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When used according to the instructions for use, in the hands of a trained user, the device provides an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures.

The Aspiration/Coag Electrode is substantially equivalent to Utah Medical Products, Inc.'s DBL-311 and DBL-511 ball electrodes used for coagulation, combined with aspiration of the Valleylab E2505-10FR disposable electrode. The device consists of a stainless steel spherical ball electrode and an attached external PEBAX® aspiration tube. The posterior end of the device fits snugly into a standard electrosurgical pen which is connected to an FDA approved electrosurgical generator and standard vacuum suction system.

This document is a Summary of Safety and Effectiveness for a medical device submitted for FDA clearance (K955093). It is a pre-amendment device submission from 1996, which means it precedes many of the current stringent requirements for clinical studies and detailed performance metrics that are expected for AI/ML device submissions today.

Therefore, the requested information, particularly regarding detailed acceptance criteria, study methodologies (like blinding, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm, etc.), and specific statistical performance metrics, is not present and not applicable to this type of submission from this era.

Here's why and how to interpret the available information in the context of your request:

Key Takeaways from the Document:

• Device Type: Aspiration/Coagulation Electrode. This is a physical surgical tool, not an AI/ML diagnostic or predictive device.
• Regulatory Pathway: 510(k) "Substantial Equivalence." The primary goal of this submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not to prove novel performance against specific quantitative criteria through a large-scale clinical trial.
• Date: 1996. Medical device regulations and expectations for clinical evidence have evolved significantly since then.

Addressing Your Specific Questions (and why they can't be fully answered by this document):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in a quantitative manner as would be for an AI/ML device. The "acceptance criteria" for a 510(k) submission from this era is typically demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is usually qualitative or based on existing performance of the predicates.
   • Reported Device Performance: The document states the device "provides an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue." This is a general statement of intended effect, not a specific performance metric (e.g., sensitivity, specificity, accuracy, F1-score) with associated confidence intervals that would be expected for an AI device. There are no numerical performance values in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. This document does not describe a clinical study with a "test set" in the modern sense of validating an algorithm. Substantial equivalence for this type of device typically relied on materials testing, bench testing, and comparisons to predicate device designs and established performance. There's no mention of human subject data, let alone its provenance or design.

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

   • Not applicable / Not provided. "Ground truth" in the context of an AI/ML device (e.g., expert consensus on image annotations, pathology results) is not relevant for this physical device.

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

   • Not applicable / Not provided. There is no "test set" or "adjudication" described.

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 / No. This is a physical electrosurgical tool, not an AI-assisted diagnostic device. MRMC studies are completely irrelevant here.

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

   • Not applicable / No. This is a physical tool; there is no "algorithm" to evaluate in standalone mode.

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

   • Not applicable / Not provided. The concept of "ground truth" as applied to AI/ML model validation is not relevant here. The "truth" for this device would be its ability to perform coagulation and aspiration, which is assessed through a combination of design characteristics, material properties, and established use of similar devices.

8. The sample size for the training set:

   • Not applicable / Not provided. No "training set" for an AI/ML model is involved.

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

   • Not applicable / Not provided. No "training set" or AI model.

In summary: This document is a historical 510(k) summary for a physical medical device. It predates the widespread use of AI in medical devices and the regulatory framework that governs their evaluation. Therefore, the detailed questions about AI/ML device performance validation metrics and study designs are not addressed within this specific submission.

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