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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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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesvs Spinal System is intended to provide immobilization 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 spondy|olisthesis 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 ceramic 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 is a 510(k) summary for a medical device (Zimmer Dynesys Top-Loading Spinal System), not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in AI/ML performance studies.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily based on design, materials, and intended use, rather than clinical performance metrics that would be assessed for an AI/ML system.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device

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 ceramic 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 is a 510(k) summary for the Zimmer® Dynesys® Top-Loading Spinal System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study demonstrating performance is not present in this type of regulatory submission.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

• Not available in this document. A 510(k) submission for a spinal fixation system primarily focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparable design, materials, function, and intended use, rather than presenting detailed performance acceptance criteria and results from a clinical or laboratory study with quantitative metrics. Performance data for such devices typically involves mechanical testing (e.g., fatigue, static strength) to ensure safety and functionality, but these specific criteria and results are not detailed in this summary.

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

• No specific sample size for a test set is provided. This document does not describe a clinical study or a specific test set. The evaluation is based on a comparison to predicate devices.
• Data provenance is not applicable as there is no specific data set described that would have a country of origin or be classified as retrospective/prospective.

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. There is no mention of a test set requiring expert-established ground truth.
• The "experts" involved would be the regulatory reviewers at the FDA and the engineers/scientists at Zimmer Spine who assessed the substantial equivalence.

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

• Not applicable. There is no test set or adjudication method described.

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 device is a spinal implant, not an AI or imaging diagnostic tool. An MRMC study is irrelevant to this product.

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

• Not applicable. This device is a medical implant, not an algorithm.

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

• Not applicable in the context of an AI/diagnostic study. For this medical device, the "ground truth" for its safety and effectiveness is established through compliance with regulatory standards, mechanical testing (not detailed here), and demonstrated substantial equivalence to predicate devices which have a history of safe and effective use. The FDA's review process ultimately determines if the device is substantially equivalent based on these factors.

8. The sample size for the training set

• Not applicable. This device is a medical implant, not an AI model, so there is no "training set."

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

• Not applicable. As above, there is no training set mentioned.

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