(195 days)
The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of 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 Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:
- · Tumor resections where bone strength has not been compromised
- Iliac crest harvests
- Ribs (excluding multiple segmental defects such as those found in flail chest)
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.
MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks.
The MacroPore OS Reconstruction System 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 Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System 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 OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System 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 Reconstruction System and prevent dislocation.
The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.
The provided text describes the MacroPore OS Reconstruction System, which is a resorbable graft containment system. The document is a 510(k) summary, demonstrating "substantial equivalence" of the device to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's an analysis based on your requested information, acknowledging that many items are not applicable or not explicitly stated in this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from Predicate Device) | MacroPore OS Reconstruction System Performance |
|---|---|---|
| Material Composition | Resorbable polylactide (PLA) | Fabricated from polylactic acid (PLA) |
| Design Principles | Provided in sheets; fixation screws and tacks of similar shapes/sizes; semi-rigid construction with pores of similar diameter and spacing; can be shaped with warm water and cut to specific shapes/sizes. | Provided in sheets and sleeves; fixation screws (2.0mm-4.75mm diameter, 3.35mm-30mm length) and tacks (1.7mm-2.2mm diameter, 3.6mm-5.6mm length). Protective Sheet size 25x25mm to 160x200mm. Sleeves 150mm to 5mm length, 5mm-40mm inner diameter, various shapes. Pore sizes 1.7mm-4.0mm. Can be cut with scissors or Power Pen, fully malleable when heated to 55°C. |
| Indications for Use | Maintain relative position of weak bony tissue (bone grafts, bone graft substitutes, comminuted fracture fragments); cement restriction in total joint arthroplasty (for flat sheets with pores up to 2.5mm); use in long, flat, short, irregular bones, appendicular skeleton, thorax (with rigid fixation); tumor resections (uncompromised bone strength), iliac crest harvests, ribs (alone). | Substantially equivalent to predicate devices. (See "Indications for Use" section in original document for full details). |
| Mechanical Properties | Tensile strength and rigidity (spring constant) comparable to predicate. | In Vitro Testing showed: |
- Viscosity stayed within appropriate range after 120 minutes at 60℃ in saline (indicating brief heating during surgical prep not significant).
- As rigid and strong as predicate device after 6 months of exposure in aging studies.
- Substantially equivalent to mechanical strengths of predicate devices under indication for use conditions (tensile strength, rigidity).
- Amorphous and non-crystalline (confirmed by DSC). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices, supported by in vitro bench testing, rather than a clinical human test set. The "test set" here refers to the samples of the device itself (MacroPore OS Reconstruction System components) used for mechanical and material characterization.
- Data Provenance: The testing was in vitro (bench testing) performed on the device components. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.
3. 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. Ground truth, in the context of expert consensus, is relevant for diagnostic or image-based devices being evaluated by human interpretation. This document describes a surgical implantable device, and its equivalency is based on material properties, design, and mechanical performance demonstrated through objective laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for clinical trials or studies involving human judgment (e.g., image interpretation). The "test set" here refers to physical device samples undergoing laboratory evaluation.
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 not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating equivalence was established by:
- Predicate Device Specifications: The material composition, design principles, indications for use, and mechanical properties of the legally marketed predicate devices (MacroPore OS Protective Sheet and Synthes Resorbable Meshes and Sheets) served as the reference or "ground truth" for comparison.
- Standardized Material and Mechanical Testing: In vitro tests (e.g., viscosity, aging studies, tensile strength, rigidity, DSC) were performed on the MacroPore OS Reconstruction System components, and the results were compared to the known or expected performance characteristics of the predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.