(103 days)
Transcend NanoTec Cervical Platform: The Transcend PEEK Cervical Interbody System with advanced NanoTec surface treatment is intended for spinal fusion procedures at one or two levels from C2-T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend NanoTec Thoracolumbar Platform: The Transcend PEEK Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend NanoTec PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft 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.
IdentiTi Porous Ti Interbody System: Intended for spinal fusion procedures at one or two levels from C2-T1 in skeletally mature patients with degenerative disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
IdentiTi Thoracolumbar Platform: Indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 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 for use with autograft comprised of cancellous and/or corticocancellous bone graft 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.
Transcend PEEK Interbody System: Intended for spinal fusion procedures at one or two levels from C2-T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems and with autograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend Thoracolumbar Platform: Indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 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 for use with autograft and/or allograft comprised of cancellous bone graft 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.
IdentiTi NanoTec Interbody System: Intended for spinal fusion procedures at one or two levels from C2-T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
IdentiTi NanoTec Thoracolumbar Platform: Indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-S1. for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft 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 IdentiTi and Transcend Interbody Systems are cervical and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and lateral 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). 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 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 IdentiTi and Transcend Interbody Systems also includes LIF AMP integrated fixation to be used with the LIF interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
This document is a 510(k) Premarket Notification from the FDA regarding several interbody systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not contained within this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for device performance (e.g., accuracy, sensitivity, specificity) or "reported device performance" against such criteria are provided in this regulatory document. The document focuses on demonstrating substantial equivalence to predicate devices through technological comparison and nonclinical testing.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document does not describe a study involving a "test set" of patient data for evaluating device performance in terms of diagnostic accuracy or similar metrics. The focus is on demonstrating equivalence through mechanical testing and nonclinical testing for biocompatibility.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth establishment by experts is relevant for studies evaluating diagnostic or prognostic algorithms. This document does not describe such a study.
4. Adjudication Method for the Test Set:
Not applicable. As no test set involving expert review is described, there's no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This document does not mention an MRMC comparative effectiveness study or any evaluation of human readers' improvement with or without AI assistance. The devices are interbody fusion systems, not AI-powered diagnostic tools.
6. Standalone Performance Study:
No. This document describes medical devices (interbody fusion systems) and their material properties and intended use, not an algorithm's standalone performance.
7. Type of Ground Truth Used:
Ground truth in the context of this submission is implicitly established through existing regulatory standards and predicate devices. For mechanical testing, the ground truth is adherence to established engineering standards (e.g., ASTM F2026, ASTM F560, ASTM F67, ASTM F136). For nonclinical testing like Bacterial Endotoxin Testing, the ground truth is compliance with relevant standards (ANSI/AAMI ST72:2011/(R)2016).
8. Sample Size for the Training Set:
Not applicable. This document pertains to physical medical devices, not an AI algorithm that would require a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI algorithm or training set, this information is not relevant to the document provided.
Summary of Relevant Information from the Document:
The provided document, K211805, is an FDA 510(k) Premarket Notification. It concerns the substantial equivalence of several interbody fusion devices (IdentiTi™ Porous Ti Interbody System, Transcend™ PEEK Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ NanoTec™ Interbody System) to legally marketed predicate devices.
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Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on:
- Technological Comparison: Comparing intended use, indications for use, design, function, and technology to predicate devices. The document states that the new devices are "substantially equivalent" in these aspects.
- Nonclinical Testing: Mechanical testing and Bacterial Endotoxin Testing (BET) were performed.
- Mechanical Testing: Performed on the predicates and deemed applicable to the modified devices because there are "no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface." This implies that the mechanical performance (e.g., strength, durability) is considered equivalent to the predicate that has already met its mechanical performance requirements.
- Bacterial Endotoxin Testing (BET): Performed per ANSI/AAMI ST72:2011/(R)2016. The results demonstrate that the subject systems are substantially equivalent to other predicate devices for nonclinical testing.
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Study That Proves the Device Meets Acceptance Criteria:
- The study primarily involves a technical comparison and nonclinical laboratory testing. No clinical studies are mentioned.
- Sample sizes: Not specified for mechanical or BET testing, as these are typically conducted on a limited number of representative samples, not human patient "test sets."
- Data provenance: Not explicitly stated, but nonclinical testing is typically performed in a controlled laboratory environment (e.g., in the US, where Alphatec Spine is based). This is not retrospective or prospective patient data.
- Experts: Not applicable for nonclinical lab testing.
- Adjudication method: Not applicable.
- MRMC Comparative Effectiveness Study: Not conducted.
- Standalone Performance: The "standalone performance" is implicitly demonstrated through the nonclinical testing showing compliance with applicable standards and the assertion of substantial equivalence in design and materials compared to already cleared devices.
- Ground Truth: For mechanical aspects, the ground truth is assumed to be met by the predicate devices adhering to established ASTM standards. For biocompatibility (BET), the ground truth is compliance with ANSI/AAMI ST72:2011/(R)2016.
- Training Set Sample Size and Ground Truth Establishment: Not applicable as this is not an AI-based 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.