(109 days)
The KHEIRON Spinal Fixation System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.
The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."
However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:
1. A table of acceptance criteria and the reported device performance:
Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.
Instead, the non-clinical test summary states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Strength (Mechanical) | "The KHEIRON Spinal Fixation System has greater or equivalent strength values compared to other devices cleared for use in the thoracolumbosacral spine." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
- Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.
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, as no clinical studies requiring expert consensus for ground truth were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical studies requiring ground truth adjudication were performed.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.
8. The sample size for the training set:
- Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.
Summary of Non-Clinical Testing:
The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:
- Static and dynamic compression bending (according to ASTM F1717)
- Static torsion (according to ASTM F1717)
- Torsional and axial gripping capacity (according to ASTM F1798)
The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.
§ 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.