(99 days)
When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;
- DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine.
The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.
The S4 Spinal System is a medical device for spinal fusion. The 510(k) summary provided does not contain explicit acceptance criteria or the details of a study proving the device meets said criteria in the format requested. Instead, it indicates that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' was completed where applicable."
Therefore, I cannot provide a direct answer to your request in the specified format from the provided text excerpt. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with acceptance criteria.
However, I can extract information related to what aspects were considered for the 510(k) clearance, which implicitly implies that the device is expected to meet the performance standards set by the predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text. The document states that "All required testing per [guidance document] was completed where applicable." This implies that standard tests relevant to orthopedic devices were performed, but the specific acceptance criteria for each test and the numerical performance results are not detailed.
2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "testing" but does not specify the sample sizes or the nature of the data (e.g., in vitro, in vivo, clinical trial, retrospective, prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. Since the document does not describe a clinical study with a "test set" requiring ground truth established by experts, this detail is absent.
4. Adjudication method for the test set:
This information is not provided in the given text. As there is no described clinical study, an adjudication method for a test set is not mentioned.
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 information is not provided in the given text. The S4 Spinal System is a mechanical implant, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant to this device and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given text. As the device is a spinal implant, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
7. The type of ground truth used:
This information is not explicitly provided in the given text. Given that the clearance is based on substantial equivalence to predicate devices and adherence to general guidance for orthopedic devices, the "ground truth" would likely be derived from established biomechanical testing standards, material property tests, and the clinical history and performance of the predicate devices.
8. The sample size for the training set:
This information is not provided in the given text. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to this device as described.
9. How the ground truth for the training set was established:
This information is not provided in the given text, for the same reason as point 8.
Summary of available information regarding performance:
- Performance Data: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' were done where applicable." This indicates that the device underwent mechanical and material testing to demonstrate its safety and effectiveness, consistent with regulatory requirements for similar orthopedic implants.
- Substantial Equivalence: The S4 Spinal System is deemed substantially equivalent in design to the following predicate devices:
This means that the S4 Spinal System's performance characteristics are considered comparable to these cleared devices, implying that it meets similar performance expectations and safety profiles. The specific "acceptance criteria" for the S4 Spinal System would therefore align with those established for its predicate devices and the relevant FDA guidance.
§ 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.