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The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the curd dries and shrinks after the birth.

The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).

The provided text describes a 510(k) summary for the Securline® Umbilical Cord Clamp. This type of device (a medical clamp) typically does not rely on complex algorithms or AI; instead, its performance is assessed through mechanical and biological compatibility tests. Therefore, many of the typical AI/ML study components, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable here.

Here's an analysis based on the information provided and typical medical device regulatory submissions for non-AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the biocompatibility or mechanical performance tests. The testing was conducted by an independent laboratory. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it would typically be prospective testing conducted in a laboratory setting. No human patient data is mentioned for these specific tests.

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

This is not applicable in the context of this device and its testing. For a simple mechanical device like an umbilical cord clamp, "ground truth" is established through standardized laboratory tests (e.g., biocompatibility standards, mechanical testing protocols) rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading by multiple experts). For the physical and biological testing of a cord clamp, objective measurements and predefined pass/fail criteria from test protocols are used, not subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging or clinical assessment where the device assists human readers. This device is a physical medical instrument, not an AI or imaging diagnostic aid.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone "algorithm only" performance study was not done. This device does not contain an algorithm or AI component. Its performance is entirely mechanical and biological (biocompatibility).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

• Standardized Biocompatibility Tests: Laboratory tests against recognized standards for cytotoxicity and skin irritation.
• Mechanical Measurement Protocols: Objective measurements of closing and gripping forces, compared against predicate devices.
• Predicate Device Equivalence: The primary "ground truth" for regulatory submission is often the performance and safety profile of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

No pathology or outcomes data is mentioned as being used directly for establishing "ground truth" for the performance tests. Clinical outcomes (like prevention of blood loss) are the intended use facilitated by the device, but the performance criteria are based on laboratory testing and comparison to predicates.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn's umbilical cord. The clipper jaws are placed over the "hinge" area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.

Precision Dynamics Corporation purchases the packaged umbilical cord clamp clipper (non-sterile) from DeRoyal Industries. Precision Dynamics Corporation upon receipt of the non-sterile finished product from DeRoyal Industries plans to distribute this device as the Securline ® Umbilical Cord Clamp Clipper.

The provided text is a 510(k) summary for the Securline® Umbilical Cord Clamp Clipper. It describes the device, its intended use, and indicates that it has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations. The document is a regulatory submission summary and an FDA clearance letter, not a study report.

Therefore, I cannot answer your request based on the provided input.

To provide the requested information, the input would need to include details of studies conducted to evaluate the device's performance against specific acceptance criteria.

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