provenance would be from internal laboratory testing at Smiths Medical. The tests are non-clinical, so country of origin of patient data or retrospective/prospective is not applicable.

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

Not applicable. The ground truth for performance was established through compliance with recognized international standards (ISO, ASTM) and FDA guidance for medical device testing, rather than expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment or adjudication of cases.

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 submission is for a physical medical device (tracheostomy tube), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

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

Not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" for this device's performance is objective compliance with established performance standards (ISO 5366, ISO 5356-1, ISO 18190, ASTM F2052-15, ASTM F2503), FDA guidance (e.g., for cleaning validation), and biocompatibility standards (ISO 10993-1). There is no clinical ground truth (e.g., pathology, outcomes data) as this is a premarket notification based on substantial equivalence to predicate devices and non-clinical testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model. Therefore, there is no training set involved.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient.

The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.

The provided 510(k) summary for the Primed Tracheostomy Tubes (K120079) indicates that the device's substantial equivalence was established through performance data related to conformity with recognized international standards, rather than a clinical study comparing device performance against specific acceptance criteria. This means the submission primarily focuses on demonstrating that the device meets established engineering and material standards applicable to tracheostomy tubes.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The submission states, "The Primed Tracheostomy Tubes conform to ISO 5356-1 and ISO 5366-1." These ISO standards establish requirements for the design, dimensions, materials, and sterile packaging of tracheostomy tubes and their connectors to ensure safety and performance. By conforming to these standards, the manufacturer asserts that their device meets the internationally recognized safety and performance benchmarks for this type of medical device.

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

This information is not provided in the given 510(k) summary. Since the submission relies on conformity to international standards (ISO), the "test set" would likely refer to engineering and material tests performed on samples of the manufactured tracheostomy tubes. The data provenance would be internal laboratory testing by the manufacturer or a certified testing facility, not clinical data from patients.

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

This information is not provided. For standard conformity testing, the "ground truth" is the specifications and testing methods defined by the ISO standards themselves. The experts involved would be engineers and technicians performing the tests according to the standard's protocols, not medical experts establishing clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As explained above, the "test set" refers to engineering and material testing, not a clinical study with human readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy. Tracheostomy tubes are mechanical devices for airway management and do not typically involve this kind of comparative effectiveness study.

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

No, a standalone (algorithm only) performance assessment was not done. This concept applies to AI/software as a medical device (SaMD) where an algorithm provides a diagnosis or outcome without direct human interpretation. Tracheostomy tubes are physical medical devices, not algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by conformity to established international engineering and material standards (ISO 5356-1 and ISO 5366-1). This is not
expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to predefined technical specifications and performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Tracheostomy tubes are physical devices, and their development does not involve "training sets" in the context of machine learning. The design and manufacturing processes are guided by engineering principles and standards.

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

This information is not applicable and not provided for the same reasons as #8. The "ground truth" for the design and manufacturing of the device is rooted in established engineering specifications and international standards, which are developed through expert committees and consensus over time, not through data labeling for a "training set."

In summary: K120079 is a 510(k) for a physical medical device (tracheostomy tubes). The demonstration of substantial equivalence relies on proving that the device has the same intended use, materials, and functional specifications as predicate devices, and importantly, conforms to relevant international standards (ISO 5356-1 and ISO 5366-1). This type of submission typically uses engineering and bench testing to demonstrate compliance with these standards, rather than clinical studies involving patient data or AI performance assessments.

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The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.

The provided text describes a 510(k) summary for the Well Lead Tracheostomy Tubes and Disposable Inner Cannula. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device.

Instead, the submission demonstrates that the new device has the same intended use and similar technological characteristics as the predicate device (K042684). Therefore, the "acceptance criteria" here refer to demonstrating this equivalence through adherence to relevant standards and a comparative analysis of features.

Here's a breakdown based on the provided text, addressing your questions where possible:

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

For this specific submission, the "acceptance criteria" are not quantitative performance metrics but rather qualitative conformity to established standards and similarity to a predicate device.

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

This document describes a substantial equivalence submission, not a clinical performance study with a test set of patient data. The "testing" mentioned refers to engineering and quality assurance tests demonstrating conformity to ISO standards, not tests on a clinical population. Therefore, there is no sample size for a test set or data provenance 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 (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert readers to establish a ground truth for a test set. The evaluation is based on technical specifications and comparison to a predicate device.

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

Not applicable. As there is no test set in the clinical sense, there is no 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

Not applicable. This is not a study involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical instrument (tracheostomy tube), not an algorithm or AI-powered system.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the existing predicate device and the accepted international standards for such devices. The new device demonstrates conformance to these standards and equivalence to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. See point 8.

