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The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: 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; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module).
The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the SteriSpine™PS Pedicle Screw:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (SteriSpine™PS Pedicle Screw), the acceptance criteria are not presented in a quantitative, pass/fail manner. Instead, the study focuses on demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability to established predicate devices under specific mechanical tests.

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

The document does not explicitly state a "test set" in the context of clinical trials or data analysis that would typically have a defined sample size and provenance. Instead, it refers to:

• Mechanical Testing: Performed on the device itself. The sample size for each specific mechanical test (e.g., number of constructs tested for static compression) is not specified.
• Cadaver Testing: Performed to validate the instrumentation. The number of cadavers or tests is not specified.
• Clinical Data: "Clinical data from a review of the literature has been presented in the class III summary." This indicates a retrospective literature review rather than a prospective clinical study with a defined sample size. The provenance of this literature data (e.g., country of origin) is not specified.

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

Since there is no "test set" in the typical sense of human-reviewed data, and the primary assessment is mechanical and literature-based, this information is not applicable to this submission. Ground truth, if considered, would be derived from the mechanical standards and the documented performance of the predicate devices.

4. Adjudication Method for the Test Set

As there is no "test set" requiring human review or ground truth establishment in this context, the adjudication method is not applicable.

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

A MRMC comparative effectiveness study was not done. The submission primarily relies on mechanical testing and a literature review for clinical data. This type of study would typically be relevant for imaging or diagnostic AI devices where human reader performance is being evaluated.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This device is a physical pedicle screw system, not an algorithm or software-only device.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" implicitly refers to:

• Engineering Standards: Adherence to ASTM F1717 and ASTM F1798.
• Reference Device Performance: The established mechanical properties of the legally marketed predicate devices (K112453, K121299, K130632).

For the clinical data, the "ground truth" is derived from:

• Clinical Literature: Published evidence regarding the performance and safety of similar pedicle screw systems.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical implant, not an AI/ML algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

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

This information is not applicable for the reasons stated in point 8.

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