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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.

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