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Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery

"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.

"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.

The provided text is a 510(k) summary for the Regular and Special Umbilical Cord Clamp and Cutter. It outlines the device description, intended use, and comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria beyond a general statement.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Details: The document states that "Bench testing was performed to ensure that the 'Regular and Special Umbilical Cord Clamp and Cutter' met its specifications. All tests were verified to meet acceptance criteria." However, it does not enumerate these specific acceptance criteria (e.g., what is the required clamping force? What is the maximum number of cuts before failure? What is the acceptable deviation for the electronic clock if applicable?). It also doesn't provide the numerical results for any of these tests, only a blanket statement of compliance.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified, but given the manufacturer is "Ningbo Feite Medical Device Co., Ltd." in China, it's highly probable the testing was conducted in China. The study is retrospective in the sense that the testing was performed before the 510(k) submission, but it's not a retrospective review of existing patient data. It refers to laboratory/bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is a manual instrument, not an AI/software device that requires expert consensus for ground truth establishment. The testing would primarily involve engineers or technicians evaluating physical properties and performance against specifications.

4. Adjudication method for the test set

• Not applicable. This type of physical device testing does not involve adjudication methods like those used for diagnostic AI where multiple experts might review cases.

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

• No. This is not an AI-assisted diagnostic device, so a MRMC comparative effectiveness study is not relevant or included.

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

• Not applicable. This is a manual medical instrument, not an AI algorithm. The "Special Umbilical Cord Clamp and Cutter" has an "electronic clock function," which might involve some internal algorithm for timekeeping, but its performance is evaluated as part of the total device functionality, not as a standalone AI component.

7. The type of ground truth used

• For physical characteristics (e.g., dimension, material, single use): Comparison to the predicate device and engineering specifications.
• For functional performance (e.g., clamping, cutting): Performance against pre-defined functional specifications (though these specific acceptance criteria are not detailed in the summary).
• For biocompatibility: Compliance with established biocompatibility standards (e.g., ISO 10993) via specific tests.
• For sterility: Compliance with sterilization efficacy standards for EO sterilization.

8. The sample size for the training set

• Not applicable. This device does not use an "AI algorithm" in the conventional sense that would require a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, no AI-specific training set.

In summary, the document states that bench testing was performed and "All tests were verified to meet acceptance criteria" and "Biocompatibility testing demonstrated that the devices are biocompatible." However, it lacks the specifics commonly requested for AI/diagnostic devices such as detailed acceptance criteria, numerical performance data, and the methodologies for establishing ground truth relevant to such devices. The nature of this device (a manual surgical instrument) means many of the requested points are not applicable.

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The Umbilical Cord Clamp is indicated for use following a live birth. It provides a means of constricting the umbilical cord in order to prevent loss of blood as the cord dries and shrinks after birth. It is used immediately following delivery of the infant and prior to the separation of umbilical cord between mother and infant.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI or diagnostic device against specific acceptance criteria.

Therefore, almost all of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not present in this document.

Here's what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Not present. This document does not establish specific performance criteria like sensitivity, specificity, or accuracy. It's a regulatory clearance based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not present. There is no mention of a test set, sample size, or data provenance as this is not a performance study as typically understood for AI/diagnostic devices.

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 present. No experts are mentioned in the context of establishing ground truth for a test set. The clearance is based on comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not present. No test set or adjudication method is described.

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/Not present. This is a physical medical device (umbilical cord clamp), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not included.

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

• Not applicable/Not present. As above, this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not present in the context of a performance study. The "ground truth" for this regulatory approval is the legally marketed predicate device to which the new device is compared for "substantial equivalence."

8. The sample size for the training set:

• Not applicable/Not present. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable/Not present. No training set ground truth to establish.

In summary, the provided document (an FDA 510(k) clearance letter) is about regulatory approval for a physical medical device (Umbilical Cord Clamp) based on substantial equivalence. It does not contain information about the performance evaluation of an AI or diagnostic device against specific acceptance criteria. Therefore, most of the requested details are not applicable or not present in this type of document.

