The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window, automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

The document provided is a 510(k) summary for the Orchid Safety Release Valve™ (K241415), which is being submitted for substantial equivalence to a previously cleared device (K232094). The primary difference between the two devices lies in a change to the contraindications, allowing for use with blood, which required additional hemocompatibility testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in numerical terms for the hemocompatibility testing. Instead, it states that "additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness." This implies that the device met internal acceptance criteria for these tests.

However, the "Table 1: General Technological Characteristics Comparison" provides a comparison of features, and for "Contraindications," it implicitly describes the change and how it was supported:

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

The document does not specify the sample size for the hemocompatibility tests or the provenance of the data (e.g., in vitro, animal, human). It only states that these tests were conducted.

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)

This information is not provided. The hemocompatibility tests are typically laboratory-based and follow established international standards (ISO 10993-4: 2017), which define parameters for assessing blood interactions, rather than relying on expert consensus for ground truth.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench or laboratory testing.

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 study was not done. This device is a mechanical medical device, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable and not provided. The device is a mechanical safety release valve, not an algorithm, so there is no "standalone" algorithm performance to evaluate.

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

For the hemocompatibility testing, the ground truth is established by the accepted scientific principles and thresholds defined within the ISO 10993-4: 2017 standard for biological evaluation of medical devices. The test results are compared against these established criteria to determine safety.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical product, 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 and not provided, as there is no training set for this type of device.

Ask a specific question about this device

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window, automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting raw performance data or detailed study methodologies.

Here's a breakdown of why I cannot fulfill your request based on this document:

• Acceptance Criteria and Reported Device Performance: While the document implies certain performance characteristics (e.g., separating when excessive tension applies, closing flow path), it does not provide a table of explicit acceptance criteria or quantitative performance metrics from a study for the subject device. It states, "There is no change in performance data since there are no changes to the device or its manufacturing processes," referring back to the predicate device.
• Sample Size and Data Provenance (Test Set): No information on a test set sample size, country of origin, or whether data was retrospective or prospective is present.
• Number of Experts and Qualifications (Ground Truth for Test Set): The document does not describe the establishment of ground truth for any test set, nor does it mention experts or their qualifications.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance, as the device is a mechanical one, not an AI-powered diagnostic tool.
• Standalone Performance Study: No standalone performance study details are provided.
• Type of Ground Truth Used: Not applicable for a mechanical device in this context, as there's no diagnostic component.
• Sample Size for Training Set: Not applicable as this is a mechanical device, not a machine learning model.
• Ground Truth for Training Set: Not applicable.

What the document does state regarding performance:

The document relies on the equivalence to its predicate device (K230266) and an "extrapolation and benefit/risk assessment" to support the expanded indications for use. It explicitly says:

• "There is no change in performance data since there are no changes to the device or its manufacturing processes." (Page 9)
• "Extrapolation results supported safety and effectiveness of the Orchid SRV in all IVs." (Page 9)
• "The conducted extrapolation and benefit/risk assessment demonstrate that the differences in the indications for use do not raise any new or different questions of safety and efficacy." (Page 9)

In essence, this FDA summary asserts that because the device is fundamentally identical to its previously cleared predicate, its performance (and the studies supporting that performance) also remain unchanged. The new submission is primarily to expand the "Indications for Use" from "peripheral IV catheters" to "all IV catheters" based on an extrapolation assessment rather than new, large-scale clinical performance studies directly included in this specific 510(k) summary.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Linear Health Science™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRVTM is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window, automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

This document does not contain acceptance criteria or study results that demonstrate the device meets those criteria.

The information provided confirms that the Orchid Safety Release Valve™ (K230266) is substantially equivalent to its predicate device, also named Orchid Safety Release Valve™ (K212064). The only difference between the proposed device and the predicate is an update to the Indications for Use to include pediatric patients two (2) weeks of age and older, whereas the predicate was for patients eighteen (18) years of age and older.

