SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Device Description

An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. SGM Femoral Nail System consists of a series of metal rods, proximal helical blades, bone locking bolts and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations. The implantable devices are manufactured from titanium alloy and are provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the SGM Femoral Nail System, a medical device for femoral fracture fixation. It is not a document about an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be found in this document.

The document details the substantial equivalence of the SGM Femoral Nail System to a predicate device (Synthes (USA) Trochanteric Fixation Nail (TFN) System) based on similar intended use and technological characteristics. The performance data provided is related to bench testing for mechanical properties of the physical device, reprocessing, and sterilization, not AI/ML algorithm performance.

Here's what can be extracted from the provided text about the device's assessment:

Device: SGM Femoral Nail System (Intramedullary fixation rod)

Regulatory Class: Class II

Acceptance Criteria and Device Performance (Based on provided document):

The acceptance criteria for this medical device, being a mechanical implant, are related to its physical and mechanical properties, as well as its ability to be reprocessed (cleaned and sterilized). The document states that the non-clinical data demonstrates the SGM Femoral Nail System is substantially equivalent to the predicate device. This implies the device's performance met the standards of the predicate and relevant ASTM standards.

Acceptance Criteria (Type of Test)	Reported Device Performance (Conclusion)
Bench Testing (Mechanical Properties):	The device passed a range of mechanical tests according to ASTM standards, demonstrating substantial equivalence to the predicate. Specific results details are not provided, but the conclusion is: "The non-clinical data demonstrates the SGM Femoral Nail System is substantially equivalent to the predicate device."
Static Four-Point Bending Test	Performed per ASTM F1264-16
Static Torsional Test	Performed per ASTM F1264-16
Bending Fatigue Test	Performed per ASTM F1264-16
Bending Fatigue Test (Locking Screws)	Performed per ASTM F1264-16
Cut-out Test (Helical Blade)	Performed per ASTM F1264-16
Torsional Properties Test (Locking Bolt)	Performed per ASTM F543-17
Driving Torque Test (Locking Bolt)	Performed per ASTM F543-17
Axial Pullout Strength Test (Locking Bolt)	Performed per ASTM F543-17
Self-Tapping Performance Test (Locking Bolt)	Performed per ASTM F543-17
Single Cycle Construct Strength Test	Performed per ASTM F384-17
Construct Fatigue Strength Test	Performed per ASTM F384-17
Reprocessing and Sterilization:	"Validated manual cleaning and steam sterilization instructions are provided for the end user before implantation... Validation testing confirmed the reprocessing instructions provided by Geasure achieve sterility of the implant and surgical instruments prior to use." This was done per FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015."

Since the device is a physical implant and not an AI/ML algorithm, the following points of your prompt are not applicable to the submitted 510(k) summary for K230456:

Sample size used for the test set and the data provenance: Not an AI/ML test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no diagnostic ground truth to establish for AI/ML.
Adjudication method for the test set: Not applicable for a physical device.
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 for AI-assisted human performance, not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical implant's mechanical properties.
The sample size for the training set: Not applicable; there is no AI/ML training set.
How the ground truth for the training set was established: Not applicable.

In summary, this document is for a traditional medical device (femoral nail system) and its clearance is based on substantial equivalence to a predicate device through non-clinical (bench) testing, not on AI/ML performance studies.

Summary

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June 30, 2023

Changzhou Geasure Medical Apparatus and Instruments Co., Ltd % Xiaoqing Xue Registration Engineer Sinow Medical AS Høyteknologisenteret, Thormøhlens Gate 55, 5008 Bergen, Norway

Re: K230456

Trade/Device Name: SGM Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: June 27, 2023 Received: June 27, 2023

Dear Xiaoqing Xue:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image contains the text '-S' stacked vertically below the name 'Jose'. The text is in a simple, sans-serif font and is black against a white background. The text is centered in the image.

Joseph P. Russell Digitally signed by Joseph P. Russell -S Date: 2023.06.30 08:56:29 -04'00'

