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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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The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.

The principal components of the MICOMED Halm Zielke Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong.

The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired.

The provided 510(k) summary for the MICOMED - Halm Zielke Instrumentation describes a spinal fixation system, not an AI/ML device, and therefore does not contain the information typically required for evaluating the acceptance criteria and study proving an AI/ML device meets those criteria.

However, based on the information available regarding the performance testing of the mechanical device, I can extract and structure the relevant data.

Here's an analysis of the provided text, modified to fit the requested format as much as possible for a mechanical device:

Description of the MICOMED - Halm Zielke Instrumentation

The MICOMED - Halm Zielke Instrumentation is a low-profile anterior spinal fixation system. Its principal components include Halm plates, screws, threaded rods, hex nuts, fluted rods, and vertebral clamps. The system is designed to correct spinal deformities (scoliosis, kyphosis, lordosis) and treat thoracolumbar spinal instability caused by fracture. The components are manufactured from implant-grade stainless steel (316LS) or titanium (ASTM F136).

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical medical device like this, acceptance criteria typically relate to mechanical strength, durability, and equivalent performance to predicate devices. The document frames performance in terms of "inherent stability (stiffness)" and resistance to "deformational forces" and "fatigue."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a numerical sample size for "calf and artificial spines." The phrasing "the calf and artificial spines" suggests a limited, but not explicitly quantified, number of specimens were used. For the fatigue testing, it states "when the call spines were subjected to one million cycles of axial compression," implying a set of calf spines.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a laboratory-based biomechanical study, which is typical for spinal implant testing. It is a prospective test in the sense that the experiment was designed and conducted to evaluate this specific device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable to this type of device and study. Biomechanical testing of spinal implants does not typically involve human experts establishing "ground truth" in the way an AI/ML diagnostic device does for image interpretation. The "ground truth" here is the physical measurement of deformation, failure, and resistance, determined by mechanical testing protocols and sensors.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "adjudication method" in the context of mechanical testing. The results are quantitative measurements from instruments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This question is not applicable. This is a biomechanical performance study of a physical implant, not a study involving human readers or AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

This question is not applicable. There is no algorithm or AI component to this device. The performance study refers to the standalone mechanical performance of the implant itself.

7. Type of Ground Truth Used

For the biomechanical study:

• Mechanical Measurement Data: The "ground truth" is derived from direct physical measurements of mechanical properties such as resistance to deformational forces (axial compression, flexion, extension, lateral bending, torsion) and assessment of device integrity after fatigue cycling (absence of device failure).

8. Sample Size for the Training Set

This question is not applicable. As a mechanical device, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. There is no "training set" for this mechanical device.

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