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The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what would typically be found in a medical device submission for performance:

The provided text describes a 510(k) submission for the Spineology Fortress™ Pedicle Screw System, a Class III medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than studies involving human participants or AI performance.

Therefore, many of the requested categories related to AI performance, human readers, ground truth for training data, and clinical study details are not applicable (N/A) to this specific submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the Spineology Fortress™ Pedicle Screw System are established by demonstrating that its mechanical performance is equivalent or superior to the predicate devices when evaluated against recognized ASTM standards. These standards define the expected performance thresholds for pedicle screw systems.

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary, but in the full submission, these would demonstrate meeting or exceeding predicate device performance. |
| ISO 1798-97(2008) Torsional Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"

As above. |
| ISO 1798-97(2008) Axial Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"

As above. |
| ASTM F543-13 Axial Pullout | "axial pullout and torque to failure per ASTM F543-13"

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F543-13 Torque to Failure | "axial pullout and torque to failure per ASTM F543-13"

As above. |
| ASTM F1717-13 Static Torsion | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F1717-13 Static Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

As above. |
| ASTM F1717-13 Dynamic Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

As above. |
| Substantial Equivalence | "The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products." and "The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices."

Overall conclusion based on all testing. |

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary document. For mechanical testing, sample sizes are typically defined by the relevant ASTM standards to ensure statistical validity (e.g., n=6 for certain tests).
   • Data Provenance: The testing was "performed" by the applicant, Spineology Inc., likely in a laboratory setting. This is not clinical data (e.g., country of origin for clinical data, retrospective/prospective). It refers to in-vitro mechanical testing.

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

   • N/A. Mechanical testing against ASTM standards does not involve "ground truth" derived from expert consensus in the same way clinical or AI studies do. The "ground truth" here is the defined performance requirement within the standard.

3. Adjudication method for the test set:

   • N/A. See point 2. The outcome is determined by adherence to the pass/fail criteria of the ASTM standards.

4. 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. This is a 510(k) for a physical implant (pedicle screw system), not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

   • No. This is a physical implant.

6. The type of ground truth used:

   • For this type of mechanical testing, the "ground truth" is adherence to the specified performance characteristics and thresholds defined within the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., acceptable flexural strength, pullout force, fatigue life). The comparison is made against predicate devices, demonstrating the new device performs at least as well.

7. The sample size for the training set:

   • N/A. This is mechanical testing of a medical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

   • N/A. See point 7.

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The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation 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 Pallas M Spinal System consists of rods, screws, revision rod system, Miss pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

Based on the provided 510(k) summary, the device is a spinal fixation system, and its performance is evaluated through bench testing, rather than clinical studies involving human or AI performance. Therefore, many of the requested categories (like sample size of a test set, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this type of submission.

The acceptance criteria are based on established standards for spinal implants.

Acceptance Criteria and Reported Device Performance

• Static axial compression bending test
• Dynamic axial compression bending test
• Static torsion test (of worst-case Pallas M Spinal System structure) |
  | Conformity to ASTM F136 (Material specification for Ti-6Al-4V ELI) | Fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. |
  | Conformity to relevant ISO Standards (for materials) | Devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards. |

Explanation: The device aims to meet the mechanical performance and material specifications defined by these ASTM and ISO standards for spinal implant systems. The reported performance indicates that the required bench tests were conducted and the materials conform to the specified standards, implying the device met the criteria outlined in those standards.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. For bench testing, "worst-case" configurations of the spinal system were tested. The mechanical testing report (Appendix 1) would typically contain detailed specimen numbers, but this is not included in the summary.
   • Data Provenance: Bench testing, performed by the manufacturer, Korea Bone Bank Co., Ltd. (South Korea).

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

   • N/A. This device underwent bench testing against engineering standards, not clinical ground truth established by medical experts for diagnostic or clinical performance.

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

   • N/A. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical bench testing. The results are typically interpreted against the pass/fail criteria defined in the ASTM standard.

4. 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:

   • N/A. This is a hardware spinal implant, not an AI or imaging device that would involve human readers or AI assistance.

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

   • N/A. This is a hardware spinal implant, not an algorithm.

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

   • Engineering Standards: The ground truth for performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F1717-04 for mechanical performance, ASTM F136 for material composition and biocompatibility).

7. The sample size for the training set:

   • N/A. There isn't a "training set" in the context of mechanical bench testing for a physical implant. The design process and selection of materials are based on general engineering principles and material science.

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

   • N/A. See point 7.

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