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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 VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). 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 degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.

The provided text describes the VertiFlex® Spinous Process Fixation Plate, a medical device for spinal fixation. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states, "No clinical testing was conducted to support this submission."

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics from clinical trials, a test set, ground truth, expert involvement, or AI-related data, is not available in the provided text.

Based on the document, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific clinical study for device performance. The "acceptance criteria" for regulatory submission seems to be substantial equivalence to predicate devices, based on design, materials, indications, and non-clinical performance.
• Reported Device Performance:
  • Non-Clinical Tests: The device demonstrated "substantial equivalence... in terms of performance" to a commercially available predicate through tests conducted in accordance with ASTM F1717-12 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), static pull-off testing in synthetic bone, and static dissociation testing. Specific performance values (e.g., load limits, displacement) are not provided.

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. No clinical test set data is provided. The non-clinical tests likely used test samples of the device and synthetic bone models.

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. No clinical test set and thus no ground truth established by medical experts for device performance are mentioned.

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

• Not applicable. No clinical test set is mentioned.

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. This device is a mechanical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway as described.

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

• No. This device is a mechanical implant. The concept of "standalone algorithm performance" is not applicable.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices against which the VertiFlex® plate was compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. No machine learning or AI training set is mentioned as this is a mechanical device.

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

• Not applicable. No machine learning or AI training set is mentioned.

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