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 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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Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.

Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.

The provided text is a 510(k) Premarket Notification for the ScalpelCric device, a cricothyrotomy set. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system, or a multi-reader multi-case (MRMC) study. The document focuses on the physical and biological characteristics of the medical device itself, its sterilization, biocompatibility, and bench testing, rather than a performance study involving diagnostic accuracy, expert review, or AI assistance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI-assisted diagnostic system, as that information is not present in the provided text.

The closest information related to "acceptance criteria" is under section 9.4 Bench Testing, which lists features to be tested and the result (all "Passed"). This refers to the physical and functional performance of the device components, not a diagnostic or AI-related performance.

Here's what I can extract from the provided text regarding device testing, but it's important to note this is not a study proving AI performance as requested:

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

The document provides a table under "9.4 Bench Testing" (page 10), which lists various tests performed on the components of the ScalpelCric set. The "Features to be tested" can be considered the acceptance criteria for those specific physical/functional aspects, and the "Result" indicates "Passed" for all.

The remaining requested information (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set details) is NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., AI/diagnostic performance) than what is described here. This document is focused on the substantial equivalence of a physical medical device (a cricothyrotomy set) to a predicate device.

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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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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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