(45 days)
The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCare Coblator IQ Controller.
The Coblator IQ Perc-D SpineWands consist of two Wands, the Coblator IQ DLR Spine Wand and the Coblator IQ DLG SpineWand, intended for use only with the Coblator IQ Controller.
These wands are single use, disposable, high frequency electrosurgery devices intended for use in percutaneous spinal disc decompression surgery. The Wands consist of a stainless steel shaft with a straight electrode configuration design. The proximal end of the devices is housed in a handle composed of polycarbonate. A cable integrated into the handle connects the Wand to the ArthroCare Coblator IQ Controller.
The Wand electrode is activated using the CIO Controller System energy which starts the Coblation process to ablate the disc tissue. The Coblation process involves use of a conductive media to create a plasma layer to ablate tissue.
The provided text is a 510(k) summary for the ArthroCare® Coblator IQ™ Perc-D® SpineWands®. It outlines the device description, intended use, and a declaration of substantial equivalence to a predicate device. However, it explicitly states that no new testing was deemed necessary for this submission, as the purpose was solely to clarify the indication for use statement. Therefore, a study demonstrating the device meets acceptance criteria as typically understood for new device performance (e.g., accuracy, sensitivity, specificity) is not present in this document.
Here's a breakdown based on the information provided, highlighting the limitations due to the nature of this particular 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document because no new performance testing was conducted for this specific submission (K132099). The submission states: "This submission seeks only to clarify the indication for use statement of the predicate device and there have been no other device, design or material changes since the previous clearance of these predicate devices (K100353), new testing was deemed to be unnecessary. The performance testing previously conducted as part of the design control activities include device acceptance criteria testing, biological testing, and packaging testing." This implies that acceptance criteria and performance data exist from the previous clearance (K100353), but they are not detailed in this document.
2. Sample size used for the test set and the data provenance:
Not applicable for this submission. As no new performance testing was conducted, there is no new test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this submission. See point 2.
4. Adjudication method for the test set:
Not applicable for this submission. See point 2.
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. The device described is an electrosurgical device, not an AI-assisted diagnostic or imaging tool involving human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgical tool, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for this submission. As no new performance testing was conducted, no new ground truth was established. For performance testing related to electrosurgical devices, ground truth would typically relate to the device's ability to achieve specific tissue effects (ablation, coagulation) under controlled conditions, often assessed through in-vitro or ex-vivo experimental setups, or potentially animal studies.
8. The sample size for the training set:
Not applicable for this device. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable for this device. See point 8.
In summary:
This 510(k) submission (K132099) is a "Special 510(k)" or similar, specifically addressing a change in the "Indications for Use" statement of an already cleared device, K100353. It explicitly states that the device itself, its materials, performance specifications, technological characteristics, sterilization, and principle of operation are identical to the predicate device. Therefore, no new performance testing was required or conducted, and the document does not contain details about acceptance criteria or performance studies that would typically be associated with a new device submission. The existing performance criteria and data would be found in the documentation for the predicate device, K100353.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.