(22 days)
The CD Horizon™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel 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 CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The provided document is a 510(k) summary for the Medtronic CD Horizon™ Spinal System. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily by showing that the new device has the same intended use, indications, fundamental scientific technology, materials, and sterilization method, with the key difference being that the subject devices are provided sterile.
The document does not describe an AI/ML-driven device or study involving acceptance criteria related to AI/ML performance metrics such as accuracy, sensitivity, specificity, or human reader improvement. The "performance data" section refers to mechanical testing, biocompatibility, and bacterial endotoxin testing, typical for a physical medical implant, not a software or AI/ML device.
Therefore, it's not possible to extract the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device (a mechanical spinal implant) and its regulatory submission.
To answer your request, if the provided document were for an AI/ML device, the following would typically be found (but is absent here):
| Acceptance Criteria Category | Specific Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Standalone Performance | Sensitivity >= 90% for detecting X condition | 92.5% |
| Specificity >= 85% for detecting X condition | 87.1% | |
| AUC >= 0.90 for condition Y | 0.93 | |
| Human-in-the-Loop Performance (if applicable) | Radiologist agreement (F1-score) improves by 5% with AI assistance | 7.2% improvement |
| Reader sensitivity increases by 5% with AI assistance | 6.1% increase | |
| False positive rate decreases by X% with AI assistance | 15% decrease | |
| Robustness/Generalizability | Maintain specified performance across different scanner types/hospitals | Achieved across N sites/M scanner models |
| Usability/Workflow | Integration compatible with existing PACS systems | Successful integration demonstrated |
Regarding the study details, based on a hypothetical AI/ML device submission, you would typically look for:
- Sample size for the test set and data provenance: Number of images/cases. Origin (e.g., US, Europe, multi-country), and whether data was collected retrospectively or prospectively.
- Number of experts and qualifications for ground truth: How many clinicians (e.g., radiologists, pathologists) annotated the data. Their specialty, board certification status, years of experience.
- Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert, consensus read, 2+1 means two initial readers and a third to resolve discrepancies).
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If conducted, details on the study design (e.g., crossover, paired), the number of readers, the effect size (e.g., how much human readers' performance metrics like AUC, sensitivity, or specificity improved with AI assistance compared to without).
- Standalone performance: Metrics (e.g., sensitivity, specificity, AUC) achieved by the algorithm alone, without human intervention.
- Type of ground truth: How the "truth" was established (e.g., expert consensus, biopsy, surgical confirmation, long-term patient outcomes, follow-up imaging, synthesis of multiple data points).
- Sample size for the training set: Number of images/cases used to train the AI model.
- How ground truth for the training set was established: Similar to the test set, but sometimes less stringent or with programmatic labeling.
In summary, the provided document does not contain any of the information requested because it pertains to a mechanical medical device (spinal implant) and not an AI/ML-driven software device.
§ 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.