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The ProMIS™ Fixation 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 disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

Device Description

The ProMIS™ Fixation System consists of 3 main single use implanted parts:

ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
Polyaxial Pedicle screws.
Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136.

AI/ML Overview

This document describes a 510(k) premarket notification for the Premia Spine Ltd.'s ProMIS™ Fixation System, which is a thoracolumbosacral pedicle screw system. The purpose of this 510(k) is to modify the sterilization method of certain rods, add new rod lengths, and introduce a modified set screw and new instrumentation. The document asserts substantial equivalence to a previously cleared device (K150380).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Description / Standard	Reported Device Performance
Sterilization Efficacy	Sterilization validation for gamma irradiation to achieve a Sterility Assurance Level (SAL) of $10^{-6}$.	Validated according to ISO 11137-2:2013 by the method of substantiation of 25kGy as a sterilization dose for SAL $10^{-6}$ (VDmax25). This applies to pedicle and set screws, and fusion rods up to 100mm. Fusion rods longer than 100mm are provided non-sterile for steam sterilization by the user.
Pyrogenicity	Bacterial endotoxin testing (BET) to achieve an Endotoxin limit of <20 EU/device.	Conducted as specified in USP <85> to achieve the Endotoxin limit of <20 EU/device.
Packaging Integrity	Validation of packaging integrity during transportation and shelf life.	Packaging validation conducted according to ASTM D4169-16 and AAMI/ISO 11607-1:2006 (R) 2010. Accelerated aging study and real-time (ongoing) study conducted according to ASTM F1980-07 (2011) and ISO 11607-1:2006 to verify integrity and assure product sterility (SAL $10^{-6}$) and safety.
Mechanical Performance (Set-Screw)	Verification of functionality and proper locking for the modified set-screw design.	The mechanical performance of the modified Set-Screw design was verified under a functionality test, demonstrating clear and smooth movements between parts and proper locking into position.
Mechanical Performance (Overall System)	Assessment of whether changes introduce a new worst-case scenario.	An engineering analysis was performed and demonstrated that the subject components (including changes in rod length and set-screw design) do not introduce a new worst case. Therefore, additional mechanical testing (of the overall system) was not performed. The basis for this is likely a comparison to the predicate device, which would have undergone its own mechanical testing.

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

The provided document does not contain information about a "test set" in the context of clinical performance or diagnostic accuracy. The performance data presented are related to engineering and manufacturing validations (sterilization, pyrogenicity, packaging, mechanical functionality) for design changes to an existing device.

Sample Size: Not applicable for a traditional test set as described in clinical studies. The sample sizes would be specific to each engineering validation (e.g., number of units tested for sterilization, packaging integrity, and set-screw functionality). These specific sample sizes are not detailed in the summary.
Data Provenance: The document does not specify the country of origin for the validation data. The studies are stated to be conducted according to international standards (ISO, ASTM, AAMI, USP), suggesting a globally recognized methodology. The data is based on retrospective engineering validation and analysis for the device modifications, rather than prospective human clinical trials.

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

Not applicable. This submission is for modifications to a spinal fixation system, focusing on engineering and manufacturing validation, not on diagnostic accuracy requiring expert interpretation of medical images or clinical outcomes. Ground truth in this context refers to established scientific and engineering principles for manufacturing and sterility.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring adjudication by human experts in this type of device submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic devices where human reader performance is compared with and without AI assistance. The ProMIS™ Fixation System is a surgical implant, not a diagnostic AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study (in the context of an algorithm's diagnostic accuracy without human involvement) was not done. The device is a physical surgical implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the various performance criteria is based on:

Established scientific standards and regulatory requirements: For sterilization (ISO 11137-2), pyrogenicity (USP <85>), and packaging integrity (ASTM D4169-16, AAMI/ISO 11607-1, ASTM F1980-07).
Engineering analysis and functional demonstration: For the mechanical performance of the modified set-screw and the overall system, demonstrating adherence to design specifications and non-deterioration of current worst-case scenarios.

8. Sample Size for the Training Set

Not applicable. There is no training set for an AI algorithm in this device submission.

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

Not applicable. There is no training set for an AI algorithm in this device submission.

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