(29 days)
The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.
TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.
The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc discase (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (TI - Sacrum) fixation only.
The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORTM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPANTM CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.
The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The statement "Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself" is a very unusual and likely erroneous statement within the context of a 510(k). Typically, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. This implies that the device is either (a) a re-submission of a previously cleared device with minor changes, or (b) the sentence is a typo and refers to a known predicate device that is not explicitly named here. Without further documentation, it's impossible to determine the true basis for substantial equivalence.
Therefore, I cannot fulfill your request for the detailed breakdowns of acceptance criteria, study methodologies, and performance metrics as this information is not present in the provided text.
Here's a breakdown of what is and is not available in the provided document, in relation to your request:
1. Table of acceptance criteria and the reported device performance:
- Not provided. The document states that the system is "substantially equivalent" but does not offer specific performance metrics or acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance:
- Not provided. No information about a test set, its sample size, or data provenance is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. There is no mention of a test set, ground truth, or experts establishing it.
4. Adjudication method for the test set:
- Not provided. No information about a test set or adjudication method is present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This device is a mechanical spinal system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human-AI collaboration is irrelevant. No information about any comparative effectiveness study is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. As stated above, this is a mechanical device, not an algorithm. No standalone performance data is provided for the device in general.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. No information about ground truth is present.
8. The sample size for the training set:
- Not applicable/Not provided. As a mechanical device, there wouldn't typically be a "training set" in the sense of machine learning. There is no information about any study sample sizes.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. There is no mention of a training set or its ground truth.
In summary, the provided 510(k) pertains to regulatory clearance based on substantial equivalence, and it does not include the detailed study results or performance data that would typically be found in a clinical study report or a more comprehensive technical document.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.