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The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.

Venner Pneux P.Y.TM TracheostomyTube

I am sorry, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device (Venner Pneux P.Y. Tracheostomy Tube). This document primarily focuses on the regulatory approval process and includes information such as the device name, regulation number, regulatory class, and the FDA's determination of substantial equivalence to predicate devices.

It does not contain information about acceptance criteria, specific device performance data from a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

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Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.

The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VITALTEC Rota-Trach Tracheostomy Tube:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. For such submissions, the primary "study" is often a comparison to the predicate device and adherence to recognized standards, rather than a separate clinical trial with specific performance metrics like sensitivity/specificity for diagnostic AI.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in diagnostic device studies (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with relevant international standards.

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

This document does not describe a "test set" in the context of a typical algorithm or AI study. The evaluation is based on non-clinical data (bench testing, material testing, and standards conformance).

• Sample Size for Test Set: Not applicable in the context of an AI study. The evaluation relies on testing of the device itself for compliance with standards and comparison specifications.
• Data Provenance: Not applicable. The "data" are results from physical and biological tests conducted on the device, as well as its specifications. The manufacturer is VITALTEC CORPORATION in Taiwan, ROC.

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

Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

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

No, an MRMC comparative effectiveness study was not done. The device is a medical device (tracheostomy tube), not a diagnostic algorithm where human readers would be assessing performance with or without AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm. The "standalone" evaluation refers to the device's conformance to standards and its specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• International Standards: ISO 5356-1 (connector dimensions), ISO 10993 series (biological evaluation), ISO 17665-1 (sterilization).
• Predicate Device Specifications: The established and accepted performance and design of the previously cleared "Medical Tracheostomy Tubes (K031553)."
• Physical and Biological Test Results: Data from tests demonstrating biocompatibility, sterility, and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm.

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

Not applicable.

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The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.

The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days.

The VersaTube consists of a polyviny1 chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.

This document describes a 510(k) premarket notification for the Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula. It outlines the device's characteristics and compares it to a predicate device. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portex® Blue Line Ultra® Tracheostomy Tube, K030381), rather than presenting a performance study against specific acceptance criteria for a novel device.

The "verification testing" mentioned is general and serves to confirm the design and performance for substantial equivalence, not to meet specific, quantified acceptance criteria for a clinical or performance study.

Therefore, I cannot answer the request directly as the information is not present in the provided text. To provide the requested information, the document would need to include:

• Specific, quantified acceptance criteria for metrics like "cuff performance," "insertion force," etc.
• Detailed results of primary studies demonstrating whether the device met those criteria, including sample sizes, ground truth establishment, and expert involvement.

Here's what I can extract based on the provided text, highlighting the absence of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance:

Information Not Provided in the Text. The document lists types of verification testing but does not provide specific acceptance criteria (e.g., "Insertion force shall be less than X Newtons") or the quantitative results of those tests.

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

Information Not Provided in the Text. The text mentions "verification testing" but does not specify sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These verification tests appear to be engineering/benchmark tests rather than clinical studies with test sets.

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

Information Not Provided in the Text. Since no clinical test set is described, there's no mention of experts establishing ground truth. The verification tests performed appear to be technical assessments of the device's physical properties.

4. Adjudication Method for the Test Set:

Information Not Provided in the Text. No adjudication method is described as there's no clinical test set requiring expert adjudication.

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

No MRMC comparative effectiveness study was done or mentioned. The document is for a tracheostomy tube, which is a physical medical device, not an AI or imaging diagnostic tool where MRMC studies are typically performed.

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

Not applicable. This device is a physical tracheostomy tube, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Information Not Provided in the Text. For the "verification testing" mentioned (Strength of neck-plate, cuff performance, insertion force, etc.), the "ground truth" would implicitly be engineering standards, physical measurements, and biological compatibility test results. However, the exact methods and standards are not detailed.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this information is not relevant.

Summary of Study (Verification Testing) Mentioned:

The document briefly lists the following "verification testing" performed to demonstrate reliable design and performance:

• Strength of neck-plate and 15 mm connector attachment to cannula
• Cuff performance
• Insertion force
• Inner cannula extraction force
• Sterilization testing
• Biocompatibility testing

However, no specific study report, methodology, acceptance criteria, or quantitative results for these tests are provided or referenced in the given text. The focus of the 510(k) is to demonstrate substantial equivalence based on technological characteristics and intended use compared to a predicate device.

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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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