(154 days)
OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.
Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears
OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots. foramina, intervertebral discs and the surrounding spinal structures.
OSI Q System Arthroscopes are rigid, fixed arthroscopes with a wide-angle view and a rod lens imaging system with a fiber optic illumination system to provide visualization of various anatomic structures during diagnostic and operative arthroscopic procedures. OSI Q System Arthroscopes have surgical stainless steel shafts and lens housing for durability and are available with various angles of view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surgical site and surgeon preference. OSI Q System Arthroscopes have a working length of 175.5 mm to 212.5 mm. diameters ranging from 3.1 mm to 5 mm. an angle of view (direction of view) of either 30° or 70°, and a field of view of either 90° or 100°. Visualization sheaths are provided in three designs, with diameters of either 5 mm or 6.1 mm, an angle of view of 0°, 30°, or 70°, and working lengths ranging from 151 mm to 185.5 mm.
The arthroscope main body tube, insertion tube, and optic tube are all made from 304 stainless steel. The other patient contacting parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate OSI Arthroscopes (K091398). The visualization sheaths are made from 316 stainless steel.
Arthroscopes are provided non-sterile and are reusable. Visualization sheaths are provided sterile for single use only.
Acceptance Criteria and Study for OSI Q System Arthroscopes (K133018)
Based on the provided 510(k) summary, the OSI Q System Arthroscopes were determined to be substantially equivalent to previously marketed predicate devices (K091398 and K992782) and therefore did not require new clinical or non-clinical studies to establish acceptance criteria or prove performance. The submission relies on the established performance of the predicate device K091398 to demonstrate the performance of the subject device.
1. Table of Acceptance Criteria and Reported Device Performance
Since no new studies were conducted, the "acceptance criteria" for the subject device are implicitly met by its technological characteristics being "the same as" or "similar to" the predicate devices. The performance reported for the subject device is directly tied to the predicate.
| Characteristic | Acceptance Criterion (Based on Predicate K091398) | Reported Device Performance (OSI Q System Arthroscopes) |
|---|---|---|
| Intended Use | Same as K091398 (and K992782 for spine) | Same as K091398; spine indications similar to K992782 |
| Operating Principle | Same as K091398 | Same operating principle |
| Basic Design | Same as K091398 | Same basic design |
| Materials | Same as K091398 | Same or very similar materials (304 stainless steel, sapphire, eutectic solder, USP Class VI epoxy for arthroscope; 316 stainless steel for sheaths) |
| Packaging & Sterilization | Same as K091398 | Similar packaging; sterilized using same materials and processes |
| Physical Dimensions | Ranges established by K091398 and K992782 | Diameter: 3.1mm, 4mm, 5mm (within predicate ranges of 2mm-5mm for arthroscopes and 5mm for predicate sheath); Working Length: 175.5mm, 178mm, 179mm, 212.5mm (within predicate ranges of 40mm-400mm); Angle of View: 0°, 30°, 70° (within predicate ranges of 0°-70°); Field of View: 90°, 100° (within predicate ranges of 90°-105°) |
| Illumination | ACMI; Wolf/Dyonics, Storz/Olympus adapters | ACMI; Wolf/Dyonics, Storz/Olympus adapters |
| Resolution | 8.98 line pairs/mm (Model AS-175) | 8.98 line pairs/mm (Model AS-175) |
| Magnification | 8.6 X total magnification at 10 mm (Model AS-175) | 8.6 X total magnification at 10 mm (Model AS-175) |
| How Provided | Non-sterile, reusable (arthroscope) / Sterile, single-use (visualization sheaths) | Non-sterile, reusable (arthroscope) / Sterile, single-use (visualization sheaths) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No new test set was used. The submission relies on existing data and regulatory clearances of predicate devices.
- Data Provenance: Not applicable for a new test set. The data provenance for the predicate device K091398 (Orthopedic Sciences, Inc., Arthroscope) and K992782 (NuVasive, Inc., Spinal Arthroscope) would be tied to their original clearances, which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new test set requiring expert ground truth establishment was used for this submission.
4. Adjudication method for the test set
- Not applicable. No new test set required adjudication for this submission.
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
- Not applicable. This device is an arthroscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an arthroscope, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The substantial equivalence determination is based on the comparison of the device's technological characteristics to legally marketed predicate devices, not on direct clinical ground truth generation for the subject device itself.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/machine learning device, no training set or its associated ground truth establishment methods are relevant.
§ 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.