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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® Spine System implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

Device Description

The Sniper® Spine System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

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

The document does not explicitly state numerical acceptance criteria for the Sniper® Spine System. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data presented refers to specific tests conducted.

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in document)
Substantial equivalence to predicate device in terms of safety and effectiveness for its intended use and indications.	Engineering analyses, dynamic axial compression bending testing according to ASTM F1717, as well as cadaveric validation was performed to demonstrate that the modified Sniper Spine System is substantially equivalent to the predicate device. The document explicitly states: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicate, the subject Sniper® Spine System has been shown to be substantially equivalent to the predicate device identified in this submission." This implies that the results of the mentioned tests supported this conclusion of substantial equivalence.

Acceptance Criteria (Implicit)

Reported Device Performance (as stated in document)

Substantial equivalence to predicate device in terms of safety and effectiveness for its intended use and indications.

Engineering analyses, dynamic axial compression bending testing according to ASTM F1717, as well as cadaveric validation was performed to demonstrate that the modified Sniper Spine System is substantially equivalent to the predicate device. The document explicitly states: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicate, the subject Sniper® Spine System has been shown to be substantially equivalent to the predicate device identified in this submission." This implies that the results of the mentioned tests supported this conclusion of substantial equivalence.

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

The document mentions "cadaveric validation" but does not specify the sample size (number of cadavers) used. It also does not provide information about the provenance of this data (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The document refers to engineering analyses and cadaveric validation, which are typically evaluated by engineers and potentially surgeons, but the specific number or qualifications are not mentioned for establishing "ground truth" in the context of expert review.

4. Adjudication method for the test set

This information is not provided in the document.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance in this document. The device in question is a physical spinal implant system, not a diagnostic AI tool.

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

This is not applicable as the device is a physical pedicle screw spinal system, not an algorithm.

7. The type of ground truth used

For the engineering and cadaveric testing mentioned, the "ground truth" would be established through:

Engineering analyses: Based on established biomechanical principles, material properties, and design specifications.
Dynamic axial compression bending testing (ASTM F1717): The ground truth is defined by the standardized test parameters and the observed mechanical performance (e.g., strength, durability, deformation) under these conditions.
Cadaveric validation: The ground truth would likely be established through direct observation of the device's performance, stability, and fit within the cadaveric spine, possibly evaluated against anatomical landmarks or surgical expectations.

8. The sample size for the training set

This is not applicable as this is not a machine learning or AI-based device.

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

This is not applicable as this is not a machine learning or AI-based device.

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K Number

K151813

Device Name

Sniper Spine System

Manufacturer

SPINE WAVE, INC.

Date Cleared

2015-07-31

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K100605

Intended Use

Device Description

The Sniper Spine System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Sniper® Spine System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving the device meets a set of acceptance criteria through a clinical or performance study in the way an AI/ML diagnostic or prognostic device would.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not directly applicable to this document. This document describes a traditional medical device (spinal implant system) and its regulatory clearance process.

Specifically, the document states:

Purpose of Submission: "The purpose of this submission is to gain clearance for the additional length rods to the cleared Sniper® Spine System." (page 3)
Performance Data: "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static axial compression and dynamic axial compression bending in accordance with ASTM F1717). Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (page 4)

This indicates that:

The "performance data" refers to mechanical and material testing (e.g., static torsion, static axial compression, dynamic axial compression bending) of the physical implant components, not a study evaluating human or AI performance.
The "acceptance criteria" for this device would be tied to the mechanical specifications and safety standards (like ASTM F1717) for spinal implants, ensuring they can withstand physiological loads. The document states that engineering rationales determined the new implants were "substantially the same" as the predicate based on these tests. This means the device met the existing standards already established for the predicate.

The questions regarding "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set" are all relevant to the evaluation of AI/ML or diagnostic devices. They are not applicable to the regulatory review of a physical implant system like the Sniper® Spine System, which relies on demonstrating substantial equivalence in design, materials, and established mechanical performance to a predicate device.

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