(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 text describes a 510(k) premarket notification for "Reprocessed Arthroscopic Shavers" by Alliance Medical Corporation. It addresses the substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics. The performance data section broadly mentions "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers." and a statement that "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." However, the document does not provide specific acceptance criteria or the detailed study results that prove the device meets these criteria.
Therefore, much of the requested information cannot be extracted from the provided text.
Here is a summary of what can be inferred or directly stated from the document, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (e.g., cutting efficiency, material integrity, sterility after reprocessing, fatigue resistance) | "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." (No specific metrics or data provided.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The testing was "Bench and laboratory testing." The country of origin is not specified, but the submitter is in Phoenix, Arizona, USA. It describes testing, which would imply prospective data collection for the validation of the reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The nature of the device (reprocessed surgical instruments) suggests that the "ground truth" would likely be based on engineering specifications and performance standards rather than expert clinical judgment in the same way an AI diagnostic tool would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the type of product, such a method would not typically be applicable; testing would involve quantifiable measurements against defined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a reprocessed medical device (arthroscopic shaver), not an AI diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- N/A. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for the reprocessed shavers is their ability to "perform as originally intended," likely referring to the manufacturer's original specifications for new shavers. This would involve performance metrics such as cutting ability, structural integrity, and sterility. Specific details are not provided.
8. The sample size for the training set:
- N/A. This is a reprocessed medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. As above, a training set is not applicable to 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.