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510(k) Data Aggregation
(91 days)
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
This document is a 510(k) premarket notification for the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against specific metrics in the way a clinical trial or algorithm performance study would.
However, based on the provided text, I can extract the relevant information regarding performance testing and regulatory acceptance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Compression Bending | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. |
| Static Torsion | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. | |
| Dynamic Compression Bending | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. | |
| Regulatory Compliance | General Controls Provisions of the Act | Compliance with annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration. | FDA determined the device is substantially equivalent and can be marketed subject to general controls provisions of the Act. |
| Special Controls (for Class II/III) | Compliance with relevant Class III regulations and potentially further announcements. | Device is Class III. FDA advises it "may be subject to additional controls." |
Explanation of "Acceptance Criteria (Implicit)": The document states that the performance testing "indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices..." This implies that the acceptance criteria for these mechanical tests were that the device's performance met or exceeded the performance of the predicate device, as demonstrated through the specified ASTM standard. The FDA's issuance of the 510(k) clearance acts as the ultimate regulatory acceptance.
2. 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 in the document. The document refers to "testing performed" but does not detail the sample sizes for the mechanical tests (e.g., number of screws, rods tested) or the methodology of how these samples were selected. The nature of these tests (mechanical performance of a physical device) typically involves in-vitro lab testing, not human subject data. Therefore, questions of "country of origin of the data" or "retrospective/prospective" are not applicable in this context.
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 is not applicable and not provided in the document. This device is a physical pedicle screw system, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The "ground truth" for this device's performance is established by standardized mechanical testing methods (ASTM F1717).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or AI performance evaluations involving human interpretation. The testing described here is mechanical and objective.
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 is not applicable and not provided in the document. An MRMC study is relevant for AI-powered diagnostic or assistive devices. This document describes a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided in the document. This question pertains to AI algorithms, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is established by the results of standardized mechanical testing according to ASTM F1717. This standard provides objective, quantifiable metrics for the structural integrity and performance of pedicle screw systems. Essentially, the "truth" is adherence to established engineering and biomechanical principles and performance benchmarks defined by the standard.
8. The sample size for the training set
This is not applicable and not provided in the document. Training sets are relevant for machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence.
9. How the ground truth for the training set was established
This is not applicable and not provided in the document, for the same reasons as point 8.
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(130 days)
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous.bone graft for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for mono- and multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
The provided text describes a 510(k) summary for the "Spartek™ Variable Angle Pedicle Screw Posterior Fusion System." This document is a premarket notification for a medical device and, as such, outlines the device's intended use, description, and comparison to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of AI/software performance studies.
Therefore, the requested information elements related to a study proving device meets acceptance criteria, such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this type of regulatory submission for a physical medical device like a pedicle screw system. These elements are typically found in submissions for diagnostic AI/ML software or other assessment tools.
Here's how the available information from the document translates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, "acceptance criteria" are typically defined by recognized standards (like ASTM F1717) for mechanical performance and a demonstration of substantial equivalence to existing predicate devices. The "reported device performance" is its ability to meet these standards and be equivalent.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | Static Compression Bending (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. |
| Static Torsion (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. | |
| Dynamic Compression Bending (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. | |
| Other special controls (not explicitly detailed in the summary) | Device tests indicate substantial equivalence to predicate devices. | |
| Substantial Equivalence | Same Indications For Use as predicate devices | Device has the same indications for use as predicate devices. |
| Similar Design, Function, and Materials as predicate devices | Device has similar design, function, and materials as predicate devices. |
2. Sample size used for the test set and the data provenance
Not Applicable. This is a physical medical device. Testing involved mechanical characterization of device components and assemblies, not a "test set" of patient data in the context of an AI/software study. The data provenance would be laboratory testing results, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. Ground truth, in the context of this device, is established by adherence to engineering standards and mechanical testing results, not by expert medical image interpretation or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As there is no "test set" in the sense of patient cases needing interpretation, there is no adjudication method.
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. This is a physical orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a physical device like a pedicle screw system, the "ground truth" for proving performance typically refers to:
- Compliance with recognized industry standards (e.g., ASTM F1717 for spinal implant mechanical testing).
- Demonstration of mechanical integrity and strength under simulated physiological loads.
- Confirmation of biocompatibility (though not detailed in this summary).
- Verification of design specifications and material properties.
The summary explicitly states: "Testing performed indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices as demonstrated through static compression bending, static torsion, and dynamic compression bending as described in ASTM F1717, and other special controls." This indicates that the ground truth for mechanical performance was adherence to the ASTM F1717 standard.
8. The sample size for the training set
Not Applicable. This is a physical medical device, not an AI/ML model that is "trained."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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