(74 days)
The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
When used with three integrated screws, the IdentiTi ALIF Standalone Interbody System implants of 20°, the IdentiTi ALIF Standalone Interbody System implants must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the IdentiTi Porous Ti Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems, regardless of the use of integrated fixation, that are cleared by FDA for use in the thoracic and lumbar spine.
The subject IdentiTi ALIF Interbody Systems are inclusive of IdentiTi ALIF Standalone Interbody System. IdentiTi ALIF Oblique Interbody System, and IdentiTi ALIF Narrow Interbody System. IdentiTi ALIF Oblique and Narrow interbody systems are subsystems of the Alphatec IdentiTi Porous Ti Interbody System.
IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device with integrated screw fixation for use in anterior and anterolateral procedures. The IdentiTi ALIF Standalone Interbody System consist of interbody devices and bone screw(s) in multiple configurations to accommodate individual patient anatomy. The IdentiTi ALIF Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The IdentiTi ALIF Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. The interbody spacers accept three bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.
The IdentiTi ALIF Standalone Interbody System implants of 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The IdentiTi Porous Ti Interbody System is an intervertebral body fusion device with implants of various lengths, widths, heights, and degrees of lordosis to accommodate individual patient anatomy. The IdentiTi interbody spacers are manufactured from commercially pure titanium Grade 2 per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi Porous Ti thoracolumbar platform includes the following sub-systems: IdentiTi ALIF, IdentiTi ALIF Oblique, IdentiTi ALIF Narrow.
The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The purpose of this 510(k) submission is to receive clearance for new IdentiTi ALIF Oblique and Narrow interbody implants, modified graft bolts for use with standard IdentiTi ALIF SA interbody implants, and new Class II instruments.
The provided text is a 510(k) summary for the IdentiTi ALIF Interbody Systems. This document pertains to the regulatory clearance of a medical device and does not describe a study involving device performance against acceptance criteria in the context of diagnostic or AI-driven systems.
Instead, this document outlines the nonclinical testing performed on the interbody systems to support their substantial equivalence to predicate devices, thus ensuring their safety and effectiveness for their intended use. The "performance data" section refers to mechanical and material testing, not clinical studies on human or AI performance.
Therefore, I cannot provide information on:
- A table of acceptance criteria and the reported device performance: The document does not define such criteria nor report performance in a way that would fit this table for a diagnostic device. It lists mechanical tests.
- Sample size used for the test set and the data provenance: Not applicable for this type of mechanical testing.
- Number of experts used to establish the ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not a diagnostic device.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable as this is not an algorithm or AI.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the information related to the nonclinical performance data that was conducted:
1. Nonclinical Performance Data
The performance data section in the document describes a series of nonclinical mechanical tests performed on the IdentiTi™ ALIF Interbody Systems to support their substantial equivalence to predicate devices. These tests evaluate the device's material properties and mechanical integrity.
| Acceptance Criteria (Implied by ASTM Standards) | Reported Device Performance |
|---|---|
| Material & Mechanical Integrity | |
| ASTM F2077 static & dynamic axial compression | Supported substantial equivalence to predicate devices |
| ASTM F2077 static & dynamic compression-shear | Supported substantial equivalence to predicate devices |
| ASTM F2077 Dynamic Compression-shear Confirmation (30° Spacer) | Supported substantial equivalence to predicate devices |
| ASTM F1714 Gravimetric Analysis (endplate integrity) | Supported substantial equivalence to predicate devices |
| ASTM F1877 Particulate Analysis (endplate integrity) | Supported substantial equivalence to predicate devices |
| ASTM F2267 Static Subsidence | Supported substantial equivalence to predicate devices |
| Static Push-out (20° Spacer) | Supported substantial equivalence to predicate devices |
| Static Screw Push-out | Supported substantial equivalence to predicate devices |
| Graft Aperture Area Analysis | Supported substantial equivalence to predicate devices |
| ASTM F543 Static Torsion | Supported substantial equivalence to predicate devices |
| ASTM F2193 Static Cantilever Bend | Supported substantial equivalence to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The study referenced in the document is a series of nonclinical mechanical and material tests performed on the IdentiTi™ ALIF Interbody Systems. The specific results of these tests (e.g., exact load values, deformation measurements) are not detailed in this 510(k) summary but are summarized as demonstrating "substantial equivalence to the predicate devices."
The "acceptance criteria" for these tests are implicitly the requirements and expected performance outlined within the referenced ASTM (American Society for Testing and Materials) standards. For a 510(k) submission, meeting these standards and demonstrating equivalence to a legally marketed predicate device (which has already proven its safety and effectiveness) is the primary method of proving the device meets regulatory requirements.
Additional Information from the Document (where applicable):
- Data Provenance: The data would be from laboratory testing performed by Alphatec Spine, Inc. or a contracted testing facility. It is inherently "prospective" in the sense that the tests are designed and executed to evaluate the new device.
- Ground Truth Type: For mechanical testing, the "ground truth" is defined by the physical properties of the materials and the mechanical performance under applied conditions as measured by calibrated equipment according to established ASTM standards.
- Clinical Information: The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means no human clinical study was conducted or relied upon for this 510(k) clearance.
§ 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.