(77 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), 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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
The Synthes USS Connector is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are rod-to-rod connectors which can connect spinal rods of 5.5mm diameter. The rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).
This document describes the 510(k) summary for the Synthes USS Connector, a spinal fixation device. It details the device's intended use, indications for use, and performance data.
Here's an analysis of the provided information, framed as acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence (Overall Safety & Effectiveness): | The Synthes USS Connector is considered "substantially equivalent" to predicate devices. |
| Mechanical Performance (Static Compression Bending): Device withstands static compression bending. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes static compression bending. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Mechanical Performance (Dynamic Compression Bending): Device withstands dynamic compression bending. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes dynamic compression bending. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Mechanical Performance (Static Torsion): Device withstands static torsional forces. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes static torsion. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Material Biocompatibility: Materials are safe for implantation. | The device is comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), which is a commonly used and accepted biocompatible material for spinal implants. |
Study used to prove device meets acceptance criteria:
The study proving the device meets the acceptance criteria is described as non-clinical testing conducted according to ASTM F1717-10. This standard covers "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the non-clinical testing (e.g., number of connectors tested). It only mentions "non-clinical testing."
Data Provenance: Not applicable, as this was non-clinical (mechanical) testing, not human-subject or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not by expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical outcomes, not for objective 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 MRMC comparative effectiveness study was done. This document describes a spinal implant, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used
The ground truth used for mechanical performance testing is the specifications and requirements outlined in ASTM F1717-10. The acceptance criterion for mechanical performance is that the device demonstrates mechanical characteristics (strength, fatigue resistance) that are "substantially equivalent" to predicate devices, as measured against the forces described in the ASTM standard.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for the mechanical testing of a physical medical device. This is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.