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The AERIAL™ Interspinous Fixation 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 the 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. AERIAL™ is intended for use with allograft bone and is not intended for stand-alone use.

AERIAL™ Interspinous Fixation is an expandable non-cervical interspinous fixation device used to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients.

This document describes the 510(k) summary for the AERIAL™ Interspinous Fixation device, a spinal implant. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of diagnostic accuracy or comparative effectiveness for an AI/ML powered device. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the provided text, addressing the applicable points:

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

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 in the document. The document describes mechanical and biocompatibility testing, which are typically performed on a set number of device samples or material samples, rather than a "test set" in the context of diagnostic data.

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 as the device is a spinal implant, not a diagnostic device requiring expert interpretation of data for ground truth establishment.

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

This information is not applicable for the reasons stated above.

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 AERIAL™ Interspinous Fixation device is a physical medical implant, not an AI/ML powered device, so a MRMC study for AI assistance is irrelevant.

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

This information is not applicable as the device is a physical medical implant, not an AI/ML algorithm.

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

For mechanical performance, the "ground truth" would be established by validated engineering standards (e.g., ASTM or ISO standards for spinal implants) and internal acceptance criteria developed by Globus Medical. The tests demonstrate the device's ability to withstand specific forces and movements.
For biocompatibility, the "ground truth" is established by recognized standards like ANSI/AAMI ST-72:2011, which define acceptable endotoxin levels, and material certifications for components.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a physical medical implant's mechanical and biocompatibility testing. This concept applies to AI/ML model development.

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

This information is not applicable for the reasons stated above.

Summary of the Study:

The "study" described in the 510(k) summary for the AERIAL™ Interspinous Fixation device is a set of engineering performance tests and biocompatibility assessments designed to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

• Mechanical Testing: Performed to assess the device's structural integrity and stability under various loads relevant to its intended use in the spine. This included axial compression, plate dissociation, offset torsion, and tension. The reported performance indicates that the device met the internal acceptance criteria for these tests, which are typically derived from relevant ASTM or ISO standards for spinal implants. The specifics of these acceptance criteria (e.g., maximum load, displacement) and the number of samples tested are not detailed in this summary.
• Biocompatibility Testing: Bacterial endotoxin testing (BET) was conducted according to ANSI/AAMI ST-72:2011. This standard sets limits for endotoxin levels in medical devices to ensure patient safety. The fact that the test was conducted in accordance with this standard implies that the device met the specified endotoxin limits. Additionally, the use of materials already established as biocompatible (meeting applicable standards or used in other cleared devices) further supports its safety.

The purpose of these tests is to establish that the new device's technological characteristics (design, intended use, material composition, function, and range of sizes) are sufficiently similar to the predicate devices and that it performs safely and effectively as intended. The "study" is a demonstration of adherence to established engineering and material science principles, rather than a clinical trial or a diagnostic accuracy study.

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The Spinal Simplicity Spinous Process Fusion (SPF) 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 (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
• tumor.

The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.

The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).

This document is a 510(k) premarket notification for a medical device called the Spinal Simplicity Spinous Process Fusion (SPF) Plate. The purpose of this notification is to demonstrate that the SPF-Plate is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Spinal Simplicity SPF-Plate are implicitly defined by demonstrating "substantially equivalent mechanical strength" to predicate devices and functioning "as intended." The document does not provide specific numerical acceptance criteria (e.g., minimum load bearing capacity in Newtons or maximum displacement in millimeters) but rather references compliance to general performance standards and comparison to predicates.

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

The document details several types of studies but does not explicitly state a sample size for a typical "test set" as understood in AI/software evaluation. Instead, it describes mechanical tests and a surgeon survey:

• Mechanical Performance Studies:
  • No specific sample sizes (number of devices tested) are provided for the static and dynamic tests listed.
  • Data Provenance: These are laboratory-based mechanical tests (in vitro). The document does not specify the country where these tests were performed, but given the US FDA submission, it's likely they were conducted in the US or a facility recognized by the FDA for such testing.
• Cadaver Implantation Studies:
  • No specific sample size (number of cadavers or implants) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Bone Block Studies:
  • No specific sample size (number of bone blocks) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Survey Data from Surgeons:
  • The sample size for the survey is not explicitly stated ("survey data from surgeons outside the United States who have implanted a version of the subject device").
  • Data Provenance: Retrospective, based on real-world experience. The data originates from surgeons "outside the United States."

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

• Mechanical Tests, Cadaver Studies, Bone Block Studies: The "ground truth" for these tests is based on engineering principles and measurements. The specific number and qualifications of the engineers or technicians conducting these tests are not provided.
• Survey Data: The "experts" are the "surgeons outside the United States who have implanted a version of the subject device." The number of surgeons is not specified. Their qualifications are implied as medical doctors who perform spinal surgery, but no specific experience level (e.g., "radiologist with 10 years of experience") is given.

4. Adjudication Method for the Test Set

• Mechanical Tests, Cadaver Studies, Bone Block Studies: Adjudication is typically inherent in the testing methodology and analysis by engineers, rather than an "adjudication method" in the sense of expert consensus on qualitative observations.
• Survey Data: No formal adjudication method is described for the survey responses. It seems that the summary of observations ("none of the surgeons observed any instances of failure...") was reported directly from the survey.

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

No MRMC comparative effectiveness study is mentioned for evaluating human readers with or without AI assistance. This document pertains to a physical medical device (SPF Plate), not an AI/software device that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device's "standalone" function refers to its physical capabilities when implanted.

7. Type of Ground Truth Used

• Mechanical Tests: Engineering measurements, physical properties, and objective results based on standardized test methods.
• Cadaver Studies & Bone Block Studies: Observational and measurement data related to implantation, material loss, and mechanical strength in simulated biological environments.
• Survey Data: Self-reported observations and experiences from practicing surgeons.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set in the computational sense. The design and development of the device would have involved engineering and materials science principles, potentially informed by clinical experience and predicate device analysis, but not a "training set" like an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this physical device. The design and validation of the device rely on engineering specifications, material science, and performance testing data rather than a data-driven "training" process.

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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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