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The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.

Device Description

The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector.

The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays.

Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place.

AI/ML Overview

The provided 510(k) clearance letter and summary for the LMA Fastrach ETT SU is for a medical device (a tracheal tube), not a diagnostic AI/ML algorithm. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device, as is standard for 510(k) submissions of traditional medical devices. This is achieved primarily through:

Comparison of features: Highlighting similarities in classification, product code, regulation number, size range, cuffed design, radiopacity, sterilization method, and eye (Murphy).
Performance data (bench testing): Verifying that the new device performs similarly to the predicate in terms of physical characteristics and durability.

Here's an analysis of the provided text in the context of your request for AI/ML device study details:

Acceptance Criteria and Device Performance (Based on provided text for a non-AI/ML device):

The "acceptance criteria" for this traditional medical device are primarily about demonstrating that it is substantially equivalent to a legally marketed predicate device and that it meets established engineering performance standards for tracheal tubes. The "device performance" is shown through bench testing.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Substantial Equivalence	Intended Use, Technology, and Design are substantially similar to the predicate device. Minor differences are mitigated through testing.	"The subject device is substantially equivalent to the predicate device with respect to intended use, technology, and design." "The basic technological and operating principles are the same for both devices." "There are no significant differences that would affect safety and efficacy."
Physical Performance	Meets performance characteristics critical to tracheal tubes (e.g., bond strength, kink resistance, cuff herniation, resistance to collapse, tracheal seal).	"Testing performed included visual inspection, dimensional testing, bonding strength (main tube with boat tip, side arm, 15mm connector and cuff bonding), kink resistance, cuff herniation, resistance to collapse, tracheal seal testing." "The LMA Fastrach ETT SU passed all evaluations and tests."
Biocompatibility	Materials comply with ISO 10993-1, ISO 18562-1, and FDA Guidance on Application of 10993-1.	"The device is biocompatible and meets the requires pertaining to biocompatibility per 10993-1, ISO 18562-1, the US FDA Guidance on Application of 10993-1." (Materials were changed to non-DEHP, and tested accordingly).
Sterility Assurance	Sterilization method achieves a 10⁻⁶ SAL (Sterility Assurance Level).	"Method of Sterilization: Ethylene Oxide 10⁻⁶ SAL" (Same as predicate).
MR Safety	Demonstrates MR Conditional status.	"MR Safety: MR Conditional" (Not declared on predicate; "Testing has been conducted" for the subject device).
Shelf-life	Demonstrated shelf-life for the product.	"Shelf-life: 1 year" (Predicate had 2 years; "Testing has been conducted" for the subject device).
Packaging Performance	Packaging protects the device and maintains sterility in accordance with standards.	"Packaging performance testing was conducted." (Packaging materials differ from predicate, necessitating this testing).
Labeling Clarity	Indications for Use and Contraindications are clear and aid safe use.	"Indication is not changing; a rewording was made for better readability." "Contraindications are not changing; a rewording was made for better readability. A statement has been added for the stabilizer rod, even though there are no known contraindications." (These indicate review and intended improvement in clarity, though the specific criteria for "readability" aren't quantified.)

Addressing your specific points for an AI/ML device study (based on the absence of this information in the document):

A table of acceptance criteria and the reported device performance: As seen above, for a mechanical device, these are primarily about physical and material properties and substantial equivalence, not performance metrics like sensitivity/specificity for an AI/ML diagnostic.
Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of a physical medical device. No "test set" of patient data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical tube's performance is established by engineering and material science standards, not expert medical opinion on a data set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudicators are mentioned as this is not a diagnostic device relying on interpretation.
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 stand-alone physical medical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a traditional mechanical device, "ground truth" is established by engineering standards, material specifications, and physical measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
The sample size for the training set: Not applicable. This device is not developed using machine learning; therefore, there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Conclusion from the provided document:

The provided FDA 510(k) clearance letter and summary pertain to a traditional medical device (a tracheal tube), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool. Therefore, the document does not contain the information relevant to AI/ML device performance studies, such as data provenance, expert adjudication, or MRMC studies. The "acceptance criteria" and "proof" in this context are based on a demonstration of substantial equivalence to a predicate device and successful completion of standard bench testing for physical and material properties.

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