(26 days)
The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below.
| Device | Description |
|---|---|
| Curved Standard Ball | |
| Burr XL, 5.0mm | An arthroscopic burr that provides abrasion, resection, debridement, and removal of bone. The Curved Dynablator XL is specifically designed for use in hip joints with a spherical ball burr and bent outer tube for access to hip pathology. |
| Curved Standard | |
| Shaver XL, 4.2mm | An arthroscopic shaver that provides resection and removal of soft tissue. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. |
| Curved Dynablator XL | An arthroscopic RF probe that provides removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. |
The provided document is a 510(k) premarket notification letter from the FDA regarding the Tricera™ Arthroscopic System. It states that the device has been determined to be substantially equivalent to previously marketed predicate devices.
Crucially, this document is an administrative letter of substantial equivalence for a medical device (an arthroscopic system) and not an AI/ML-enabled medical device.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets AI/ML-specific acceptance criteria (such as performance metrics for an algorithm, ground truth establishment, training/test set details, MRMC studies, etc.) is not applicable to this document's content.
The document describes a physical medical device (an arthroscopic system) and its accessories, including fluid management, shaver blades, and RF probes, used for orthopedic and arthroscopic procedures. The "performance data" mentioned (Section 8) refers to testing related to packaging, verification and validation, shelf life, and electromagnetic compatibility (EMC), which are standard for physical medical devices and do not involve AI/ML performance metrics.
In summary, because this is not an AI/ML device, I cannot provide the requested information related to AI/ML acceptance criteria and studies.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.