(88 days)
Reprocessed Arthroscopic Shavers are intended to resect tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.
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 and/or bone away from the surgical site.
The provided document is limited in detail regarding specific acceptance criteria and the studies conducted. It primarily focuses on demonstrating substantial equivalence of reprocessed arthroscopic burs to predicate devices. Here's a breakdown of the information that can be extracted, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (Safety & Effectiveness) | "Performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended." |
| Biocompatibility | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Validation of Reprocessing | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Function Test(s) | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Design, Materials, Intended Use | "The design, materials, and intended use of the Reprocessed Arthroscopic Burs are identical to the predicate devices." |
| Mechanism of Action | "The mechanism of action of the Reprocessed Arthroscopic Bur is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized." |
| Changes to Claims, Intended Use, Clinical Applications, Patient Population, Performance Specifications, Method of Operation | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench and laboratory testing was conducted," but it does not specify the sample size for any of these tests. It also does not provide information on data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not available in the provided document. The studies were described as "Bench and laboratory testing," which typically does not involve human expert adjudication in the same way clinical studies would.
4. Adjudication Method for the Test Set
This information is not applicable/not available as the studies described are bench and laboratory tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies conducted were "Bench and laboratory testing" focused on the performance of the reprocessed burs themselves, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is an arthroscopic bur, a physical surgical tool, not an
AI algorithm. Therefore, there is no "algorithm-only" performance to assess.
7. The Type of Ground Truth Used
The ground truth for the "Bench and laboratory testing" would have been established by engineering and quality control standards for medical device performance. For example:
- Biocompatibility: Likely relies on standardized tests showing no adverse biological reactions.
- Reprocessing Validation: Involves demonstrating the sterilization and cleanliness of the reprocessed device meets required standards.
- Function Tests: Involves objective measurements of the device's cutting ability, rotational speed, durability, etc., against predefined specifications derived from new devices or industry standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a reprocessed physical medical tool, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 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.