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To monitor intra-cuff pressures of supraglottic airways.

The SureSeal™ supraglottic airway with attached Cuff Pilot ™ is indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients and emergency procedures using either spontaneous or Positive Pressure Ventilation (PPV).

• An alternative to a face mask.
• . An airway device in routine anesthesia procedures.
• Securing the immediate airway in anticipated or unexpected difficult airway situations.
• Use in elective surgical procedures where tracheal intubation is not necessary.
• Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly ● unconscious patient requiring artificial ventilation when tracheal intubation is not possible.

The Cuff Pilot™ is a simple device which allows the user to monitor the cuff pressure of supraglottic airways. It has been designed to display pressure ranges via color coded zones. The Cuff Pilot™ is designed with an internal bellows, is compressed as pressure increases and expands when intra-cuff pressure is less. There is an O-ring indicator that is on the bellows and this indicates the status of pressure within the define color coded pressure zones.

The SureSeal™ supraglottic airway is very similar in design, performance, indications for use, technology of operation, and materials to our LMA airways. It will have the Cuff Pilot™ attached and is considered MR Safe.

Let me break down the information from the provided text regarding the acceptance criteria and study for the Cuff Pilot™ and SureSeal™ with Cuff Pilot™.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove efficacy against a specific set of acceptance criteria in the manner one might expect for a novel AI device. Therefore, some of the requested information, particularly regarding ground truth, expert adjudication, MRMC studies, and explicit acceptance numbers for performance metrics beyond general accuracy ranges, is not present because it's not typically part of a 510(k) for this type of device. The "acceptance criteria" here are largely implied by demonstrating equivalence to the predicate device's performance characteristics.

Cuff Pilot™

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The studies are described as "bench testing" and "subjected samples," which implies a set of physical devices were tested, but the exact number isn't quantified in this summary.
• Data Provenance: The tests are non-clinical bench tests performed by the manufacturer (Teleflex Medical). There is no mention of country of origin for data as it's not human subject data. The studies are prospective in the sense that they were conducted for the purpose of this submission.

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

• Not applicable. This device is a mechanical pressure monitor, not an AI or diagnostic tool requiring expert interpretation for ground truth. The "ground truth" (actual pressure) would have been established using calibrated pressure measurement equipment during the bench testing.

4. Adjudication method for the test set:

• Not applicable for a mechanical device undergoing bench testing. The "adjudication" would be direct measurement against calibrated standards.

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 is a medical device, not an AI or diagnostic imaging system. No human reader studies (MRMC) were conducted.

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

• Not applicable. The Cuff Pilot™ is a standalone mechanical device. Its performance is evaluated intrinsically through the bench tests mentioned.

7. The type of ground truth used:

• Calibrated pressure measurements from laboratory equipment. The accuracy of the device's reading (color-coded zones) was compared against these known, precise pressure values.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

• Not applicable, as there is no training set.

SureSeal™ with Cuff Pilot™

This device is the SureSeal™ supraglottic airway (which includes the Cuff Pilot™ attached). The information provided focuses on the SureSeal™ component's equivalence to a predicate (LMA Classic™) and the overall device's MR safety.

1. Table of Acceptance Criteria and Reported Device Performance:

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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 KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.

Tube with two attached, inflatable balloons. Ventilation openings between the balloons. Can be sterilized in an autoclave. Proximal ISO Standard 15mm connector for attachment to breathing circuit. Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. Connected to a Breathing Circuit. Inserted blindly. Seals the esophagus. Cuffs are inflated with one inflation port. Instructions that patient should have fasted before using the product. Latex free product.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing this is a 510(k) premarket notification for a Class I device seeking substantial equivalence, not a detailed clinical trial report.

Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission seeking substantial equivalence to a predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634). For devices seeking substantial equivalence, the "acceptance criteria" are generally that the new device performs as well as or similarly to the predicate device, especially regarding performance characteristics relevant to its intended use and safety. The study provided here is primarily a comparison to the predicate device, demonstrating that the design and certain performance characteristics are "substantially equivalent."

Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the acceptance criteria are implicit: the new device's characteristics should match or be demonstrably similar to the predicate device. The "reported device performance" is the comparison data presented.

