(148 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the GII Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The GII Spinal system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
The GII Spinal Fixation System implants are intended to be used as temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures, attaching longitudinal member to the spine by means of spinal anchors. The GII Spinal System is both a rod-based systems and a plate-based system designed on the same pedicular screw foundation. The longitudinal members consist of spinal rods or plates. The spinal anchors consist of pedicular screws. Transverse connectors are also included in the system to provide rigidity to the construct. Optional construct spacers are available to allow better seating of the plates or connectors onto the pedicular screws as well as poliaxiality.
The provided text describes a medical device, the GII Spinal Fixation System, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the context of typical AI/software performance evaluation.
Instead, the document focuses on regulatory equivalence to predicate devices, device description, and indications for use. The "Performance Characteristics" section explicitly states: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." This indicates an engineering-based performance assessment for mechanical equivalence, not a clinical or AI-driven performance study comparing outputs to a ground truth or human readers.
Therefore, I cannot provide the requested information from the provided text for most of the points.
Here's what I can extract and what is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of clinical or AI performance metrics. The underlying acceptance criteria for this type of device (spinal fixation system) would typically relate to mechanical strength, fatigue life, biocompatibility, and sterilization, demonstrating equivalence to predicate devices.
- Reported Device Performance: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." No specific numerical performance values (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not present. The document describes mechanical tests, not a clinical performance study with a 'test set' of data in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not present. Ground truth establishment by experts is relevant for clinical or diagnostic AI systems, not for a spinal fixation system's mechanical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present.
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
- Not applicable / Not present. This device is a physical implant, not an AI diagnostic tool that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not present. For mechanical testing, the "ground truth" would be established engineering standards (e.g., ASTM or ISO standards for spinal implants) and direct measurement of mechanical properties, rather than clinical ground truth types.
8. The sample size for the training set
- Not applicable / Not present. This device is not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not present.
In summary, the provided document is a 510(k) summary for a physical medical device (spinal fixation system) and discusses its regulatory clearance based on substantial equivalence to predicate devices, primarily substantiated by mechanical performance tests (Static and Fatigue tests). It does not contain the characteristics of a study for evaluating AI or software performance as requested in your prompt.
§ 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.