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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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MacroPore Protective Sheet (MPS) is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton:

1. Comminuted fractures of the naso-ethmoidal and infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Trauma of the midface or craniofacial skeleton
4. Reconstructive procedures of the midface or craniofacial skeleton.

The system is not intended for use in the mandible and/or for full load bearing procedures.

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.

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.

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.

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Repair of long bone fractures due to trauma or reconstruction
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy

The Metagen Activelock™ Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. The fundamental components of the system are a 4.5 mm wide x 250 mm long metal band, a titanium sleeve which slides onto the band, and a Nitinol clamp which secures the band. There are two metal band designs in the system; a .30 mm thick Ti 6Al-4V band, and a .Smin thick Nitinol band. Both bands in this system are secured with the same Nitinol clamp. The sleeve is a low profile titanium block with slots to accept the band and sharp tines which project into the bony surface. The Nitinol clamp component provides a positive method of securing the band. When viewed from the top the clamp is an open. rectangular block. A side view shows the through slot that accepts and ultimately secures the band. Because of the super-elastic properties of the Niinol material, the clamp component can be physically stretched along its with a cerclage applicator instrument . The cerclage applicator instrument device by design limits the elongation of the slot well within the clamp's elastic range. The clamp is in no danger of undergoing permanent (plastic) deformation.

When the slot is elongated, the band fits easily through the slot. Upon release of the stretching force, the clamp retracts toward its resting position and engages the hand with sufficient force to lock the band securely in place. Mechanical testing of the assembled device comparing the band in both titanium and Nitinol to 18 and 16 gage twisted monofilament wire assemblies shows that the Activelock ™ system exceeds the strength of the twisted wire assemblies.

The provided submission is a 510(k) summary for the Metagen Activelock™ Cerclage System, seeking to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through a dedicated study with specific acceptance criteria that would typically generate the detailed performance data requested. Therefore, many of the requested data points (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, ground truth details, and training set information) are not applicable or provided in this type of submission.

However, based on the "Mechanical Testing" section, we can infer a primary acceptance criterion and its reported performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The text mentions "static tensile tests were performed" comparing the Metagen system (both maximum material condition (MMC) and least material condition (LMC) clamps and bands) against "both 16 gage and 18 gage AISI Type 316L stainless steel cerclage wires." While not a specific number, it indicates a comparative mechanical test rather than a clinical trial with human subjects.
• Data Provenance: The data is generated from in vitro mechanical testing. There's no information on country of origin, and it's by definition a prospective test (not retrospective human data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This was a mechanical engineering test comparing tensile strength of physical devices, not a study requiring expert clinical assessment or ground truth establishment in the traditional sense. The "ground truth" here is the measured tensile strength of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This was a mechanical test, not a subjective clinical assessment that would require adjudication.

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 device is a physical cerclage system, not an AI or imaging diagnostic algorithm. There were no human readers or AI in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the comparison was the measured tensile strength of "clinically accepted 16 and 18 gage stainless steel cerclage wire." This is an objective, quantitative measurement from mechanical testing of existing, predicate devices.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.

9. How the ground truth for the training set was established:

• Not applicable for the reason above.

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