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510(k) Data Aggregation
(81 days)
The Everest Spine Galleon Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
The Everest Spine Galleon Pedicle Screw System consists of longitudinal rods, polyaxial screws, and cross connectors. The Everest Spine Galleon Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.
The provided document describes the Galleon Pedicle Screw System, a medical device. The acceptance criteria and the study proving the device meets these criteria are outlined in section "7. Performance Testing".
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable function to predicate device | "demonstrate comparable function" |
| Comparable performance characteristics to the predicate device | "demonstrate comparable performance characteristics" |
| Performed in accordance with ASTM F1717 | "completed in accordance with ASTM F1717" |
| Withstand bending stress (implied) | The longest pedicle screw (SE-112-CA-5.75 55mm) was tested to "provide greatest potential for bending stress". |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated as a numerical value for number of screws. It mentions "Representative samples of the device".
- Data provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The testing was conducted by or for Everest Spine LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study described is a mechanical performance test, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication method for the test set
This information is not applicable as the study is a mechanical performance test, not a study requiring adjudication of expert opinions.
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 information is not applicable as the study is a mechanical performance test, not an MRMC study related to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the study is a mechanical performance test, not an algorithm performance study.
7. The type of ground truth used
The concept of "ground truth" as typically applied in diagnostic studies (e.g., expert consensus, pathology) is not directly applicable to this mechanical performance test. The "ground truth" here is the physical behavior of the device under specific, standardized test conditions defined by ASTM F1717 and compared against the benchmark of the predicate device's performance under similar conditions.
8. The sample size for the training set
This information is not applicable as the study is a mechanical performance test and does not involve training a model or algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the study is a mechanical performance test and does not involve training a model or algorithm.
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