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The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-IF system is an implant system for interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add a notch in the posterior portion of the U-shaped body. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

Here's a breakdown of the acceptance criteria and study information for the coflex-IF device, based on the provided FDA 510(k) summary:

• Note: This document is a 510(k) summary for a spinal implant (coflex-IF), which is a physical medical device, not a software or AI-based diagnostic device. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) are not applicable to this type of submission. The information provided focuses on engineering and mechanical testing for substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Information (Where applicable, based on a physical medical device)

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

   • Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data, but "The worst case device" was tested. This refers to a manufactured physical device chosen as representative of the most challenging conditions or configurations.
   • Data Provenance: Not applicable in the context of human data. The testing is described as mechanical performance testing of the device itself.

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

   • Not applicable. Ground truth for a physical device's mechanical performance is established through standardized engineering tests (e.g., ASTM F 1717-13) and comparison to the predicate device, not expert consensus on human data.

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

   • Not applicable. Mechanical testing results are objective measurements of physical properties, not subject to human adjudication in the way clinical diagnostic interpretations would be.

4. 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 is a physical spinal implant, not an AI software/diagnostic device.

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

   • Not applicable. This is a physical spinal implant, not an AI algorithm.

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

   • For mechanical performance, the "ground truth" is defined by the standards set by ASTM F 1717-13 and the established performance of the predicate device. The goal is substantial equivalence, meaning the new device performs acceptably within the same safety and effectiveness parameters as the legally marketed predicate.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model requiring a training set of data. Device design and manufacturing parameters are based on engineering principles and material science, not machine learning.

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

   • Not applicable. As above, there is no AI training set for this type of device.

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The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process 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), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

The screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.

This document describes the Precision Spine Interspinous Plate System, a medical device. As such, acceptance criteria and performance data are related to the mechanical and biomechanical properties of the device, not to an AI/ML algorithm. Therefore, many of the requested categories in your prompt are not applicable.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for biomechanical tests. Instead, it states that the device's strength was found to be "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria are implicitly met by demonstrating substantial equivalence to the performance of predicate devices.

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

• Sample Size: Not specified for the biomechanical tests.
• Data Provenance: The tests were conducted internally by Precision Spine or a contracted lab, as it falls under "Performance Data" from the manufacturer. It is a prospective study design as the tests are conducted to demonstrate performance of the new device. The country of origin of the data is not specified, but the manufacturer is based in Pearl, MS, USA.

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

• Not Applicable. This device is a physical implant, and its performance is evaluated through engineering tests (static and dynamic biomechanical testing), not through expert clinical interpretation or ground truth derived from expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not Applicable. As above, this is a physical device subject to engineering and biomechanical testing, not clinical adjudication of interpretations.

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 physical implant, not an AI/ML algorithm.

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

• Not Applicable. This device is a physical implant, not an AI/ML algorithm.

7. The type of ground truth used:

• Engineering/Biomechanical Testing Standards: The "ground truth" for the device's performance is established by the results of standardized biomechanical static and dynamic testing. The implicit "ground truth" for substantial equivalence is the performance observed in predicate devices, which likely also underwent similar testing against established standards.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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