Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

Device Description

The BME Nitinol Compression Plating System™ (NCP) consists of a sterile bone plate offered in various configurations (outlined below) and sterile titanium screws. The Nitinol bone plate is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Nitinol bone plate is activated at room temperature upon release from a constraining instrument. In its final configuration, the plate actively provides continuous compression across the fusion site.
The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants.
The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nitinol Compression Plating System™ based on the provided document:

The document describes a 510(k) premarket notification for a Class II medical device, indicating that the primary goal of the studies was to demonstrate substantial equivalence to existing predicate devices, rather than establishing standalone performance against specific clinical efficacy metrics. Therefore, the "acceptance criteria" are predominantly related to mechanical and material performance benchmarks compared to predicates, and the "study" involves bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the performance of the predicate device or established ASTM standards. The "reported device performance" is the finding of substantial equivalence to these criteria.

Acceptance Criterion (Standard or Predicate Performance)	Device Performance (Conclusion)
Static Bend: Performance equivalent to GPC predicate per ASTM F382(2008) e1	Substantially Equivalent to predicate.
Dynamic Bend: Performance equivalent to GPC predicate per ASTM F382(2008) e1	Substantially Equivalent to predicate.
Post Fatigue Corrosion: Performance equivalent to predicate/standard per ASTM F2129-08	Substantially Equivalent to predicate (though predicate is listed as "NA," implying compliance with the standard is the key).
Post Fatigue Nickel Leaching: Performance equivalent to GPC predicate/screws (no specific standard listed)	Substantially Equivalent to predicate.
Corrosion: Performance equivalent to BME Triad predicate per ASTM F2129-08	Substantially Equivalent to predicate.
Galvanic Corrosion: Performance equivalent to standard per ASTM F3044-14	Substantially Equivalent to predicate (though predicate is listed as "NA," implying compliance with the standard is the key).

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

Sample Size for Test Set: The document mentions "The test device is the representative worst-case condition for all configurations" (Page 5). While it specifies the part number NP-35S-5 for the tested device, it does not explicitly state the number of samples tested for each benchmark. It implies that a sufficient number was tested to represent the worst-case and draw conclusions.
Data Provenance: The data provenance is from bench testing conducted by BioMedical Enterprises, Inc. (BME). This is not clinical data, so it doesn't involve countries of origin or retrospective/prospective distinctions.

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

This section is not applicable as the described studies are bench tests, not clinical studies involving "ground truth" established by medical experts. The "ground truth" here is the adherence to engineering standards and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are bench tests, not clinical studies requiring adjudication of outcomes by experts.

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. The device is a physical bone plating system, not an AI-powered diagnostic or decision-support tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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 bone plating system, not an algorithm.

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

The "ground truth" for these studies is:

Engineering Standards: Specifically, ASTM F382(2008) e1, ASTM F2129-08, and ASTM F3044-14.
Predicate Device Performance: The observed mechanical and material performance characteristics of the GPC Medical Bone Fixation Plates and Screw System™ and BME Speed Triad™ (K133844).

8. The Sample Size for the Training Set

This section is not applicable. The described studies are bench tests for a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would involve internal development and testing, but not a "training set" in this sense.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

BioMedical Enterprises, Incorporated Mr. Joe Soward Director, Quality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K143023 Trade/Device Name: Nitinol Compression Plating System™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 16, 2014 Received: October 21, 2014

Dear Mr. Soward:

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 (reporting of medical

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Page 2 - Mr. Joe Soward

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143023

Device Name Nitinol Compression Plating System™

Indications for Use (Describe)

· Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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(510(k) Summary)

Nitinol Compression Plating System™ Product:

Submitter Information

BioMedical Enterprises, Inc. 14785 Omicron Drive. Ste. 205 San Antonio, Texas 78245 Telephone: Fax: (210) 677-0355 Joe W. Soward Contact:

October 16, 2014 Date Prepared:

Classification name: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)

Classification:	Class II
Product Code:	HRS
Common/Usual Name:	Bone Plate and Screws
Proprietary Name:	Nitinol Compression Plating system™™

Intended Use:

The Nitinol Compression Plating System™ is indicated for:

Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

Substantial Equivalence:

The Nitinol Compression Plating System™ is substantially equivalent to primary predicate GPC Bone Plates and Bone Screws cleared in K092493. The bundled clearance also included the DHS/DCS Plate System, the designs and indications of which we do not claim substantial equivalence. In addition, the BME Nitinol Compression Plating System™ is manufactured from many of the same materials and is substantially equivalent in potentiodynamic breakdown testing as cleared reference device BME Speed Triad™ K133844.

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Device Description

The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants.

The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

Performance Bench Testing:

BME conducted a series of tests to compare the submitted devices to the predicates. A summary of the testing is shown in Table 5-2. The test device is the representative worstcase condition for all configurations.

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Description	Part Number	Predicate	Standard	Conclusion
Static Bend	NP-35S-5	GPC	ASTMF382(2008) e1	SubstantiallyEquivalent topredicate.
DynamicBend	NP-35S-5	GPC	ASTMF382(2008) e1	SubstantiallyEquivalent topredicate.
Post FatigueCorrosion	NP-35S-5	NA	ASTM F2129-08	SubstantiallyEquivalent topredicate.
Post FatigueNickelLeaching	NP-35S-5	GPCGPCScrews	None	SubstantiallyEquivalent topredicate.
Corrosion	NP-35S-5	BMETriad	ASTM F2129-08	SubstantiallyEquivalent topredicate.
GalvanicCorrosion	NP-35S-5	NA	ASTM F3044-14	SubstantiallyEquivalent topredicate.

Table 5-2: Summary of Bench Testing

Details of the bench testing can be found in individual test reports included with this submittal. The full test reports describe the purpose of each test, apparatus and equipment used, protocol, results, statistical analyses if any, and conclusions. Based on the results of this comparison, the Nitinol Compression Plating system™ is as safe, effective and performs as well or better than the GPC and BME predicate devices outlined within this submission.

Regulation Number and Section

§ 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.