RPM™ Reinforced PTFE Mesh is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE mesh helps create the space needed for bone-derived cells to repopulate and repair the defect. RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells. The PTFE mesh is designed to maintain space and conform to tissue contours. RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the RPM™ Reinforced PTFE Mesh, a medical device for bone grafting. The document focuses on demonstrating substantial equivalence to predicate and reference devices through non-clinical testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Tensile Strength	Tensile strength ≥ reference device (Bio-Gide®)	Tensile strength ≥ reference device (Bio-Gide®)
Lamination Strength	Lamination strength ≥ reference device (Cytoplast™ Regentex™ Titanium 250)	Lamination strength ≥ reference device (Cytoplast™ Regentex™ Titanium 250)
Suture Retention Force	Suture retention force ≥ reference device (Cytoplast™ Regentex™ Titanium 250)	Suture retention force ≥ reference device (Cytoplast™ Regentex™ Titanium 250)
Cytotoxicity	Non-cytotoxic (passed ISO 10993-5)	Non-cytotoxic
Irritation	Non-irritant (passed ISO 10993-10)	Non-irritant

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample sizes used for each in vitro bench test. It mentions that "in vitro product characterization testing was performed" and "A series of bench tests were conducted."
The data provenance is from non-clinical testing (in vitro characterization studies and biocompatibility studies). No information about country of origin for the data is provided, but it's generated as part of a US FDA submission. The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. The "ground truth" in this context is established by the design and execution of the scientific tests based on recognized standards (ASTM, ISO). There are no human "experts" establishing ground truth in the way one would for image interpretation in AI. The testing itself is the ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The test results are objective measurements against established standards and comparisons to reference devices.

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 submission is for a physical medical device (reinforced PTFE mesh), not an AI/imaging diagnostic device. Therefore, no MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

Performance against established industry standards: ASTM D638-14 for tensile strength, and ISO 10993-5 and ISO 10993-10 for biocompatibility.
Comparative performance against legally marketed predicate/reference devices: The specified predicate device (Osteo-Mesh™ TM-300) and reference devices (Cytoplast™ Regentex™ Titanium 250 and Bio-Gide® Resorbable Bilayer Membrane) serve as benchmarks for tensile strength, lamination strength, and suture retention force.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device or a study involving a "training set" in that sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. Refer to point 8.

Summary

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October 19, 2017

Osteogenics Biomedical, Inc. Shane Shuttlesworth President 4620 71st St. Bldg. 78-79 Lubbock, Texas 79424

Re: K171774

Trade/Device Name: RPM Reinforced PTFE Mesh Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: June 14, 2017 Received: June 14, 2017

Dear Shane Shuttlesworth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171774

Device Name RPM™ Reinforced PTFE Mesh

Indications for Use (Describe)

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar bony defect sites.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

l. SUBMITTER

Applicant Name:	Osteogenics Biomedical, Inc.
Address:	4620 71st St, Bldg. 78Lubbock, Texas 79424
Phone:	(806) 796-1923
Fax:	(806) 796-0059
Contact Person:	Shane ShuttlesworthPresident
Date Prepared:	May 10, 2017

II. DEVICE

Trade Name:	RPM™ Reinforced PTFE Mesh
Common Name:	PTFE Mesh
Regulation Number:	21 CFR 872.3930
Regulation Name:	Bone Grafting Material
Regulatory Class:	II
Product Code:	NPK (Barrier, Synthetic, Intraoral)

lll. PREDICATE DEVICE

Predicate Device:	Osteo-Mesh™ TM-300 (Osteogenics Biomedical, Inc.
	K984230

Cytoplast™ Regentex™ Titanium 250 (K972278) and Bio-Gide® Resorbable Bilayer Membrane (K050466) were used as a reference devices in this submission.

IV. DEVICE DESCRIPTION

RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the

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bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells.

The PTFE mesh is designed to maintain space and conform to tissue contours.

RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes. Outer dimensions include:

12 mm x 24 mm
14 mm x 24 mm
17 mm x 25 mm
20 mm x 25 mm
25 mm x 36 mm
25 mm x 30 mm
30 mm x 41 mm
. 24 mm x 38 mm
30 mm x 40 mm
13 mm x 18 mm
. 13 mm x 19 mm

V. INDICATIONS FOR USE

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

RPM™ Reinforced PTFE Mesh is substantially equivalent to the predicate device, Osteo-Mesh™ TM-300, and the reference device, Cytoplast™ Regentex™ Titanium 250. RPM™ Reinforced PTFE Mesh is identical in design, function, and intended use to the legally marketed predicate device Osteo-Mesh™ TM-300. RPM™ Reinforced PTFE Mesh is identical in composition,

biocompatibility, sterilization, model sizes, packaging, shelf life, physical properties, and intended use to the legally marketed reference device Cytoplast™ Titanium 250. See comparison table below:

	RPM™ ReinforcedPTFE Mesh	Osteo-Mesh™ TM-300(K984230)	Cytoplast™ Regentex™Titanium 250(K972278)
	Osteogenics Biomedical,Inc.	Osteogenics Biomedical,Inc.	Osteogenics Biomedical,Inc.
Product Code	NPK	LEY	LYC
Indications forUse	For stabilization andsupport of bone grafts inalveolar bony defectsites.Rx Only	For stabilization andsupport of bone grafts indento-alveolar bonydefect sites.Rx Only	A temporarilyimplantable material(non-resorbable for useas a space-makingbarrier in the treatmentof periodontal defects.
			Rx Only
			Rx Only
Operational	RPM™ Reinforced PTFE	Osteo-Mesh™ TM-300 is	Cytoplast™ Regentex™
Principles	Mesh is placed between	placed between bone	Titanium 250 is placed
	bone grafts and the	grafts and the	between bone grafts and
	periosteum in dental	periosteum in dental	the periosteum in dental
	bone grafting procedures	bone grafting procedures	bone grafting procedures
	to stabilize and support	to stabilize and support	to stabilize and support
	the bone graft. The PTFE	the bone graft. The PTFE	the bone graft. The PTFE
	mesh helps create the	mesh helps create the	mesh isolates the space
	space needed for bone-	space needed for bone-	needed for bone-derived
	derived cells to	derived cells to	cells to repopulate and
	repopulate and repair	repopulate and repair	repair the defect.
	the defect.	the defect.
Design	Titanium frame	Titanium mesh may be	Titanium frame
	embedded between two	trimmed and shaped to	embedded between two
	layers of PTFE. Titanium	create additional space	layers of PTFE. Titanium
	frame may be trimmed	for bone growth.	frame may be trimmed
	and shaped to create	Macropores allow direct	and shaped to create
	additional space for	contact between the	additional space for
	bone growth.	bone graft and the	bone growth.
	Macropores allow direct	periosteum. Direct
	contact between the	contact between the
	bone graft and the	periosteum and bone
	periosteum. Direct	graft allows naturally
	contact between the	occurring
	periosteum and bone	revascularization and
	graft allows naturally	infiltration of cells.
	occurring
	revascularization and
	infiltration of cells.

Composition	100% PTFE,	Titanium	100% PTFE,
	Titanium		Titanium
Pores	Macro	Macro	Micro
Use	Single	Single	Single
Shelf Life	4 years	N/A	4 years
Biocompatible	Yes	Yes	Yes
Sterilization	Sterile	Non-Sterile	Sterile
Model Sizes	Various	Various	Various
Maximum	12 months	Not Stated	Not Stated
Duration of
Implantation

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PERFORMANCE DATA VII.

Nonclinical Tests Submitted

The substantial equivalence of RPM™ Reinforced PTFE Mesh and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, and clinical history of the reference devices.

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Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows:

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its reference devices. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties.

Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification. Lamination strength and suture retention force were characterized and compared to the reference device, Cytoplast™ Regentex™ Titanium 250.

Test	Test Method	Results
Tensile Strength	ASTM D638-14	Tensile strength ≥ reference device
Lamination Strength	Internal	Lamination strength ≥ reference device
Suture Retention Force	Internal	Suture retention force ≥ reference device

The comparative bench testing is summarized in the table below.

In vitro biocompatibility testing was performed to assess biocompatibility of the RPM™ Reinforced PTFE Mesh as an implantable material.

The subject device passed the following FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.

Test	Test Method/Model	Results
Cytotoxicity	ISO MEM Elution Assay with L-929Mouse Fibroblast Cells, ISO 10993-5	Non-cytotoxic
Irritation	Oral Mucosa Irritation, ISO 10993-10	Non-irritant

VIII. CONCLUSION

The results of in vitro device characterization tests show that the subject device, RPM™ Reinforced PTFE Mesh, is substantially equivalent to the predicate device or reference devices. Tensile strength testing shows that the subject device is at least as strong, statistically, as the reference device, Bio-Gide®. Lamination strength and suture retention force tests show that the subject device is at least as strong, statistically, as the reference device, Cytoplast™ Titanium 250. Biocompatibility testing demonstrated that the subject device is non-cytotoxic and a non-irritant.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.