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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 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.

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