(32 days)
The IVA Cage (ACIF, Ti ACIF) are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage
The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.
The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.
The document discusses:
- Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
- Regulation Number: 21 CFR 888.3080
- Regulatory Class: Class II
- Product Code: MAX, ODP
- Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
- Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
- Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
- Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).
There is no mention of:
- Acceptance criteria for an AI-powered device.
- A study evaluating AI performance (standalone or with human-in-the-loop).
- Sample sizes for test or training sets related to AI.
- Experts or ground truth establishment for AI.
- MRMC comparative effectiveness study or related effect sizes.
Therefore, I cannot provide the requested information based on the given input text.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.