(86 days)
Reprocessed Arthroscopic Burs 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.
The Arthroscopic Bur components reprocessed by Alliance Medical Corporation include a bur or blade at the end of a long rod that rotates within a long hollow stainless steel housing. The housing has a window cut out on one side of the distal end, allowing the bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur or blade. This system attaches to a motorized handpiece that drives the internal bur 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 Burs. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.
The document states that "Bench and laboratory testing was conducted to demonstrate Performance (safety and effectiveness) of the Reprocessed Arthroscopic Burs" and lists the types of testing:
- Biocompatibility
- Validation of reprocessing
- Function test(s)
It concludes that "Performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended." However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about MRMC comparative effectiveness studies.
- Details on standalone algorithm performance.
- The specific type of ground truth used for the performance testing (e.g., pathology, outcomes data).
- Training set sample size or how its ground truth was established, as this is a reprocessed device and not an AI/algorithm-driven device in the typical sense of a training set.
The document focuses on establishing substantial equivalence to predicate devices through design, materials, intended use, and mechanism of action being identical, along with general performance testing categories. It is a regulatory submission for a medical device rather than a research paper detailing an AI model'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.