This document describes a 510(k) premarket notification for the "Snap-Off Self-Compressive Screw" by Neosteo. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effectiveness of an AI/ML-based device.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use: Fixation of bone reconstruction in forefoot surgery.
Design: Self-compressive screws of various lengths.
Materials: Titanium alloy per ASTM F136.
Mechanical Safety and Performance: Resistance to torsion and pull-out strength.

The "Non-Clinical Test Summary" section mentions that resistance to torsion (according to ASTM F543 Annex 1) and pull-out strength (according to ASTM F543 Annex 3) tests were performed. It states, "The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices." However, it does not provide specific acceptance criteria or the reported performance data from these tests.

The "Clinical Test Summary" explicitly states, "No clinical studies were performed." Therefore, there is no information about human readers, AI assistance, ground truth establishment for clinical data, or effect sizes.

To answer your request, I must state that the provided text does not contain the requested information regarding acceptance criteria and performance study details typical for an AI/ML device. The document is a 510(k) summary for a physical medical device (bone screw) seeking substantial equivalence, not an AI/ML diagnostic or assistive device that would have performance metrics like sensitivity, specificity, or human improvement with AI.

Therefore, I cannot populate the table or provide details for points 1-9 as they pertain to AI/ML device evaluation criteria, which are not present in this document.

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 consists of a stylized depiction of an eagle or bird-like figure with three heads in profile, facing to the right. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

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

Neosteo % Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K150772

Trade/Device Name: Snap-off Self-compressive Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 13, 2015 Received: April 1, 2015

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 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

May 8, 2015

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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

K150772

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

Device Name

Snap-Off Self-Compressive Screws

Indications for Use (Describe)

The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery.

Type of Use (Select one or both, as applicable)

X | 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)

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Image /page/3/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font size.

l. SUBMITTER'S INFORMATION

A. 510(k) Owner

NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34

B. Contact Person

JD Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Tel: 512 388 0199 Fax: 512 692 3699 Email: jdwebb@orthomedix.net

C. Date of Preparation of the 510(k) Summary

19th March 2015

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Image /page/4/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left, with the word "neosteo" in orange to the right of the spiral. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font, also in orange. The spiral design appears to be made up of a series of dots connected by lines.

DEVICE IDENTIFICATION II.

	"Screw" type devices
Trade or proprietary name	Snap-Off Self-Compressive Screw
Common or usual name	Self-compressive screw
Classification regulation	21 CFR 888.3040
Proposed Regulatory Class	Class II
Panel	87 "Orthopedic"
Product code	HWC
Primary Predicate Device	Spin® Snap-Off Screw (K991477) from NewDeal SA
Secondary Predicate Device	Self-Compressive Screws (K131471) from Neosteo

III. DEVICE DESCRIPTION

The Snap-Off Self-Compressive Screw consists of screws available in several lengths.

All the implants are made of titanium alloy.

The fixation is provided thanks to the threading of the screw, which allows compression.

A. Materials

Snap-Off Self-Compressive Screw: Titanium alloy per ASTM F136

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Image /page/5/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font.

510(k) Summary

IV. INTENDED USE

The Snap-Off Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.

SUMMARY OF OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL V. EQUIVALENCE

The Snap-Off Self-Compressive Screw is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

VI. NON-CLINICAL TEST SUMMARY

Snap-Off Self-Compressive Screw:

The following mechanical tests were performed:

Resistance to torsion according to ASTM F543 Annex 1 o
Pull out strength according to ASTM F543 Annex 3 o

The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices.

VII. CLINICAL TEST SUMMARY

No clinical studies were performed.

VIII. CONCLUSIONS NON-CLINICAL AND CLINICAL

NEOSTEO considers the current Snap-Off Self-Compressive Screw to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.