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The GSO GS1 Cannulated Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Cannulated Screw System should be removed after fusion.

As a pedicle screw system, the GSO GS1 Cannulated Screw System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, the GSO GS1 Cannulated Screw System is indicated for 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).

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Cannulated Screw System is indicated for:

1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Idiopathic scoliosis
3. Kyphotic deformities of the spine
4. Paralytic scoliosis and/or pelvis obliquity
5. Vertebral fracture or dislocation
6. Neuromuscular scoliosis associated with pelvic obliquity
7. Vertebral fracture or dislocation
8. Tumors
9. Spondylolisthesis
10. Stenosis
11. Pseudarthrosis
12. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

The GSO GS1 Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods.

The current submission, the GSO GS1 Cannulated Screw System, adds the following components to the GSO GS1 System: 5.5mm and 1/4" straight longitudinal rods in lengths of 50 - 480mm; 5.5mm and 1/4" pre-bent rods in lengths of 30 - 120mm; and multi-directional cannulated screws with standard or reduction heads in diameters of 5.5mm - 8.5 and lengths of 25mm - 100mm (depending on the screw diameter) to fit either 5.5mm or 1/2" rods. These additional components are compatible with the previously cleared GSO GS1 rods, screws, hooks and connectors. The GSO GS1 Spinal System can be installed with any suitable instrumentation.

The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6Al-4V Titanium alloy conforming to ASTM F136.

The provided 510(k) summary for the GSO GS1 Cannulated Screw System describes a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to acceptance criteria, study design, expert involvement, and ground truth for AI performance are not applicable in this context.

This regulatory submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through device description and non-clinical testing.

Here's a breakdown of what is provided in relation to the device's acceptance:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This is a mechanical device, and "test set" in the context of AI/SaMD (which implies a dataset of patient information) is not relevant. The testing was non-clinical (mechanical).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. There was no ground truth based on expert review of patient data for this mechanical device. The "ground truth" for mechanical testing would be the established engineering standards and measurements.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of mechanical testing for a medical implant.

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:

• Not Applicable. This device is a spinal implant, not an AI system or an imaging modality requiring human readers.

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

• Not Applicable. This is a hardware device.

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

• For the non-clinical testing, the "ground truth" was based on established engineering standards (ASTM F1717-12) for mechanical properties, specifically failure loads. The performance of the new device was compared against these objective, verifiable mechanical measurements for the predicate device.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI/SaMD for this mechanical device.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture or dislocation
5. Revision of previous cervical or cervico-throracic spine surgery
6. Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.

The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

This appears to be a 510(k) premarket notification document for a spinal implant system, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate "device meets acceptance criteria" in the context of a traditional medical device (spinal implant).

Acceptance Criteria and Reported Device Performance for GSO PCT Spinal System

Study Details (Non-AI/ML Medical Device)

• Sample sized used for the test set and the data provenance: Not applicable. For this type of device, mechanical testing is done on device samples, not patient data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
• Adjudication method for the test set: Not applicable.
• 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: Not applicable. This is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used:
  • For mechanical strength: Engineering standards (ASTM F1717) and physical measurements.
  • For substantial equivalence: Comparison against legally marketed predicate devices based on indications, design, and materials.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The primary study conducted for the GSO PCT Spinal System was non-clinical mechanical testing.

• Study Type: Mechanical performance testing.
• Methodology: The testing was conducted according to ASTM F1717. ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," typically evaluates the static and fatigue strength of spinal implant constructs under various loading conditions (e.g., compression, torsion, bending) to ensure they can withstand the anticipated physiological stresses without failure.
• Results: The mechanical testing demonstrated that the GSO PCT Spinal System possesses "sufficient strength for its intended use."

Additionally, the submission relies on demonstrating substantial equivalence to existing legally marketed devices (Mountaineer OCT Spinal System, Altius OCT System, and OASYS System). This comparison serves as a form of "study" to support the safety and effectiveness by showing similarity in:

• Indications for Use
• Design
• Materials of construction (CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136).

Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data and direct comparison to predicates.

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The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for 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).

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Idiopathic scoliosis
3. Kyphotic deformities of the spine
4. Paralytic scoliosis and/or pelvis obliquity
5. Vertebral fracture or dislocation
6. Neuromuscular scoliosis associated with pelvic obliquity
7. Vertebral fracture or dislocation
8. Tumors
9. Spondylolisthesis
10. Stenosis
11. Pseudarthrosis
12. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslink that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are a vophed to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink components are used to attach two rods in parallel. The GSO GS1 Spinal System can be installed with any suitable instrumentation.

The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GSO GS1 Spinal System:

This document is a 510(k) summary for a spinal implant system, and as such, it focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria through extensive clinical trials for new medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: The primary "test set" for this submission was the mechanical testing of the GSO GS1 Spinal System components. The document does not specify a numerical sample size for the mechanical tests (e.g., number of rods, screws tested), but it states that testing was "conducted according to ASTM I-1717." ASTM standards typically specify sample size requirements for such tests.
• Data Provenance: The mechanical testing data was generated prospectively by Gold Standard Orthopaedics, LLC. The location of the testing is not specified, but it would have been conducted in a qualified lab for such ASTM standards. There is no mention of "country of origin of data" in the context of clinical data for this 510(k).

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

• Not applicable. This submission relies on non-clinical mechanical testing and comparison to predicate device characteristics/indications. It does not involve human interpretation of medical images or clinical outcomes that would require "experts to establish ground truth" in the way a diagnostic AI device would. The "ground truth" for mechanical testing is derived from the established ASTM standard and the measured failure loads compared to published data from predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As above, this is a mechanical testing and substantial equivalence submission, not a study requiring adjudication of expert opinions on clinical cases.

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 comparative effectiveness study was not done. This 510(k) is for a spinal implant, which is a physical medical device, not an AI-powered diagnostic tool. Clinical testing (including MRMC studies) was explicitly stated as "not necessary to demonstrate the substantial equivalence of the GSO GS1 Spinal System to the predicate devices."

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

• Not applicable. This is a spinal implant, not an algorithm or AI device.

7. The Type of Ground Truth Used

• For mechanical performance: The "ground truth" was established by standardized mechanical testing (ASTM I-1717), which measures physical properties like failure loads. The acceptance criterion was based on the "published failure loads" of predicate devices, essentially using their established performance as a benchmark.
• For indications for use, materials, and design: The "ground truth" for substantial equivalence was the characteristics and indications of the legally marketed predicate devices (CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833) and Synergy Spinal System Interpore Cross International (K010515)).

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.

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

• Not applicable. (See point 8).

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