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510(k) Data Aggregation
(89 days)
The Zavation Spinal System is a pedicle screw system intended to provide immobilization 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: degenerative spondylolisthesis with objective evidence of neurological imparment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.
This submission describes a medical device, the Zavation Spinal System, which is a pedicle screw system. The provided text outlines the device's indications for use, materials, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically proves a device meets acceptance criteria in the context of an AI/ML medical device.
In the context of the provided text, the "acceptance criteria" for this traditional medical device are primarily related to its mechanical performance and substantial equivalence to legally marketed predicate devices, not performance metrics for an AI/ML algorithm. The "study" refers to mechanical testing.
Here's the breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for substantial equivalence of a traditional medical device) | Reported Device Performance |
|---|---|
| Mechanical Performance (Static compression bending, torsion, and dynamic compression bending) according to ASTM F1717. | "The mechanical test results demonstrated substantial equivalency to the predicate device." |
| Substantial Equivalence to Predicate Devices regarding technological characteristics, performance, and intended use. | "The Zavation Spinal System possesses the same technological characteristics as the predicate devices. These include: basic design (rod based fixation system having polyaxial pedicle screws with various screw and rod diameters and lengths), material (titanium alloy), mechanical safety and performances, and intended use (as described above). The Zavation Spinal System devices are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices." |
The following information is NOT available in the provided text as it pertains to AI/ML device studies, which this submission is not.
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 provided. This is a traditional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices tested mechanically.
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 provided. The "ground truth" for this device's performance is established through mechanical testing standards (ASTM F1717) and comparison to predicate device characteristics, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This method is used for resolving discrepancies in expert labeling of data, which is not relevant to mechanical testing.
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 provided. This is specific to AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is specific to AI/ML device performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the mechanical testing, the "ground truth" is defined by the established ASTM F1717 standard for spinal implant mechanical performance. For substantial equivalence, the "ground truth" is the characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. This is a traditional medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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