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A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, III) fractures. 5). Orbital floor fractures. 6). Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones. B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications: 1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.). 2). Lefort (I, II, III) osteotomies. 3). Tumor reconstruction in midface or craniofacial procedures. 4). Bone graft procedures in the midface or craniofacial skeleton. 5). Pediatric reconstructive procedures. 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. 7). Craniotomy flap fixation.

MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets 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 and Protective Sheets to the desired shape or size. The MacroPore Plate and Protective Sheets 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. The MacroPore FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer. Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.

This document describes the MacroPore FX, PS, NS, LP bone fixation system, which is a medical device. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing acceptance criteria and device performance in the way typically seen for a new AI/software-based medical device.

Therefore, many of the requested categories related to clinical study design and results for acceptance criteria cannot be directly answered from this document. This document details in vitro testing for mechanical properties and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of performance metrics for a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes in vitro mechanical testing but does not specify the sample size (number of devices or tests performed) for this testing.
• Data Provenance: The testing appears to be conducted by the manufacturer ("MacroPore, Inc."). The document does not specify the country of origin of the data beyond implying it's part of the manufacturer's submission for FDA clearance in the USA. It is in vitro data, not human patient data (retrospective or prospective).

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

This is not applicable as the study involved in vitro mechanical testing comparing device properties, not a clinical assessment requiring expert interpretation of patient data or establishment of a clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable, as it involved in vitro mechanical testing, not a clinical assessment requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI

Not applicable. This is not an AI/software-based device, and no MRMC study was conducted.

6. If a Standalone (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

The "ground truth" in this context refers to the established mechanical properties and design characteristics of the predicate devices. The new device's performance was measured in vitro and compared against these established characteristics to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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