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Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.

Drawings and a bill of materials for the EchoStim device are attached.

This 510(k) document describes a medical device called the EchoStim Facet Tip, which is an electrically insulated anesthesia conduction needle. The submission is for substantial equivalence to existing predicate devices, not for a novel device requiring extensive performance studies as might be seen for AI/ML-based devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. This document focuses on demonstrating that the EchoStim Facet Tip is substantially equivalent to already marketed devices based on materials, technological characteristics, and intended use.

Here's why each specific requested point is not applicable or not found in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. For a substantial equivalence submission of this type of medical device, the "acceptance criteria" are primarily met by demonstrating similarity to predicate devices, rather than through specific performance metrics outlined like a diagnostic accuracy table. There is no performance data reported in this document.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of performance evaluation for this type of device in this submission. The evaluation is based on comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment needed for a test set as described here.
4. Adjudication method: Not applicable. No adjudication method is mentioned as there's no diagnostic decision-making process being evaluated.
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: Not applicable. This is a needle, not an AI/ML device, so MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth in the context of diagnostic accuracy is relevant here.
8. The sample size for the training set: Not applicable. There is no training set for a traditional medical device like this needle.
9. How the ground truth for the training set was established: Not applicable. There is no training set.

Summary based on the provided document:

The provided document is a 510(k) premarket notification for an anesthesia conduction needle. The focus is on demonstrating substantial equivalence to predicate devices. There are no performance studies, acceptance criteria for performance metrics, or data related to AI/ML device evaluation within this document. The "performance" in this context refers to the device meeting its intended use by being similar to already approved needles.

Key information present related to comparison:

• Predicate Devices:
  • UniPlex Cannula, K000722, Pajunk Gmbh.
  • Plexalong Set, K013041, Pajunk Gmbh.
• Basis for Substantial Equivalence: "The EchoStim Facet Tip Needle is substantially equivalent to the Pajunk needle predicated devices in that it is similar with respect to materials, technological characteristics and intended use."
• Comparison Data: "A comparison chart of the two devices is attached." (though not provided in the excerpt)

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