(192 days)
When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.
When used as a posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2).
The overall levels of fixation for the Universal Sacral System as a whole are T8-S2. The levels of pedicle screw fixation are L3-S2.
The SYNTHES (U.S.A.) Universal Sacral System allows a screw to be connected to the rod through a wide array of screw/rod angles. It consists of a sacral screw assembly with a sacral collar a nut, and a rod. The assembly consists of a sacral screw, a rod/screw connector, and a locking ring. This system is to be used with the SYNTHES (U.S.A.) Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System.
The SYNTHES (U.S.A.) Universal Sacral System is manufactured from titanium alloy, which conforms to ASTM Standard F1295-92, and 316L stainless steel which conforms to ASTM Standard F138-86.
The Synthes Universal Sacral System is provided non-sterile; moist heat sterilization is recommended.
This document describes a medical device, the SYNTHES (U.S.A.) Universal Sacral System, and its substantial equivalence to other existing spinal fixation systems. It is not a study that presents acceptance criteria or device performance data in the typical sense of a clinical or analytical performance study for an AI/ML powered device.
Therefore, I cannot extract the information required by your prompts (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) because this type of information is not present in the provided text.
The document discusses:
- Device Name: SYNTHES (U.S.A.) Universal Sacral System
- Intended Use: For severe spondylolisthesis (Grades 3 and 4) of L5-S1, and as a non-pedicle screw system for scoliotic, lordotic, or kyphotic deformities, degenerative disk disease, and fractures of the posterior thoracolumbar spine (T8-S2). Pedicle screw fixation levels are L3-S2.
- Device Description: Allows a screw to connect to a rod through wide angles. Consists of a sacral screw assembly, sacral collar, nut, and rod. To be used with the SYNTHES (U.S.A.) Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System.
- Materials: Titanium alloy (ASTM F1295-92) and 316L stainless steel (ASTM F138-86).
- Comparison Devices: Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System Side Opening Screw and Transverse Bar, and the Sofamor Danek Texas Scottish Rite Hospital (TSRH) Pedicle Spinal Screw System Variable Angle Screw, and the Titanium TSRH Spinal System (Screws) Variable Angle Screw.
- Substantial Equivalence Claim: The SYNTHES (U.S.A) Universal Sacral System is substantially equivalent to the aforementioned comparison devices based on similar intended use, component dimensions, sizes, and materials.
- Sterilization: Provided non-sterile; moist heat sterilization is recommended.
There is no mention of an "acceptance criteria" table with reported device performance metrics in the context of an AI/ML algorithm's output. The "study" mentioned here is the comparison done for 510(k) clearance, asserting equivalence to predicate devices rather than proving performance against specific acceptance criteria using a test set, ground truth, or expert review as you've outlined. This document predates the widespread use of AI/ML in medical devices by decades (dated 1997).
§ 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.