(155 days)
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Cervical Stand Alone System
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
CONSTRUX Mini PEEK Spacer System:
The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.
CONSTRUX Mini PEEK Ti Spacer System:
The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
Cervical Stand Alone System
The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
This document is a 510(k) premarket notification for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System. It primarily addresses expanded indications for use, specifically the inclusion of allograft bone.
Based on the provided text, there is no acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered medical device. The document is for a medical implant (intervertebral body fusion device) and discusses its substantial equivalence to predicate devices, focusing on materials, design, and indications for use.
Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.
However, I can extract information related to the clinical data that supported the expanded indication:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not define specific performance acceptance criteria for an AI/ML device. It discusses the "substantial equivalence" of the implant system to predicate devices based on design, materials, and intended use, and the safety of using allograft bone.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," not a specific test set with a defined sample size for this submission.
- Data Provenance: The data was "Published retrospective clinical data." The country of origin is not specified but implicitly relates to the use of similar cervical interbody fusion devices.
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):
- Not Applicable. No ground truth establishment by experts for a specific test set is mentioned in the context of this 510(k) submission. The clinical data referred to supports the safety of using allograft bone.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is mentioned.
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 document is for a physical medical implant, not an AI/ML device, so an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document is for a physical medical implant, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the context of an AI/ML ground truth. However, the "Published retrospective clinical data" would have relied on clinical outcomes data related to spinal fusion procedures and the use of allograft. The "outcomes demonstrated that the use of allograft... poses no new risks to patients."
8. The sample size for the training set:
- Not Applicable. No training set is mentioned as this is not an AI/ML device submission.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment for a training set is mentioned.
In summary, this 510(k) submission focuses on the substantial equivalence of a spinal implant system with expanded indications for use (specifically regarding bone graft material), rather than the performance of an AI/ML powered 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.