(140 days)
The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
The Adena-Zina System consists of a variety of a variety of shapes and sizes of screws and 5.5 and 6.35 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, fixed angle reduction screws, multi-axial and multiaxial reduction screws, T-links, domino connectors, and sacro-illiac connectors.
This document describes a 510(k) premarket notification for the Adena-Zina System, a pedicle screw spinal system. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a novel clinical study with acceptance criteria in the way a new drug or a more complex diagnostic device might.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically regarding device performance and human interpretation, is not applicable in the context of this 510(k) summary for a pedicle screw spinal system. This document primarily describes mechanical performance testing against established standards.
However, I can extract and present the information that is available concerning performance testing and the comparison to a predicate device.
Summary of Device Performance Testing (Not Acceptance Criteria in the context of a clinical study for AI/diagnostic devices):
The Adena-Zina System underwent mechanical performance testing to demonstrate its substantial equivalence to a predicate device.
| Test Type | Standard | Reported Device Performance |
|---|---|---|
| Static Compression Bending | ASTM F1717-12 | Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System) |
| Static Torsion | ASTM F1717-12 | Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System) |
| Fatigue Compression Bending | ASTM F1717-12 | Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System) |
| Axial Grip Testing | ASTM F1798-13 (for connectors) | Meets or exceeds performance of the predicate device (K123809 – Medtronic CD Horizon Spinal System) |
Regarding the specific questions posed:
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A table of acceptance criteria and the reported device performance:
- As shown in the table above, the "acceptance criteria" here are defined by meeting or exceeding the performance of the predicate device for specified mechanical tests according to ASTM standards. There are no specific quantitative acceptance criteria listed in this summary, but rather a comparative statement.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided. The testing described is mechanical bench testing of components, not clinical data from patients. The manufacturer is Shanghai Sanyou Medical Company, Limited (China).
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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. This is mechanical testing against engineering standards, not expert-based clinical ground truth assessment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical bench testing.
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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. This is a medical device (implantable system) for spinal fixation, not an AI software or diagnostic imaging device that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this type of submission is adherence to recognized industry standards (ASTM F1717-12, ASTM F1798-13) and comparable performance to a legally marketed predicate device (Medtronic CD Horizon Spinal System, K123809).
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence for this type of device.
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How the ground truth for the training set was established:
- Not applicable.
In conclusion: The provided document is a 510(k) summary for an orthopedic implant. The "performance testing" described refers to mechanical bench testing conducted to demonstrate that the device is substantially equivalent to a predicate device in terms of engineering characteristics. It does not involve clinical studies, human readers, or AI algorithms typically associated with the "acceptance criteria" and "study" questions posed.
§ 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.