(25 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-S1 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 disease (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, lordosis, 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 (T1 - 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, connectors, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORM 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-SPAN™ 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) premarket notification for the TENOR™ Spinal System. It details the product description, indications for use, and a statement of substantial equivalence to itself. The FDA letter confirms the device is substantially equivalent to legally marketed devices.
This document does not report on any studies that prove the device meets specific acceptance criteria.
The concept of "acceptance criteria" and performance metrics (like accuracy, sensitivity, specificity) typically applies to medical devices that perform a diagnostic, analytical, or algorithmic function, such as AI-driven software, imaging systems, or lab tests. For these types of devices, performance is quantifiable and a "study" is conducted to demonstrate that the device meets predetermined thresholds.
The TENOR™ Spinal System is a physical spinal implant (components like clamps, screws, plates, rods). For such devices, "acceptance criteria" are usually based on:
- Biocompatibility: Demonstrated through testing to ensure the materials are safe for implantation in the human body.
- Mechanical Strength and Durability: Tested according to recognized standards (e.g., ASTM, ISO) to ensure the components can withstand the stresses and movements of the spine over time.
- Sterilization: Validated methods to ensure the device is sterile when implanted.
- Design and Manufacturing Controls: Adherence to Quality System Regulation (21 CFR Part 820) to ensure consistent quality.
- Substantial Equivalence: As explicitly stated in the document ("Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself."), the primary "study" or justification for market clearance of this type of device is often through demonstrating that it is substantially equivalent to a device already legally on the market. This means it has the same intended use and technological characteristics, or if there are different technological characteristics, they do not raise new questions of safety and effectiveness.
Since the provided text does not contain information about a study with performance metrics or acceptance criteria for algorithm output or diagnostic accuracy, I cannot fill out the requested table or answer most of the questions.
Here's what can be inferred or stated based on the given document, acknowledging its limitations for the specific request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for performance metrics. | Not specified in the document for performance metrics. |
| Substantial Equivalence to Predicate Device | Demonstrated as substantially equivalent to itself. (This implies it's equivalent to a legally marketed predicate device). |
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" of patient data in the context of device performance metrics is described. The "study" mentioned for substantial equivalence is a comparison to a predicate device, not a clinical trial with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "test set" with ground truth established by experts is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI or imaging device where human readers would be involved in interpreting outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to the physical and biocompatible properties of the materials, and the established safety and effectiveness of the predicate device it is equivalent to.
8. The sample size for the training set
Not applicable. No "training set" in the context of AI or algorithmic development is mentioned.
9. How the ground truth for the training set was established
Not applicable.
§ 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.