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The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with autograft to facilitate fusion.

The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

The VisuALIF Challenging Access System an extension to the VisuALIF System and both are part of the Cynch Spinal System. It is available in various sizes to accommodate individual patient anatomy. The VisuALIF Challenging Access implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. VisuALIF Challenging Access is intended to be used with the two (2) or more bone screws provided with the accompanying anterior cover plate assembly. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.

The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

This document describes the SpineSmith Cynch Spinal System – VisuALIF Interbody Fusion Implant System. The submission is for an extension to an already cleared device and demonstrates substantial equivalence to a predicate device (VisuALIF System, K102090). Substantial equivalence is the primary acceptance criterion for 510(k) clearances.

Here's an analysis based on the information provided, reinterpreting "acceptance criteria" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

• Titanium alloy screws/cover plate assembly per ASTM F-136.
  These are the same as used in the predicate device. |
  | Design Characteristics (similar to predicate) | - 'U' shaped implant design to allow for placement of autograft bone.
• The primary change is the addition of additional screw holes and positions to the existing VisuALIF System to provide surgeons with additional surgical approach options, which is considered a minor difference. |
  | Biocompatibility | Implied as the materials are the same as the predicate and commonly used in implants. (Not explicitly stated as a separate test in this summary, but assumed for existing materials.) |
  | Mechanical Performance (equivalent to predicate) | - Static and dynamic compression testing (per ASTM F2077-03) conducted.
• Static and dynamic compression-shear testing (per ASTM F2077-03) conducted.
• Subsidence testing (per ASTM F2267-04) conducted.
• Expulsion testing (per ASTM Draft Standard F-04.25.02.02) conducted.
  Conclusion: "The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the VisuALIF Challenging Access System is substantially equivalent to the predicate device." |

2. Sample Size for Test Set and Data Provenance

• Test Set (for mechanical testing): The document does not specify exact sample sizes (number of implants tested) for the non-clinical mechanical tests (static, dynamic, subsidence, expulsion). Instead, it states that testing was "conducted in accordance with" specific ASTM standards. These standards typically define the number of samples required for such tests.
• Data Provenance: The data comes from non-clinical mechanical testing performed by the manufacturer, SpineSmith Partners, LP. It is not patient or human subject data.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for this spinal implant relates to its mechanical properties and equivalence to a predicate device, which is established through standardized engineering tests, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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

• Not applicable. This device is a physical spinal implant, not a diagnostic imaging device or AI-driven system that would involve human readers or image interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This device is an implant, not an algorithm. Its "standalone performance" refers to its mechanical integrity, which was evaluated through the non-clinical tests mentioned.

7. Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" is defined by the pass/fail criteria and methodologies outlined in the referenced ASTM standards (e.g., F2077-03, F2267-04, F-04.25.02.02 draft standard) for static and dynamic compression, compression-shear, subsidence, and expulsion. The results of the new device were compared against these standards and against the established performance of the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.

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

• Not applicable. See point 8.

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