FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

MacroPore Protective Sheet is an absorbable, macroporous implant in sheet form manufactured from polylactic acid (PLA). The purpose of the sheet is to provide fixation of non-load bearing bone defects in the cranio-facial area of the mammalian skeletal system. MPS can be cut with scissors, is thermoplastic when heated to 55 C (for example, by the use of sterile hot water) and thus can be conformed three dimensionally to any bone defect. It can be rolled into a tube or used as a flat sheet. It can be used in conjunction with internal bone fixation devices such as plates and screws which can be also used to fixate the MPS and prevent dislocation. The system includes a selection of resorbable screws and tacks. MPS is provided in sheets of 40 x 40 mm and in premanufactured shapes and can be provided in other sizes as needed for particular surgical procedures. Its thickness ranges from 500 microns to 1000 microns according to the defect to be treated. The pore size ranges from 500 microns to 2000 microns with pores distributed uniformly throughout the sheet in an offset or aligned pattern.

AI/ML Overview

This document is a 510(k) premarket notification for the MacroPore Protective Sheet (Protego™ System) and does not describe a study involving acceptance criteria and device performance in the way a clinical study or AI/ML device validation might.

Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. Therefore, the "acceptance criteria" here relate to FDA's standards for substantial equivalence, primarily concerning intended use, design, and material composition, rather than statistical performance metrics of a specific study.

Here's a breakdown based on the provided text, addressing your points where applicable and noting where the information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are the characteristics of the predicate devices against which the MacroPore Protective Sheet (MPS) is compared for substantial equivalence. The "reported device performance" refers to how MPS aligns with these characteristics.

Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (MacroPore Protective Sheet)
Intended Use: For use in trauma and reconstructive procedures in the midface and craniofacial skeleton for comminuted fractures of naso-ethmoidal and infraorbital areas, frontal sinus wall, and general midface/craniofacial trauma/reconstruction. Not for mandible or full load-bearing.	Intended Use: Identical to predicate devices. For use in trauma and reconstructive procedures in the midface and craniofacial skeleton for comminuted fractures of naso-ethmoidal and infraorbital areas, frontal sinus wall, and general midface/craniofacial trauma/reconstruction. Not for mandible or full load-bearing.
Design: Thin sheet with perforations; various thicknesses (e.g., 500-1000 microns for LactoSorb); various sizes; specific pore sizes (e.g., 1500-2000 microns for LactoSorb); uniform aligned pattern.	Design: Sheet form, 500-1000 microns thickness; 40x40mm (can be other sizes); pore size 500-2000 microns, uniformly distributed in offset or aligned pattern. Can be cut, thermoplastically conformed, rolled.
Material: Resorbable polymer, specifically poly(L-lactide-co-glycolide) 82:18, low crystallinity (for LactoSorb). Titanium for other predicates.	Material: Absorbable polymer, specifically poly(L-lactide-co-D,L-lactide) 70:30, amorphous.
Degradation Profile: Maintains 70% strength for 6-8 weeks, fully degraded 9-15 months (for LactoSorb).	Degradation Profile: Degrades more slowly than LactoSorb, fully degraded after 36 months (shown in animal studies).
Sterilization: Ethylene Oxide sterilizable, validated per ANSI/AAMI/ISO 11135-1994, SAL 10^-4.	Sterilization: Ethylene Oxide sterilizable packaging; sterilization by EtO treatment; validated per ANSI/AAMI/ISO 11135-1994, SAL 10^-4.

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

Sample Size: Not applicable. This document does not describe a clinical study with a "test set" in the context of device performance evaluation. The substantial equivalence determination is based on a review of technical and performance characteristics compared to existing devices. The "animal studies" mentioned for degradation are not detailed in terms of sample size or provenance.
Data Provenance: Not applicable for a traditional test set. The data presented is descriptive of the device's characteristics and comparison to predicate devices, which are already marketed in the US.

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

Number of Experts/Qualifications: Not applicable. "Ground truth" in this context is established by the known characteristics and approved uses of the predicate devices, and the detailed technical specifications and material properties provided by the manufacturer for the new device. The FDA (specifically the General and Plastic Surgery Device Section of the Surgical and Rehabilitation Devices Panel) reviews this information to make the equivalence determination.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" or diagnostic/classification task requiring expert adjudication in this type of submission.

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

This is not applicable to a 510(k) premarket notification for a passive implantable medical device like the MacroPore Protective Sheet. Such studies are relevant for diagnostic imaging or AI-powered devices, which this is not.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the comparison of intended use, design, and material of the MacroPore Protective Sheet is derived from the FDA-cleared information and known characteristics of the predicate devices (LactoSorb Trauma Plating System, Tilghman Titanium Mesh Skeletal Orbit Liner, Motech Titanium Surgical Mesh, and Leibinger Titanium DynamicMesh), combined with the manufacturer's specifications and testing data (e.g., degradation in animal studies, sterilization validation) for the MPS itself.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This pertains to AI/ML device development, which is not relevant here.

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

Ground Truth for Training Set: Not applicable. This pertains to AI/ML device development.

Summary

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.