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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

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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The LMA StoneBreaker™ is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of urinary tract (i.e. kidney, ureter and bladder) stones.

The LMA StoneBreaker™ is a portable, non-electrical, pneumatic contact intracorporeal lithotripter, intended for use to fragment stones in the urinary tract (i.e. kidney, ureter and bladder). Its weight of approximately 500g with a probe, and with no extraneous electrical or pneumatic connections, makes this device highly portable. It is recommended for use with endoscopes equipped with a straight working channel. The device is powered by a detachable cartridge of high pressure carbon dioxide gas, with a maximum pre-adjusted operating pressure of 31 bars. The mechanical shock generated by the device is transferred through the length of the probe to the tip, which is in direct contact with the stone to be fragmented, providing high speed fragmentation of the calculus in situ.

Three sizes of probe (1.0mm, 1.6mm and 2.0mm) are available for use with the LMA StoneBreaker™

A LMA StoneBreaker™ Carbon Dioxide (CO2) gas cartridge provides the necessary energy for one surgical procedure. Once the cartridge is perforated by the built-in screw system, the compressed gas passes through a pre-adjusted pressure regulator in the device and a mechanical shockwave required for fragmentation of urinary stone is generated when the trigger is depressed.

Expended gas will leave the device through a specially designed exhaust port and the attached exhaust line The trigger snaps back to its starting position when the gas is expended through the exhaust port, and the device is now ready for further use.

The LMA StoneBreaker™, Probes, Exhaust Line and accessories are delivered non-sterile and it must be cleaned, disinfected and sterilized before initial use and before each subsequent use.

The provided context is a 510(k) summary for the LMA StoneBreaker™ and related FDA correspondence. It does not contain information about specific acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, types of ground truth, training set sample sizes, or how ground truth for training was established.

The document states that "Performance and clinical data are shown in Section 2" (page 2, Section 6 of the 510(k) Summary), but Section 2 (Device Information) and Section 6 (Performance Characteristics) actually provide a general statement that "The operational, technological and clinical data demonstrate that the LMA StoneBreaker™ is substantially equivalent in safety and effectiveness to that of the predicated devices cited above," without detailing the specific data or studies that led to this conclusion.

Therefore, I cannot fulfill the request using the provided information as it does not contain the specific details about acceptance criteria, study methodologies, and results you are asking for.

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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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The ILM Endotracheal Tube is indicated for airway management by oral intubation of the trachea.

The ILM ETT is a straight, cuffed, wire-reinforced tracheal tube, with a Murphy Eye. It is available in a three sizes with internal diameters of 7.0mm, 7.5mm and 8.0mm. The airway tube is made from silicone and features a stainless steel reinforcing wire to prevent kinking or occlusion of the tube. The tip of the tube is molded from a softer grade of silicone for passage through the vocal cords. The airway tube features an inflatable silicone cuff for sealing the tube in the trachea. The tip of the ILM ETT is beveled in two directions to aid passage of the tube through the trachea. Depth markings are printed on the airway tube (in centimeters). These indicate the distance to the distal tip of the tube. The tube also has a printed black line to indicate its caudal surface. The ILM ETT features a small diameter silicone tube connected to a pilot balloon with a luer check valve for inflation of the cuff. The ILM ETT can be connected to the anesthesia circuit by a removable 15mm standard male connector which conforms to ISO5356-1 (1987). A connector is supplied with each ILM ETT. The ILM ETT is designed to be compatible with the LMA-Fastrach (an oropharyngeal airway). To ensure compatibility, a marker line indicates when the tube passes through the LMA-Fastrach. In addition, the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach.

The provided text is a 510(k) summary for the ILM Endotracheal Tube (ILM ETT) and a subsequent FDA approval letter. It outlines the device's description, intended use, and comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a scientific study, device performance metrics, sample sizes, expert involvement, or statistical methods.

The core of the submission for the ILM ETT is a claim of substantial equivalence to an existing legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube. The document explicitly states:

"The ILM ETT and the Euromedical Silicone Wire-Reinforced Endotracheal Tube have identical performance, and with the exception of the labeling, they are the same device. The two devices use the same materials and are dimensionally identical. They are molded and assembled in the same manufacturing plant to the same specifications (except for the labeling)."

Therefore, the "acceptance criteria" and "study" are implicitly tied to demonstrating this substantial equivalence, rather than a de novo performance study against concrete numerical thresholds.

Here's an analysis based on the provided text, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Critically Missing: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific airflow resistance) nor quantitative performance data for the ILM ETT itself. Its performance is asserted as being identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of a de novo performance study. The "test" for substantial equivalence relied on a direct comparison of specifications and manufacturing processes to the predicate device.
• Data Provenance: Not applicable. No clinical or performance data is presented. The equivalence claim is based on manufacturing and design documents.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. No dedicated expert panel was used to establish ground truth for a test set, as no performance study data is presented. The FDA reviewers are the "experts" who evaluate the substantial equivalence claim based on the provided technical documentation.
• Qualifications of Experts: N/A for establishing ground truth data. The FDA reviewers fall under "Division of Cardiovascular, Respiratory, and Neurological Devices." The approval letter is signed by an "Acting Director" with "Ph.D., M.D." qualifications, indicating medical and scientific expertise.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no test set requiring multi-reader adjudication. The process was a regulatory review of documentation for substantial equivalence.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. The provided document makes no mention of an MRMC study. This is a 510(k) submission based on substantial equivalence, not a comparative clinical trial.

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

• Standalone Performance: Not applicable. This is a medical device, an endotracheal tube, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop during its use for intubation.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the predicate device. The applicant's submission relies on the assertion that the ILM ETT is materially and functionally identical to this already approved device. Therefore, the ground truth is the regulatory acceptance and historical performance of the predicate device.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI component or "training set" for this device.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth Establishment: Not applicable, as there is no training set.

Summary of the "Study" (in the context of a 510(k) based on substantial equivalence):

The "study" here is essentially the comparison and verification of design specifications, materials, and manufacturing processes between the proposed ILM ETT and the legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube.

The applicant provided documentation to the FDA asserting that the two devices are:

• Identical in performance.
• Made from the same materials.
• Dimensionally identical.
• Molded and assembled in the same manufacturing plant to the same specifications (except for labeling changes, which were minor administrative updates).

The FDA reviewed this documentation and, based on the submitted evidence, concluded that the ILM Endotracheal Tube was "substantially equivalent" to the predicate device. This substantial equivalence effectively "proves" that the device meets the (implicit) acceptance criteria of being as safe and effective as a device already on the market. There was no independent performance study conducted, or at least, none is described in this summary.

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