(30 days)
The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle 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) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli) or Cobalt Chrome.
The provided text describes a 510(k) premarket notification for the Preference Pedicle Screw System. It focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not available in the provided document.
Here's a breakdown of the available and unavailable information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (N/A – See comments) | Reported Device Performance | Comments |
|---|---|---|
| Not specified | Substantially equivalent | The document states, "The pre-clinical testing performed indicated that the Preference Pedicle Screw System is substantially equivalent to predicate devices." In a 510(k) submission for this type of device, the "acceptance criteria" for performance are often met by demonstrating that the new device performs at least as well as, and is as safe and effective as, existing legally marketed predicate devices. This typically involves mechanical and material testing to ensure it meets established standards (e.g., ASTM standards for spinal implants) and showing that its design, function, and materials are similar. The specific numerical thresholds or criteria for these tests are not detailed in this summary. The FDA's acceptance is based on this finding of substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "pre-clinical testing" but does not detail the number of units tested (e.g., for mechanical strength, fatigue).
- Data Provenance: The testing was "pre-clinical," meaning it was likely laboratory-based (in-vitro) or potentially animal studies, but the exact location (e.g., country of origin of the data) is not specified. It is not explicitly stated if it was retrospective or prospective, but pre-clinical testing is typically prospective in its design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a pedicle screw system, a mechanical implant. Performance is evaluated through engineering and materials testing, not typically through ground truth established by medical experts in the way an AI diagnostic device would be.
4. Adjudication method for the test set:
- Not Applicable. As above, this is a mechanical device, not a diagnostic one requiring expert adjudication of results.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device (pedicle screw system), not an algorithm or AI.
7. The type of ground truth used:
- Not Applicable in the traditional sense. For mechanical devices, "ground truth" would relate to engineering standards, material properties, and biomechanical performance data. For instance, the "truth" is that the device can withstand certain loads or stresses without failure according to established physical criteria. The document only broadly states "pre-clinical testing."
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary:
The provided document is a 510(k) summary for a physical medical device (pedicle screw system). The regulatory pathway for such devices largely relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical performance testing (e.g., mechanical, material, and biocompatibility testing). It does not involve the kind of clinical study and performance metrics common for AI/ML-based diagnostic devices, which would require detailed information on acceptance criteria, ground truth, expert adjudication, and reader studies. The "performance testing" mentioned in the document refers to these pre-clinical tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.
§ 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.