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The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Wands are bipolar, single use, high frequency electrosurgical devices.

I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary and an FDA clearance letter for the ArthroCare® Perc-D™ SpineWand™. It discusses the device's labeling and substantial equivalence to a predicate device, but not performance studies with specific metrics.

Therefore, I cannot provide the requested information in the format specified because the necessary data is not present in the input.

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The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Wands are bipolar, single use, high frequency electrosurgical devices.

The provided text describes a Special 510(k) submission for the ArthroCare® PercD™ SpineWand™ where the proposed modification is related to materials. It explicitly states that "The indications for use, technology, principle of operation, performance specifications, packaging, and sterilization parameters of the SpineWands remain the same as in the predicate cleared 510(k)".

This indicates that the current submission (K053447) is not a new device requiring extensive new performance data. Instead, it relies on the substantial equivalence to a previously cleared predicate device (K030954). Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the current K053447 submission, as such a study would primarily have been part of the original predicate device clearance.

Even for the predicate device, a 510(k) summary might describe preclinical and clinical data, but it would not typically present detailed acceptance criteria and a study in the format requested, especially for a device from 2005. The 510(k) process is about demonstrating substantial equivalence, not conducting new rigorous clinical trials for every submission unless significant changes warrant it.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on the regulatory process of demonstrating substantial equivalence for a minor material modification rather than presenting a performance study against specific acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device