The justification for this expanded indication is that "Pediatric extrapolation results supported safety and effectiveness of the Orchid SRV in pediatric patients." Additionally, the submission states that "The device performance of the subject and predicate device are identical and compatible with IV therapy in adult and pediatric patients. The results of pediatric extrapolation supported the similarities in risk profiles across all patient populations. Therefore, the change in indication does not questions of safety or effectiveness."

Here's what can be extracted based on your request, though limited by the document's content:

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

The document does not explicitly state specific acceptance criteria in a numerical or measurable format for performance, nor does it provide a table reporting on these. It generally asserts that the device is identical in performance to its predicate. The only performance-related characteristic mentioned is:

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

The document does not specify a sample size or data provenance for any test set. It mentions "Pediatric extrapolation results," but no details on how these results were obtained (e.g., sample size, type of study).

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):

This information is not provided in the document. The concept of "ground truth" and expert involvement in a test set as typically found in AI/imaging studies is not relevant to this device's submission, which relies on demonstrating substantial equivalence to a predicate.

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

This information is not provided as there is no described test set or adjudication process in the context of this 510(k) submission.

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:

This is not applicable as the device (Orchid Safety Release Valve™) is a physical, tension-activated accessory, not an AI or imaging device involving human readers.

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

This is not applicable as the device is not an algorithm.

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

The concept of "ground truth" in the context of an algorithm's performance is not applicable here. The safety and effectiveness for the expanded pediatric indication were supported by "pediatric extrapolation results," implying an analysis of existing data or principles rather than a new data collection with a "ground truth" as typically defined for AI/diagnostic studies.

8. The sample size for the training set:

There is no mention of a training set in this document as the device is not an AI algorithm.

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

This is not applicable as there is no training set mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

The Orchid SRV™ is for use with patients eighteen (18) years of age and older.

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

The provided text describes the Orchid Safety Release Valve™ (Orchid SRV™), a medical device intended to reduce peripheral IV mechanical complications. The information focuses on its substantial equivalence to a predicate device (SafeBreak® Vascular) and outlines various performance and safety tests.

Here's a breakdown of acceptance criteria and associated study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D)
• Force to Disconnect
• Air Leakage Device Activated (ISO 80369-20:2015 Annex D)
• Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C)
• Water Leakage Female (ISO 80369-20:2015 Annex C)
• Water Leakage Male (ISO 80369-20:2015 Annex C)
• Flow Rate
• Re-assembly Prevention
• Assembly Weight
• Particulate Testing (USP ) | Not explicitly stated in the comparison table, but implied similar functionalities. | These tests were performed to demonstrate that the proposed Orchid SRV™ met applicable design and performance requirements. |
  | Usability Testing | Performed | Not specified | Performed. |
  | Clinical Simulation Testing | Performed | Not specified | Performed. |
  | Sterilization | Ethylene Oxide, SAL 10⁻⁶ | Ethylene Oxide, SAL 10⁻⁶ | Same. Sterilization validation followed AAMI TIR28:2016 and ISO 14937:2009 (half dose method, overkill approach). |
  | Biocompatibility | Meets requirements outlined in ISO 10993-1:2018 for externally communicating, prolonged exposure device indirectly contacting the blood path. Required tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Haemocompatibility) were performed. | Not specified, but generally a requirement for such devices. | Biocompatibility testing performed on the final Orchid Safety Release Valve™ demonstrates compliance. |

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

The document does not specify the exact sample sizes (number of devices or cases) for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for the performance testing.

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

This information is not provided in the document. The listed tests are primarily engineering and laboratory-based performance evaluations, rather than studies requiring expert interpretation of diagnostic inputs or outcomes.

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

Not applicable. The tests described are objective performance evaluations based on established international standards (ISO, ASTM, USP) and device specifications, not subjective assessments requiring adjudication by multiple experts.

