(97 days)
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements. and extracutaneous bridge elements, which provide fixation of the skull relative to the torso to immobilize the cervical spine when used with a frame or surgical table adaptor.
The transcutaneous bone anchorage elements are titanium threaded skull pins. of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor.
Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.
This document describes a medical device, the Anjon Bremer Halo System, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device. Therefore, the questions related to acceptance criteria, study details for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes are not applicable to the content provided.
The document focuses on:
- Device Description: The Anjon Bremer Halo System is composed of transcutaneous bone anchorage elements (titanium threaded skull pins) and extracutaneous bridge elements (crown or ring) for cervical spine immobilization and therapeutic traction.
- Indications for Use: To provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
- Predicate Devices: The device acts as its own predicate (K171863) and is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin (K915800) and the Bremer Halo System Titanium Skull Pin (K993099).
- Non-Clinical Testing: This section outlines the engineering and biocompatibility tests performed on the Anjon Bremer Halo System to ensure its safety and performance. This includes:
- Testing of Skull Pins to failure under load (ASTM F1541).
- Biocompatibility assessment (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity testing per ISO 10993).
- Testing of the Halo for deformation under load (ASTM F1831).
- Product and sterile barrier stability testing per ISO 11607-2, including post-gamma irradiation and accelerated aging.
- Sterilization validation using the VDmax25 method (ISO 11137).
- Conclusion: Based on the non-clinical testing and comparison to predicate devices, the Anjon Bremer Halo System is concluded to be substantially equivalent.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text pertains to a traditional mechanical medical device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.