(71 days)
The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist and jaw, also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
The Smith & Nephew, Inc., Endoscopy Division sterile, disposable Endoscopic Surgery Blades as indicated for use during arthroscopic resection of soft and osseous tissue in various large and small articular cavities including the hip joint. Blades which are size-appropriate are indicated for use in the following joints : shoulder, knee, elbow, ankle, wrist, jaw and the hip joint.
The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are to be used for illumination and visualization of joint spaces during arthroscopic procedures. Sterile, disposable Endoscopic Surgery Blades consist of several concentric tubes and various tip designs. The blades are used to resect and remove tissue endoscopically. The inner blade is driven by a motor. Tissue is removed by suction through the inner diameter of the inner blade.
This submission for Smith & Nephew, Inc. Endoscopy Division Arthroscopes and Accessories, Endoscopic Surgery Blades, and Manual Instruments is a 510(k) premarket notification. This type of submission claims substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and conducting a new study to prove those criteria are met.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document is essentially a regulatory filing for a medical device seeking market clearance based on its similarity to existing approved devices.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: These are not defined because the submission is based on substantial equivalence. The "performance" is implicitly deemed equivalent to the predicate devices.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth, Training Set, Ground Truth for Training Set: These are elements of a de novo study or a clinical trial to establish safety and efficacy. A 510(k) submission based on substantial equivalence to predicate devices typically relies on existing data or design specifications of the predicate devices, rather than new, independent studies with these specific parameters.
The Summary of Device Function and Comparison of Technological Characteristics of Predicate Device sections effectively serve as the "proof" in a 510(k) context – they argue that the new devices are so similar to already approved ones that they can be considered equally safe and effective.
In summary, the provided document is a 510(k) submission, which asserts substantial equivalence to predicate devices, and therefore does not include the detailed study design and results necessary to answer the questions about acceptance criteria and study data.
§ 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.