Search Results

The Battalion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in three material varieties: Polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy. All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, and the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136. All implants are provided sterile.

As an accessory, this system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of all of these instruments are made of surgical grade stainless steel (17Cr-4Ni ) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before use.

The provided text is a 510(k) premarket notification for a medical device (Battalion Universal Spacer System) and does not describe acceptance criteria for an AI/ML powered device or a study proving that the device meets such criteria.

The information primarily focuses on:

• Regulatory Clearance: A letter from the FDA confirming substantial equivalence to predicate devices, allowing the device to be marketed.
• Device Description: Details about the materials, sizes, and components of the intervertebral body fusion device.
• Indications for Use: The specific medical conditions and patient population for which the device is intended.
• Predicate Devices: Identification of existing devices used as benchmarks for substantial equivalence.
• Performance Data (Non-clinical): A list of non-clinical mechanical tests performed according to ASTM standards to demonstrate the structural integrity and durability of the physical implant. These tests are standard for spinal implants to ensure they can withstand physiological loads.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for an AI/ML device, as this document pertains to a traditional medical implant.

Ask a specific question about this device