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The Orthobiom™ Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.

The Orthobiom™ Spinal System is intended to be used with bone graft.

The Orthobiom™ Spinal System is designed as a pedicle screw based system. The system consists of rods, pedicle screws, fixed connectors, and one cross connector. The Orthobiom™ Spinal System uses rods, screws, and/or hooks to achieve correction and subsequent maintenance of the corrected scoliotic spine and use fusion to maintain the corrected spine.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified. This submission focuses on mechanical equivalency rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is based on established engineering standards and comparisons to predicate devices, not expert human interpretation.

4. Adjudication method for the test set: Not applicable. This is 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: Not applicable. This is a medical device for spinal surgery, not an AI-powered diagnostic or interpretive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used: Mechanical testing standards and performance data of existing predicate devices. The "ground truth" for this submission is the established mechanical performance of legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This submission describes testing for a physical device, not an AI or machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Study Proving Device Meets Acceptance Criteria:

The provided document, K071663, is a 510(k) premarket notification for the Orthobiom™ Spinal System. The primary method used to demonstrate that the device meets acceptance criteria is through performance testing showing its mechanical equivalence to predicate devices.

The document states: "Performance Standards: Testing performed indicate that the Orthobiom™ Spinal System is as mechanically sound as predicate devices."

While the specific details of these "testing" are not included in the provided text (e.g., what specific tests were performed, the number of samples, or the results in quantitative terms), the FDA's clearance (JUL - 2 2008 letter) indicates that they reviewed this testing data and found the device substantially equivalent.

The study is essentially a benchtop mechanical testing study comparing the Orthobiom™ Spinal System to its identified predicate devices: Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916). The acceptance criterion is an implicit one: the Orthobiom™ system must demonstrate comparable mechanical properties (e.g., strength, fatigue resistance, torsional stability) to these predicate devices to be considered "as mechanically sound."

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