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The NEO Pedicle Screw System™ is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical firation 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, tumor, pseudarthrosis, and/or failed previous fusion.

The NEO Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40 mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

This document pertains to the 510(k) premarket notification for a medical device called the "NEO Pedicle Screw System™." This submission is for a Class II medical device, and as such, it focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a totally new level of device performance through extensive clinical trials.

Therefore, the information typically sought regarding acceptance criteria and studies proving the device meets those criteria (especially in the context of device performance metrics like accuracy, sensitivity, specificity, or human-AI reader performance improvements) is not present in this type of regulatory submission.

Here's why and what information IS available:

1. Nature of the Device: The NEO Pedicle Screw System™ is an orthopedic implant (pedicle screws and rods) used for spinal fixation. Its primary function is mechanical support. Unlike diagnostic AI software, its performance is not measured by diagnostic accuracy or an effect size on human reader improvement.
2. Regulatory Pathway (510(k)): The 510(k) pathway for Class II devices primarily requires demonstration of "substantial equivalence" to a predicate device already on the market. This is achieved by showing that the new device has:
   • The same intended use as the predicate.
   • The same technological characteristics as the predicate, OR
   • Different technological characteristics, but these do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate.
3. Focus of Testing: The testing detailed in this document is primarily non-clinical and focuses on:
   • Material properties: Biocompatibility (ISO 10993-1), chemical analysis.
   • Mechanical performance: Static and dynamic axial compression, static torsion (in accordance with ASTM F1717), showing comparability to other marketed systems.
   • Sterilization: Validation (ISO 11137-2), pyrogenicity.
   • Packaging: Shelf life (ISO 11607-1), transport studies.
   • MRI Compatibility: Magnetic field interactions, heating, artifacts (ASTM F2052-15, F2182-11a, F2119-07).
   • Usability: WetLab study with orthopedic surgeons.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, MRMC studies, or specific effect sizes, as this device is a mechanical implant and not an AI/diagnostic software.

However, I can extract the information relevant to the types of studies conducted for this specific device:

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

For this device, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are based on meeting established standards for mechanical performance, biocompatibility, sterility, and durability, demonstrating "comparability" and "substantial equivalence" to predicate devices. The document implies that the device met these standards, as it received 510(k) clearance.

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

• Sample Size for Test Set: Not applicable in the context of diagnostic AI. For mechanical and biological testing, sample sizes are dictated by the specific ASTM/ISO standards referenced (e.g., number of test specimens for mechanical strength, number of samples for sterility validation), but these specifics are not provided in this summary. Data provenance is implied to be from the manufacturer's own internal testing and external certified labs commissioned by the manufacturer. It is not clinical data (retrospective or prospective) in the sense of patient data.

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

• Not applicable for this type of device. "Ground truth" in the context of AI diagnostic performance relies on expert consensus or biopsy/pathology. Here, the "truth" for mechanical performance is defined by adherence to engineering standards (ASTM, ISO), and human experts (orthopedic surgeons) were involved in a "WetLab study" for usability, but not to establish "ground truth" for a diagnostic test.

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

• Not applicable. This refers to methods for consolidating expert opinions in diagnostic 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:

• No. An MRMC study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is a surgical implant, not a diagnostic AI.

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

• Not applicable. This refers to the performance of an AI algorithm alone.

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

• For this device, "ground truth" is established by:
  • Engineering standards and specifications: For mechanical strength (ASTM F1717), sterility (ISO 11137-2), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052-15, F2182-11a, F2119-07), and packaging (ISO 11607-1).
  • Functional verification: For the monoaxial mode and overall usability (WetLab confirmation by surgeons).
  • Published scientific literature: Used for clinical evaluation to demonstrate equivalence to predicate devices, as "Clinical studies were not required."

8. The sample size for the training set:

• Not applicable. This term is relevant for machine learning models.

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

• Not applicable. This term is relevant for machine learning models.

In summary, the provided document describes a regulatory submission for a physical medical device (spinal implant) through the 510(k) pathway. The evidence presented focuses on ensuring the device is safe and effective as a mechanical and biological component, rather than as a diagnostic tool or AI algorithm.

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The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of 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.

The cleared range of Sterispine™ Ps system include multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 60mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Components of Sterispine™ PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

This looks like a 510(k) summary for a medical device called "Sterispine™ PS", which is a thoracolumbosacral pedicle screw system. From the information provided, it's clear that this is not a software device or an AI/ML powered device, and therefore does not have acceptance criteria or a study related to software performance.

The document describes premarket notification for a traditional medical device (implants for spinal fusion) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Discussion of testing" section refers to mechanical and biocompatibility testing for the physical device components, not software performance.

Here's why the requested information about acceptance criteria and studies for device performance (in the context of AI/ML) cannot be found in this document:

• Device Type: This is a physical implant (pedicle screw system), not a diagnostic algorithm, image analysis tool, or any other type of software that would typically have performance metrics like sensitivity, specificity, or AUC.
• Regulatory Pathway: A 510(k) for a physical medical device like this often relies on demonstrating substantial equivalence to legally marketed predicate devices through material comparisons, mechanical testing, and functional similarities, rather than clinical performance studies of a software output.
• "Device Performance" Context: When the document refers to "testing," it's discussing the physical properties of the implant (e.g., static compression, torsion, bacterial endotoxin) to ensure it's safe and performs as intended mechanically, not the accuracy of an algorithm.

Therefore, since the request is based on the assumption of an AI/ML driven device, which this is not, I cannot extract the requested information.

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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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