(89 days)
The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Disk Whisk System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a device already legally marketed, or it has different technological characteristics but does not raise different questions of safety and effectiveness. The FDA's 510(k) process is a premarket notification, not a premarket approval process that involves detailed clinical efficacy studies like those required for Class III devices.
Therefore, I cannot provide the requested information based on the provided text.
Here's why:
- No Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or thresholds that the Disk Whisk System needs to meet.
- No Study Details: The letter refers to a "510(k) notification of intent to market," which typically includes a comparison to predicate devices, but does not detail any clinical study or performance testing study that would establish and prove acceptance criteria.
- No Performance Data: There are no reported device performance figures.
- No Information on Sample Size, Ground Truth, Experts, Adjudication, or Training: Since no study is described, these details are absent.
The provided text focuses solely on the regulatory clearance process (510(k)) and the device's indications for use: "The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone."
To answer your questions, one would need access to the actual 510(k) submission document or related performance data, which is not included in this FDA clearance letter.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.