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The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the anesthesia machine after insertion into the patient. It is intended that the user will be able to inflate the device cuff and ventilate the patient.

The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking of the tube when movement of the head or neck is required following intubation.

The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery. The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the spring prevent kinking or occlusion of the tube. The cuff is intended to provide a seal against the trachea, ensuring that Inspiratory and expiratory gasses are directed through the tube and not allowed to escape to the patients "upper" airway, thus preventing loss of ventilation and aspirated stomach contents from entering the lungs. This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, and it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ SU and LMA CTrach Airways.

This document is a 510(k) summary for the LMA Fastrach™ ETT SU, a reinforced tracheal tube. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving their fulfillment:

Crucially, the provided text DOES NOT contain specific acceptance criteria with quantifiable metrics or a detailed study designed to demonstrate the device meets such criteria.

Instead, this is a Premarket Notification (510(k)) summary, which is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating equivalence in design, materials, intended use, and performance characteristics, often through bench testing and comparison to predicate devices, rather than a full-scale clinical trial with pre-defined acceptance criteria and efficacy/safety outcomes.

Here's how to address your points based on the available information, highlighting what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantifiable performance metrics for the LMA Fastrach™ ETT SU itself. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to predicate devices in areas like material composition, design, and intended use, and by ensuring the device meets relevant recognized standards (which are not detailed here).
• Reported Device Performance: The document states, "Clinical evaluation data is shown in Section 6." However, Section 6 is not provided in the input text. Therefore, specific reported device performance metrics against any acceptance criteria are unknown.

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

• Sample Size: Unknown. The document references "Clinical evaluation data is shown in Section 6," but Section 6 is not provided. Without this section, detailed information about any test set's sample size is unavailable.
• Data Provenance: Unknown, as the specific data or studies are not detailed.

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 / Unknown. This type of detail is typically associated with studies involving subjective interpretation (e.g., imaging, pathology reviews). For a device like a tracheal tube seeking 510(k) clearance, the "ground truth" for demonstrating substantial equivalence is usually based on engineering specifications, material testing data, and functional performance benchmarks (e.g., flow rates, pressure integrity, kink resistance) compared to predicate devices, rather than expert consensus on diagnostic images.
• If a clinical study was indeed performed and involved expert assessment (e.g., ease of intubation, lack of complications), this information is not in the provided text.

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

• Not Applicable / Unknown. As explained above, an adjudication method like 2+1/3+1 is typically used in studies involving multiple readers for subjective assessments. This is not relevant to the information presented 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

• Not Applicable. This is a medical device (tracheal tube), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this 510(k) hinges on demonstrating substantial equivalence to the predicate devices. This typically involves:
  • Material composition analysis: Comparing the chemical/physical properties of materials used to those in predicate devices.
  • Design verification: Ensuring dimensional, structural, and functional aspects match or are appropriately justified against predicate devices.
  • Performance testing: Bench testing (e.g., kink resistance, cuff inflation/deflation characteristics, flow dynamics, tensile strength) to show performance is equivalent or better than predicates and meets relevant standards.
  • Biocompatibility testing: Ensuring materials are safe for patient contact.
• While the document mentions "Clinical evaluation data is shown in Section 6," without that section, we don't know if outcomes data (e.g., intubation success rates, complication rates) from a clinical study were used as part of the ground truth. However, for a 510(k) of this nature, detailed clinical outcomes are often not required if substantial equivalence can be shown through non-clinical means.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device, not a machine learning model that requires a training set.

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

• Not Applicable. As above, no training set is relevant here.

In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices for a reinforced tracheal tube. It does not contain the level of detail regarding acceptance criteria, study methodologies, sample sizes, or expert involvement that would be present in a comprehensive clinical study report for proving device performance against specific, quantifiable endpoints. The key missing piece of information is "Section 6: Clinical evaluation data," which might have provided some of the requested performance details.

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