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The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic deformities such as scoliosis, Scheuermann's disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.

The Micomed Posterior Doublerod System is a low profile, top loading spinal fixation system available in titanium and stainless steel. The system consists of pedicle screws, polyaxial screws*, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. * polyaxial screws are only available in titanium

The provided text describes a 510(k) submission for a medical device, specifically the Micomed Posterior Doublerod System. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and performance.

However, the document primarily outlines the regulatory approval process and device specifications, and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical or even a detailed standalone performance study would. The "Testing and Performance" section is brief and refers to biomechanical performance as per an ASTM standard, rather than a comprehensive study with specific acceptance criteria that one would typically associate with AI/software performance.

Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI/software performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, training sets), cannot be extracted from the provided text.

Here is the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to biomechanical testing, which typically involves a set number of test specimens (e.g., screws, rods) rather than patient data.
• Data Provenance: Not specified, but given the nature of biomechanical testing, it would involve engineered test samples rather than patient data. The company is based in Germany, so if there were any clinical aspects not detailed, it might have European origin.

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

• Not applicable. Biomechanical testing adherence to ASTM standards does not involve expert-established ground truth in the way clinical or image-based AI studies do. The "ground truth" is typically defined by the test parameters and failure modes according to the ASTM standard.

4. Adjudication method for the test set

• Not applicable. Biomechanical testing results are typically objective measurements against a standard, not subject to adjudication by multiple human 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic or interpretive tasks, not for physical medical devices undergoing biomechanical testing.

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

• Not applicable. This device is a physical spinal fixation system, not an algorithm. The reported "standalone" performance is the biomechanical performance of the device's components.

7. The type of ground truth used

• Ground Truth: Adherence to defined biomechanical performance standards and metrics outlined in ASTM F1717-96.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not a machine learning algorithm.

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

• Not applicable. This device is a physical medical device, not a machine learning algorithm.

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The Micomed Posterior Doublerod System is a pedicle screw system indicated for treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scollosis, Scheuermann's disease); degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.

The Micomed Posterior Doublerod System is a low profile, top-loading spinal fixation system available in titanium. The system consists of pedicle screws of varying lengths and diameters, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System.

The acceptance criteria and device performance for the Micomed Posterior Doublerod System are primarily based on biomechanical equivalence to predicate devices, as detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with strict acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, many of the typical data points required for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance studies, and training set details) are not applicable or not explicitly reported in this type of submission.

Here's a breakdown of the requested information:

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

• Not applicable/Not reported. This 510(k) relies on a comparative biomechanical assessment and substantial equivalence argument, not a diagnostic accuracy study with a test set of patient data. The "test set" here refers to biomechanical testing of the device itself. The document states "acceptable biomechanical behavior when compared to" several predicate devices, implying in-vitro mechanical testing.

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

• Not applicable/Not reported. Ground truth in this context would likely refer to established biomechanical standards and engineering principles, not expert interpretations of patient data.

4. Adjudication method for the test set:

• Not applicable/Not reported. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not the primary focus of this 510(k) summary.

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 mechanical spinal fixation system, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a mechanical spinal fixation system, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" implicitly used for this type of submission is:
  • Biomechanical performance standards and data established for similar spinal fixation systems (predicate devices).
  • Material specifications (ASTM F136 for titanium).
  • Clinical experience and regulatory history of the predicate devices for establishing appropriate indications for use.

8. The sample size for the training set:

• Not applicable/Not reported. There is no "training set" in the context of an AI device. For a traditional mechanical device, "training" might informally refer to iterative design and testing, but not in the sense of machine learning.

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

• Not applicable/Not reported. As there is no training set as understood in AI, this question does not apply.

In summary, the Micomed Posterior Doublerod System gained acceptance based on demonstrating substantial equivalence to numerous established predicate spinal fixation systems, primarily through biomechanical comparison studies and conformance to material standards (ASTM F136). The focus of this 510(k) was to show that the new device performs acceptably and is as safe and effective as devices already on the market, rather than to prove superior clinical efficacy or diagnostic accuracy through extensive clinical trials or AI performance evaluations.

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