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SafeBreak® Vascular is intended to separate when excessive tension is exerted across intravenous (IV) and intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV or IO catheter.

SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement.

SafeBreak® Vascular is intended to be used on peripheral IV catheters, midlines, peripherally inserted central catheter (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs in adults and pediatric populations two (2) weeks of age and older receiving intermittent or continuous infusions with an electronic pump.

SafeBreak® Vascular is placed in-line with an intravenous or intraosseous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV or IO catheter.

SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

This document is a 510(k) summary for the SafeBreak® Vascular device (K231957). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K223486). The primary purpose of this 510(k) is to expand the indications for use, not to introduce a new device or demonstrate the initial performance of a novel technology. Therefore, the information provided focuses on the differences in indications and how these changes do not raise new questions of safety or effectiveness, rather than presenting a de novo study proving the device's initial performance against specific acceptance criteria.

Based on the provided text, a direct table of acceptance criteria and reported device performance from a new study is not available, as the submission focuses on validating an expanded indication rather than a new device or a new primary performance study. The document refers to prior clinical studies for the predicate device.

Here's an analysis of the information available relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria or detailed reported device performance for K231957. The entire submission is a comparative assessment against the predicate device (K223486) to justify expanding its "Indications for Use" to include a broader range of vascular access types and patient ages.

The key performance characteristic mentioned for both the subject and predicate devices is the "Separation force" of 1-5 lbf. This is the functional acceptance criterion that the device is designed to meet, ensuring it separates when excessive tension is applied.

Implied Acceptance Criteria for Expanded Indications:

The document implicitly argues that the proposed expanded indications do not negatively impact the device's safety and effectiveness. This implies that the device, under the expanded indications, must continue to meet the established safety and performance requirements of the predicate device. These include:

• Effective separation when excessive tension is applied.
• Stopping fluid flow from the infusion pump and blood flow from the patient's catheter upon separation.
• Aiding in the reduction of mechanical complications.
• Maintaining biocompatibility and sterility.

Table: Acceptance Criteria (Implied) and Performance (Reported for Predicate/Subject)

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

The document states: "The randomized and non-randomized clinical studies sponsored and conducted by Lineus Medical on the SafeBreak® Vascular device in the previous DEN190043 support the safety and effectiveness of the device in adolescents and adults."

• Test Set Sample Size: Not specified in this document. It refers to "clinical studies" from a previous submission (DEN190043). To get the exact sample size, one would need to review the DEN190043 submission.
• Data Provenance: The studies were "sponsored and conducted by Lineus Medical." The country of origin is not specified but generally, FDA submissions rely on data from studies conducted in the US or in compliance with international standards accepted by the FDA. The studies were clinical, implying prospective data collection.

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

This information is not provided in the given text. Clinical studies typically involve healthcare professionals for data collection and assessment, but the number and specific qualifications of experts establishing a "ground truth" (e.g., for image interpretation or diagnosis) are not mentioned, especially since this is a mechanical device. The clinical studies likely focused on direct patient outcomes and device performance during use.

4. Adjudication Method for the Test Set

This information is not provided in the given text. For clinical studies, adjudication methods (e.g., by an independent clinical events committee) are common, but details are not included here.

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

A MRMC comparative effectiveness study is typically relevant for interpretative devices like imaging diagnostics. This is a mechanical device. Therefore, a MRMC study is not applicable and not mentioned in the document. The "clinical studies" mentioned would likely have focused on clinical outcomes, complication rates, and device functionality in a real-world setting.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

This is a mechanical device, not an algorithm, so the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance (e.g., separation force, flow cessation) would be evaluated in laboratory and clinical settings.

7. The Type of Ground Truth Used

For the previous clinical studies on the predicate device:

• The "ground truth" would likely be objective clinical outcomes such as actual rates of IV/IO mechanical complications, successful separation events, and confirmation of flow cessation.
• The document also states: "Review of clinical literature and pediatric extrapolation supports the use of the device..." This indicates that existing medical consensus and established data from scientific literature also serve as a form of "ground truth" for the expanded indications.

8. The Sample Size for the Training Set

This concept is primarily relevant for machine learning algorithms. For a mechanical device, there isn't a "training set" in the same sense. The device's design is likely refined through engineering studies, bench testing, and potentially pilot clinical evaluations. The clinical studies on the predicate device (DEN190043) would represent performance validation, not a "training set" for an algorithm. Therefore, not applicable in the context of a "training set" for an algorithm.

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

As with point 8, this question is primarily relevant for algorithm development. For a mechanical device, the design and engineering specifications define its intended function. Performance is then validated against these specifications through various tests. Thus, not applicable for this type of device.

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SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.

SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and pediations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.

SafeBreak® Vascular is placed in-line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.

SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

The purpose of this 510(k) submission is to expand the indications for use of the product to include pediatric populations greater than one (1) year of age.

The provided text is a 510(k) Summary for the SafeBreak® Vascular device and focuses on establishing substantial equivalence to a previously cleared predicate device (K222791), primarily to expand its Indications for Use to include pediatric populations greater than one year of age.

The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The "device" in this context is a physical medical device (an intravenous catheter force-activated separation device), not an algorithm or AI system. Therefore, the requested information points regarding AI/ML study design, such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The "clinical data" section merely states that:

• Randomized and non-randomized clinical studies sponsored by Lineus Medical for a previous submission (DEN190043, which likely led to K222791) support the safety and effectiveness of the device in adolescents and adults.
• Review of clinical literature supports extrapolating adult data to pediatric populations.

This is a regulatory filing for a physical device, based on prior clinical data (not detailed here) and literature review for an expanded indication, rather than a performance study of a new AI/ML algorithm.

Therefore, I cannot provide the requested information based on the provided text, as it describes a non-AI/ML medical device and its predicate comparison.

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SafeBreak® Vascular is intended to separate when is exerted across a peripheral IV administration set. When SafeBreak@ Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

SafeBreak® Vascular is placed in-line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.

SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

The purpose of this special 510(k) is to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Primary Difference:
The K222791 device is a special 510(k) to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf. The predicate device (DEN190043) had a separation force of "4 ± 1 lbf." The reference device (K212064, Orchid SRV™) supported the expanded pull force range.

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

The document does not specify the exact sample size used for the performance testing.
The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. The testing appears to be primarily mechanical testing.

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

This information is not provided in the document. The testing described is mechanical performance (Separation Force Testing), which typically does not involve human experts establishing ground truth in the same way clinical studies or image analysis tasks would.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the testing described is mechanical performance. Adjudication methods are typically associated with subjective assessments or diagnostic 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

An MRMC comparative effectiveness study was not conducted. This device is a mechanical device, not an AI or diagnostic imaging device that involves human readers.

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

This concept is not applicable as the device is a mechanical IV catheter force-activated separation device, not an algorithm or software. The performance testing was for the mechanical function of the device itself.

7. The Type of Ground Truth Used

The ground truth for the performance testing (mechanical testing) was the pre-defined engineering specification for the separation force range (1-5 lbf). The "ground truth" here is the physical measurement against a specified engineering tolerance.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a mechanical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided as there is no training set for a mechanical device.

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