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The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.

The Manan Manta Catheter Fixation Disk is made of soft silicone. It is sutured or adhered to the skin and a drainage catheter is snapped into the device. A nylon tie-wrap is used to secure the catheter into the device.

The provided document is a 510(k) summary for the Manan™ Manta Catheter Fixation Disk, dated April 22, 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance. This type of regulatory submission in 1998 would typically not include the detailed performance study information requested in the prompt, especially not in the format of acceptance criteria tables, sample sizes for training/test sets, expert qualifications for ground truth, or discussions of AI algorithms and MRMC studies, as these concepts relate to more recent advancements in medical device evaluation, particularly for AI/ML devices.

Therefore, many of the requested data points (such as acceptance criteria, reported performance against those criteria, detailed study designs, ground truth methodologies, and AI-specific metrics) are not present in this document. The document confirms that the device is a simple mechanical fixation device, not an AI-powered diagnostic or therapeutic system.

Based on the provided text, here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain an explicit table of acceptance criteria or reported device performance for the Manan™ Manta Catheter Fixation Disk. The substantial equivalence determination is based on the device's similarity in design and intended use to a legally marketed predicate device (Manan Medical Products Manta Catheter Fixation Disk, 510(k) No. K954132), rather than performance against pre-defined quantitative acceptance criteria in a detailed clinical study.

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

Not applicable. The document describes a substantial equivalence submission, not a performance study requiring a test set of data in the context of AI/ML or a detailed clinical trial. The device is a physical catheter fixation disk, and its evaluation would likely involve engineering tests (e.g., tensile strength, biocompatibility – not detailed here) and potentially limited human factors evaluations, but not a "test set" of patient data in the manner implied by the prompt.

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

Not applicable. This information pertains to performance studies for diagnostic or prognostic devices, particularly those involving image interpretation or complex data analysis. The Manan™ Manta Catheter Fixation Disk is a mechanical fixation device, and the concept of "ground truth" established by experts for a test set is not relevant to its regulatory submission as presented.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data or outcomes in performance studies.

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. An MRMC study is used to evaluate the performance of diagnostic devices, often involving human readers and potentially AI assistance. This device is a mechanical catheter fixation device and does not involve "readers" or "AI assistance."

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

Not applicable. This device is not an algorithm and does not have standalone performance in the context of AI/ML systems.

7. The Type of Ground Truth Used:

Not applicable. The concept of "ground truth" as typically discussed in performance studies (e.g., pathology, outcomes data, expert consensus) is not directly relevant to the 510(k) submission for this mechanical device. The substantial equivalence is based on comparing the device's design, materials, and intended use to a predicate device.

8. The Sample Size for the Training Set:

Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical product.

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

Not applicable for the same reason.

Summary based on the document:

The Manan™ Manta Catheter Fixation Disk is a soft silicone device intended for the fixation of percutaneous drainage catheters. Its 510(k) submission (K981229) demonstrated substantial equivalence to a predicate device, the Manan Medical Products Manta Catheter Fixation Disk (K954132). The regulatory classification is Class II (21 CFR 876.5130/Procode: 78 KNY). The document does not provide details on specific performance studies with acceptance criteria, sample sizes, expert-established ground truth, or AI-related metrics because it is a submission for a mechanical device undergoing a substantial equivalence review, not an AI/ML device requiring a clinical performance study as described in the prompt.

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