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The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8 - L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.

The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.

The SEURAT™ Universal Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism. Various sizes of these implants are available. SEURAT™ Universal Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

SEURAT™ Universal Pedicle Screw System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. The rods, screws utilized as part of the proposed system are identical to devices cleared previously via K120714, K132365, and K140219. The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously via K120714, K121568, K132365, and K140219.

The fundamental scientific technology and intended use are unchanged from the legally marketed predicate pedicle screw systems. The proposed system will use a modified version of DALI Spinal Fixation System previously cleared via K121568, a modified version of RAPHAEL Pedicle Screw System previously cleared via K132365 and additional lengths for anatomically bigger patients, and a modified version of PICASSO-II MIS Spinal System previously cleared via K140219 predicate based on the K120714, PICASSO MIS Spinal System) and additional size and lengths for anatomically bigger patients. The modifications include additional hexalobe screw-head driver feature; screw thread profiles, sizes, and lengths; and/or Minimally Invasive Spine (MIS) screw housing tower ring enhancement which will accommodate wider range of surgeons' usage preference, anatomically bigger patients, and/or consolidation of similar sub-components throughout all CTL Medical's pedicle screw systems for manufacturing efficiency.

The provided document describes a medical device, the SEURAT™ Universal Pedicle Screw System, and the testing conducted to support its substantial equivalence to predicate devices. It is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel claims of safety and effectiveness through extensive clinical trials.

Therefore, the information you've requested regarding AI algorithm performance, sample sizes for training/test sets in that context, expert adjudication, AI improvement effect size, and specific ground truth definitions for an AI system are not applicable to this document. The study described is a mechanical performance safety study, not a study of an AI device.

Here's the information relevant to the mechanical performance study, extracted and formatted as requested:

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 in the provided text, but it would have been a number of device units tested according to the ASTM F1717 standard.
• Data Provenance: Not applicable as this is a mechanical testing study, not a study involving human or patient data. The testing was performed according to an industry standard (ASTM F1717).

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

• Not applicable. The "ground truth" here is the physical performance of the device against a mechanical standard, not a clinical observation by experts. The standard (ASTM F1717) defines the testing methodology and performance benchmarks.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for clinical studies where multiple reviewers assess data. In mechanical testing, results are quantitative measurements interpreted against pre-defined acceptance criteria.

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 not a study involving human readers or AI.

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

• Not applicable. This device is a pedicle screw system, not an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" for this study is defined by the acceptance criteria established by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be mechanically tested and what performance metrics they must achieve to be considered safe and effective in terms of mechanical stability and durability.

8. The sample size for the training set:

• Not applicable. No training set is involved as this is mechanical testing of a medical device, not an AI or machine learning study.

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

• Not applicable. See point 8.

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The Picasso II MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The Picasso II MIS Spinal System is comprised of percutaneous cannulated poly axial screws, a set screw and rods designed to allow for minimally invasive surgery. The screw diameters are 5.5mm, 6.5mm and 7.5mm. The screw length ranges from 30mm in 5mm increments.

The Picasso II system will utilize Ø6.0mm MIS rods. Straight and curved rods are provided with the subiect system. Straight rods are available in 35mm-600mm lengths, and curved rods are available in 35mm-150mm lengths.

The implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. The device specific instrumentation intended for patient contact is manufactured from stainless steel materials that conform to ASTM F899.

The provided document is a 510(k) premarket notification for a medical device (Picasso II MIS Spinal System), not a study evaluating an AI device. This type of notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI device evaluation.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable to this document.

However, I can extract information related to the device and the non-clinical testing performed to support its substantial equivalence.

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

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document implies acceptance criteria by stating that the modified housing dimensions "do not create a worst case construct as compared to the predicate" and that "mechanical test results submitted in support of the predicate systems are considered applicable to the subject system." This suggests that the device must perform at least as well as, or not worse than, the predicate devices in specific mechanical tests. The specific numerical acceptance criteria (e.g., maximum deflection, ultimate load) are not explicitly stated in this document.
• Reported Device Performance: The document states, "Results of the engineering analysis provided in support of this premarket notification demonstrate that the modified housing dimensions for the proposed system do not create a worst case construct as compared to the predicate." It also indicates that non-clinical tests were conducted "to confirm the results of the engineering analysis." However, actual performance values (e.g., specific forces, deflections) are not reported. The conclusion is a qualitative statement of equivalence.

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

• This information is not applicable as this is not an AI device study requiring a "test set" in that context. The testing involved mechanical evaluations of the physical device. The sample size for the mechanical tests is not specified. Data provenance is also not applicable in the context of data for an AI algorithm.

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

• This is not applicable. This document describes the mechanical testing of a physical medical device, not an AI algorithm requiring expert-established ground truth.

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

• This is not applicable. This refers to expert adjudication in AI studies, which is not relevant here.

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:

• This is not applicable. This type of study is for evaluating observer performance with AI in diagnostic or other decision-making tasks, which is not the subject of this 510(k) submission.

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

• This is not applicable. This document does not concern an AI algorithm.

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

• This is not applicable. For mechanical testing of a physical device, the "ground truth" would be the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1798-13). There is no "ground truth" in the clinical AI sense.

8. The sample size for the training set:

• This is not applicable. This document does not describe an AI device or a training set.

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

• This is not applicable. This document does not describe an AI device or a training set.

Summary of Relevant Information from the Document:

• Device: Picasso II MIS Spinal System (spinal pedicle fixation system)
• Purpose of Study/Submission: To demonstrate substantial equivalence to predicate devices (Picasso MIS Spinal System and Raphael System) to obtain clearance for market.
• Testing Performed: Non-clinical mechanical tests were conducted in accordance with ASTM F1798-13.
  • Static axial grip
  • Static torsional grip
  • Static cantilever bending
  • Static tulip head disassociation (nominal and extreme angle)
• Conclusion: The subject device is substantially equivalent to the predicate devices, with no impact on device performance due to minor differences. The modified housing dimensions do not create a worst-case construct compared to the predicate.

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