(58 days)
The K&J IVA (ACIF) PEEK Cage is 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 system 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 K&J IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I 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 K&J IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate.
This document is a 510(k) summary for the K&J IVA PEEK Cage. It asserts substantial equivalence to a previously cleared device (K162220).
Therefore, there is no acceptance criteria or study that proves this specific device meets acceptance criteria presented in this document. The manufacturer explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162220. No testing is required."
To answer your request, one would need to review the 510(k) submission for the predicate device, DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220), as that is where the original performance data and substantial equivalence arguments would have been presented.
Based on the provided text for K212038:
- A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data for this specific device are provided because it is considered identical to a predicate device.
- Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance testing was conducted for this device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance testing was conducted for this device.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant (intervertebral body fusion device), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant (intervertebral body fusion device), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance testing was conducted for this device.
- The sample size for the training set: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.
§ 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.