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510(k) Data Aggregation
(88 days)
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 and/or radiculopathy 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 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 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. AMP™ Anti-Migration Plate may be used with IdentiTi LIF interbody spacers to provide integrated fixation. IdentiTi LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
The IdentiTi Interbody System with advanced NanoTec surface treatment 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 and/or radiculopathy 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 NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The IdentiTi NanoTec 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. AMP™ Anti-Migration Plate may be used with IdentiTi NanoTec LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
The Transcend PEEK 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 and/or radiculopathy 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 Transcend PEEK Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Transcend PEEK 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. AMP™ Anti-Migration Plate may be used with Transcend LIF interbody spacers to provide integrated fixation. Transcend LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. Transcend ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 and/or radiculopathy 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 Transcend NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Transcend NanoTec 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. AMP™ Anti-Migration Plate may be used with Transcend NanoTec LIF interbody spacers to provide integrated fixation. Transcend NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
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 in addition to the integrated screws. 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. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. 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 in addition to the integrated screws.
The IdentiTi ALIF Standalone Interbody System with advanced NanoTec surface treatment 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 NanoTec 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 Nanotec ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi NanoTec 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. The IdentiTi NanoTec ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi NanoTec 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 in addition to the integrated screws.
The IdentiTi and Transcend Interbody Systems are thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and posterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi), or (3) a combination of commercially pure porous titanium (CPT) Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. The IdentiTi and Transcend NanoTec Interbody Systems implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment. The purpose of this Traditional 510(k) is to receive clearance for expanded indications for the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogeneic bone consisting of cortical bone, as well as allogeneic bone consisting of demineralized allograft bone with bone marrow aspirate.
This document pertains to the Alphatec Spine interbody systems (IdentiTi™ Porous Ti, IdentiTi™ NanoTec™, Transcend™ PEEK, Transcend™ NanoTec™, IdentiTi™ ALIF Standalone, and IdentiTi™ NanoTec™ ALIF Standalone Interbody Systems) and their expanded indications for use.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria values (e.g., "device must withstand 1000N axial compression"). Instead, it lists the types of non-clinical tests performed, implying that the devices met the requirements of these standard tests. The reported "performance" is implicitly that the devices passed these tests.
| Test Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ASTM F2077 | Static and dynamic axial compression, compression-shear and torsion tests performed. (Implicitly passed) |
| Subsidence Testing | ASTM F2267 | Static subsidence test performed. (Implicitly passed) |
| Expulsion Resistance | ASTM Draft F-04.25.02.02 | Static push-out test performed. (Implicitly passed) |
| Material Characterization | F1714 | Gravimetric analysis performed. (Implicitly passed) |
| Particulate Analysis | F1877 | Particulate analysis performed. (Implicitly passed) |
| Integrated Fixation | Screw push-out | Screw push-out test performed. (Implicitly passed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each non-clinical test (e.g., number of interbody devices tested for axial compression). It refers to the tests generally.
Regarding data provenance, the tests are non-clinical (laboratory tests) and therefore do not involve patient data or data from specific countries of origin. The data is prospective as it was generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" for the non-clinical performance tests is based on established engineering standards (ASTM) and the physical properties of the devices themselves, not on expert medical opinion or consensus.
4. Adjudication Method for the Test Set
This question is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters, where discrepancies in interpretation need to be resolved. The non-clinical tests outlined here are objective measurements against predefined standards.
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
This question is not applicable to this submission. The device is an intervertebral body fusion system, a physical implant, not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this submission. The device is a physical interbody fusion system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" is based on engineering standards and material science specifications. The tests are designed to assess the physical and mechanical properties of the interbody systems against recognized benchmarks for safety and effectiveness in their intended use.
8. The sample size for the training set
This question is not applicable to this submission. As the device is a physical implant and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable to this submission for the same reason as above (no training set).
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(227 days)
The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).
The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:
"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.
The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):
1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):
| Test | Acceptance Criteria (Implied by Test Method) | Reported Device Performance |
|---|---|---|
| Functional performance testing and verification analysis | Insulation Effectiveness, Electrical Resistance, Current Density (as per standard engineering principles for electrical stimulation instruments) | "All functional performance testing passed. Substantial equivalence has been shown via analysis and testing." |
| Electrical safety testing and/or evaluation | Compliance with IEC 60601-1: 2005 for medical electrical equipment. | "Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements." |
| Biocompatibility testing | Compliance with ISO 10993 for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. Risk analysis performed considering body contact and duration. | "A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices." |
| Reprocessing (Cleaning and Sterilization) | Cleaning validation study based on AAMI TIR30:2011 acceptance criteria. Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013 to assure an SAL of 10^-6. | "The subject devices can be adequately cleaned and steam sterilized prior to use." |
The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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