(26 days)
When use as a posterior pedicle screw fixation system, the Synthes Posterior Universal Spinal System devices are 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Synthes Posterior Universal Spinal System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5 - S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system, Synthes Posterior Universal Spinal System devices are intended for scoliotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine. In addition, when used with 3.5/6.0mm parallel connectors, the Synthes Posterior Universal Spinal System can be linked to the CerviFix System.
Synthes Posterior Universal Spinal System consists of stainless steel or titanium components and consists of rods, hooks, side-opening screws with collar and variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transverse bars, parallel connectors, Schanz screws, clamp with posterior nut and associated manual surgical instruments.
Please note: The provided text is a 510(k) premarket notification for a medical device modification, specifically the Synthes Posterior Universal Spinal System. It focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information regarding AI study design (like sample size for test sets, expert qualifications, MRMC studies, training set details) is not applicable or cannot be extracted from this type of document.
However, I can extract information related to the device's functional performance expectations based on the substantial equivalence claim.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: Satisfy requirements for posterior thoracolumbar and sacral fixation. | "supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation" |
| Indications for Use (Pedicle Screw System): |
- Immobilization for acute/chronic instabilities/deformities (degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, failed fusion).
- Treatment of severe spondylolisthesis (Grade 3 and 4) of L5-S1 with fusion, implant removal post-fusion. | Device is intended for these uses, implying performance is equivalent to predicates for these indications. |
| Indications for Use (Non-Pedicle Screw System): - Scoliotic/kyphotic deformities (scoliosis, Schuermann's disease).
- Degenerative disc disease (back pain of discogenic origin).
- Fractures of posterior thoracolumbar spine.
- Linkage to CerviFix System with 3.5/6.0mm parallel connectors. | Device is intended for these uses, implying performance is equivalent to predicates for these indications. |
| Biocompatibility: Materials (stainless steel or titanium) are suitable for implantation. | Implied by use of standard implant materials (stainless steel, titanium). |
| Sterility: Device can be safely sterilized. | Not explicitly stated, but standard for implantable devices. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This submission relies on mechanical testing and substantial equivalence, not a clinical test set with patient data.
- Data Provenance: Not applicable for patient data. The "testing" mentioned is likely mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth typically refers to clinical diagnosis or outcome data; this document refers to mechanical performance.
4. Adjudication method for the test set
- Not applicable due to the nature of the submission (mechanical testing and substantial equivalence, not a clinical trial with human observers).
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. This is a physical medical device (spinal implant), not an AI/software device. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device.
7. The type of ground truth used
- For this 510(k), the "ground truth" for the device's performance is established by demonstrating equivalence to previously cleared predicate devices and by mechanical testing that satisfies established engineering requirements for spinal fixation. There is no biological or patient-specific "ground truth" described in the document.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.