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The MacroPore Hydrosorb Spine System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The MacroPore Hydrosorb Spine System is a resorbable graft containment system composed of various sized porous plates / sheet, non-porous plates / sheets, and associated fixation screws manufactured from polylactic acid (PLA). The MacroPore Hydrosorb Spine System is composed of MacroPore Sheets, Plates, and Screws provided with and without USP barium sulfate beads (18mg - 20mg/bead) imbedded into the PLA polymer for radiopacity. MacroPore Sheets and Plates can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Plates / Sheets to the desired shape or size. The MacroPore Sheet and Plates are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Screws range in size from 2.4mm to 6.5mm in outer diameter with lengths ranging from 4mm to 30mm. The MacroPore Sheets and Plates are provided in various sizes ranging from 1.0mm to 5.0mm in thickness according to the region to be treated. The MacroPore Sheets and Plates range in size from as small as 24mm x 18mm to as large as 100mm x 100mm. The MacroPore Sheets and Plates are provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. The radiopaque barium sulfate beads have an approximate nominal mass of 18mg - 20mg and range in size from 0.5mm - 2.0mm in diameter. All configurations are to be within a mass of 100 grams of polymer. Various manual instruments (screw drivers, taps, drill bit, etc.) are used in conjunction with the MacroPore Hydrosorb Spine System to assist in the installation process.

Here's a breakdown of the acceptance criteria and study information for the MacroPore Hydrosorb Spine System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MacroPore Hydrosorb Spine System are primarily established through demonstrating substantial equivalence to predicate devices. This means the device met the performance characteristics (mechanical, material, and functional) to be considered as safe and effective as already legally marketed devices.

Study Information

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

   • The document describes in vitro testing rather than human clinical trials or a specific "test set" of patient data.
   • For the in vitro aging studies, no specific sample size (number of devices or material samples) is provided.
   • For the in vitro mechanical testing, no specific sample size is provided.
   • For crystallinity testing (DSC), "sterile and nonsterile samples" were tested; specific sample size is not given.
   • Data provenance is not provided but strongly suggests lab-based, pre-clinical testing ("in vitro").

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This was an in vitro engineering and material science study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was based on established scientific principles and comparison to predicate device characteristics.

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

   • Not applicable. There was no clinical ground truth requiring adjudication. The evaluation was based on objective physical and material property measurements and direct comparison to predicate device specifications and performance.

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 medical device (spinal implant) clearance and not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was involved.

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

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

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

   • The "ground truth" for this submission was based on established material science principles and engineering specifications, with direct comparison to the physical and mechanical characteristics of legally marketed predicate devices. The goal was to demonstrate "substantial equivalence" based on objective measurements rather than clinical ground truth from patient data.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model. There was no "training set" in the context of an algorithm.

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

   • Not applicable, as there was no training set.

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