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. This device is a mechanical IV accessory, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers with AI assistance" are not relevant to its evaluation.

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

Not applicable. The device is a mechanical component and does not involve an algorithm. The performance evaluation is inherently "standalone" in the sense that it assesses the device's functional characteristics directly.

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

The "ground truth" for the performance tests is derived from:

• Engineering specifications and design requirements: For parameters like separation force.
• International standards (ISO, ASTM, USP): These standards define acceptable methodologies and thresholds for various tests (e.g., tensile strength, air/water leakage, sterilization, biocompatibility).
• Functional objectives: The device must reliably separate and close flow paths under specific tension.

8. The sample size for the training set

Not applicable. This device is a mechanical component, not a machine learning model, so there is no concept of a "training set" in the context of its development or validation.

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

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

Ask a specific question about this device

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 adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

SafeBreak® Vascular is used with peripheral intravenous (IV) catheters and installed for in-line use with an IV administration set. It connects between the IV administration tubing and the patient's peripheral IV access device. When excessive force is applied to the IV administration set, SafeBreak® Vascular separates at a force lower than the force required to dislodge the peripheral IV catheter or disrupt the IV securement dressing (4 ± 1 1bf). 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 may be used for a maximum of seven days.

Here's a breakdown of the acceptance criteria and the studies that prove the SafeBreak® Vascular device meets those criteria, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

• Dislodgement: SafeBreak® Group: 2 (2.9% subjects, 2.5% catheters); Control Group: 4 (5.8% subjects, 4.3% catheters).
• Infiltration: SafeBreak® Group: 8 (11.4% subjects, 9.9% catheters); Control Group: 10 (14.5% subjects, 10.8% catheters).
• Occlusion: SafeBreak® Group: 2 (2.9% subjects, 2.5% catheters); Control Group: 1 (1.5% subjects, 1.1% catheters).
• Phlebitis (VIP Score ≥2): SafeBreak® Group: 1 (1.4% subjects, 1.2% catheters); Control Group: 10 (14.5% subjects, 10.8% catheters).
• Total MCs: SafeBreak® Group: 13 (18.6% subjects); Control Group: 25 (36.2% subjects). |
  | Separation Force Testing | The device separates at the specified force, 4 ± 1 lbf. (This specification was derived from a characterization study of peripheral IV securement devices to understand when the catheter would move/dislodge/securement device disrupt on swine skin). | Met. Non-clinical performance testing must demonstrate that the device performs as intended, including separation force testing. (The text states this was done and implied conformance without giving a specific value for the product itself, but rather stating the acceptance criteria was derived from this study. Therefore, the device is presumed to have met its own derived specification.) |
  | Validation of Anti-Reconnect Feature | After the separation of the two sub-assemblies, the device cannot be reconnected by hand. | Met. Non-clinical performance testing demonstrated this. |
  | Air Leak Testing | Air leakage on aged non-separated and separated device meets specified acceptance criteria: Non-separated (intact) (b) (4); Patient side (male) (b) (4); Administration set side (female) (b) (4). | Met. Non-clinical performance testing demonstrated this. |
  | Burst Pressure (check valve leakage) per ISO 8536-12 | No signs of air or water leakage when the IV tubing line is under pressure. | Met. Non-clinical performance testing demonstrated this. |
  | Counterflow (check valve leakage) per ISO 8536-12 A.1 | The check valve from the IV tubing line withstands a pressure of 200 kPa in the counter flow direction, while it is subjected to a water excess pressure at 40°C for fifteen (15) minutes. | Met. Non-clinical performance testing demonstrated this. |
  | Duckbill Valve Testing | The valve on the patient side withstands (b) (4) back pressure. | Met. Non-clinical performance testing demonstrated this. |
  | Luer Connection Testing (ISO 80369-7, ISO 80369-20) | Device passes tests for Falling Drop Positive Pressure Liquid Leakage, Sub-atmospheric pressure air leakage, Stress Cracking, Resistance to Separation from Axial load, Resistance to Separation from Unscrewing, Resistance to Overriding. | Met. Non-clinical performance testing demonstrated this. |
  | Pump Occlusion Alarm Testing | The check valve on the IV tubing side (separated) withstands (b) (4) of back pressure at various flow rates and triggers the occlusion alarm. | Met. Non-clinical performance testing demonstrated this. |
  | Flow Inhibition Testing | The device does not impact the flowrate accuracy of commonly used infusion pumps. | Met. Non-clinical performance testing demonstrated this. |
  | Crush Testing | The snap fit fingers are not broken or dislodged when the device is subjected to force of 200 lbf, which simulates a patient lying on the device. | Met. Non-clinical performance testing demonstrated this. |
  | Feature Verification: Transparency | The air-water interface is visually detectable, when the device is partially filled with distilled water, per ISO 8536-9, A.1. | Met. Non-clinical performance testing demonstrated this. |
  | Biocompatibility | Evaluated in accordance with FDA's Guidance Document titled Use of International Standard ISO 10993-1. Prolonged contact duration (>24hr to 30 days). Includes Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity, Subacute/Subchronic Toxicity, Particulates. | Met. Biocompatibility testing demonstrated that the device is biocompatible for its intended use across all specified endpoints. |
  | Shelf-Life/Sterility (1 year) | Shelf-life established at 1 year, based on testing non-aged devices after simulated shipping, 1-year accelerated aged devices, and 1-year real-time aged devices. Passed dye penetration and burst strength testing. Validated ethylene oxide sterilization to SAL of 10-6 per ISO 11135:2014. Sterilant residuals assessed per ISO 10993-7:2008. Bacterial endotoxin testing per ANSI/AAMI ST72:2011 ( (b)(4) | Met. Non-clinical performance testing demonstrated this. |

