(130 days)
The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The K2M Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F136)
The provided text is a 510(k) Summary for the K2M Expandable Interbody System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this document.
Here's an breakdown based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it details non-clinical performance evaluations to show equivalence to predicate devices.
| Acceptance Criteria (Not explicitly stated for clinical outcomes) | Reported Device Performance (Non-clinical evaluations) |
|---|---|
| Mechanical integrity under various loads (implied by testing against predicate) | "The worst case K2M Expandable Interbody System implants were tested in static compression, static torsion, static compression shear and dynamic compression (per ASTM F2077), subsidence (per ASTM F2267) and expulsion and determined to be equivalent to predicate devices." |
| Biological safety (implied by endotoxin testing) | "bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSVAAMI/ST72:2011." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical laboratory testing, not a clinical study with a "test set" of patients. The sample size would refer to the number of implants tested, but this detail is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical study establishing ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical study with a "test set" and adjudication is described.
5. 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 device is a physical interbody fusion system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical interbody fusion system, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for non-clinical testing is typically defined by standardized methods and measurements, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.