(86 days)
The 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 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 text describes the 510(k) summary for "Reprocessed Arthroscopic Shavers" by Alliance Medical Corporation. This pertains to the reprocessing of existing medical devices, not a new device with its own specific performance criteria derived from a study comparing it to an AI or human system.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. This document focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." However, it does not provide specific quantitative acceptance criteria or detailed reported performance metrics (e.g., cutting force, sharpness retention, etc.) for the reprocessed devices. The acceptance criteria described are largely qualitative, focusing on equivalence to the original devices and successful reprocessing.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a study evaluating a diagnostic or AI device with a test set of data. The "test set" in this context refers to the reprocessed devices themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the reprocessed devices is that they perform as originally intended, which would be validated through engineering and functional testing.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This is not an AI-assisted diagnostic or classification device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a reprocessed physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
For the reprocessed devices, the "ground truth" is that they retain the performance characteristics (e.g., physical dimensions, material integrity, sharpness, cutting efficiency) and safety profiles of the original, new devices. This would be established through a combination of:
- Biocompatibility Validation: Ensuring no harmful residuals or material degradation from reprocessing.
- Reprocessing Function Test(s): Verifying the effectiveness of sterilization and cleaning protocols.
- Performance Testing: Bench and laboratory testing to confirm that the reprocessed shavers perform equivalently to new shavers as "originally intended." This likely involves mechanical testing, cutting force measurements, and visual inspection for integrity.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of available information regarding acceptance criteria and "study":
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Acceptance Criteria (Implicit):
- Substantial Equivalence: The reprocessed devices must be substantially equivalent to the predicate (original, new) devices in terms of design, materials, intended use, mechanism of action, performance specifications, and safety.
- Biocompatibility: The reprocessing process must ensure the device remains biocompatible.
- Functional Performance: The reprocessed device must "perform as originally intended," implying retained cutting ability, structural integrity, and proper function.
- Sterility: The reprocessing must achieve appropriate sterility.
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Study/Evidence Provided:
- "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers."
- "Biocompatibility Validation of reprocessing Function test(s)"
- "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended."
The document generally asserts equivalence and adequate testing without providing granular details about the specific tests performed, the quantitative acceptance thresholds, or the exact results of those tests. This level of detail is typical for a 510(k) summary for reprocessed devices, where the focus is often on demonstrating that the reprocessing does not alter the fundamental characteristics or performance of the device relative to its original, legally marketed form.
§ 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.