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The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical Plate System is intended for single use only.

The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions.

The ACPI Anterior Cervical Plate System consists of a variety of anterior cervical spinal bone plates and self-drilling / self-tapping bone screws for fixation of the vertebral body(s) of the cervical spine, using an anterior approach for the development of a cervical spinal fusion (C2-C7), and associated instruments. The bone screws form an interlocked construct on the vertebral bodies. The spinal bone plates include an integrated bone screw locking mechanism consisting of an integrated tab retained by a captive locking screw, covering a portion of the underlying bone screw head to prevent bone screw back-out. The bone screws are self-drilling / self-tapping, in various diameters and lengths, and are available in variable angle and fixed angle configurations. All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was designed to be compatible with common surgical instruments available in operating rooms equipped for spine surgery. The device specific instruments are considered to be Class II. The instruments are medical grade stainless steel, some have silicone rubber handles, and they are provided non-sterile. Stainless steel and titanium implant components must not be used together in a construct.

The provided text describes a medical device, the GSO ACP1 Anterior Cervical Plate System, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study details, and performance metrics—such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies—are not applicable to this document.

The "acceptance criteria" for this device are demonstrated through non-clinical testing against established ASTM standards and a comparison to legally marketed predicate devices.

1. Table of Acceptance Criteria and 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 device's acceptance was based on non-clinical mechanical testing and comparison to predicate devices, not on a clinical test set with data provenance.

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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and direct measurement, not by expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not used for mechanical testing.

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 is not an AI-powered device, so MRMC studies involving human readers and AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:

• Adherence to ASTM F1717 standard for mechanical testing.
• Conformity to material specifications (ASTM standard, medical implant grade titanium alloy).
• Demonstrated substantial equivalence in indications for use, design, mechanical testing, and materials to previously cleared predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI-powered device, and therefore does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. As this is not an AI-powered device, there is no training set or ground truth associated with it in that context.

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The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GS1 Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.

The GSO GS1 Spacer is a slightly curved, hollow spacer with pyramidal teeth on the superior and inferior ends to resist expulsion. The device contains openings to allow the surgeon to pack the device with bone graft (autograft or allograft) prior to insertion. Openings in the anterior-posterior direction permit bone growth through the device. The GSO GS1 Spacer is intended for use with supplemental internal fixation.

The GSO GS1 Spacer is fabricated from medical grade titanium alloy.

Here's an analysis of the GSO GS1 Spacer's acceptance criteria and the study that proves it meets those criteria, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (spinal spacer), not a research paper on an AI/machine learning device. Therefore, many of the requested categories like "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," and "Ground truth for training set" are not applicable. The device is a physical implant, and its "performance" is assessed through biomechanical testing, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance for GSO GS1 Spacer

Study Details

1. Sample Size Used for the Test Set and the Data Provenance:

   • Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, the number of units tested for each type of test (static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion) is not provided.
   • Data Provenance: The testing was non-clinical mechanical testing, performed in a lab setting to established ASTM standards. No geographical or retrospective/prospective human data provenance is applicable.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • Not applicable. The ground truth for this device (a physical implant) is based on engineering and material science principles, and adherence to established mechanical testing standards (ASTM F2077). Expert medical opinion would be involved in defining the clinical context and predicate devices, but not in establishing "ground truth" for the mechanical performance of the test set in the way it's understood for diagnostic AI.

3. Adjudication Method for the Test Set:

   • Not applicable. This is not an AI/diagnostic study requiring adjudication of interpretations. The "adjudication" would be based on whether the physical device passed the mechanical tests according to predefined thresholds.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not applicable to a physical spinal implant.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Not applicable. There is no algorithm or AI component to this device. The "standalone" performance refers to the device's mechanical integrity as measured by physical tests.

6. The Type of Ground Truth Used:

   • Ground Truth: Mechanical performance standards (e.g., ASTM F2077) and the established performance of legally marketed predicate devices (ROI Spacer and CAS Spine Spacer System). The "ground truth" is that the device must withstand certain forces and loads as defined by these standards and comparative data.

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this physical medical device.

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