(87 days)
Disposable Arthroscopy Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Simus Surgery (FESS). The FESS application is limited to those small blades, which are appropriate for the procedure.
The arthroscopic blade is composed of stainless steel tubing with plastic connectors. A small tube is fitted within a larger tube. The distal ends of the tubes are serrated and/or sharpened. The proximal end of each stainless steel tube is insertion molded into plastic connectors. The inner tube is fitted into the outer tube. The inner tube rotates within the outer tube and creates a scissor action that cuts soft tissue in the arthroscopy procedure. The assembled arthroscopic blade is connected to a power device that is adjusted by the clinician to rotate the inner tubing during use at the selected RPMs. Depending on the size and configuration of the device, the inner tube may be fitted with a plastic sheathing, or copper bearings, may be plated with an alloy such as nickel/tin and may be lubricated to facilitate rotation within the outer shaft. In addition the inner and outer tubes must be straight with no bends or kinks to ensure adequate rotation of the shafts during use. Burs must be absent from the cutting edges to prevent inadequate rotation and freezing up of the inner shaft during use.
Reprocessed Arthroscopic Blade
Note: The provided text describes the regulatory submission for a reprocessed medical device, not an AI/ML powered device. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable and will be marked as "Not Applicable". The study focuses on demonstrating substantial equivalence through performance and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" are implied by showing the reprocessed device performs "equal to, or better than" the predicate device in specific tests.
| Test | Acceptance Criteria (Implied: Equal to or better than predicate) | Reported Device Performance (Reprocessed device vs. Predicate) |
|---|---|---|
| Free-spin test | Must perform equal to or better than predicate | Performed equal to or better than predicate (specifically, replacement sheathing acts as a better friction barrier) |
| Cut-test | Must perform equal to or better than predicate | Performed equal to or better than predicate |
| Shed test | Must perform equal to or better than predicate | Performed equal to or better than predicate |
| TOC test | Must demonstrate substantial biocompatibility | Passed, demonstrating substantial biocompatibility |
| ETO residual test | Must demonstrate substantial biocompatibility | Passed, demonstrating substantial biocompatibility |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test (free-spin, cut, shed, TOC, ETO residual). It refers to "the reprocessed devices" and "predicate devices" generically.
- Sample Size: Not explicitly stated for each test.
- Data Provenance: Not explicitly stated, but the tests were performed by "MIT" (Medical Instruments Technology, Inc.), suggesting internal testing. The submission does not specify country of origin for test data, nor if it was retrospective or prospective, though it would logically be prospective testing conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is not an AI/ML study involving human expert interpretation for ground truth. Performance was assessed through objective physical and chemical tests.
4. Adjudication Method for the Test Set
- Not Applicable. This is not an AI/ML study involving human interpretation or adjudication. Test results would be quantitative measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done. This is a submission for a physical medical device, not an AI/ML diagnostic or assistive tool.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in the context of device performance. The tests (free-spin, cut, shed, TOC, ETO residual) were performed on the devices themselves to assess their inherent physical and chemical properties and performance, without human "in-the-loop" interpretation as would be relevant for an AI algorithm.
7. The Type of Ground Truth Used
- Benchmark Performance: The ground truth for performance tests (free-spin, cut, shed) was based on the performance of the legally marketed predicate device (Dyonics Shavers K833587).
- Established Standards: For biocompatibility tests (TOC, ETO residual), the ground truth would be established safety and biocompatibility standards and acceptable limits for residual ethylene oxide and total organic carbon.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML study; there is no "training set" in the conventional sense. The "training" for their reprocessing procedure would involve process development and validation, not a data-driven model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the reprocessing method itself would have been established through process validation studies to ensure consistent and effective reprocessing.
§ 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.