(102 days)
The Synthes USS (including Matrix, USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS liiosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle scew fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix), can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS Hibsacral, and ClampFix).
In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Fracture, Polyaxial, USS Iliosacral, and ClampFix) can be interchanged with all USS 6.0 mm ods and transconnectors.
The Synthes Matrix MIS Rods are spinal rods to be used as part of the Synthes Matrix System of posterior pedicle screw fixation implants. The titanium rods are available straight or curved in two bend radii and a range of lengths. The Synthes Matrix MIS rods are to be implanted via a minimally invasive approach.
The Synthes Matrix MIS Rods are intended to be used with the Synthes Matrix System Implants. The Synthes Matrix Implants consist of a family of non-cervical spinal fixation devices intended for use as a posterior pedicle screw fixation system (T1-S2), posterior hook fixation system (T1-L5) or anterolateral fixation system (T8-L5).
The provided document is a 510(k) premarket notification for a medical device called "Synthes Matrix MIS Rods," a spinal rod system. It is important to note that this document is for a physical medical device, not an AI/ML-driven device or software. Therefore, the questions related to AI/ML performance metrics, ground truth, experts, and training sets are not applicable to this submission.
The acceptance criteria and supporting study are described in terms of non-clinical performance to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in design | The Synthes Matrix MIS Rods are modifications to the design of predicate devices but are substantially equivalent in design. |
| Substantial equivalence to predicate devices in function | The Synthes Matrix MIS Rods are modifications to the surgical technique of predicate devices but are substantially equivalent in function. |
| Substantial equivalence to predicate devices in material | The Synthes Matrix MIS Rods utilize materials that are substantially equivalent to those of predicate devices (titanium rods mentioned, which is common for spinal implants). |
| Substantial equivalence to predicate devices in intended use | The Synthes Matrix MIS Rods have an intended use that is substantially equivalent to predicate devices. The document details indications for use such as posterior pedicle screw fixation, posterior hook fixation, and anterolateral fixation for various spinal conditions. |
| Non-Clinical Performance demonstrating substantial equivalence | "The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices." (Exact tests are not detailed in this summary, but would typically include mechanical testing, biocompatibility, and sterilization validations for physical implants). |
| Clinical performance (Not required for this device) | "Clinical data and conclusions were not needed for this device." |
2. Sample sized used for the test set and the data provenance
- Not Applicable: This is a physical medical device. The "test set" would refer to non-clinical performance testing of the device hardware. The document states "The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices," implying successful completion of required non-clinical tests, but it does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: As a physical medical device, there is no "ground truth" established by experts in the context of an AI/ML system's diagnostic or predictive performance. Substantial equivalence for this type of device is determined by comparing its technical characteristics and performance to legally marketed predicate devices, typically through engineering and biocompatibility testing, not expert consensus on data interpretation.
4. Adjudication method for the test set
- Not Applicable: There is no adjudication method for a "test set" in the context of an AI/ML system. The assessment for this physical device relies on engineering tests and regulatory review against predicate devices.
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 a physical spinal rod system, not an AI-assisted diagnostic or treatment device. Therefore, MRMC studies and "human readers improving with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm or software.
7. The type of ground truth used
- Not Applicable: For this physical device, "ground truth" in the AI/ML sense (e.g., pathology, outcomes data) is not used. The "truth" for this device's acceptance is its demonstrated substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical strength, biocompatibility).
8. The sample size for the training set
- Not Applicable: This is a physical medical device; there is no training set as would be used for an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set or associated ground truth for this physical medical 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.