(63 days)
The BLACKSTONE MEDICAL INC. Laparoscopic Disc Removal System is to be used in the anterior Laparoscopic decompression of the intervertebral disc in the lumbar region of the spine.
Unilateral leg pain greater than back pain. Paresthetic discomfort in a specific dermatomal distribution. Positive straight leg raising test and/or positive bowstring sign. Patient demonstrates possible neurological findings (wasting, weakness, sensory alteration, and reflex alteration). Patient shows no improvement after at least six weeks of conservative therapy. A positive CT or MRI that shows a subligamentous herniation at the location consistent with clinical findings.
The BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is an assortment of surgical instruments utilized in minimally invasive Laparoscopic lumbar discectomy surgical procedures.
This submission (K972768) describes the BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System. This is a premarket notification (510(k)) and centers around demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria through clinical studies.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and the type of ground truth is not applicable to this 510(k) submission.
The basis for this 510(k) clearance is the substantial equivalence of new disc removal tools and introduction instruments to already legally marketed predicate devices.
Here's why the questions are not applicable based on the provided text:
- No specific acceptance criteria are defined for device performance metrics: The document focuses on the technological and material similarity to predicates, not on quantitative performance targets (e.g., success rates, accuracy, precision, etc.).
- No clinical study is described that proves acceptance criteria are met: The provided text explicitly states: "The conclusion that the BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is substantially equivalent to legally marketed predicate systems was reached through consideration of the requirements of substantial equivalence determinations." This indicates a comparison to existing devices, not a de novo performance study against defined acceptance criteria.
- No mention of AI/algorithm: This is a surgical instrument system, not an AI or imaging device with algorithms requiring test and training sets, ground truth establishment, or expert reviews.
Table of Acceptance Criteria and Reported Device Performance:
Not applicable, as no specific performance acceptance criteria or performance study results are provided in this 510(k) summary. The demonstration is based on substantial equivalence.
Remaining Points (2-9):
These points are also not applicable as they relate to the methodology of performance studies typically conducted for AI/algorithm-based devices or devices requiring de novo clinical efficacy/effectiveness studies, which is not the case for this 510(k) submission. The submission relies on a comparison to predicate devices, not on a new clinical study with the described elements.
§ 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.