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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes in skeletally mature patients for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to clear device modifications to the Aileron Interspinous Fixation System.

This document is a 510(k) premarket notification for the "Aileron Interspinous Fixation System," a medical device. It is primarily concerned with establishing substantial equivalence to previously cleared devices rather than presenting a detailed study of the device's performance against specific acceptance criteria for a new medical AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria for a diagnostic or AI device is largely not applicable to this document. This document focuses on the mechanical and material properties of an implantable spinal fixation device.

However, I can extract the relevant "performance data" that the FDA considered in its substantial equivalence determination, and infer some "acceptance criteria" related to mechanical strength.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The document does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance measures (e.g., sensitivity, specificity). Instead, it refers to performance testing done "in accordance with a modified ASTM F1717 setup" and other specific mechanical tests. The "acceptance" is implicitly that the device performs equivalently to the predicate devices when subjected to these tests.

The study that "proves" the device meets these criteria is referred to as "Performance Data" in the 510(k) summary. The conclusion explicitly states: "The information presented demonstrates the substantial equivalency of the Aileron Interspinous Fixation System." This means the device's mechanical performance was demonstrated to be equivalent to its predicate devices through the listed tests.

Regarding the specific questions about "diagnostic/AI device" studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study using a test set of data (e.g., medical images or patient records) for diagnostic assessment. The "test set" here refers to physical specimens of the device used for mechanical testing in a lab setting. No patient data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic devices, would typically refer to clinical diagnosis or pathology. For mechanical implant testing, the "ground truth" is established by relevant engineering standards (e.g., ASTM F1717) and the results of the physical tests themselves. No medical experts are mentioned as establishing ground truth for these mechanical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to consensus readings for diagnostic images or data, which is not relevant here.

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 device is a mechanical implant, not an AI-powered diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the engineering standard (ASTM F136 for material, modified ASTM F1717 for mechanical testing) and the physical properties/performance of the device itself as measured under laboratory conditions.

8. The sample size for the training set: Not applicable. This device does not involve machine learning algorithms that require a training set.

9. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor. (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.

The ARX® Spinal System, PILOT® Spinal System, PILOT Posterior Lumbar Plating System, and CONOUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor. (5) failed previous fusion. (6) pseudoarthrosis, (7) spinal stenosis, (8) spondvlolisthesis.

The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a medical device, the Aileron Interspinous Fixation System, and states that its substantial equivalency to predicate devices was demonstrated through performance data. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, as typically understood in the context of clinical or diagnostic performance. Instead, the "Performance Data" section details mechanical testing to demonstrate substantial equivalency.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Note: The document states "subsequent engineering analysis was presented," implying the device met the requirements/comparisons set by these ASTM standards to demonstrate substantial equivalency with predicate devices. Specific quantitative acceptance criteria or raw performance values are not provided.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable or specified for mechanical testing. This typically refers to patient data, which is not part of this "Performance Data" section.
• Data provenance: Not applicable. Mechanical testing is performed in a lab setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in this context, usually refers to clinical diagnostic accuracy, which is not assessed here. The "ground truth" for mechanical testing is adherence to ASTM standards and comparison to predicate devices, which would be evaluated by engineers.

4. Adjudication method for the test set:

• Not applicable.

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, an MRMC study was not done. This study solely focuses on the mechanical performance of a spinal implant, not on AI-assisted diagnostic capabilities.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For the mechanical testing, the "ground truth" implicitly refers to the established standards of ASTM F1717 and ASTM F1798, and the performance characteristics of the predicate devices for comparison.

8. The sample size for the training set:

• Not applicable. This is not an AI model requiring a training set.

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

• Not applicable.

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