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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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The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.

The Venner PneuX ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device.

The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate 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. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment 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 provided text does not describe a study involving an AI/ML device, but rather a medical device, the Venner PneuX™ ETT (Endotracheal Tube). Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithm performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to the provided document.

The document focuses on demonstrating substantial equivalence of the Venner PneuX™ ETT to a predicate device (K093135) through performance testing, biocompatibility evaluation, and material/design comparisons.

Here's the relevant information about the device's acceptance criteria and study proving it meets them, based on the provided text:

Device: Venner PneuX™ ETT (Endotracheal Tube)

Acceptance Criteria and Reported Device Performance (based on this document, primarily focused on equivalence to predicate and relevant standards):

Regarding the non-applicable questions due to the nature of the device (not an AI/ML diagnostic system):

2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the medical device, not a data set for an AI algorithm. The document doesn't specify the number of units tested for each performance test, only that "samples" or "device" units were tested. Data provenance typically refers to the origin of data for AI/ML models (e.g., patient demographics, clinical sites), which is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for this type of conventional medical device. Performance is measured against engineering specifications and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for labelling data for AI, which is not relevant 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 for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is adherence to industry standards (e.g., ISO 5361, ISO 10993) and established engineering specifications.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a premarket notification for a conventional medical device, the Venner PneuX™ ETT, demonstrating its substantial equivalence to a predicate device by meeting various performance, material, and safety standards through physical testing, not through AI/ML model validation.

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The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.

The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.

The provided text describes the 510(k) premarket notification for the APA Oxy Blade, a rigid laryngoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable as this submission is for a Class I medical device, which typically relies on comparisons to predicates and engineering/performance verification for regulatory clearance, not extensive clinical performance studies or AI algorithm validation.

Here's a breakdown of the available information:

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

The document outlines performance data categories and successful outcomes, which effectively serve as the acceptance criteria and reported performance.

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

• Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X blades were tested"). Instead, it uses phrases like "The results from testing were provided," "all devices and pouches passed the tests," "All blades successfully passed," and "All devices successfully met the acceptance criteria." This implies that a sufficient number of samples were tested to demonstrate conformity, as per standard engineering verification practices for medical devices of this class.
• Data Provenance: The tests are described as "Performance testing was performed to characterize the APA Oxy Blade," indicating that these were prospective engineering and bench tests conducted specifically for this submission. The country of origin of the testing data is not specified, but the applicant, Venner Medical (Singapore) Pte Ltd, is based in Singapore.

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

• Not Applicable. This device is a physical medical instrument (laryngoscope blade) and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" like in an AI/diagnostic study. The "ground truth" here is objective measurement against engineering specifications and biological safety standards.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is not an expert-driven diagnostic study requiring adjudication. The tests involve objective measurements (e.g., dimensions, flow rate, pull strength, visual inspection for fogging/leaks, lab results for biocompatibility).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is typically performed to evaluate the diagnostic performance of software or imaging devices, often involving human readers. The APA Oxy Blade is a physical instrument, and its clearance relies on substantial equivalence and bench testing, not MRMC studies.

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

• No. This device does not involve an algorithm. The "standalone performance" is demonstrated through the various engineering and biocompatibility tests described (e.g., flow rate, anti-fogging, mechanical strength, material safety).

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility), and pre-defined acceptance criteria for physical and functional properties. For example, "acceptance criterion of > 15 L/min" for flow testing.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not Applicable. As per point 8.

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The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.

The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.

The Venner™ Tracheal Seal Monitor is indicated for use to monitor, maintain, and regulate the pressure within the PneuX P.Y.™ Endotracheal or Tracheostomy Tube Cuff in adult patients in ICU units where intubation is expected to be more than 24 hours but less than or equal to 30 days.

Acceptance Criteria and Device Performance

Study Details

Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). While "a variety of settings" and "other devices" are mentioned as comparators, specific details are lacking.

Number of Experts and Qualifications:
Not specified. The document does not indicate the number of experts used to establish ground truth or their qualifications.

Adjudication Method:
Not specified. The document does not describe any adjudication method for establishing ground truth.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The performance testing focused on the device's technical specifications and engineering performance rather than its impact on human reader performance.

Standalone Performance (Algorithm Only):
Yes, a standalone performance study was done. The performance testing evaluated the device's ability to maintain and regulate cuff pressure, its reaction time to change pressure, and the performance of its safety over-pressure valve. This involved testing the device against its specifications in various physical settings and environmental stresses. The device also underwent system-level software verification and validation testing to ensure it performed as intended and met its requirements.

Type of Ground Truth:
The ground truth used for performance testing appears to be based on engineering specifications and predefined thresholds. For example, the pressure accuracy was compared against a ± 5% tolerance, and the safety valve operation was evaluated against specific pressure thresholds (57 mmHg for opening, 27 mmHg for closing/resetting).

Sample Size for Training Set:
Not applicable. The described testing is not typical for an AI/ML algorithm that would require a "training set." The device is an electro-mechanical control unit with software, and its validation focused on meeting pre-defined engineering and safety standards.

How Ground Truth for Training Set Was Established:
Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm. The ground truth for the device's performance was established through its design specifications and industry safety standards to demonstrate functional accuracy and safety.

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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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The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for the "Venner Pneux P. Y. EndoTracheal Tube." It primarily discusses the regulatory approval process, the device's classification, and general compliance requirements, but it does not detail any specific acceptance criteria for performance or a study demonstrating the device meets such criteria.

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