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The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The svstem components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and Invibio PEEK Optima LT-1 in accordance with ASTM F2026 -Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclaye in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the Autoclave manufacturer.

The provided text describes a 510(k) premarket notification for the Axle™ Interspinous Fusion System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics is largely not applicable to this document.

Here's an breakdown of why and what information can be extracted based on the provided text:

General Context of the Document:

This is a 510(k) submission, specifically a "Special 510(k): Device Modification." This means X-spine Systems, Inc. is seeking to market a modified version of an already cleared device. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is typically achieved through comparison of design, materials, manufacturing processes, and sometimes non-clinical performance testing (bench testing), rather than large-scale clinical trials.

Missing Information (and why):

Most of the requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, etc.) is relevant for studies conducted to establish the de novo efficacy or safety of a new and novel device, particularly those involving AI/ML components for diagnostic or prognostic purposes. The Axle Interspinous Fusion System is a mechanical implant, and its 510(k) submission does not involve AI or these types of clinical study methodologies.

Information Extracted from the Document:

Despite the above, I can provide a limited answer based on the provided text, focusing on what is relevant to a 510(k) for a mechanical device:

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

For a mechanical implant like the Axle Interspinous Fusion System, "acceptance criteria" and "reported device performance" are typically defined by engineering standards and successful completion of specified mechanical tests, demonstrating equivalence to the predicate device. The document states:

Self-correction/Clarification: The document doesn't explicitly list numerical "acceptance criteria" (e.g., "must withstand X N of compression"). Instead, it states that the device was tested using specific ASTM standards and additional tests. The acceptance for a 510(k) is that the device performs comparably to the predicate device under these tests, thereby demonstrating "substantial equivalence." The document concludes that the modified device "substantially meet[s] the performance criteria established by the cleared parent device," implying it met the unstated performance thresholds benchmarked against the predicates.

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

• This information is not provided as the device is a mechanical implant primarily evaluated through bench testing. The "test set" here refers to the physical samples of the device undergoing mechanical scrutiny, not a clinical data set. There is no mention of country of origin or retrospective/prospective data collection as it's not a clinical study in that sense.

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)

• This information is not applicable/provided. "Ground truth" in the context of mechanical testing refers to the physical properties and performance characteristics of the materials and device components. Experts in this field would be engineers and material scientists interpreting the results of mechanical tests, but their number and specific qualifications are not detailed in this 510(k) summary.

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

• This information is not applicable/provided. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective 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

• This information is not applicable. The Axle Interspinous Fusion System is a surgical implant, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted, nor is AI involved.

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

• This information is not applicable. As stated, this is a mechanical implant with no AI component.

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

• The "ground truth" for this device's evaluation is primarily engineering specifications and measurements from mechanical (bench) testing against established ASTM standards and comparable performance to the predicate devices.

8. The sample size for the training set

• This information is not applicable/provided. The concept of a "training set" is relevant for machine learning models, which are not involved here.

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

• This information is not applicable/provided for the same reasons as #8.

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The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.

The provided text describes a medical device, the "Axle™ Interspinous Fusion System," and its clearance by the FDA based on substantial equivalence to a predicate device. The information primarily focuses on the device's design, intended use, and biomechanical testing to demonstrate performance.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• Static Compression Bending
• Static Torsion
• Fatigue Compression Bending | "Biomechanical testing results indicate that the Axle Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."
  (Specific numerical values or thresholds for performance are not provided in this summary, but the claim is one of equivalence to the predicate device, Medtronic CD Horizon Spinal System (K091445), specifically the Medtronic SPIRE Spinous Process Plate component.) |

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

The document mentions "biomechanical testing" and refers to "ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This is a laboratory-based biomechanical test, not a clinical study involving human patients. Therefore, the concept of "test set sample size" and "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable here. The samples would be the physical implant constructs tested in the lab. The number of samples tested for each biomechanical scenario is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device's clearance is based on mechanical performance compared to a predicate device, not on diagnostic accuracy requiring human expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation is based on biomechanical testing against established ASTM standards and comparison to a predicate device's performance, not on subjective human assessment requiring adjudication.

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

No. This is a spinal implant for fixation, not an image analysis or diagnostic AI device that would typically undergo an MRMC study. The evaluation focuses on physical characteristics and mechanical performance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The "Axle Interspinous Fusion System" is a physical medical device, an 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's performance is established by the ASTM F1717 standard test methods for spinal implant constructs in a vertebrectomy model and the performance characteristics of the predicate device (Medtronic CD Horizon Spinal System, specifically the Medtronic SPIRE Spinous Process Plate component). The acceptance criteria are that the device's mechanical performance is substantially equivalent to the predicate performance when tested according to these standards.

8. Sample Size for the Training Set:

Not applicable. Since this is a physical medical device and not an AI/machine learning system, there is no "training set."

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

Not applicable. As there is no training set for an AI/machine learning model, the establishment of ground truth for such a set is irrelevant in this context.

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