(100 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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), tumor, 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 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).
The document describes the K113149 510(k) submission for the Synthes USS Line Extension (connectors), which are non-cervical spinal fixation devices.
Here's an analysis of the provided text with respect to your questions:
1. Table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Substantially equivalent to predicate devices (Synthes USS, K962608; Synthes USS, K963045; Synthes Click'X, K992739; Synthes Click'X, K031175; Synthes USS Illiosacral and Polyaxial, K082572; Synthes Matrix System, K092929; Synthes Matrix System, K100634; Synthes Matrix System, K100952; Synthes 6.0 CoCr and CP Ti-3 Rods, K103287) | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
| Static Torsion | Substantially equivalent to predicate devices | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
| Dynamic Compression Bending | Substantially equivalent to predicate devices | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
Explanation: The acceptance criteria are implicitly met if the "non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified" was successful. The document states that the testing was conducted "to determine" this, and the FDA's clearance implies the substantial equivalence was demonstrated.
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the specific sample sizes (number of devices tested) for the non-clinical tests. It refers to "non-clinical testing according to ASTM F1717-10". ASTM F1717-10 is a standard for testing spinal implant constructs, and it would specify the required number of samples for each test type. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the data is not specified, but the firm (Synthes Spine) is located in West Chester, PA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is based on the physical properties and performance measured against a standard (ASTM F1717-10), not on expert consensus or human interpretation.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of medical images or patient outcomes, not for mechanical bench 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
This question is not applicable. MRMC studies are relevant for AI-powered diagnostic or interpretive devices that assist human readers (e.g., radiologists). This submission concerns a physical medical device (spinal connectors), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The ground truth used for these non-clinical tests is the performance metrics defined by the ASTM F1717-10 standard and the performance characteristics of the identified predicate devices. The new device's performance is compared against these established benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical bench testing for spinal implants. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
§ 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.