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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 intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.

The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.

The Busse Umbilical Cord Clamp Cutter (K021055) is designed to safely cut the umbilical cord clamp. The device is composed of a natural resin with a stainless steel blade. It does not contact the patient, is non-sterile, and is labeled for single patient use.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Busse Umbilical Cord Clamp Cutter are based on its functional performance when used with specific umbilical cord clamps.

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify an exact numerical sample size for the product qualification testing. It broadly states that the device was "tested with Busse Posi-Grip Umbilical Cord Clamps."
• Data Provenance: The data is from "Product qualification testing" conducted by the submitter (Busse Hospital Disposables Inc. or Azary Technologies LLC on their behalf). No information on the country of origin or if it was retrospective or prospective is provided, but it would typically be considered prospective in-house testing.

3. Number of Experts and Qualifications:

Not applicable. The study described is a functional performance test of a medical device, not a diagnostic or interpretive device requiring expert review for ground truth establishment.

4. Adjudication Method:

Not applicable, as no expert review or adjudication of results is mentioned or relevant for this type of functional performance test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This device is a mechanical cutter, not involved in image interpretation or diagnosis.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted. The product qualification testing focused solely on the "umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps." This test assesses the intrinsic functionality of the device without human interaction beyond its intended operation.

7. Type of Ground Truth Used:

The ground truth for the performance test was operational success – whether the device could physically cut the umbilical cord clamps without problems. This is a functional outcome directly observed during testing.

8. Sample Size for Training Set:

Not applicable. This device is a mechanical cutter and does not involve AI or machine learning that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this mechanical device.

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Sterile, single-use, disposable umbilical cord clamp, 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 cord dries and shrinks after the birth, prior to and after cutting.

Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).

This document describes a 510(k) premarket notification for an Umbilical Cord Clamp. It does not contain information about acceptance criteria or a study proving device performance in the way a medical AI/ML device submission would. The document focuses on establishing substantial equivalence to predicate devices based on material, configuration, function, manufacturing, packaging, and sterilization.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

Information not available in the provided document for this device:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Extracted Information (where applicable):

1. A table of acceptance criteria and the reported device performance:
Not applicable. This device is a physical umbilical cord clamp, not a diagnostic AI/ML device. The submission establishes substantial equivalence rather than meeting specific performance metrics against acceptance criteria typical for AI/ML.

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. No "test set" in the context of an AI/ML device study is mentioned. The device was subjected to non-clinical biocompatibility testing.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance would relate to its structural integrity, sterility, and biocompatibility, which were assessed through non-clinical tests.

8. The sample size for the training set:
Not applicable.

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

Summary of Nonclinical Tests and Results (as provided in the document):

• Tests: Biocompatibility (cytotoxicity, hemolysis)
• Result: "no problems noted"
• Testing body: An independent lab.

Conclusion: The provided document is for a traditional physical medical device (umbilical cord clamp) and not for an AI/ML device. Therefore, the questions related to AI/ML device evaluation (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission. The device demonstrates safety and effectiveness through substantial equivalence to predicate devices and results from non-clinical biocompatibility testing.

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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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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 blodd loss and seepage as the cord dries and shrinks after the birth.

Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp.

This document is a 510(k) summary for the Securline® Umbilical Cord Clamp #3500. It details the device's purpose, classification, and the substantial equivalence determination by the FDA. However, it does not contain the specific information required to answer your questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel studies. The FDA's letter explicitly states that the review determined the device is "substantially equivalent... to legally marketed predicate devices." This typically means the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Therefore, many of the details you've requested regarding specific performance criteria, study design, and data provenance are generally not included in a 510(k) summary, as the primary goal is to establish substantial equivalence to a predicate, not to present de novo performance data.

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