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

• Sample Size (Test Set):
  • Intention to Treat (ITT) population: (b)(4) subjects (divided into roughly equal SafeBreak® and Control groups). Specific numbers: (b)(4) SafeBreak® and (b)(4) Control.
  • Per Protocol (PP) population: 139 subjects (70 SafeBreak®, 69 Control).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was performed in (b)(4), indicating a specific location rather than multiple. The fact it's a De Novo submission to the FDA implies the study was conducted to US regulatory standards, likely in the US or a country with comparable ethical and clinical trial standards.
  • Retrospective or Prospective: Prospective, randomized, controlled trial.

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

• The clinical study did not use "experts" in the sense of adjudicators for imaging or similar interpretations. Instead, it was a randomized controlled trial where patient outcomes and events were directly measured and recorded by clinical staff.
• The "ground truth" for clinical endpoints like delays of therapy and mechanical complications was based on the direct observation and documentation of events in the study subjects during the clinical trial.
• The qualifications of the clinicians involved (e.g., nurses, physicians) are implied by their roles in a clinical trial setting but not explicitly detailed (e.g., "radiologist with 10 years of experience"). However, human factors testing did involve 15 registered nurses (RNs) as participants.

4. Adjudication Method for the Test Set

• For the clinical trial, there's no mention of an external adjudication committee or specific adjudication method (like 2+1 or 3+1).
• Events like mechanical complications and delays of therapy were recorded as part of the trial protocol. The data appears to have been collected directly by the study sites and analyzed as part of the trial results.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where different readers interpret cases (e.g., radiologists interpreting images).
• The SafeBreak® Vascular is a mechanical device, and its effectiveness was measured by clinical outcomes (delays of therapy, mechanical complications) rather than interpretive performance.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was extensively done, but for bench testing, not clinical performance.
• The "Summary of Nonclinical/Bench Studies" section details numerous standalone tests performed on the device itself (e.g., Separation Force Testing, Anti-Reconnect Feature, Air Leak Testing, Luer Connection Testing, Flow Inhibition, Crush Testing, Biocompatibility, Shelf-Life/Sterility, Microbial Ingress, Transparency). These tests evaluate the device's inherent physical and functional characteristics without human interaction in a clinical setting.
• "Algorithm only" performance typically refers to AI/software, which is not applicable here as SafeBreak® Vascular is a mechanical device.

