The Alians Fragment Specific range consists of plates and screws designed for hand and forearm fractures, osteotomies and arthrodeses in adults.
The implants of the Alians Fragment Specific range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
The instruments of the Alians Fragment Specific range will be provided non sterile for sterilization by health care professionals prior to use.
Single use kits (Initial FS) contain implants and instruments provided sterile by gamma sterilization.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Alians Fragment Specific" range of bone fixation plates and screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through comprehensive clinical trials with pre-defined acceptance criteria and detailed study results as one might find for a novel AI/software medical device.

Therefore, the document does not contain the information required to answer most of your questions, as these questions are typically relevant to the validation of AI-driven medical devices or devices where clinical performance claims are being made based on specific outcome measures.

Here's what can be extracted and what cannot:

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

This information is not available in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing (mechanical tests) and similarity in design, materials, and intended use to predicate devices, not on setting and meeting specific clinical acceptance criteria.

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

This information is not available in the document. The document refers to "non-clinical tests" such as comparative static bend tests, fatigue bend tests, torsional tests, insertion and removal tests, and pull-out tests. These are mechanical tests performed on the device components themselves, not on patient data or clinical datasets. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply in this context.

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 information is not applicable/not available. Since no clinical studies or human-involved ground truth establishment for a diagnostic/interpretive task were performed, there were no experts establishing ground truth in this context.

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

This information is not applicable/not available. As no clinical test set requiring human adjudication was involved, this is not relevant.

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 information is not applicable/not available. The device is a physical implant (bone fixation plates and screws), not an AI/software device designed to assist human readers. Therefore, an MRMC study is not relevant.

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

This information is not applicable/not available. The device is a physical implant, not an algorithm.

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

This information is not applicable/not available in the context of clinical or diagnostic performance. For the mechanical non-clinical tests, the "ground truth" would be the established engineering standards and specifications (e.g., ASTM F382, ASTM F543) that the device must meet or be comparable to the predicate device.

8. The sample size for the training set

This information is not applicable/not available. The device is a physical implant, and there is no "training set" in the machine learning sense.

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

This information is not applicable/not available. As there is no training set, this question is not relevant.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (bone fixation plates and screws) and primarily demonstrates substantial equivalence through mechanical testing and comparison to predicate devices, rather than through clinical studies requiring data sets, ground truth, or expert adjudication as would be found for AI/software devices.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

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

June 16, 2017

Newclip Technics % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K170843

Trade/Device Name: Alians Fragment Specific 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: March 17, 2017 Received: March 21, 2017

Dear Mr. J.D. Webb:

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

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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 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" (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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170843

Device Name Alians Fragment Specific

Indications for Use (Describe)

The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

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 for the ALIANS FRAGMENT SPECIFIC 4. range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Fragment Specific range.

Summary preparation date: January 10, 2017

1. Submitter:

Contact Person:

J.D. Webb NEWCLIP TECHNICS P.A. de la Lande Saint Martin The OrthoMedix Group, Inc. 45 rue des Garottières 1001 Oakwood Blvd Round Rock, TX 78681 F-44115 Haute-Goulaine - France Telephone: (33) 2 28 21 37 12 Telephone: 512-388-0199

Alians Fragment Specific 2. Trade name: Fracture fixation plates and screws Common Name: Product code: HRS - Plate, Fixation, Bone HWC - Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030) Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)

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3. Primary predicate or legally marketed devices which are substantially equivalent:

. APTUS® Wrist 2.5 System of Medartis (K142906)

Secondary predicate or legally marketed devices which are substantially equivalent:

Trimed Bone Plates of Trimed (K060041) .
2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), .
Universal Distal Radius System of Newclip Technics (K130774). •
Footmotion Plating System of Newclip (K161448) .
Activ Ankle Locking Plating System of Newclip (K143061) .

4. Description of the device:	The Alians Fragment Specific rangeconsists of plates and screws designed forhand and forearm fractures, osteotomiesand arthrodeses in adults.
	The implants of the Alians FragmentSpecific range will be provided non sterilefor sterilization by health care professionalsprior to use or provided sterile by gammasterilization.The instruments of the Alians FragmentSpecific range will be provided non sterilefor sterilization by health care professionalsprior to use.Single use kits (Initial FS) contain implantsand instruments provided sterile by gammasterilization.
Materials:	Titanium alloy Ti-6Al-4V (conform to ASTMF136 and ISO 5832-3).CP-titanium (conform to ASTM F67 andISO 5832-2).Stainless steel and other instrumentmaterials
Function:	The implants of Alians Fragment Specificrange are indicated for hand and forearmfractures, osteotomies and arthrodeses inadults.

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5. Substantial equivalence claimed to predicate devices:

The Alians Fragment Specific range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

6. Indications for Use:

The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.

7. Non-clinical Test Summary:

The following tests were conducted:

Comparative static bend test. (ASTM F382) ●
Comparative fatigue bend test. (ASTM F382) .
. Torsional test (ASTM F543)
Insertion and removal test (ASTM F543) .
Pull-out tests. (ASTM F543) •
Endotoxins testing was performed using LAL quantitative kinetic . chromogenic method.

8. Clinical Test Summary:

No clinical studies were performed.

9. Conclusions Non-clinical and Clinical:

Newclip considers the Alians Fragment Specific range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.

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.