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The CORMED NV , SOLAS™, Spinal System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (15 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOLAS™ is 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 turnor and failed previous fusion (pseudoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The SOLAS™ Spinal System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The SOLAS™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

The SOLAS'" Spinal system can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation.

The SOLAS™ design allows adjustment in both the saggital and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the SOLASTM implants.

The provided document is a 510(k) premarket notification for the SOLAS™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any clinical studies, sample sizes, expert involvement, or adjudication methods.

The document primarily focuses on:

• Device Description: What the device is, its components, and materials.
• Intended Use/Indications for Use: What the device is designed to treat.
• Potential Risks: General risks associated with spinal fixation devices.
• FDA Communication: The FDA's determination of substantial equivalence to predicate devices, allowing the product to be marketed.

In the context of 510(k) submissions for Class II devices like the SOLAS™ Spinal System, substantial equivalence is often demonstrated through:

• Bench Testing: Mechanical, fatigue, and material testing to ensure the device meets recognized standards (e.g., ASTM F136 for titanium alloy) and performs comparably to predicate devices.
• Comparison to Predicate Devices: Showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to an already legally marketed device.

Since no clinical study information is present in the provided text, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance.

Here's a table based on the absence of information regarding acceptance criteria and performance studies in the provided document:

Table of Acceptance Criteria and Reported Device Performance

Detailed Answers to Specific Questions:

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

   • As shown above, the document does not provide specific acceptance criteria or quantitative reported device performance data from clinical studies. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which typically involves comparing device features, intended use, and general performance through non-clinical means (like bench testing against standards, which are not detailed here).

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

   • No information about test set sample sizes or data provenance (country, retrospective/prospective) is available in the provided text. This type of detail would be found in a clinical study report, which is not part of this 510(k) summary.

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)

   • No information about experts creating ground truth for a test set is provided. This suggests there wasn't a clinical performance study involving expert assessment for this 510(k) submission.

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

   • No adjudication method is mentioned, as there is no described test set or clinical study requiring such a process.

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 or comparative effectiveness study is mentioned. This device is a mechanical spinal implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

   • This is a mechanical spinal implant; it does not involve an algorithm, nor a "standalone" or "human-in-the-loop" performance study in the context of AI or diagnostic imaging.

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

   • No ground truth is mentioned, as there are no clinical studies or diagnostic assessments detailed in the provided document. For a 510(k) of a spinal implant, "ground truth" often relates to successful fusion rates or absence of device-related complications, typically assessed in post-market surveillance or larger clinical trials (not usually required for 510(k)).

8. The sample size for the training set

   • No training set information is provided or relevant, as this is a physical medical device, not an AI model.

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

   • Not applicable, as there is no training set for an AI model.

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