(90 days)
The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and
- failed previous fusion
The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
The Blackstone Pedicle Screw System consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Blackstone Pedicle Screw System
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Blackstone Pedicle Screw System) |
|---|---|---|
| Substantial Equivalence | Demonstrate substantial equivalence to legally marketed predicate devices in intended use, indications, technological characteristics, and principles of operation. Differences should not raise new safety or effectiveness issues. | - Same intended use as predicate devices. |
- Similar indications as predicate devices.
- Similar technological characteristics and principles of operation as predicate devices.
- Mechanical testing addressed technical differences, showing no new safety or effectiveness issues. |
| Mechanical Performance | Mechanical performance (e.g., strength, durability) must be comparable to predicate devices to ensure safety and effectiveness. | Mechanical testing was conducted which demonstrates that the system is substantially equivalent to predicate devices. |
Explanation of Implicit Criteria: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. Therefore, the explicit acceptance criteria are not stated in terms of specific performance metrics for the device itself but rather its ability to perform at least as well as and be as safe and effective as the predicate devices. The "performance data" section states that mechanical testing was conducted to prove this equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a sample size for a "test set" in the context of clinical data or human evaluation. The performance data section refers to "mechanical testing," which implies laboratory-based tests on device components or finished products.
- Sample Size for Test Set: Not applicable/Not specified in the provided document, as the study described is mechanical testing, not a user-based or clinical study.
- Data Provenance: Not applicable/Not specified. The tests are laboratory-based mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information would be relevant for studies involving human interpretation or clinical outcomes. The document discusses mechanical testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are used to resolve discrepancies in human assessments, which is not relevant to mechanical testing.
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, an MRMC comparative effectiveness study was not done. The document describes mechanical testing for a medical device (pedicle screw system), not an AI-assisted diagnostic or interpretative system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the mechanical integrity and functionality of the physical pedicle screw system itself, which was assessed through mechanical testing.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical testing would be the performance characteristics of the predicate devices. The Blackstone Pedicle Screw System was deemed acceptable if its mechanical performance was "substantially equivalent" to these known and previously approved devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned for this device, there is no ground truth established for it.
§ 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.