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The MacroPore OS Trauma System is intended to maintain the relative position of weak bony tissue such as bone graft substitutes, or bone fragments from comminuted fractures. The MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position weak bony tissue in trauma and reconstructive orthopedic procedures involving:

Long bones
Flat bones
Short bones
Irregular bones
Appendicular skeleton
Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Trauma System is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

Tumor resections where bone strength has not been compromised
Iliac crest harvests
Ribs

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Device Description

MacroPore OS Trauma System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws manufactured from poly (L-lactide) 70:30 (PLA). The MacroPore OS Trauma System is composed of MacroPore OS Trauma Protective Sheets, MacroPore OS Trauma Protective Sleeves, and MacroPore OS Trauma Screws.

The MacroPore OS Trauma Protective Sheets and Protective Sleeves 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 OS Trauma to the desired shape or size. MacroPore OS Trauma Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Trauma Protective Sheets and Protective Sleeves to the desired shape or size.

The MacroPore OS Trauma Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Trauma Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Trauma and prevent dislocation.

The MacroPore OS Trauma Screws range in size from 2.0mm to 4.8mm in diameter. The MacroPore OS Trauma Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The MacroPore OS Trauma Protective Sleeves are provided in lengths of 150mm to 5mm with diameters that range from 10mm up to 25mm. The MacroPore OS Trauma Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 500 microns to 3000 microns in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Trauma Protective Sheets and Protective Sleeves ranges from 0.75 mm to 3.0 mm according to the orthopedic region to be treated.

AI/ML Overview

The provided text describes a 510(k) summary for the MacroPore OS Trauma System, focusing on its substantial equivalence to predicate devices rather than adherence to a specific set of acceptance criteria with quantified performance metrics. Therefore, many of the requested categories for a study proving adherence to acceptance criteria cannot be extracted directly from this document.

Here's an attempt to populate the table and answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Material Compatibility (Heating)	Viscosity should stay within an "appropriate range" after prolonged heating at 60°C for 120 minutes.	"The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes."
Mechanical Properties (Aging)	Device should be "as rigid and as strong as the predicate" after 6 months of exposure.	"Testing demonstrated that the MacroPore OS Trauma Protective Sheet is as rigid and as strong as the predicate after 6 month of exposure."
Mechanical Properties (General)	To be "substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."	"Testing determined the MacroPore OS Trauma System to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
Crystallinity	Material should be "amorphous and non-crystalline" (i.e., no endothermic spikes on DSC).	"The tests ran on the sterile and nonsterile samples revealed no endothermic spikes, indicating that the implants are amorphous and non-crystalline."
Indications for Use	Must share "substantially equivalent indications for use" with predicate devices.	"The MacroPore OS Trauma System shares substantially equivalent indications for use with the predicate devices." (and "shares identical indications for use wording with the predicate device, MacroPore OS, with the exception of indications for rib bones.")
Design and Materials	"Nearly identical" to predicate devices, with similar shapes, sizes, pore diameter/spacing, and dimensions. Mechanical characteristics (tensile strength, rigidity/spring constant) must be "substantially equivalent."	"The design and materials... are nearly identical... pore size and spacing... within the pore size and spacing specifications... dimensions... comparable... mechanical characteristics... substantially equivalent."

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

The document describes in vitro testing but does not specify sample sizes for mechanical or material tests. It also does not mention any clinical test sets or data provenance (e.g., country of origin, retrospective/prospective). The study is entirely focused on in vitro engineering and material characterization.

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

Not applicable. The ground truth for in vitro mechanical and material properties is established through standardized engineering and material science testing methods (e.g., viscosity measurements, mechanical testing, DSC), not through expert consensus on qualitative observations.

4. Adjudication method for the test set

Not applicable. This was in vitro testing, not a clinical study requiring adjudication of expert 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 is a medical device for bone fixation, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device does not involve algorithms or AI.

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

For the in vitro testing, the "ground truth" was based on objective measurements and established scientific principles related to material properties (viscosity, crystallinity) and mechanical performance (rigidity, strength, tensile strength). The comparison was made against predicate device characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set. All testing described is analytical or comparative to predicate devices.

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

Not applicable. There is no training set.

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