(228 days)
The MacroPoreOS Protective Sheet 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 MacroPoreOS Protective sheet is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the MacroPoreOS Protective Sheet 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 MacroPoreOS Protective Sheet 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
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.
MacroPoreOS Protective Sheet is a resorbable, macroporous implant in sheet form manufactured from polylactic acid (PLA). MacroPoreOS Protective Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPoreOS Protective Sheet to the desired shape or size. MacroPoreOS Protective Sheet is fully malleable when heated to approximately 65℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPoreOS Protective Sheet can be rolled into a tube or used as a flat sheet. MacroPoreOS Protective Sheet can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to further stabilize the anatomical region. The MacroPoreOS System includes MacroPoreOS Protective Sheets, a selection of resorbable MacroSorb Screws, MacroSorb Tacks and associated manual instruments.
MacroPoreOS 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 pore size ranges from 500 microns to 2500 microns in diameter, with pores distributed uniformly throughout the sheet in an offset or aligned pattern. The thickness of the MacroPoreOS Protective Sheet ranges from 0.50 mm to 2.0 mm according to the orthopedic region to be treated, however, not to exceed a total mass of 18 grams.
The MacroPoreOS Protective Sheet is fabricated from polylactic acid (PLA).
Here's an analysis of the acceptance criteria and study information for the MacroPoreOS Protective Sheet (K994158), based on the provided text:
Acceptance Criteria and Device Performance (K994158)
The provided document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria in the same way a clinical trial might. Therefore, the "acceptance criteria" here are largely defined by the characteristics of the predicate device and the mechanical properties deemed equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (MacroPoreOS Protective Sheet) |
|---|---|
| Intended Use: Similar to predicate (Sofamar Danek Timesh and other MacroPore Protective Sheets) for reinforcing weak bony tissue and cement restriction. | "The MacroPoreOS Protective Sheet shares indications for use with the predicate device as both the I he Macrol oroon Trotective Sheet and the Timesh predicated for reinforcing weak bony tissue in orthopedic procedures. The MacroPoreOS Protective Sheet and the Timesh predicate also share cement restriction indication for use." |
| Material: Biocompatible, amorphous polymer. | "Fabricated from polylactic acid (PLA)." "Poly (L-lactide-co-D,L-lactide) 70:30, amorphous." |
| Design: Thin semi-rigid sheet, macroporous, cuttable to size. Pore size and spacing comparable to predicate. | "Resorbable, macroporous implant in sheet form manufactured from polylactic acid (PLA). Can be cut with scissors... fully malleable when heated... Pores are 500 microns to 2500 microns in diameter, distributed uniformly... thickness ranges from 0.50 mm to 2.0 mm." "The pore size and spacing of the predicate device is within the pore size and spacing specifications of the MacroSorbOS Protective Sheet." |
| Dimensions: Provided in rectangular sheets, comparable to predicate. | "Sheets of 20 x 20 mm to 120 x 120 mm" and "Dimensions of the predicate device are also operiodions or the MacroSorbOS Protective sheet as both devices are provided in rectangular sheets that oompanders..." (implying similar size formats). |
| Mechanical Properties: Initial and in-vivo strengths and rigidity substantially equivalent to predicate. | In Vitro Testing: |
- Effect of Heating: Viscosity stayed within appropriate range over 120 minutes at 60°C.
- Accelerated Aging: As rigid and strong as the predicate after simulated 6-month in vivo exposure. Retains strength for 9 months, decreases to zero after approximately 18 months.
- Mechanical Testing: "Determined the MacroPoreOS Protective Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." |
| Crystallinity: Amorphous (non-crystalline). | "The tests ran on the sterile and non-sterile samples revealed no endothermic spikes. From this we verify the implants are amorphous or non-crystalline." |
| Resorption: Intended to be metabolized by the body. | "The polymer devices are intended to be metabolized by the body and do not require removal." (Implied by accelerated aging test showing strength decrease over time). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense (e.g., patient data for diagnostic accuracy). The "testing" primarily involved in vitro studies and comparative analysis to predicate devices.
- Sample Size: Not explicitly stated in terms of patient numbers or clinical cases. The samples for in vitro tests would be material samples of the MacroPoreOS Protective Sheet itself.
- Data Provenance: The 'data' are results from laboratory testing (in vitro) performed by the manufacturer, MacroPore, Inc. There is no mention of country of origin for clinical data or whether it was retrospective or prospective, as no human clinical data is presented for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" based on expert consensus for clinical cases is mentioned, as this submission relies on demonstrating substantial equivalence through mechanical and material properties, not clinical diagnostic or treatment efficacy data from human subjects.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a 510(k) premarket notification for a Class II bone fixation appliance. It does not involve AI, image interpretation, or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by the known, accepted properties and performance of the legally marketed predicate devices (Sofamar Danek Timesh K974017, MacroPore Protective Sheet K972913, MacroPore Protective Sheet K983360) and standard scientific/engineering principles for material characterization and mechanical testing. The MacroPoreOS Protective Sheet's characteristics (material, design, mechanical strength, resorption profile) are compared to these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The "training" for the device, if one were to stretch the analogy, would be the research and development process that led to its design, informed by predicate device characteristics.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there's no training set. The "ground truth" for the device's design parameters was established through comparison to legally marketed predicate devices and physical/chemical characterization tests (e.g., DSC for crystallinity, viscosity testing, accelerated aging).
§ 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.