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The indications for use of the Joey Clamp Opening Tool is to open the Joey Clamp® umbilical cord clamp.

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This document is a 510(k) summary for the "Joey Clamp Opening Tool". It states that the device is "substantially equivalent" to an existing legally marketed device, the "Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263]". This type of submission (510(k)) does not typically require extensive clinical studies with detailed acceptance criteria and performance data as would be found in a Premarket Approval (PMA) application. For 510(k) devices, the primary demonstration is substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.), and expert qualifications is not explicitly provided in this 510(k) summary because it is generally not a requirement for this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

However, I can extract and infer some high-level information based on the document:

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

Since this is a 510(k) submission, there isn't a table of quantitative acceptance criteria and reported device performance in the same way a clinical trial would present it. The acceptance is based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

• Acceptance Criteria for 510(k): The device is substantially equivalent to the predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or it has the same intended use and different technological characteristics but the new device does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
• Reported Device Performance: "The Joey Clamp Opening Tool is substantially equivalent to the Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263] that is legally marketed in the U.S." The stated intended use is "to open the Joey Clamp umbilical cord clamp." The performance required is simply the ability to open the specified clamp in a safe and effective manner, comparable to the predicate device.

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

Not applicable for this 510(k) summary. No specific clinical test set details are provided.

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 for this 510(k) summary. No ground truth establishment by experts for a test set is described.

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

Not applicable for this 510(k) summary. No adjudication method for a test set 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 for this device. This is a manual tool, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable for this device. This is a manual tool, not an algorithm.

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

Not applicable for this 510(k) summary. The "ground truth" for a 510(k) generally refers to the safety and effectiveness profile of the predicate device, which is already legally marketed.

8. The sample size for the training set:

Not applicable for this device. No training set is involved as it is not an AI/ML device.

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

Not applicable for this device. No training set ground truth establishment is described.

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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.

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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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The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.

The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.

This document is a 510(k) premarket notification for the Dynarex Umbilical Cord Clamp. It serves to establish substantial equivalence to a predicate device rather than to describe a study proving the device meets acceptance criteria. As such, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth methodologies associated with a device performance study are not present in this document.

The document states:

• "The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market."
• "Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices."
• "The Dynarex Umbilical Cord Clamp is indicated for use to compress the umbilical cord and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."

Therefore, based on the provided text, there is no information available to answer the specific questions about acceptance criteria and a study proving their fulfillment. The manufacturer is asserting equivalence to an existing device rather than providing new performance data.

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The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.

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This is a medical device 510(k) premarket notification for the Koala Clamp & Cutter, an umbilical cord clamp and cutter device. The submission aims to demonstrate substantial equivalence to a predicate device, the ClampCut by PriceInvena APS (510(k) No. 982464).

Given the nature of this submission, which is for a physical medical device (an umbilical cord clamp and cutter) and not an AI/ML-driven diagnostic or prognostic device, the concepts of "acceptance criteria," "device performance" in the context of AI metrics (like sensitivity, specificity), "sample size for test/training sets," "ground truth establishment by experts/pathology," "MRMC studies," or "standalone algorithm performance" are not applicable.

The document focuses on comparing the physical characteristics, materials, intended use, and general performance attributes (like sterility) of the Koala Clamp & Cutter to its predicate device. This is a common approach for 510(k) submissions for non-software/AI devices, where substantial equivalence is demonstrated through engineering and material comparisons, and potentially performance testing related to its mechanical function.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device evaluation. The document does not contain data or studies related to AI/ML performance.

However, I can extract the comparison chart provided, which highlights the device's technical specifications:

1. Table of Acceptance Criteria and Reported Device Performance
(Note: "Acceptance Criteria" here refers to the comparison points for substantial equivalence, not AI performance metrics. "Device Performance" refers to the characteristics of the Koala Clamp.)

The remaining requested information (2-9) is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML-driven diagnostic/prognostic tool. There are no AI algorithms, test sets, training sets, ground truth derived from expert consensus, or MRMC studies described in this document. The "study" proving the device meets criteria is implicitly the declaration of substantial equivalence based on the comparison of physical and performance characteristics to a legally marketed predicate 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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