For: Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230456

Device Name SGM Femoral Nail System

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

K230456

Preparation Date:	May.29, 2023
Submitter:	Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.Address: No. 12, Jinfeng Road, West Taihu Science and TechnologyIndustrial Park, Changzhou, Jiangsu, P.R. China
Applicant Contact	Jing Huang, Management RepresentativeChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.Address: No. 12, Jinfeng Road, West Taihu Science and TechnologyIndustrial Park, Changzhou, Jiangsu, P.R. ChinaPostcode: 213149Email: huangjing@geasure.comPhone:+86 13656146897
DesignatedSubmissionCorrespondent	Company: Sinow Medical ASAddress: Høyteknologisenteret, Thormøhlens Gate 55, 5008, Bergen,NorwayContact Person: Xiaoqing XueTelephone: +86 15161196032Email: xue@bergemed.com
Subject Device	Name of Device	SGM Femoral Nail System
	Regulatory Class	II
	Regulation Number	21 CFR 888.3020 and 888.3040
	Product Codes	HSB, HWC
	Classification Name	Intramedullary fixation rod;Smooth or threaded metallic bone fixationfastener
	Classification Panel	Orthopedic
	Common Name	Rod, Fixation, Intramedullary And Accessories;Screw, Fixation, Bone
Primary PredicateDevice	Manufacturer	Synthes (USA)
	Name of Device	Synthes (USA) Trochanteric Fixation Nail (TFN)System
	510(K) Number	K011857
	Regulatory Class	II
	Regulation Number	21 CFR 888.3020 and 888.3040
	Product Codes	HSB, HWC
	Classification Name	Intramedullary fixation rod;Smooth or threaded metallic bone fixationfastener
fastener
Classification Panel	Orthopedic
Common Name	Rod, Fixation, Intramedullary And Accessories;Screw, Fixation, Bone
Intended Use /Indications for Use	SGM Femoral Nail System is intended to treat stable and unstablefractures of the proximal femur including pertrochanteric fractures,intertrochanteric fractures, basal neck fractures, and combinationsthereof. The long SGM Femoral Nail is additionally indicated forsubtrochanteric fractures, pertrochanteric fractures associated with shaftfractures, pathologic fractures (including prophylactic use) in bothtrochanteric and diaphyseal regions, long subtrochanteric fractures,proximal or distal non-unions, malunions, and revisions.
Device Description	An intramedullary fixation nail is a metal rod implanted into themedullary cavity of a bone to treat fractures that occur in long bones ofthe body. SGM Femoral Nail System consists of a series of metal rods,proximal helical blades, bone locking bolts and end caps. The rods arecannulated and are provided with screw holes to accommodate screws ofvarious diameters and lengths. The rods are available in a range of sizesused for specific anatomic locations and fracture configurations. Theimplantable devices are manufactured from titanium alloy and areprovided non-sterile.
Mechanism ofAction	The SGM Femoral Nail System permits an intramedullary approach forthe fixation of fractures of the femur. The SGM Femoral Nail Systemconsists of a series of cannulated nails, cannulated helical blades,cannulated end caps, and locking bolts. The helical blade providesresistance to varus collapse and rotational control of the medial fracturesegment compared to single screw fixation. The end cap is designed forproximal closure of the nail to prevent bone ingrowth.
Materials	Titanium alloy (Ti-6Al-4V) ELI
Coatings/Colorants	The devices are colored using an anodizing manufacturing process. Nocoatings or colorants are added to the device with this process.
Patient Contact	Bone and surrounding tissue
Contact Duration	Permanent (>30 days)
SterilizationMethod	The devices are provided non-sterile. Validated manual cleaning andsteam sterilization instructions are provided for the end user beforeimplantation.
Environment of Use	Healthcare facility/Hospital
Single Use	Yes
End cap	Length: 0mm, 5mm and 10mm
Helical Blades	Length:75mm-120mmDiameter:Ø11mm
Locking bolt	Length:26mm-100mmDiameter: Ø4.9mm
Intramedullaryfixation nails	Length:short 170mm, 200mm and 235mm; long 320mm-420mmDiameter: Ø10mm, Ø11mm,Ø12mm
angle	130°
Performance -Animal	No animal study data is submitted in this 510(k).
Summary ofintended use andtechnologicalcharacteristics	The SGM Femoral Nail System is substantially equivalent to thepredicate device when evaluating intended use and technologicalcharacteristics.The subject device has the identical intended use as the predicate device.The subject device and predicate devices are substantially equivalentwith only minor differences in technological characteristics regarding:• Intramedullary Fixation Nail size• Helical Blade size• Locking Bolt sizeThese differences do not raise different questions of safety andeffectiveness.
Non-clinical test	• Performance-bench test including:Static Four-Point Bending Test per ASTM F1264-16Static Torsional Test per ASTM F1264-16Bending Fatigue Test per ASTM F1264-16Bending Fatigue Test of Locking Screws per ASTM F1264-16Cut-out Test of Helical Blade per ASTM F1264-16Torsional Properties Test of the Locking Bolt per ASTM F543-17Driving Torque Test of the Locking Bolt per ASTM F543-17Axial Pullout Strength Test of the Locking Bolt per ASTM F543-17Self-Tapping Performance Test of the Locking Bolt per ASTMF543-17Single Cycle Construct Strength Test per ASTM F384-17Construct Fatigue Strength Test per ASTM F384-17•Reprocessing and sterilizationSGM Femoral Nail System must be cleaned and sterilized prior to use.Geasure completed manual cleaning and steam sterilization validationtesting per FDA guidance document, Reprocessing Medical Devicesin Health Care Settings: Validation Methods and Labeling, issuedMarch 17, 2015. Validation testing confirmed the reprocessinginstructions provided by Geasure achieve sterility of the implant andsurgical instruments prior to use.
Performance -Clinical	No clinical study data is submitted in this 510(k).
Conclusion	The non-clinical data demonstrates the SGM Femoral Nail System issubstantially equivalent to the predicate device

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Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.