(52 days)
The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hemias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons.
The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).
Discectorny Instruments are made of medical grade stainless steel. They are used for partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes. Percutaneous access is achieved by small incisions and introduction of sleeves.
The provided text describes surgical instruments and does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot generate the requested table and study information.
The document discusses:
- Device Name: Orthopedic Manual Surgical Instruments, Percutaneous Discectorny System (Trade Name: Forceps, dilator, working sleeves, cannulas, trephines, deflectors)
- Intended Use: Partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes (Percutaneous Lumbar Disc Decompression).
- Technological Characteristics: Basic arthroscopic instruments with longer shafts, integrated in tubular sheaths, providing punching, grasping, cutting, suction/irrigation functions.
- Performance Data: Instruments were tested to assure no breakage of the jaw or other parts.
- Clinical Tests: "No Clinical tests were performed."
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, and this document pertains to manual surgical instruments with no mention of AI/ML, I cannot fulfill the request as specified.
§ 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.