(481 days)
The Spinal Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
The Spinal Fixation System consists of screws, rods, transverse bar assembly, set screws. It is made of titanium Alloy (Ti6AI4VELI), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
This document is a 510(k) summary for a medical device (Spinal Fixation System) and outlines its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-assisted system's performance, as the request implies.
The document discusses substantial equivalence for a spinal fixation system, which is a medical implant, not an imaging or diagnostic device. The "acceptance criteria" discussed are related to performance testing verifying the physical properties and safety of the implant, not the diagnostic accuracy of an algorithm.
Therefore, I cannot provide the information requested based on the provided text. The prompt asks for details about a study proving a device meets acceptance criteria, specifically on aspects like sample size, ground truth, expert adjudication, MRMC studies, and training set details, which are relevant to diagnostic or AI-based devices. The provided document concerns a physical implant called a "Spinal Fixation System" and its regulatory clearance via a 510(k) submission, demonstrating substantial equivalence to a predicate device based on material, intended use, and mechanical testing.
The document does not contain information about:
- A table of acceptance criteria for diagnostic performance.
- Sample sizes for test sets in a diagnostic context.
- Number of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document focuses on:
- Device Description: Made of titanium alloy, non-sterile, sterilized via autoclave.
- Intended Use: Posterior, non-cervical, pedicle fixation for specific spinal conditions.
- Technological Characteristics Comparison: Comparing the subject device (Spinal Fixation System) to a predicate device (General Spinal System K122994) in terms of product code, regulation, intended use, material, test items (static compression bending, static torsion, dynamic compression bending), test standard (ASTM F1717), how supplied, sterilization method, single use, and prescription/OTC use.
- Performance Data: Mentions "sterility and performance testing" and "Test data and report information are included in this submission," but does not detail the specific acceptance criteria or results of these tests in the provided text. These tests would typically involve mechanical strength, fatigue, and material biocompatibility, not diagnostic accuracy.
To answer your question, information relevant to diagnostic or AI-assisted devices would need to be present in the provided text, which it is not.
§ 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.