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The MIS Spinal Systems are intended to provide immobilization 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 MIS Spinal System can be used in an open approach and a percutaneous approach.

The MIS Spinal System is intended 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, Curvatures (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Failed previous fusion.

The MIS spinal system consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537).

The provided text is a 510(k) summary for a spinal system, not a summary of an AI/ML-driven medical device study. Therefore, the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device is not present in the input.

Specifically, the document focuses on demonstrating substantial equivalence of a physical medical device (spinal screws and rods) to previously cleared predicate devices based on design, materials, manufacturing process, and mechanical performance testing. It does not mention any AI/ML components, software, or algorithms.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and reported device performance: This document reports mechanical testing data (substituted from predicate devices), not performance metrics for an AI/ML algorithm (e.g., accuracy, sensitivity, specificity).
2. Sample size used for the test set and data provenance: There is no mention of a test set for an AI/ML algorithm. The "testing" referred to is mechanical reliability testing of the physical hardware.
3. Number of experts used to establish ground truth and qualifications: Ground truth for AI/ML models is typically established by experts (e.g., radiologists, pathologists). This is not applicable here as there is no AI/ML component.
4. Adjudication method for the test set: Not applicable for mechanical hardware testing.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is for evaluating the impact of AI assistance on human readers, which is not relevant to a spinal implant.
6. Standalone (algorithm only) performance: There is no algorithm.
7. Type of ground truth used: No AI/ML ground truth is involved.
8. Sample size for the training set: Not applicable as there is no AI/ML model to train.
9. How ground truth for the training set was established: Not applicable.

In conclusion, the provided text does not contain the necessary information to describe the acceptance criteria and study proving an AI/ML device meets them, as it pertains to a physical medical device (spinal system hardware).

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The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.

This FDA submission is for a medical device, the GALAXY MIS Screw System, which is a pedicle screw spinal system used for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories regarding clinical study details (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable in this context.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For non-clinical (mechanical) testing, sample sizes typically refer to the number of devices or components tested, and provenance is not relevant.

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

This is not applicable. Ground truth, in the context of clinical studies and AI, refers to expert-validated diagnoses or outcomes. This submission involves non-clinical mechanical testing, where the "ground truth" is defined by the physical properties measured against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among experts or raters. Mechanical tests are typically performed according to standardized protocols without expert adjudication in this sense.

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 is not applicable. The device is a surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study would be conducted.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by the acceptance criteria established in the ASTM F1717 standard for various mechanical properties (static compression, tension, torsion, dynamic compression bending). This is a technical standard rather than an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

This is not applicable, as there is no training set for this device.

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The FOCUS Spinal 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. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation 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; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation 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; curvatures (i.e., scoliosis, kyphosis, and for lordosis); turnor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

FOCUS Spinal System consists of cannulated polyscrews, straight rods, curved rods, crosslinks and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

Here's an analysis of the provided text regarding acceptance criteria and performance study details:

The provided document describes a 510(k) submission for the FOCUS Spinal System. It is a Class III medical device, specifically a pedicle screw spinal system.

Based on the content, the acceptance criteria and the study proving the device meets these criteria are primarily focused on mechanical performance and substantial equivalence to a predicate device, rather than clinical performance or AI-assisted diagnostic capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient studies. The "test set" for this device refers to physical samples of the FOCUS Spinal System components used for mechanical testing.

• Sample Size: The document states that "Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct." The exact number of constructs tested is not specified.
• Data Provenance: The tests are mechanical in nature, performed on the device itself. There is no mention of human subjects, patient data, country of origin of data, or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: This information is not provided as the study described is a mechanical performance study, not a clinical study requiring expert assessment for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable, as there is no clinical data or image interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done?: No. The provided text does not mention any MRMC study or any comparison of human readers with or without AI assistance. The device is a physical spinal fixation system, not an AI diagnostic tool.
• Effect Size of Human Readers Improvement with AI: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done?: No. This device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The ground truth for this device is based on mechanical engineering standards (ASTM F1717) and a comparison of the mechanical performance of the FOCUS Spinal System to a predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the device's substantial equivalence determination.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI model, and therefore does not involve a "training set" in the machine learning sense.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for an AI model. The "ground truth" for the device's safety and effectiveness relies on its mechanical properties meeting established standards and being comparable to legally marketed predicate devices.

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