(105 days)
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The MOJAVE 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 bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.
This is a 510(k) premarket notification for a medical device called the "MOJAVE Expandable Interbody System". This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove the device meets these criteria in the way a clinical trial or a performance study for an AI/CADe device would.
Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission. This document aims to show the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance evaluations and comparative analysis of design, materials, and intended use.
Here's an analysis based on the provided text, indicating "N/A" (Not Applicable) or "Not Provided" where the information is not present in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate/standards) | Reported Device Performance (MOJAVE) |
|---|---|
| Static Compression, Torsion, Compression Shear (per ASTM F2077, implied) | Performed similarly to or better than predicate devices. |
| Dynamic Compression Shear (per ASTM F2077) | Performed similarly to or better than predicate devices. |
| Subsidence (per ASTM F2267) | Performed similarly to or better than predicate devices. |
| Expulsion (per ASTM F2267, implied) | Performed similarly to or better than predicate devices. |
| Bacterial Endotoxin Testing (BET) / Limulus Amebocyte Lysate (LAL) testing (per ANSI/AAMI/ST72:2011) | Testing was conducted in accordance with the standard. (Specific results not provided but implied to meet acceptance). |
Note: The "acceptance criteria" here are implied by the performance of predicate devices and adherence to relevant ASTM and ANSI/AAMI standards for intervertebral body fusion devices. The exact numerical thresholds for "similarly to or better than" are not specified in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided. The non-clinical testing typically involves a specific number of devices per test, but this detail is not included in the summary.
- Data Provenance: Not provided, but all testing would be conducted in a laboratory setting, likely in the US, as K2M, Inc. is based in Leesburg, Virginia. The data is non-clinical/pre-clinical.
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)
- N/A. This information is for clinical studies or studies establishing ground truth for diagnostic AI/CADe devices. This document describes mechanical and biological compatibility testing of an implantable device, not diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for non-clinical performance evaluation of an implantable device.
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
- N/A. This device is an intervertebral body fusion implant, not an AI/CADe diagnostic tool. Therefore, MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical testing: The "ground truth" or reference for evaluating performance in a 510(k) for an implantable device like this typically comes from:
- Validated ASTM standards: These standards define how to perform tests (e.g., static compression, dynamic compression shear) and often include performance benchmarks or methodologies for comparison.
- Performance of legally marketed predicate devices: The new device must perform "similarly to or better than" established predicate devices under the same testing conditions.
- The "ground truth" is not clinical pathology or outcomes data in this context, but rather engineering and material performance specifications.
8. The sample size for the training set
- N/A. This refers to machine learning models. This document describes a physical medical device.
9. How the ground truth for the training set was established
- N/A. This refers to machine learning models. This document describes a physical medical 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.