(86 days)
Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.
The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a burr or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the burr to cut one structure while the adjacent one is still protected by the housing on the opposite side of the burr or blade. This system attaches to a motorized handpiece that drives the internal burr or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.
The provided document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Arthroscopic Shavers. It doesn't describe the acceptance criteria and study for a software-as-a-medical-device (SaMD) or an AI/ML device. Instead, it focuses on the substantial equivalence of a reprocessed medical device (arthroscopic shavers) to predicate devices.
Therefore, the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not available in the provided text.
The document discusses:
- Device Description: Arthroscopic shavers used to abrade, cut, and excise tissue and bone, remove loose fragments, and shave debris in arthroscopic surgeries.
- Intended Use: Resecting tissue and bone in articular body cavities during various surgeries (orthopedic, maxillofacial, hand, foot, plastic surgery).
- Indications Statement: Cutting and removal of soft and hard tissue or bone in orthopedic surgical procedures of joints, jaw, or sinuses.
- Technological Characteristics: States that the design, materials, and intended use of the reprocessed shavers are identical to predicate devices.
- Performance Data: Mentions that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers." It also states "Biocompatibility Validation of reprocessing Functionality Test(s)" was done and "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended."
However, it does not provide specific acceptance criteria or detailed results of these tests in a quantitative manner as requested for an AI/ML device. The focus is on demonstrating that the reprocessed device performs as originally intended by the predicate devices, not on proving a novel algorithm's performance.
§ 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.