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Used for decompression and simultaneous internal feeding.

Moss Tubes, Inc. Nasal Tube - Mark IV

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Moss Tubes, Inc. Nasal Tube - Mark IV". This type of document does not typically contain detailed information about acceptance criteria or specific study results. It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, most of the requested information cannot be extracted from the provided text. I will indicate where information is missing.

Here's what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance

• Acceptance Criteria: Not explicitly stated in the document. A 510(k) clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. The acceptance criteria would likely relate to demonstrating this equivalence through performance testing, material biocompatibility, and sterilization validation, but the specific metrics are not detailed here.
• Reported Device Performance: Not explicitly stated. The document affirms the device's substantial equivalence to a predicate device based on its intended use (decompression and simultaneous internal feeding). No specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rates, durability) are provided.

Study Details

1. Table of Acceptance Criteria and Reported Device Performance: This information is not present in the provided document.

2. Sample size used for the test set and the data provenance: Not mentioned. 510(k) submissions often include bench testing and sometimes limited clinical data, but the specifics of any test set (e.g., sample size, country of origin, retrospective/prospective) are not provided in this clearance letter.

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 (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 device is a "Nasal Tube," which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a physical device like a nasal tube, "ground truth" might relate to physical properties, biocompatibility, or functional performance, but the specifics are not detailed.

8. The sample size for the training set: Not applicable and not mentioned. This is not an AI device that typically involves a "training set." Any "training" would be related to user training or manufacturing processes.

9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms that the Moss Tubes, Inc. Nasal Tube - Mark IV has been reviewed and found substantially equivalent to predicate devices for its stated indications for use. However, it does not contain the detailed study design, acceptance criteria, or performance data that would typically be required to answer most of your specific questions, as these details are usually part of the full 510(k) submission, not the clearance letter itself.

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