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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.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer® Dynesys® Spinal System, including the Dynesys® Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers and polyethylene terephthalate (PET) cords.

The Dynesys® pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with hydroxyapatite (HA). The Dynesys® Spinal System is also cleared for connection with the Zimmer® DTO™ implant. The Zimmer® DTO™ implant allows the connection of the Dynesys® Spinal System to the OPTIMA™ZS Spinal System when the two systems are used on contiguous levels.

This document primarily concerns a 510(k) submission for the Zimmer® Dynesys® Top-Loading Spinal System. The purpose of this submission is not to introduce a new device or evaluate its clinical performance in a standalone study or against specific acceptance criteria related to a device's performance. Instead, it's an update focusing on:

• Instrument labeling changes.
• Identifying an alternative material vendor for a non-implanted component.

The submission explicitly states: "This submission does not make any modifications to the subject dynamic stabilization device." and "Since this submission focuses on the instruments, no performance testing was performed on the implants."

Therefore, many of the requested details about acceptance criteria, device performance tables, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth for clinical device performance are not applicable to this specific 510(k) submission.

However, the document does contain information about performance testing related to the changes being submitted.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: The underlying acceptance criteria for the original Dynesys® Top-Loading Spinal System (predicate device K092234) would have been established at that time, likely through mechanical testing and preclinical studies. For this submission, the acceptance criteria are related to validating the changes made (instrument design, material vendor for non-implanted parts). The general acceptance criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance:
  • Cadaver lab testing: "to evaluate human factors regarding the combination of instrument design changes as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate device."
  • Biocompatibility testing: "ensured the subject Dynesys® Top-Loading Spinal System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices."
  • Sterilization, Dry Time and Cleaning testing: "ensured the subject Dynesys® Top-Loading Spinal System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices for the instruments."

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

• Sample Size: Not specified for any of the tests mentioned (cadaver lab, biocompatibility, sterilization/cleaning).
• Data Provenance: Not specified. These are likely internal laboratory tests.

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)

• Not applicable as this submission does not involve clinical data or "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" here is the functionality and safety of the revised instruments and alternative material.

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

• Not applicable for the reasons stated above.

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 spinal fixation system, not an AI-powered diagnostic device.

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

• Not applicable for the reasons stated above.

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

• For the tests performed:
  • Cadaver lab: Functional performance and human factors assessment (likely by trained personnel/surgeons).
  • Biocompatibility: Adherence to established standards (e.g., ISO 10993).
  • Sterilization/Cleaning: Validation against predefined protocols and industry standards.
• The "ground truth" for this submission is whether the updated components/instruments meet engineering and regulatory standards and perform equivalently to the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML development.

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

• Not applicable.

Summary relevant to this submission:

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device (Dynesys® Top-Loading Spinal System, K092234) for the specific changes being made (instrument labeling and non-implant material vendor). The "study that proves the device meets the acceptance criteria" consists of:

• Cadaver lab testing: To validate instrument design changes and human factors, demonstrating equivalence.
• Biocompatibility testing: To ensure the materials remain biocompatible after manufacturing changes, demonstrating equivalence to standards.
• Sterilization, Dry Time and Cleaning testing: To ensure processing instructions remain equivalent and effective.

No specific quantitative "device performance" metrics or clinical studies are detailed in this summary because the submission explicitly states there are no changes to the implant itself or its functional scientific technology.

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