(22 days)
The Endius Atavi System is indicated for use for posterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include: an endoscope, a light source, light guide, a camera control unit, and a camera head.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) summary for the Endius Atavi System does not contain any information related to specific acceptance criteria or a study designed to prove the device meets those criteria.
The document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to existing marketed devices.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.
Here's why:
- No Acceptance Criteria: The document does not define any quantitative or qualitative performance metrics that the device is intended to meet.
- No Study Details: There are no descriptions of any performance studies, clinical trials, or validation tests. The submission hinges on substantial equivalence, meaning it relies on the safety and efficacy of its predicate devices, rather than presenting new performance data for the modified device.
- Focus on Substantial Equivalence: The core of this 510(k) is the assertion that the "proposed Endius Atavi System is substantially equivalent to the current Endius Atavi System" (Section 5.8). This regulatory pathway often means that detailed performance studies might not be required if the device is sufficiently similar to a legally marketed predicate.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.