(141 days)
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty.
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.
The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.
The provided text describes a medical device called the Osteo-site® Vertebral Balloon and its substantial equivalence submission to the FDA (K200763). However, it does not describe an AI/ML medical device or a study involving human readers and AI assistance for image interpretation.
Instead, this document focuses on the Osteo-site® Vertebral Balloon, a physical medical device used for kyphoplasty, and describes its mechanical and material performance testing in comparison to predicate devices, not an AI model's performance in medical image analysis.
Therefore, I cannot provide the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.
The acceptance criteria detailed in the document are for the physical properties and performance of the balloon device itself:
Acceptance Criteria and Reported Device Performance (Osteo-site® Vertebral Balloon)
| Test Performed | Acceptance Criteria |
|---|---|
| Unconstrained Burst Volume | Proposed device exceeds the predicate's maximum rated volume before burst failure. |
| Constrained Burst Pressure | Proposed device exceeds the predicate's maximum rated pressure while constrained. |
| Inflated Balloon Dimensions | Proposed inflated balloon dimensions are similar to the predicate device. |
| Deflation Time with Contrast Solution | Deflation time is similar to the predicate device of the same size and volume profile. |
| Tensile Force Testing | Device material and bond strengths are similar to the predicate device. |
| Fatigue Testing | Proposed device must withstand three cycles of inflation at maximum psi. |
The document states: "No clinical testing was conducted for this submission." This further confirms that the study is not related to human interpretation of images or AI performance.
§ 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.