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AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. A table of components can be found in Section 11. The AnyPlus Spinal Fixation System includes components from GSS Pedicle Screw System previously cleared in K053573. These components will keep their original cleared trade name. A table of components can be found in Section 11 identified as GSS Pedicle Screw System 510(k): K053573. The components are manufactured from Ti6Al4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. A table of components can be found in Section 11.

The provided text describes a 510(k) summary for the "AnyPlus Spinal Fixation System," a medical device. This document does not describe a study involving "acceptance criteria" and "device performance" in the way one would typically expect for an AI/ML or diagnostic device. Instead, it focuses on demonstrating "substantial equivalence" of a spinal fixation system to predicate devices through technical characteristics and intended use.

Therefore, many of the requested elements are not applicable to the provided document. I will extract and describe the information that is present.

1. Table of Acceptance Criteria and Reported Device Performance

This section is Not Applicable in the context of the provided document. The document describes a spinal fixation system, not an AI/ML or diagnostic device with performance metrics like accuracy, sensitivity, or specificity. The submission aims to demonstrate "substantial equivalence" to predicate devices based on material, design, and intended use, rather than meeting specific performance acceptance criteria from a clinical study.

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

This section is Not Applicable. The document is a 510(k) summary for a physical spinal fixation system. It does not involve a "test set" of data or data provenance in the context of device performance evaluation as would be relevant for an AI/ML device. The evaluation is based on technical specifications, material properties, and comparison to legally marketed predicate devices.

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

This section is Not Applicable. There is no "ground truth" derived from experts in this context, as it is not a diagnostic or AI/ML device being evaluated. The evaluation relies on engineering principles, material science, and regulatory comparison.

4. Adjudication Method for the Test Set

This section is Not Applicable. There is no "test set" or adjudication process described for this type of medical device submission.

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

This section is Not Applicable. MRMC studies are relevant for diagnostic devices (often involving human readers and AI assistance). The "AnyPlus Spinal Fixation System" is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.

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

This section is Not Applicable. This concept applies to AI/ML software. The device is a physical spinal fixation system, not an algorithm.

7. The Type of Ground Truth Used

This section is Not Applicable. As stated, there is no "ground truth" in the context of a diagnostic or AI/ML evaluation for this device. The regulatory approval is based on demonstrating substantial equivalence to predicate devices, material testing, and design specifications.

8. The Sample Size for the Training Set

This section 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 section is Not Applicable. As there is no training set mentioned, establishing ground truth for it is not relevant to this document.

Summary of Relevant Information from the Provided Text:

The document is a 510(k) summary for the AnyPlus Spinal Fixation System. The primary goal of this submission is to demonstrate substantial equivalence to predicate devices already on the market, rather than meeting specific performance acceptance criteria through a clinical study or AI/ML evaluation.

• Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods, and connectors made from Ti6Al4V ELI (Titanium Alloy) according to ISO 5832-3 and ASTM F-136. It is intended to create a rigid spinal construct.
• Intended Use: Non-cervical spinal fixation for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature patients as an adjunct to fusion. Indications include degenerative disc disease, spondylolisthesis, trauma, deformities/curvatures, tumor, stenosis, pseudoarthrosis, and failed previous fusion.
• Predicate Devices:
  • GSS Pedicle Screw System (K053573) - Also from GS Medical Co., Ltd.
  • Synthes Pangea System (K052123)
  • INCOMPASS SPINAL FIXATION SYSTEM (K021564)
• Demonstration of Equivalence: The submission argues that the AnyPlus Spinal Fixation System is "as effective, and performs as well as or better than the predicate devices" based on comparing technical characteristics (materials, components, intended use, and classification) to these predicate devices. The materials used (Titanium Alloy Ti-6Al-4V ELI) and compliance with standards (ASTM F1717-04, ASTM F1798-97, ASTM F136-98, ISO 5832-3:1996, ANSI/AAMI/ISO 17665-1) are highlighted as part of this demonstration.

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