The Converge™ 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.

Device Description

The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.

The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.

The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Converge™" device, a bone plate and screw system. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "The results demonstrate substantial equivalence to predicate device" for a series of non-clinical tests. This implies that the acceptance criteria were met by demonstrating performance comparable or superior to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Static bend performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Dynamic bend performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Post fatigue corrosion performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Post fatigue nickel leaching performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Corrosion performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Galvanic corrosion performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
MRI compatibility (MR Conditional determination).	Results indicate it is MR Conditional.
MRI RF heating simulation performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Bone screw insertion and removal performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Plate compression performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Bone screw torsion performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Bone screw pull-out performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.
Bone screw corrosion resistance performance comparable to predicate.	Results demonstrate substantial equivalence to predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the non-clinical tests. It only lists the types of tests performed. The data provenance (country of origin, retrospective/prospective) is not mentioned, but as this is a non-clinical study, it would typically be conducted at an engineering or testing lab and not involve human subjects or geographical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as the submission is for a medical device (bone plate and screws) and relies on non-clinical engineering and material testing, not human-read clinical data. Therefore, there's no "ground truth" to be established by medical experts in this context.

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

This section is Not Applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes.

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 section is Not Applicable. The document explicitly states "Clinical Evidence: Not Applicable." The submission is for a device, not an AI or imaging diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

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

This section is Not Applicable. The device is a physical bone plate and screw system, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by engineering standards and direct measurement according to scientifically validated test methods. For example, a "static bend" test would establish its ground truth based on measurable mechanical properties and material failure points as defined by engineering principles, rather than expert consensus or pathology reports.

8. The sample size for the training set

This section is Not Applicable. There is no "training set" as this is a non-clinical device submission, not a machine learning or AI algorithm.

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

This section is Not Applicable for the same reason as 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

August 11, 2016

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

Re: K153573 Trade/Device Name: Coverge™ 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: July 8, 2016 Received: July 11, 2016

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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,

Vincent J. Devlin -S

for

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) K153573

Device Name Converge™

Indications for Use (Describe)

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

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Converge™.

1. Submitted By:	BioMedical Enterprises, Inc.14785 Omicron Dr., Suite 205San Antonio, TX 78245
Date:	August 9, 2016
Contact Person:	Joe SowardDirector Quality Compliance andRegulatory AffairsOffice: 210-881-0011Fax: 210-677-0355
	Gretchen UptonRegulatory Affairs SpecialistOffice: 210-881-0043Fax: 210-677-0355
2. Proprietary Name:	Converge™
Common Name:	Bone Plate and Screws
Classification Name and Definition:	21 CFR 888.3030 – Single/multiplecomponent metallic bone fixation appliancesand accessories.
	21 CFR 888.3040 – Smooth or threadedmetallic bone fixation fastener.
Device Product Code, Device Panel:	HRS – Orthopedic Devices
	HWC – Orthopedic Devices
3. Primary Predicate:	GPC Medical Bone Plates and Bone ScrewsK092493
Reference Device:	Nitinol Compression Plating System™K143023

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4. Device Description:

5. Intended Use

6. Technological Characteristics Comparison

The Converge™ Nitinol Compression Plate system and primary predicate GPC Medical Bone Plate system share the same technological characteristics. More specifically, they share the same indications and intended use. The primary differences between the devices involve differences in geometry related to plate configuration and plate thickness, delivery method, and implant material, in that the Converge™ plate is made of nitinol and the GPC plate is made of titanium.

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7. Substantial Equivalence - Non-Clinical Evidence

The Converge™ is substantially equivalent to primary predicate GPC Medical Bone Plates and Bone Screws cleared in K092493. That clearance also included the DHS/DCS Plate System, the designs and indications of which we do not claim substantial equivalence. In addition, the BME Converge™ is manufactured from the same materials using the same processes as FDA cleared reference device BME Nitinol Compression Plating System™ K143023.

BME conducted a series of tests to compare the submitted devices to the predicates. The testing included: Static bend, Dynamic bend, Post fatigue corrosion, Post fatigue nickel leaching, Corrosion, Galvanic corrosion, MRI compatibility, MRI RF heating simulation, Bone screw insertion and removal, Plate compression, Bone screw torsion, Bone screw pull-out and Bone screw corrosion resistance. The results demonstrate substantial equivalence to predicate device.

8. Substantial Equivalence - Clinical Evidence

Not Applicable

Substantial Equivalence - Conclusions

The design characteristics of the subject devices do not raise any new types of questions regarding safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate system and are substantially equivalent.

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.