(167 days)
When used as a pedicle screw fixation system, the Eisertech Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
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Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
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Degenerative spondylolisthesis with objective evidence of neurologic impairment
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- Fracture
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- Dislocation
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- Scoliosis
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- Kyphosis
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- Spinal tumor and/or
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- Failed previous fusion (pseudoarthrosis)
The Eisertech Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies)
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- Spinal stenosis
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- Spondylolisthesis
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- Spinal deformities
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- Fracture
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- Pseudoarthrosis
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- Tumor resection and/or
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- Failed previous fusion
The Eisertech Spinal System consists of a variety of polyaxial screws, rods, hooks, locking nuts, and rod-to-rod connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. All components are made of titanium allow per ASTM F136.
This document is a 510(k) premarket notification decision letter from the FDA for the "Spinal System" device by Eisertech, LLC. It outlines the regulatory classification, indications for use, and a summary of non-clinical tests conducted to establish substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a tabular format as performance metrics for a diagnostic or AI device. Instead, it details mechanical testing performed on the Spinal System to demonstrate its safety and effectiveness relative to a legally marketed predicate device.
Acceptance Criteria (Implied from Mechanical Testing Standards):
| Acceptance Criteria Category | Specific Test / Standard | Acceptance Outcome (Reported Device Performance) |
|---|---|---|
| Static Strength - Bending | ASTM F1717 - Static Compression Bending | Device passed, demonstrating substantial equivalence to the predicate. |
| Static Strength - Torsion | ASTM F1717 - Static Torsion | Device passed, demonstrating substantial equivalence to the predicate. |
| Dynamic Strength - Bending | ASTM F1717 - Dynamic Compression Bending | Device passed, demonstrating substantial equivalence to the predicate. |
| Interconnection Strength - Pull-off | (Not a specific ASTM F1717 component, but a custom test for tulip/screw shank) | Device passed, demonstrating substantial equivalence to the predicate. |
| Interconnection Strength - Static Torsion | (Custom test for tulip/screw shank) | Device passed, demonstrating substantial equivalence to the predicate. |
| Interconnection Strength - Dynamic Torsion | (Custom test for tulip/screw shank) | Device passed, demonstrating substantial equivalence to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to mechanical testing of a physical device, not a test set of data. Therefore, concepts like sample size for a test set of data, country of origin, or retrospective/prospective data provenance are not applicable in this context. Mechanical testing typically involves a number of physical samples (e.g., individual screws, rods, or assembled constructs) to ensure statistical validity of the results, but the exact number of samples used for each mechanical test is not specified in this summary.
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)
This question is not applicable. The "ground truth" for a mechanical implant like the Spinal System is established by engineering standards and physical measurements, not by expert consensus on clinical images or data. The "experts" involved would be mechanical engineers and quality control personnel following established test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., image reading). For mechanical testing, the results are derived from objective measurements against defined pass/fail criteria, not subjective interpretations requiring adjudication.
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 question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Spinal System is a physical implant, not an AI diagnostic tool, so such a study would not be performed for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention. The Spinal System is a physical medical device, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance of the Spinal System is based on:
- Established engineering standards: Specifically, ASTM F1717 for static and dynamic testing of spinal implant constructs.
- Physical measurements and defined tolerances: The device components and assembled constructs must meet specific strength, stiffness, and fatigue resistance criteria as outlined in the relevant ASTM standards or internal design specifications.
8. The sample size for the training set
This question is not applicable. "Training set" refers to data used to train an AI model. The Spinal System is a physical medical device, and its performance is evaluated through mechanical testing, not by training an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.