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The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer.

The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

This document describes the FDA's clearance of the HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the requested information about acceptance criteria and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size) is largely not applicable in the context of this 510(k) submission.

Explanation:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is "substantially equivalent" to a device already on the market (a predicate device). This often relies on comparing technical characteristics, materials, and mechanical or non-clinical performance, rather than clinical efficacy against pre-defined acceptance criteria for patient outcomes.
• Mechanical Testing vs. Clinical Studies: The performance data section explicitly states, "Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed." This indicates that the primary basis for clearance was a comparison of mechanical properties, not clinical performance against specific metrics.
• Absence of Clinical Study Details: The document does not mention any clinical studies, patient data, ground truth establishment by experts, or statistical analyses of human reader performance (MRMC) or standalone algorithm performance that would be typical for AI/ML device clearances requiring such details.

However, based on the provided document, I can extract the following relevant information regarding performance and its basis for substantial equivalence:

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

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

• Not Applicable in the traditional sense for clinical data. The performance claims are based on mechanical testing of the devices themselves, not on a test set of patient data.
• Data Provenance: The mechanical testing was performed by the manufacturer, Globus Medical Inc.

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

• Not Applicable. No expert-established ground truth for patient data is mentioned as part of this 510(k) clearance.

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

• Not Applicable. No adjudication method for expert review of patient data 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:

• Not Applicable. This is a physical medical device (spinal fixation system), not an AI/ML algorithm for image interpretation or diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for clinical ground truth. For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device's established mechanical properties.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device relying on a training set of data.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary: The provided document is a 510(k) clearance for a spinal implant system. The "study" referenced is mechanical performance testing to demonstrate substantial equivalence to predicate devices, not a clinical study involving patient data, expert review, or AI performance metrics.

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