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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; .
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• Who are having the device removed after the development of a solid . fusion mass.

The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonateurethane). The pedicle screws are provided with or without hydroxyapatite coating.

The provided text describes a 510(k) summary for the Dynesys® Spinal System, focusing on the addition of hydroxyapatite coated pedicle screws. The submission seeks to demonstrate substantial equivalence to previously cleared Dynesys® Spinal System devices.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to predicate devices. The performance reported is that "there are no fundamental technological differences" and that the new components are "substantially equivalent ... based on intended use, design, and function" to the original Dynesys® Spinal System pedicle screw components.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Testing and analysis of proposed hydroxyapatite coated pedicle screw components." However, it does not specify the sample size used for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This submission appears to be based on bench testing and analysis rather than clinical data from a human test set.

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)

This information is not provided in the document. Given that the submission focuses on demonstrating substantial equivalence through technological characteristics and intended use, and likely involves bench testing, the concept of "ground truth" as established by medical experts for a diagnostic or clinical test set is not directly applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. As noted above, the submission does not seem to involve a clinical test set requiring adjudication of findings by multiple experts.

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

No MRMC comparative effectiveness study was done. This device is a spinal fixation system, not a diagnostic imaging device with an AI component.

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

This is not applicable. The Dynesys® Spinal System is a medical device (spinal implant), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant to this 510(k) submission. The "truth" in this context is established through engineering principles, material science testing (e.g., mechanical properties, biocompatibility), and comparison to the design and performance of the predicate device, rather than clinical outcomes or expert consensus on medical images. The core ground truth for this submission is whether the new components are materially and functionally similar to the existing, cleared components.

8. The sample size for the training set

This is not applicable. The Dynesys® Spinal System is a medical device, not an AI model, and therefore does not have a "training set."

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

This is not applicable. As there is no AI model or training set, this question is not relevant.

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