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The Novel III Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 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.

In addition, the Novel Spinal System 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 tumor and failed previous fusion (pseudarthrosis).

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

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ////™ Spinal Fixation and Adjustable Bridge System implants.

This 510(k) summary does not contain information related to an AI/ML device. The submission is for a medical device (spinal fixation system) and its modified sterilization trays, not a software algorithm that performs diagnostic or prognostic functions.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth, MRMC studies) are not applicable to this document.

Here's an analysis based on the information provided in the 510(k) summary, focusing on the device modification mentioned:

Acceptance Criteria and Study for Novel III™ Spinal Fixation and Adjustable Bridge System (Modified Sterilization Trays)

This 510(k) submission primarily concerns a "Special 510(k): Device Modification" related to redesigning custom sterilization trays for the Novel III™ Spinal Fixation and Adjustable Bridge System. The core spinal fixation device itself has already been cleared (predicates K081153 and K103147).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are focused on the sterilization process for the redesigned trays, not on the clinical performance of the spinal system or an AI/ML algorithm.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • For the sterilization validation, the sample size is not explicitly stated in the summary, but it would typically involve a statistically relevant number of sterilization cycles and biological indicator tests. The summary just states it was "satisfactorily performed."
  • For mechanical testing of the implant, the sample size is not specified but would follow ASTM F 1717-04 guidelines.
• Data Provenance: The data provenance for the tests performed (sterilization validation, mechanical testing) is not specified beyond being generated by Medyssey Co. Ltd. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are relevant for clinical studies, not typically for device performance testing like sterilization or mechanical strength.

3. Number of Experts and Qualifications for Ground Truth Establishment

This item is not applicable as the submission does not involve an AI/ML algorithm or a diagnostic/prognostic device that requires expert ground truth establishment from clinical images or data. The ground truth for sterilization is a defined SAL, established through validated laboratory procedures.

4. Adjudication Method for the Test Set

This item is not applicable. The type of testing performed (sterilization validation, mechanical testing) does not involve human readers or adjudication processes.

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

This item is not applicable. No MRMC study was performed as this is not an AI/ML device, nor is it a diagnostic imaging device where human reader performance would be the primary endpoint. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system."

6. Standalone Performance (Algorithm Only)

This item is not applicable as there is no algorithm or software component for standalone performance evaluation in this 510(k) submission.

7. Type of Ground Truth Used

• For Sterilization Validation: The ground truth is the Sterility Assurance Level (SAL), which is a quantitative measure (1 x 10⁻⁶), established through specific, validated laboratory methods involving biological indicators and physical parameters of the sterilization cycle.
• For Mechanical Testing: The ground truth is the performance specifications defined by the ASTM F 1717-04 standard.
• For Substantial Equivalence: The ground truth is the characteristics and performance of the predicate devices and the regulatory standard for equivalence.

8. Sample Size for the Training Set

This item is not applicable. There is no "training set" as this is not an AI/ML device.

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

This item is not applicable as there is no training set.

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