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• The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
• The integral LiftLoc™ Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
• The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
• The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device.
• The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

The LiftLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The LiftLoc™ Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The LiftLoc™ Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.

Following conventional placement of the LiftLoc™ Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc™ Safety Infusion Set may then be removed from the patient.

Conventional clinical practice is used to remove the LiftLoc™ Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc™ safety disc to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc™ safety disc and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc™ Safety Infusion Set, now with a protected needle, is discarded in a sharps container.

The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad will also be available as an accessory.

Here's a breakdown of the acceptance criteria and study information for the LiftLoc™ Safety Infusion Set, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The 510(k) summary provided does not explicitly list numerical "acceptance criteria" for performance. Instead, it states that the device was deemed "substantially equivalent" to predicate devices based on comparative testing and a simulated use study. The performance described is the successful meeting of the intended function and safety features.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 500 LiftLoc™ Safety Infusion Sets.
   • Data Provenance: The study was a "simulated use study," implying it was conducted in a controlled environment, likely in the US, rather than a clinical setting with patient data from a specific country. It is a prospective test specifically for this device.

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

   • The document states, "A total of 500 LiftLoc™ Safety Infusion Sets were successfully inserted by clinicians..."
   • Number of Experts: The number of clinicians is not specified, only that "clinicians" performed the insertions.
   • Qualifications of Experts: Their specific qualifications (e.g., number of years of experience, specialty) are not detailed beyond being identified as "clinicians."

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

   • The document does not describe a formal adjudication method for the simulated use study. The success of insertion, activation, and absence of sharps injuries were likely directly observed and recorded.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical medical device (infusion set), not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

   • No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not a software algorithm. Its performance is intrinsically linked to human interaction (clinician use).

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

   • The "ground truth" for the simulated use study was direct observation of the device's function and safety features during simulated use by clinicians. It aligns most closely with expert observation/direct functional assessment against predetermined success criteria (e.g., successful insertion, proper safety mechanism activation, absence of injury).

7. The sample size for the training set:

   • There is no mention of a "training set." This typically refers to data used to train AI/machine learning algorithms. As this is a mechanical device, a training set in that context is not relevant. The device itself was likely developed and refined through engineering and iterative testing, but not "trained" on a dataset.

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

   • Not applicable, as there was no "training set" in the context of an AI/machine learning algorithm.

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