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The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.

The PowerLoc* Clear Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the PowerPort* device, the PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles and 2 ml/s for 22 Ga. needles.

The PowerLoc* Clear Safety Infusion Set is comprised of a standard non-coring Huber type needle and administration set with an integral needle-stick safety mechanism.

The PowerLoc* Clear Safety Infusion Set is a standard intravascular administration set with a non-coring Huber right angle needle and a manually activated needle-stick safety mechanism which reduces the risk of accidental needle-stick injuries by shielding the needle after use. The device is used to access surgically implanted vascular ports and indicated for use in the administration of fluids and drugs, as well as blood sampling.

The PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system through the Bard PowerPort* device family. The maximum recommended infusion rate is 5 mils for 19 gauge and 20 gauge, and 2 mils for 22 gauge needles.

The device functions in a similar manner to the predicate devices. The insertion site is prepared and the device is primed using a syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the implanted port with non-dominant hand and removing the device while simultaneously activating the needle-stick safety mechanism with the dominant hand.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PowerLoc* Clear Safety Infusion Set.

Important Note: This document is a 510(k) summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical trial or performance study with specific device performance metrics in the way one might expect for a novel AI or diagnostic device. The "acceptance criteria" here refer more to meeting established engineering and regulatory standards rather than performance metrics like sensitivity/specificity for a diagnostic.

Acceptance Criteria and Device Performance

There is no table of specific acceptance criteria and reported device performance in the traditional sense of a diagnostic or risk-based AI device accuracy. Instead, the document states that the device was evaluated against various recognized standards and guidance documents. The "acceptance criteria" were met if the device demonstrated compliance with these standards and showed equivalence to predicate devices.

Study Details

It is important to understand that this is a 510(k) submission, not a detailed clinical study report for a diagnostic algorithm. The "study" here refers to "design verification evaluations through testing examination."

1. Sample Sizes Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "verification testing" being performed but does not specify the number of devices or units tested for each standard.
   • Data Provenance: Not applicable in the context of clinical patient data. The provenance relates to laboratory and engineering testing under controlled conditions, likely conducted by the manufacturer (Bard Access Systems, Inc.) or its designated testing facilities, presumably in the US (Salt Lake City, Utah). The testing would be prospective in the sense that new devices were manufactured and then tested according to the protocols.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. This device is not a diagnostic system requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" here is adherence to engineering specifications and regulatory standards.

3. Adjudication Method for the Test Set:

   • Not applicable. This is not a situation where expert adjudication of conflicting interpretations is required. Compliance with standards and specifications is typically determined by objective measurements and predefined pass/fail criteria.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The PowerLoc* Clear Safety Infusion Set is a physical medical device (needle and administration set) and does not involve human readers interpreting data.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device does not contain an AI algorithm. Its performance is entirely mechanical and material-based. The "algorithm" here is the design of the physical device itself and its interaction with the human user in terms of safety features.

6. Type of Ground Truth Used:

   • The "ground truth" is defined by the FDA recognized standards (e.g., ISO 11135, ISO 10993-1, ISO 11607-1, etc.) and guidance documents referenced in Section 6.8. Compliance with these standards, through objective measurements and predefined acceptance criteria during verification testing, serves as the "ground truth" that the device is safe and effective for its intended use.

7. Sample Size for the Training Set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

8. How Ground Truth for the Training Set Was Established:

   • Not applicable. There is no training set for this type of device.

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