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Indicated use - When a sample of a patient's expired gas is to be analyzed.

Targeted population - Any patient requiring monitoring of expired gases.

Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy

The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter

The provided text describes a medical device (Gas Sampling Interface Kits) and compares it to a predicate device, but it does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific information you've asked for. The document focuses on establishing substantial equivalence to a predicate device based on intended use, design, materials, and generic performance testing (e.g., "Luer fittings: Yes" implies they perform as expected, but no specific metrics are given).

Here's an output demonstrating what I can extract and highlighting the missing information:

Description of Device: Gas Sampling Interface Kits (Disposable Gas Sampling Lines)

Intended Use: When a sample of a patient's expired gas is to be analyzed. Targeted population: Any patient requiring monitoring of expired gases. Environment of use: Hospital, anesthesia, ICU, PACU, respiratory therapy.

Predicate Device: Gibeck, Inc. - disposable gas sampling lines - K841722

Below is a table showing the available comparison points, but crucially, acceptance criteria and specific performance metrics are absent.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states "Performance Testing: Luer fittings: Yes" without providing any specific criteria (e.g., leak rate, pressure resistance) or quantitative results. The acceptance criteria for any performance characteristic are not provided. The reported device performance is implicitly considered acceptable due to its equivalence to the predicate device.

Missing Information (Not available in the provided text):

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not mentioned; this document describes a traditional device comparison, not an AI efficacy study.
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 AI algorithm.
7. The type of ground truth used: Not applicable in the context of this device and the provided document. The "ground truth" here is the functional performance and material composition, which are tested against engineering specifications (not detailed here) and compared to the predicate.
8. The sample size for the training set: Not applicable; this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable; this is a physical medical device, not an AI algorithm.

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