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510(k) Data Aggregation
(29 days)
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system.
The provided text describes a 510(k) premarket notification for a line extension to the Array® Spinal System, a spinal fixation device.
Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Specifications for Mechanical Performance | "Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance." The design requirements were based on those of previously cleared predicate devices. |
| Safety and Effectiveness | "these technological differences do not present any new issues of safety or effectiveness." (This is a conclusion reached from the performance testing and comparison to predicate devices, rather than a direct measurement of "safety" and "effectiveness" as quantitative criteria.) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human subject studies. The performance testing was mechanical in nature. Therefore, information regarding sample size for a test set of patients and data provenance (country of origin, retrospective/prospective) is not applicable here as it appears to be a benchtop mechanical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is mechanical performance testing comparing the new device to predicate devices, not a clinical study requiring expert ground truth for patient data.
4. Adjudication method for the test set
This information is not applicable for the same reasons as above.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
An MRMC study was not done. The study described is mechanical performance testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a spinal fixation system, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the mechanical performance testing would be the design specifications and performance characteristics of the predicate devices. The new device's performance was evaluated against these established benchmarks.
8. The sample size for the training set
The document does not refer to a "training set" in the context of machine learning or AI. For mechanical testing, the equivalent would be the number of components or assemblies tested, which is not specified in the provided text.
9. How the ground truth for the training set was established
For mechanical testing, the "ground truth" (i.e., the acceptable performance levels) was established based on "requirements established in design specifications for its mechanical performance," which were "established based on those of the previously cleared predicate devices."
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