THE SYNTEC HUMERAL NAIL SYSTEM IS INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS. INCLUDING 2-PART SURGICAL NECK FRACTURES, 3-PART FRACTURES, AND 4-PART FRACTURES, PROXIMAL HUMERAL FRACTURES WITH DIAPHYSEAL EXTENSION INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.

Device Description

The Syntec Humeral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) straight nail with a 5° proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over ø2.0 calibrated guide wires. Those nail accepts only an ø3.8mm Cortical Screw in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8 ~ ø 9 in 9mm lengths is available for proximal closing of the nail. The Syntec Humeral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance:

The provided document is a 510(k) Summary for a medical device (Syntec Humeral Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a study report that rigorously tests a device against pre-defined acceptance criteria using clinical or algorithmic performance metrics.

Therefore, I cannot extract the information required to populate all sections of your request. Specifically, the document does not contain information on:

Acceptance criteria and reported device performance related to specific clinical or diagnostic outcomes.
Sample size for a test set (clinical or imaging data).
Data provenance for a test set.
Number of experts used to establish ground truth or their qualifications.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm-only) performance.
Sample size for a training set.
How ground truth for a training set was established.

The document only refers to "Performance Data" in the context of mechanical testing according to a standard, and then makes a general statement about substantial equivalence based on that.

Here's what can be extracted and inferred from the provided text according to your request:

1. Table of Acceptance Criteria and the Reported Device Performance

Based on the document, the "acceptance criteria" appear to be related to demonstrating mechanical equivalence to a predicate device based on a recognized standard. The reported performance is a general statement of equivalency.

Acceptance Criterion	Reported Device Performance
Mechanical performance in accordance with ASTM-F1264-14	"The testing was done to our Syntec Humeral Nail System device to demonstrate substantial equivalence."
Safety and effectiveness as the predicate device (K132945)	"According device test report of performance data demonstrate that the Syntec Humeral Nail is as safe and effective as K132945."
Same intended uses, indications, technological characteristics, and principles of operation as the predicate device	"Thus, the Syntec Humeral Nail System is substantially equivalent in design, configuration, function, and indications for use to the I.T.S. IM Nail Systems CFN-CTN-CHN (K132945)."

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

The document mentions "device test report of performance data" and testing according to ASTM-F1264-14, which refers to mechanical testing. It does not specify sample sizes of devices tested, nor does it refer to patient data or its provenance for any clinical or diagnostic performance assessment.

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

Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert interpretation of clinical data or images.

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

Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert consensus.

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. The Syntec Humeral Nail System is an intramedullary fixation rod, a physical implant. It is not an AI-powered diagnostic device or an AI-assisted tool for human readers.

6. If a standalone (i.e. 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 (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties and behaviors of the device as measured against the specifications outlined in the ASTM standard. There is no clinical or diagnostic "ground truth" as described (expert consensus, pathology, outcomes data) relevant to the performance data cited here.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model.

Summary of what the document does convey regarding "acceptance criteria" and "study":

The "study" described, albeit briefly, is primarily focused on mechanical performance testing against the ASTM-F1264-14 standard to demonstrate that the Syntec Humeral Nail System performs similarly to its predicate device (I.T.S. IM Nail Systems CFN-CTN-CHN). The "acceptance criteria" appear to be met when the device's mechanical test results support a conclusion of substantial equivalence regarding safety and effectiveness compared to the predicate, particularly in its intended uses and technological characteristics. There is no mention of clinical trials or studies assessing patient outcomes or diagnostic accuracy in the context of what you've asked.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and collaboration.

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

June 8, 2017

Syntec Scientific Corporation Kavin Chu Regulatory Affairs Manager Syntec Scientific Corporation - Taipei Office 3F., No. 96, Sec. 3, Zhongxio East Road Da'an Dist., Taipei, 10652 TW

Re: K161327

Trade/Device Name: Syntec Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: April 21, 2017 Received: May 10, 2017

Dear Mr. Chu:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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" (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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

r (if known)
--------------	--

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number K161327

Device Name

SYNTEC HUMERAL 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

Syntec, Taipei-Taiwan

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Image /page/3/Picture/0 description: The image shows a logo for Syntec Scientific. The logo features a large orange circle overlapping a blue stylized "S". Below the graphic is the text "SYNTEC SCIENTIFIC" in a simple sans-serif font. The logo is clean and modern, using contrasting colors to make it visually appealing.

YNTEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Manager

This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.

K161327 - 1 of 3

510(k) SUMMARY

Submitted By:	Syntec Scientific Corporation
Address:	No.2, Kung San RoadChuan Shing Industrial Zone,Shen Kang, Chang Hua Hsien, Taiwan R.O.C.TEL: +886-4-798-7099FAX: +886-4-798-7077
Date Summary Prepared:	April 29, 2016
Contact person:	Kavin Chu
Name of the device:	Syntec Humeral Nail System
Trade or proprietary name:	Syntec Humeral Nail System
Common or usual name:	Intramedullary Rod
Classification name:	Intramedullary Fixation Rod
Produce code:	HSB
Regulation number:	888.3020
Class:	Class II
Predicate devices:	I.T.S. IM Nail Systems CFN-CTN-CHN (K132945
Prior Submission:	None

1. Description of the Device

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Image /page/4/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a large red circle overlapping a blue letter 'S'. Below the graphic is the text 'SYNTEC SCIENTIFIC' in a serif font. The logo is simple and uses contrasting colors to make it visually appealing.

TEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Manager

(nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

2. Intended Use

The Syntec Humeral Nail System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension into the shaft, and impending pathologic humeral fractures.

1. Technological Characteristics, comparison to predicate device Syntec Humeral Nail System is identical to the I.T.S. IM Nail Systems CFN-CTN-CHN cleared for market in 510(k) K132945 and essentially Equivalent (SE) to the predicate.
  The indications for use for the Syntec Humeral Nail System are patterned after the predicate devices and supported by an extensive collection of literature references.

	Subject device	Predicate Device
Device Name	Syntec Humeral Nail System	I.T.S. IM Nail SystemsCFN-CTN-CHN
Applicant	Syntec Scientific Corporation	I.T.S. GmbH
510(k)	K161327	K132945
Material Comparison	Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V)	Surgical Titanium Alloy (Ti6AL-4V)
Nail Diameter	$\phi$ 7, $\phi$ 8, $\phi$ 9	$\phi$ 7, $\phi$ 8, $\phi$ 9
Nail Length	From 160mm to 240mm(in 20mm increments)	From 140mm to 320mm(in 10 and 20mm increments)
Nail Type	Standard	Left and Right

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Image /page/5/Picture/0 description: The image shows the logo for Syntec Scientific. The logo features a large orange circle to the left, partially overlapping a blue letter 'S'. Below the symbol, the words 'SYNTEC SCIENTIFIC' are printed in a simple, sans-serif font, with 'SYNTEC' appearing above 'SCIENTIFIC'.

TEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang

K161327 - 3 of 3

Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Manager

	From 20mm to 70mm(in 5mm increments)	From 20mm to 70mm(in 2mm and 5mm increments)
Screw Length
Screw Diameter	ø3.8mm Cortical Screw	ø3.5mm Cortical Screw
End Cap Diameter	ø 8 , ø 9	No information provide
End Cap Length	9mm	in +0,+5, +10,+15, +20, +25 & +30 lengths

4. Performance Data

The procedure of evaluating the device tests was according to the standard of ASTM-F1264-14. The testing was done to our Syntec Humeral Nail System device to demonstrate substantial equivalence.

5. Substantial Equivalence

We believe that Syntec Humeral Nail System does not add new or increased risks and complications, based on current engineering technology and clinical results published about intramedullary rods as well as based on what has been previously cleared by FDA.

According device test report of performance data demonstrate that the Syntec Humeral Nail is as safe and effective as K132945. In addition, the Syntec Humeral Nail System has the same intended uses and indications, technological characteristics, and principles of operation to the predicate device. Thus, the Syntec Humeral Nail System is substantially equivalent in design, configuration, function, and indications for use to the I.T.S. IM Nail Systems CFN-CTN-CHN (K132945).

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.