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The regional anesthesia catheter securement device is a sterile single use securement device intended for securing regional anesthesia catheters at the skin insertion site to help prevent catheter migration. The maximum period of use is 7 days.

The Lock-It™ Plus regional anesthesia catheter securement device consists of an adhesive backed polyethylene foam pad, with a clear molded plastic latch mechanism securely adhered to the top surface of the foam pad. The regional anesthesia catheter securement device is available for use with catheters using 16/17gauge needles. The regional anesthesia catheter securement device is provided individually packaged or in anesthesia conduction kits.

The provided text describes a 510(k) submission for the Lock-It™ Plus Regional Anesthesia Catheter Securement Device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical data and a user evaluation, rather than defining and proving acceptance criteria with a detailed study.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria and a study proving those criteria, is largely absent from the document. The text does not provide quantitative acceptance criteria for device performance or a study explicitly designed to meet them.

However, based on the provided text, here is an attempt to address the requested information as much as possible:

Acceptance Criteria and Device Performance

• Percent flow restriction
• Catheter retention force
• Tape adhesion force | Data submitted demonstrates that the catheter securement device performs equivalently to the predicate device. |
  | Clinical (User Evaluation): | |
  | Equal to or better performance than a device currently sold by Smiths Medical International (UK) related to "performance characteristics" (specific characteristics not detailed). | The clinical user evaluation concluded that the proposed device was equal to or better than a device currently sold by Smiths Medical International (UK). |
  | Securement of regional anesthesia catheters at the skin insertion site to help prevent catheter migration for a maximum period of 7 days. | "This user evaluation provided useful support that the device performs as intended." (Implicitly, this includes securement for 7 days as per indication). |

Study Details

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

• Sample Size (Test Set): Not specified. The document only mentions a "clinical user evaluation" conducted at "three sites OUS (outside the U.S.): Royal Free Hospital, Ipswich Hospital and Lewisham Hospital." The number of patients or catheters evaluated is not provided.
• Data Provenance: Prospective user evaluation conducted OUS (outside the U.S.) at Royal Free Hospital, Ipswich Hospital, and Lewisham Hospital.

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

• The document describes a "clinical user evaluation," implying that the "users" (presumably healthcare professionals involved in regional anesthesia) provided feedback on performance. However, it does not specify "experts" establishing a "ground truth" in a formal sense for the test set. The evaluation compared the device to another commercially available device and gathered user feedback on performance characteristics. The qualifications of these users are not detailed.

3. Adjudication method for the test set:

• Not specified. The user evaluation "inquired as to the performance characteristics" and concluded the device was "equal to or better than" the comparator. There is no mention of a formal adjudication process.

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. This was not an MRMC study and did not involve AI. It was a user evaluation of a physical medical device.

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

• No. This device is a physical securement device, not an algorithm.

6. The type of ground truth used:

• User judgment/feedback. For the clinical user evaluation, the "ground truth" was the subjective and objective assessment of the device's performance characteristics by the clinical users compared to a known device. For the non-clinical data, the "ground truth" was likely laboratory measurements of quantifiable metrics like flow restriction, retention force, and adhesion force.

7. The sample size for the training set:

• Not applicable/Not specified. This was not a machine learning model, so there was no "training set."

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

• Not applicable. See above.

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