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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.

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.

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