7. Type of Ground Truth Used

• For the clinical study (test set): The ground truth was clinical outcomes data obtained directly from the randomized controlled trial. This includes:
  • Direct measurements of "delay of therapy" (minutes per 24 hours per subject).
  • Observed and documented "peripheral IV mechanical complications" (dislodgement, infiltration, occlusion, phlebitis).
  • Observed and documented "SafeBreak® Vascular separations."
  • Reported "Adverse Events."
• For bench testing: The ground truth was established by engineering specifications, regulatory standards (e.g., ISO, ASTM, USP), and physiological models (e.g., swine skin for separation force characterization).

8. Sample Size for the Training Set

• Not applicable in the conventional sense for AI/machine learning. The SafeBreak® Vascular is a mechanical device, not typically trained using data sets.
• Instead of a "training set," the device underwent extensive design, development, and iterative testing to refine its performance characteristics (e.g., separation force). The "Separation Force characterization study" is an example of such a process, where a specification was defined based on understanding peripheral IV securement devices on swine skin. This could be considered analogous to a "training" or "development" phase for the device's physical design and specifications.

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

• As mentioned above, for a mechanical device, the concept of a "training set ground truth" is not directly applicable.
• Ground truth for defining device specifications (which could be likened to "training"):
  • Bench Testing Standards: Established through validated engineering principles and national/international standards (e.g., ISO, ASTM).
  • Clinical Relevance Studies: The "Separation Force characterization study" used a clinically relevant model (swine skin) to understand critical forces on peripheral IVs. This empirical data informed the acceptable force range for the SafeBreak® Vascular's separation. This data acted as the "ground truth" to establish the device's target performance specification.

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The I-PORT™, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The I-PORT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children.

The 1-PORT™, Injection Port is a sterile, single use, low profile injection port through which physician prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual iniection device. The device is designed to reduce the hardships of multiple daily subcutaneous injections by allowing users to receive physician prescribed medication, including insulin, without repeated needle punctures of the skin. The I-PoRT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without additional needle sticks.

The provided text describes the 510(k) summary for the I-PORT™ Injection Port, not a study evaluating its performance against acceptance criteria using AI or human readers. The document focuses on regulatory approval, establishing substantial equivalence to predicate devices, and demonstrating compliance with standards.

Therefore, many of the requested categories for summarizing a study with AI and expert review are not applicable to this document. I will fill in the relevant information that is present.

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format you've requested for typical AI or diagnostic device studies. Instead, it states:

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

• Sample Size: Not specified. The document only mentions "Representative samples of the device" for bench testing.
• Data Provenance: Not specified. The testing described is laboratory/bench testing, not data collected from human subjects.

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. This is a medical device for drug administration, not an AI or diagnostic device with ground truth established by experts interpreting images or clinical data. The "ground truth" here is compliance with engineering and material specifications.

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

Not applicable. No expert adjudication method is described for this type of device testing.

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. This is not an AI-assisted diagnostic device; it is a physical medical device.

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

Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluates the device's physical properties and functionality.

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

The "ground truth" in this context refers to engineering and material specifications, and compliance with recognized standards. For example:

• Internal specifications and user needs.
• Requirements of ANSI/AAMI/ISO 10993-1:2003 for biocompatibility.
• A Sterility Assurance Level (SAL) of 10-6.
• Pyrogen-free status as tested by LAL.
• Compliance with various ASTM and ISO standards for packaging, sterilization, and general requirements for intravascular catheters.

8. The sample size for the training set

Not applicable. No training set is relevant for this type of physical medical device and its associated testing.

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

Not applicable. No training set is relevant.

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