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The Fidji Small Cement Restrictor is intended for use in conjunction with standard PMMA cement and is designed to occlude the medullary canal during the introduction of the cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

The Fidji Small Cement Restrictor is a hollow, trapezoidal block that is machined from cxtruded Polyetherctherketone (PEEK), which complies with ASTM F202. It contains a titanium alloy, removable anchor that is designed to aid in maintaining its position within the medullary space of the femur or humerus. It also contains tantalum inserts that serve as location and orientation markers for radiographs.

This is a 510(k) premarket notification for a medical device (Spine Next Fidji Small Cement Restrictor), which compares it to a predicate device to demonstrate substantial equivalence. These submissions typically do not contain detailed information about acceptance criteria, clinical trials, or performance metrics in the way that PMA (Pre-Market Approval) applications or studies for AI/software devices do.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

Here's a breakdown of what can be extracted and what is explicitly not present:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) is typically "substantial equivalence" to a predicate device in terms of design, materials, indications for use, and performance characteristics.
• Reported Device Performance:
  • Functional Design: "virtually identical in their function and principle of operation" to the predicate.
  • Material: Made from Polyetheretherketone (PEEK) matching ASTM F202, identical to the predicate device's material.
  • Mechanical Compression Characteristics: "similar mechanical compression characteristics since their material of construction is identical."
  • Safety: Stated as "similar" to the predicate device.
  • Indications for Use: Identical to the predicate, with a specific warning against spinal use.

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

• This information is not provided in the document. 510(k) submissions for devices like this typically rely on engineering comparisons, material testing, and similarity to an existing device rather than large-scale clinical test sets or data provenance studies.

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. As explained above, this type of expert review is not typically part of a 510(k) for this kind of device.

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

• This information is not provided.

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 information is not provided. This device is a physical implant, not an AI or software device. Therefore, MRMC studies are not applicable.

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

• This information is not provided. This device is a physical implant, not an algorithm. Therefore, standalone algorithm performance is not applicable.

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

• For physical devices in a 510(k), the "ground truth" is typically established through:
  • Material specifications: Conformance to ASTM standards (e.g., ASTM F202 for PEEK).
  • Engineering design comparisons: Demonstrating similarity in shape, dimensions, and mechanism.
  • Mechanical testing: To confirm similar characteristics (like compression) to the predicate.
  • Existing clinical history of the predicate device: Assuming the predicate device's safety and effectiveness for its intended use is well-established.

8. The sample size for the training set

• This information is not provided. Training sets are relevant for AI/machine learning models, not for physical medical implants of this nature.

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

• This information is not provided. Not applicable to this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a 510(k) premarket notification which aims to demonstrate substantial equivalence to a legally marketed predicate device (Medtronic Sofamor Danek Cement Restrictor (K013663)). The proof relies on a comparative analysis rather than a traditional clinical trial or performance study with acceptance criteria in the typical sense.

The core of the "proof" is based on:

• Comparison of Indications for Use: Both devices are for occluding the medullary canal, preventing cement flow, and facilitating cement pressurization during arthroplasty, and neither is for spinal indications.
• Comparison of Functional Design and Principle of Operation: Stated as "virtually identical."
• Comparison of Materials of Construction: Both use PEEK and comply with ASTM F202.
• Comparison of Mechanical Characteristics: Stated as "similar mechanical compression characteristics" due to identical materials.
• Claim of Similar Safety and Effectiveness: Based on the above similarities and the predicate's established history.

Crucially, the FDA's acceptance of the 510(k) filing (via the letter of substantial equivalence) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance, which is substantial equivalence to the predicate. The letter affirms this based on the information provided in the submission, with the added condition of including a specific warning about spinal use.

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When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the JAVA Spinal Fixation System is also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after development of a solid fusion mass. The system includes screws, rods, and connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

This document, K031265, describes the Spine Next SHIRAZ JAVA Spinal Fixation System. However, it does not contain the information needed to fill out the table regarding acceptance criteria and device performance as it pertains to AI/ML or diagnostic performance. This submission is for a traditional medical device (spinal fixation system), not a software as a medical device (SaMD) or an AI-powered diagnostic tool. Therefore, the requested information on AI/ML-related performance metrics, such as sample size, ground truth, expert adjudication, or MRMC studies, is not applicable or available in this document.

The document primarily focuses on:

• Device Description and Materials: The system includes screws, rods, and connectors made from Titanium Alloy (Ti6A4V).
• Indications for Use: Treatment of severe spondylolisthesis and various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine as an adjunct to fusion.
• Performance Data: Biomechanical testing was performed in accordance with ASTM F1717 and ASTM F1798. These are standards for mechanical properties of spinal implant systems, not for diagnostic accuracy or algorithmic performance.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices (Moss Miami K021880).

Therefore, I cannot provide the requested information for acceptance criteria and study proving AI device meets acceptance criteria, as this device is a physical spinal fixation system and not an AI-driven one.

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