Search Results

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.

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. .

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 (polycarbonate-urethane).

The K043565 510(k) submission for the Dynesys® Spinal System describes the device and its intended use, but it does not include acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

This document pertains to a traditional medical device (spinal fixation system) and its substantial equivalence to a predicate device, rather than an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this submission.

The relevant information from the provided text focuses on the comparison of technological characteristics for additional screw components to the existing Dynesys Spinal System, establishing substantial equivalence based on materials, design, and function.

Table of Acceptance Criteria and Reported Device Performance:

Answers to Specific Questions (based on the provided text for a non-AI/ML device):

1. A table of acceptance criteria and the reported device performance: As shown above, specific performance metrics or acceptance criteria for an AI/ML component are not present. The "performance" described is the finding of substantial equivalence of additional screw components to the predicate device based on material, design, and function.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This submission concerns a physical medical device (spinal fixation system), not an AI/ML device requiring a test set of data. The testing mentioned refers to mechanical or physical characteristics of the screw components.

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. No "ground truth" in the context of an AI/ML diagnostic or predictive model is established in this submission. The evaluation is based on engineering and design principles, and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the AI/ML sense to be adjudicated.

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. No AI component is described, so no MRMC study with AI assistance would have been conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm mentioned in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's substantial equivalence is the existing, legally marketed predicate device, and the engineering principles and standards applied to the new components.

8. The sample size for the training set: Not applicable. There is no AI/ML model that would require a training set.

9. How the ground truth for the training set was established: Not applicable. No training set is associated with this device submission.

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 neurological impairment, kyphosis, 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; a)
• b) Who are having the device fixed or attached to the lumbar or sacral spine; and
• c) Who are having the device removed after the development of a solid fusion mass.

The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.

This document is a 510(k) Pre-Market Notification for the DYNESYS® Spinal System. It is an application for regulatory clearance, claiming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. It states that "Establishment of equivalence is based on similarities of intended use, design, and performance characteristics" to the predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document does not describe a clinical study with adjudication.

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 document is for a medical device (spinal system), not an AI-assisted diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This document does not discuss a clinical study with ground truth. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model that would have a training set.

9. How the ground truth for the training set was established:
Not applicable. This document describes a medical device, not a machine learning model.

Additional relevant information from the document:

• Device Name: DYNESYS® Spinal System
• Intended Use: "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 neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis)."
• Predicate Device: Silhouette™ Spinal Fixation System (K980288)
• FDA Limitation: The FDA added a limitation to the labeling: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while the device was found substantially equivalent for specified uses, potential broader uses were explicitly excluded without further proof.

Ask a specific question about this device