(93 days)
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.
The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.
The PIVOX™ Oblique Lateral System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft or allograft and must be used with supplemental fixation. The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral System plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
The provided text describes a 510(k) premarket notification for the PIVOX™ Oblique Lateral Spinal System, which is a medical device for spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and biocompatibility assessments. It does not contain information about studies involving human readers, AI, or clinical ground truth derived from expert consensus, pathology, or outcomes data in the context of device performance evaluation as one might find in an AI/ML device submission.
Therefore, many of the requested elements are not applicable to the information contained in this 510(k) summary. I can, however, extract the relevant acceptance criteria, reported performance, and details about the studies reported.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." However, the specific numerical acceptance criteria values for each test are not explicitly detailed in the provided text; only that they were met.
| Test Type | Acceptance Criteria (Not explicitly stated, but "pre-determined" and "met") | Reported Device Performance (Met Acceptance Criteria) |
|---|---|---|
| For Interbody Cages: | ||
| Static Compression | (Implicitly met pre-determined criteria) | Met |
| Static Compression Shear | (Implicitly met pre-determined criteria) | Met |
| Compression Fatigue | (Implicitly met pre-determined criteria) | Met |
| Compression-Shear Fatigue | (Implicitly met pre-determined criteria) | Met |
| Subsidence | (Implicitly met pre-determined criteria) | Met |
| Expulsion | (Implicitly met pre-determined criteria) | Met |
| For Plates and Screws: | ||
| Construct Static Compression | (Implicitly met pre-determined criteria) | Met |
| Construct Compression Fatigue | (Implicitly met pre-determined criteria) | Met |
| Construct Static Torsion | (Implicitly met pre-determined criteria) | Met |
| Static Push-Out | (Implicitly met pre-determined criteria) | Met |
2. Sample Size Used for the Test Set and Data Provenance
This submission pertains to mechanical and biocompatibility testing of a physical implant device, not a data-driven AI/ML model for diagnostic or prognostic purposes. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI studies are not applicable here.
The tests were conducted according to ASTM standards for spinal implants (ASTM F1717, F2077, F2267, and F-04.25.02.02). The sample sizes (number of constructs or samples tested) for these specific mechanical tests are not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's performance is established through standardized laboratory mechanical testing based on engineering principles and material science, not through expert human interpretation of medical images or other data.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to expert discrepancies in establishing ground truth for diagnostic AI, which is not relevant to this device's testing.
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 is a physical spinal implant, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question relates to AI algorithm performance for diagnostic/prognostic tasks, which is not relevant to this device.
7. The Type of Ground Truth Used
The "ground truth" for the PIVOX™ Oblique Lateral Spinal System is established through pre-defined engineering specifications and performance standards for medical implants, primarily determined by:
- Mechanical Testing Standards: Adherence to ASTM standards (F1717, F2077, F2267, F-04.25.02.02) which define how mechanical properties (e.g., strength, durability, resistance to subsidence/expulsion) are measured and what qualifies as acceptable performance for a device of this type.
- Biocompatibility Standards: Compliance with ISO-10993 for biological evaluation, confirming the safety of materials (PEEK, titanium alloy, tantalum, stainless steel, silicone) for long-term implantation, relying on material specifications and a history of safe use.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" applies to machine learning models. This submission describes an implantable medical device undergoing mechanical and biocompatibility testing. The "design verification testing" is analogous to a validation step rather than a training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's submission. The ground truth for evaluating the device's substantial equivalence is established by universally recognized engineering and material science standards and guidance documents for spinal implants.
§ 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.