(176 days)
MacroPore Protective Sheet is intended for use in trauma and reconstructive procedures in the oral cavity in conjunction with rigid internal fixation. The following specific indications are included:
-
- to maintain the position of bony fragments in bone graft procedures of the mandible or maxilla,
-
- for regeneration of bone tissue of the mandible or maxilla.
The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.
In addition to its function of providing fixation of non-load bearing areas, MPS serves as a protective sheathing to prevent soft tissue prolapse into defects that remain, or to prevent dislocation of autograft, allograft and/or bone graft substitutes that may be necessary in the reconstructive procedures. The macroporosity of the system permits mesenchymal stem cells from surrounding tissues to populate the defect and allows the ingrowth of blood vessels. This, combined with the inherent strength of MPS, facilitates osteogenesis by allowing the natural healing processes of the body to proceed in a protected environment without interference due to undesired interposition of soft tissue.
- for regeneration of bone tissue of the mandible or maxilla.
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 and to protect non-load and low-load bearing bone defects in the oral cavity from soft tissue interposition from adjacent soft and connective tissues (e.g. musculature) but allow, due to its porosity, for the proliferation of blood vessels and the migration of bone forming cells from such soft tissues into the bone defect. This facilitates bone regeneration.
MPS can be cut with scissors, is thermoplastic when heated to 55C (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 either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MPS and prevent dislocation. In the mandible or in any load bearing region, rigid internal fixation is essential. The system includes a selection of resorbable screws and tacks and associated manual instruments.
MPS 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. Its thickness ranges from 250 microns to 1000 microns according to the defect to be treated.
The provided 510(k) summary (K983360) describes MacroPore Protective Sheet, a medical device intended for use in trauma and reconstructive procedures in the oral cavity. The submission aims to establish substantial equivalence to predicate devices rather than proving a pre-defined set of acceptance criteria in the manner of a clinical trial for a new drug or a novel, high-risk device. Therefore, the "acceptance criteria" discussed below are inferred from the equivalence argument made by the manufacturer and the FDA's regulatory framework for 510(k) submissions.
The study that "proves" the device meets acceptance criteria is primarily a comparison of the subject device (MacroPore Protective Sheet) to legally marketed predicate devices based on intended use, design, and material characteristics, along with various in vitro and in vivo tests to support these comparisons.
Here's an analysis of the provided information, formatted to align with your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds against which the device was tested to "pass." Instead, the criteria are the characteristics of the predicate devices that the MacroPore Protective Sheet must demonstrate substantial equivalence to. The reported performance is the evidence presented to show this equivalence.
| Acceptance Criterion (Inferred from Predicate Devices) | Reported Device Performance (MacroPore Protective Sheet) |
|---|---|
| Intended Use Equivalence: |
- Maintain position of bony fragments in bone graft procedures (mandible/maxilla)
- Regeneration of bone tissue (mandible/maxilla)
- Protection from soft tissue prolapse/stabilize bone grafts | Equivalence Claimed:
- Intended uses are the same as or included in predicate devices (e.g., LactoSorb Panels and Fasteners for mandibular graft procedures; M-TAM and TRAM for fixation, reconstruction, and graft containment).
- Serves as a protective sheathing to prevent soft tissue prolapse and stabilize bone grafts, facilitating osteogenesis. |
| Design Equivalence (Physical Form, Macroporosity): - Thin sheet with macroporosity
- Varying sizes/thicknesses | Equivalence Claimed:
- "Similar physical designs" to predicate devices (Lactosorb, titanium mesh).
- Provided in sheets 20x20mm to 120x120mm, thickness 250-1000 microns.
- Macroporous design to prevent soft tissue prolapse, stabilize grafts, permit fluid/cell exchange, allow blood vessel proliferation. |
| Material Equivalence (Biocompatibility, Degradation Profile): - Specific polymer composition (for bioresorbable predicates)
- Degradation characteristics suitable for clinical use | Equivalence Claimed:
- Fabricated from poly(L-lactide-co-D,L-lactide) 70:30, amorphous (contrasted with LactoSorb's 82:18 poly(L-lactide-co-glycolide) and titanium's non-resorbability).
- Accelerated degradation testing showed similar degradation rate to Polypin (same material). Slower mechanical property degradation than LactoSorb.
- Mechanical stability unchanged for nine months; complete resorption in 12-36 months. No late inflammatory reactions expected due to amorphous nature (contrasted with mixed crystallinity polymers). |
| Mechanical Properties (Stiffness, Strength, Shapeability): - Resistance to deformation, sufficient strength for non-load bearing/supplemental fixation.
- Ability to be shaped to anatomical structures. | Demonstrated:
- Stiffness: Laboratory test showed MPS stiffness >9x M-TAM and >200x Prolastic Sheeting in a cylindrical configuration.
- Strength: Data on related Protego FX plates and screws (K972913) shows significant strength in tension and bending, and screws have appropriate shear/pullout strength for supplemental fixation.
- Shapeability: Thermoplastic when heated to 55°C, can be conformed 3D. Viscosity tests showed minimal effect of prolonged heating (120 min at 60°C). |
| Sterilization: - Sterility assurance level (SAL). | Demonstrated:
- Sterilization by electron beam irradiation; SAL of 10-6. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of a statistical clinical trial with human subjects. The evidence comes from:
- In vitro tests: No sample sizes are provided for the material degradation, viscosity, or stiffness tests.
- In vivo animal studies:
- One landmark study by Lemperle et al. used "edentulated canine mandible" (number of animals not specified) and "parietal bones" (number of animals not specified).
- Another animal study extended these findings using a "30 mm (critical size) segmental defect in the canine radius" (number of animals not specified).
- Data Provenance:
- In vitro testing: Conducted internally or by a contracting lab (not explicitly stated, but implied as part of the manufacturer's submission).
- In vivo testing: From animal studies (canines), both cited literature (Lemperle et al.) and directly conducted for resorbable polymers.
- Retrospective/Prospective: The animal studies would be considered prospective experimental studies. The comparison to predicate devices is a retrospective analysis of existing device characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This query is not directly applicable to a 510(k) submission based on substantial equivalence, especially for a device of this nature. "Ground truth" from experts is typically associated with diagnostic imaging AI devices or observational studies where expert consensus defines the 'true' condition.
For this device:
- For in vitro material properties: The "ground truth" is defined by scientific measurement standards and established material science principles. No human experts are used for this type of ground truth establishment in this context.
- For in vivo animal studies: The "ground truth" (e.g., new bone formation, healing) is established by histological and radiological assessment by veterinary pathologists/researchers involved in the studies, not a panel of experts. Their qualifications are not specified in the summary.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, there isn't a "test set" in the sense of human cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study assesses how human readers perform with and without AI assistance, which is not relevant for a physical implantable device like the MacroPore Protective Sheet.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- In vitro tests: Standardized material property measurements (e.g., degradation rate, viscosity, stiffness, tensile strength, shear strength, pullout strength).
- In vivo animal studies: Histological and radiological evidence of bone formation, healing, and soft tissue exclusion in animal models. The "concept of protecting bone defects from soft tissue interposition to facilitate bone regeneration" was the core hypothesis validated in these animal studies.
- For the 510(k) submission itself: The "ground truth" for substantial equivalence is the set of established characteristics and intended uses of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.