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The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis)
In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors. The titanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided.

This 510(k) premarket notification for the Altiva HydraLok™ System does not contain specific acceptance criteria or details of a comprehensive study proving the device meets acceptance criteria related to its performance characteristics (e.g., strength, durability, biomechanical stability).

The document states, "Performance data were submitted to characterize the HydraLok System." However, the actual performance data, acceptance criteria for that data, and the study design are not provided within this summary.

Based on the provided information, I cannot complete the requested tables and descriptions because the document primarily serves as a regulatory submission summary rather than a detailed performance study report.

Here's what can be inferred from the document regarding the type of data submitted, but not the specifics:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available from the provided text. The document only states that "Performance data were submitted to characterize the HydraLok System." No specific criteria or reported performance values are given.

2. Sample size used for the test set and the data provenance

• Not available from the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This specific type of "ground truth" establishment is typically relevant for AI/diagnostic devices, not for a spinal fixation system, unless the performance data involved human assessment of biomechanical outcomes, which is not indicated here.

4. Adjudication method

• Not applicable. See point 3.

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 mechanical device, not an AI or diagnostic tool where human reader performance would be enhanced by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical device.

7. The type of ground truth used

• Not applicable. For a mechanical device, performance is typically evaluated against engineering specifications, material properties, and biomechanical testing standards, rather than "ground truth" derived from expert consensus, pathology, or outcomes data in the way AI/diagnostic devices are.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI system that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Summary of available information:

The document is a 510(k) summary for a medical device called the "HydraLok™ System," a pedicle screw spinal fixation system. It outlines the company, contact, date, trade name, common name, classification, device description, intended use, and predicate device information. It explicitly states that "Performance data were submitted to characterize the HydraLok System," which is a mandatory part of a 510(k) submission to demonstrate substantial equivalence to a predicate device. However, the details of that performance data, including specific acceptance criteria, test results, study methodology, sample sizes, and how ground truth was established, are not contained within this summary document.

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