Search Results

Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand Officening vising high frequency (RF) current.

Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.

This document is a 510(k) summary for a medical device called the "Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens". It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way that would be expected for a diagnostic AI device.

Therefore, many of the requested categories are not applicable to the provided text.

Here's an analysis based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The document focuses on substantial equivalence to predicate devices and adherence to general controls for medical devices.
• Reported Device Performance: Not reported in terms of specific performance metrics from a study as this is not a diagnostic device with performance claims like sensitivity or specificity. The key performance aspect highlighted is the bipolar technology, which "eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards" and "permits the surgeon to work in a wet or irrigated surgical field without current shunting." These are functional benefits rather than quantitative "performance" in the context of device accuracy.

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

• Not Applicable. This submission is for an electro-surgical instrument, which is typically cleared through substantial equivalence based on engineering specifications, biocompatibility, electrical safety testing (ISO standards), and comparison to existing predicate devices, rather than a clinical trial with a "test set" in the context of diagnostic performance. There is no mention of a clinical study or a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As there is no clinical "test set" or diagnostic ground truth to be established, no experts were utilized in this manner for this type of device submission.

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

• Not Applicable. No clinical test set or adjudication process is 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. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant to this submission.

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

• Not Applicable. This is a hardware electro-surgical device, not an algorithm.

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

• Not Applicable. Given the nature of the device (electro-surgical instrument), the "ground truth" for its safety and effectiveness would come from engineering testing, adherence to recognized standards (though none are mandated for this specific device per the document), and demonstration of substantial equivalence in form and function to legally marketed predicate devices. No formal "ground truth" as you'd find in a diagnostic study is mentioned.

8. The sample size for the training set

• Not Applicable. There is no mention of a training set as this is not a learning algorithm or a device requiring data training.

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

• Not Applicable. No training set is mentioned.

Ask a specific question about this device