Study Information

The provided document is a 510(k) premarket notification for a Class I device establishing substantial equivalence to an existing predicate device. This type of submission, especially for Class I devices, typically relies on demonstrated comparability through engineering testing and material analysis rather than extensive human clinical trials.

1. Sample size used for the test set and the data provenance:

   • The "test set" in this context refers to the specific device characteristics measured for the KING LTS™ (new device) and compared to the KING LT™ (predicate device).
   • Specific sample sizes for the measurements of internal volume, resistance, and weight are not explicitly stated (e.g., "n=X devices were tested for resistance"). However, the comparison is made on "Size 4 for both the KING LTS™ and the KING LT™," implying that at least one unit of each size 4 device was used for these measurements. It's likely that a small number of devices were tested per characteristic to ensure consistency.
   • Data Provenance: The data appears to be from internal manufacturer testing ("Manufacturer's tests have shown the device to successfully withstand fifty or more cleaning and autoclave sterilization cycles."). The country of origin for the new product is Germany ("Product manufactured in Germany is new to U.S. market.").

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

   • This question is not applicable to this type of 510(k) submission. "Ground truth" for diagnostic or AI devices is typically established by multiple experts. For this device (an oropharyngeal airway), the "truth" is established by direct measurement of physical and performance characteristics, and by clinical consensus on its intended use and safety profile, which are aligned with the predicate. No expert panels for ground truth determination are described.

3. Adjudication method for the test set:

   • Not applicable. There is no expert adjudication described for the physical and performance measurements reported.

4. 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 not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was conducted or described.

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

   • Not applicable. This is not an AI algorithm.

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

   • The "ground truth" for this device's performance is based on engineering measurements and specifications (e.g., internal volume, resistance, weight, material composition, sterilization capabilities) and alignment with established medical device standards (e.g., ISO 5356-1, ASTM F1242-96) and regulatory classifications (CAE - 21 CFR 868.5110). Clinical "ground truth" is implied by its similarity to an already legally marketed and accepted predicate device with a known safety and effectiveness profile.

7. The sample size for the training set:

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

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

   • Not applicable. As this is not an AI device, there is no training set or ground truth for such a set.

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The KING LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Each device is constructed of medical grade elastomeric and thermoplastic materials. All fittings conform to ISO 5356-1/1996: Anesthetic and Respiratory Equipment - Conical Connectors; Part 1 Cones and Sockets. The device incorporates the following components or features:

• . Bi-directional gas flow through a ventilation channel.
• Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere
• . Indicators for proper placement permanently printed on the tube
• A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.

This document describes a premarket notification (510(k)) for the KING LT-D Disposable Oropharyngeal Airway, not an AI device. Therefore, many of the requested criteria (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, software validation) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a disposable version of an existing product. The acceptance criteria are related to material properties, design conformity, and intended use, rather than performance metrics of an AI algorithm.

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

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a premarket notification (510(k)) submission demonstrating substantial equivalence to a legally marketed predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634).

The acceptance criteria are primarily met by:

• Direct comparison of characteristics (e.g., intended use, design, dimensions, materials, sterile status) to the predicate device.
• Compliance with recognized standards: ISO 5356-1/1996-12-15, ASTM F1242-96, and EN30993/ISO 10993 for biocompatibility.
• Risk analysis and verification/validation activities: The document states that "the designated individual(s) performed all verification and validation activities and the results of the activities demonstrated that the predetermined acceptance criteria were met."
• Conformance with design control procedures as per 21 CFR 820.30.

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

Not applicable. This is a medical device submission based on substantial equivalence to a predicate, not a study involving a test set of data in the context of an AI/software device. The product is manufactured in Malaysia.

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. This device is not software driven and does not involve AI or the establishment of ground truth by experts in the sense of diagnostic accuracy studies.

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

Not applicable. There is no test set or adjudication process described 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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm. The document explicitly states: "This device is not software driven. Software validation and verification is not applicable."

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

Not applicable in the context of an AI device. For this medical device, the "ground truth" or basis for acceptance is primarily the characteristics and performance of the legally marketed predicate device and compliance with established international and ASTM standards for design, materials, and intended use.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

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The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "KING LTTM" oropharyngeal airway. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for that specific information based on the text provided. This document is a regulatory approval notice, not a study report.

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