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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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• A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit.
• A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care.
• ventifator care.
  Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.

Not Found

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets it. The document is an FDA 510(k) clearance letter for a breathing circuit bacterial filter, which indicates that the device has been found substantially equivalent to predicate devices. It does not include specific performance data or a study description as requested.

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The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

Sleeved Filter, Sleeved HME/Filter.

This is a marketing clearance letter for a medical device submitted to the FDA. It does not contain information about the acceptance criteria and study results for an AI/ML device. Therefore, I cannot extract the requested information from the provided text.

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The HME-Booster™ makes it possible to feed additional moisture into the system during rne innie Dooter - manoon p specifically when the use of an HME alone is no longer adequate due to a patient's moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HMEanoother and hime sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a device called "HME-Booster™". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval notice, not a study report.

Therefore, I cannot extract the requested information from the provided text.

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Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.

Indications For Use:

1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2. A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.

Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121

This document is an FDA 510(k) clearance letter for a medical device and does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on new clinical trials or detailed performance studies with acceptance criteria as one would find in a clinical trial report. The FDA is acknowledging that the device is similar enough to existing, legally marketed devices that it can be marketed without requiring new, extensive proof of safety and efficacy.

Therefore, I cannot extract the requested information from the provided text as it is not present.

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A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Breathing Circuit Bacterial Filter

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a "Breathing Circuit Bacterial Filter" and discusses regulatory aspects, not performance studies or acceptance criteria for a device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device