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510(k) Data Aggregation
(477 days)
The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pharynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
The LMA Fastrach™ ETT (reusable) and LMA Fastrach™ ETT Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
The LMA™ family of airways includes 2 types of airways: Generically referred to as supraglottic airways and Tracheal Tubes specific for use with the LMA Fastrach™ device. The supraglottic airways are airways that incorporate a large cuff that sits above the glottic opening and the opposite end has a standard 15 mm OD connector that connector to a gas source. The LMA Flexible™ is the same as the Classic™ except that the shaft is wire reinforced allowing for great flexibility. The LMA ProSeal™ which has a second lumen for drainage. The LMA Fastrach™ single use which has a rigid handle to assist with insertion. The LMA Fastrach™ ETT and LMA Fastrach™ ETT Single Use is straight, cuffed, wire reinforced tracheal tube that is designed to be used with the LMA Fastrach™ supraglottic airway.
The provided 510(k) summary focuses on demonstrating the MR Conditional environment of use for various LMA airway devices and tracheal tubes. It does not contain information about studies related to diagnostic performance, accuracy, or human reader improvement with AI assistance. The "acceptance criteria" and "device performance" in this context refer to engineering and safety specifications related to MRI compatibility, not clinical diagnostic metrics.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM F2052-06e1) | Reported Device Performance (as stated in the document) |
|---|---|
| No new risks associated with MR Conditional use. | Bench testing per ASTM F2502-06e1 demonstrated that the devices meet the pass/fail criteria. |
| Magnetic field-induced displacement force should not pose a hazard. | Devices meet the requirements, with additional instructions for fixation (taping, cloth, or plastic holding device) for those exceeding 45 degrees deflection. |
| Performance of the inflation check valve during and after MRI exposure should not be affected. | "There was no affects [sic]" on the check valve performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions testing on "4 models of the LMA™ devices" (LMA ProSeal™, LMA Fastrach™ ETT, LMA Supreme™, LMA Flexible™). It also states that other models (LMA Classic™, LMA Unique™, LMA Classic Excel™, and LMA Fastrach™ Single Use) were deemed substantially equivalent based on the LMA Supreme™'s results due to similar complete plastic, non-magnetic materials (except for the check valve). The exact number of individual units tested within these models is not specified.
- Data Provenance: Not applicable in the traditional sense of clinical data. This refers to bench testing conducted according to a specific ASTM standard (F2052-06e1) to assess MRI compatibility. The country of origin of this specific testing data is not specified, but the submission is to the FDA (USA). The testing is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of test is defined by the technical specifications and pass/fail criteria of the ASTM F2052-06e1 standard for magnetically induced displacement force and material compatibility in an MRI environment. It does not involve human experts establishing a "ground truth" for clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The assessment is based on objective measurements against the ASTM F2052-06e1 standard, not on human interpretation or adjudication.
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. This 510(k) submission is for the MRI compatibility of medical devices, not for a diagnostic AI system. Therefore, an MRMC comparative effectiveness study is not relevant and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is the physical properties and behavior of the devices as measured against the pass/fail criteria defined by the ASTM F2052-06e1 standard. This standard is an engineering specification for assessing magnetic field-induced displacement force and other MRI compatibility factors for medical devices.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained in this context. The study involves bench testing of physical devices.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI algorithm or training set involved.
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