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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

• 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).

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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:

• 1. to maintain the position of bony fragments in bone graft procedures of the mandible or maxilla,
• 2. 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.

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.

• 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.

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