(217 days)
Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.
Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition.
The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.
The provided text describes a 510(k) submission for a medical device, the "Quick - Radius Disposable Set." The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel device or an AI/algorithm-based diagnostic tool.
Therefore, the information required to populate the fields related to acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not present in the provided text.
The document states:
- "The proposed device is a line extension to the predicate device with new presentation forms." (Page 3, Section VI)
- "The proposed and predicate devices have the same basic design, intended use and biocompatibility profile." (Page 3, Section VI)
- "Difference between the proposed device and the predicate includes addition of a presentation form in a sterile condition." (Page 3, Section VI)
- "The subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include: performance, shape and dimensions, material and manufacturing, sizes, biocompatibility and device usage." (Page 3, Section VII)
- "The EO sterilization has been validated to a sterility assurance level (SAL) of 10-6, according to ISO 11135" (Page 3, Section VII)
- "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 3, Section VI and Page 4, Section VIII)
In conclusion, this submission is for a physical medical device (bone plates and screws set) seeking 510(k) clearance based on substantial equivalence to predicate devices, mainly through demonstrating equivalent design, materials, and a validated sterilization process. It does not involve software, AI, or diagnostic claims that would necessitate the types of performance studies and acceptance criteria typically associated with those technologies.
Therefore, I cannot fill in the requested table and answer the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as the provided text does not contain such information. The "performance data" section in the document (Section VII) refers to the performance of the physical components (e.g., mechanical performance, biocompatibility) rather than diagnostic accuracy metrics.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.