The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Adult - additive subtalar alignment for flat foot.

Children - flexible flat foot treatment in children and adolescents.

Device Description

The Normed Vario Subtalar Screw is a conical, threaded cannulated screw. It is designed to be inserted into the sinus tarsi of the foot for subtalar arthoroereisis. It is made from medical grade titanium alloy, Ti-6Al-4V (ASTM F136). The implant is offered in 2 sizes: Small (10mm - 13mm) and Large (13mm -16mm). The implants are provided nonsterile and single-use only. The instruments are non-sterile and reusable.

AI/ML Overview

This document describes the Normed Vario Subtalar Screw, a medical device. The provided text is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical studies with specified acceptance criteria and detailed performance metrics. Therefore, many of the requested categories for a study proving acceptance criteria will not be directly applicable or available in this type of submission.

Here's an analysis based on the provided text:

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

The submission does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. This type of detail is more common in PMA submissions or in reports of clinical trials designed to prove efficacy and safety against predefined endpoints.

Instead, the document states:
"Non-clinical testing demonstrated for the Normed Vario Subtalar Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy."

The testing mentioned is:

Testing	Standard
Vario Screws Static Compression Load	Custom Test
In-vitro cytotoxicity	ISO 10993-5
Sterility validation	Custom Test

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met if the device performs comparably to the predicate devices and adheres to relevant standards (like ISO 10993-5 for biocompatibility). The specific "performance requirements" defined by Design Control activities are not detailed in this public summary.

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 primarily describes non-clinical testing. For the "Vario Screws Static Compression Load" and "Sterility validation," details on sample size, data provenance, and study design (retrospective/prospective) are not provided in this summary. These would typically be found in detailed test reports, not the 510(k) summary. For "In-vitro cytotoxicity" (ISO 10993-5), the standard specifies methodologies, but the sample size used in the specific test for this device is not reported here.

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

This information is not applicable as the submission focuses on non-clinical engineering and biocompatibility testing, not clinical studies requiring expert ground truth establishment for diagnostic or treatment outcomes.

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

This information is not applicable for the non-clinical testing described. Adjudication methods are typically used in clinical studies when multiple experts assess patient data or 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

An MRMC comparative effectiveness study was not done. This device is a medical implant (subtalar screw), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is a physical implant, not an algorithm.

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

For the non-clinical tests:

Vario Screws Static Compression Load: "Ground truth" would be engineering specifications and mechanical properties expected for the materials and design, compared against predefined failure limits or performance benchmarks.
In-vitro cytotoxicity (ISO 10993-5): Ground truth is established by the standard itself, which defines acceptable levels of cytotoxicity based on cellular response to extracts from the material.
Sterility validation: Ground truth is the absence of viable microorganisms, confirmed through standard microbiological testing methods.

8. The sample size for the training set

This information is not applicable as the device is a physical implant and does not involve machine learning algorithms that require a training set.

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

This information is not applicable as the device does not involve machine learning and therefore has no training set.

Summary

{0}------------------------------------------------

510(k) Premarket Notification Normed Vario Subtalar Screw

510(k) Summary Pursuant to 21 CFR 807.92

General Company Information

Company Name:	Normed® Medizin-Tecknik GmbH
Company Address:	Ulrichstrasse 7D-78532Tuttlingen, Germany
Company Telephone:	+(011) 49 7461 93 43 0+(011) 49 7461 93 43 20
Contact:	David Furr, MSFDC Services, LLCPrincipal Regulatory Affairs Consultant
Contact Address:	8708 Capehart CoveAustin, Texas 78733(512) 906-9654

April 10, 2014 Date:

Normed Vario Subtalar Screw Device Trade Name:

HWC

Common Name:

Subtalar Arthroereisis Implant

Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040)

Class:

Product Code:

Predicate Device:

Normed Pellegrin Calcaneus Stop Screw, K133035 (cleared 12/13/13)

ﻟﺮ

{1}------------------------------------------------

510(k) Premarket Notification Normed Vario Subtalar Screw

Memometal Technologies SubFix Arthroereisis Implant. K093820 (cleared 5/19/10)

Metasurg Subtalar Implant, K111265 (cleared 8/9/11)

Device Description:

Intended Use:

The Vario Subtalar Screw System is indicated for adult, children and adolescent patients.

The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Adult - additive subtalar alignment for flat foot.

Children - flexible flat foot treatment in children and adolescents.

Technological Characteristics:

The Vario Subtalar Screw System is similar to legally marketed predicate devices listed previously. The screws share

{2}------------------------------------------------

510(k) Premarket Notification Normed Vario Subtalar Screw

similar indications of use, are manufactured from the same materials and incorporate similar technological characteristics.

Performance Data (Nonclinical and/or Clinical):

Non-clinical testing demonstrated for the Normed Vario Subtalar Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy. Summary of testing is as follows:

Testing	Standard
Vario Screws Static Compression Load	Custom Test
In-vitro cytotoxicity	ISO 10993-5
Sterility validation	Custom Test

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

July 3, 2014

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

Normed® Medizin Technik GmbH % David Furr Principal Regulatory Affairs Consultant FDC Services,LLC 8708 Capehart Cove Austin, Texas 78733

Re: K140962

Trade/Device Name: Normed Vario Subtalar Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 12, 2014 Received: May 14. 2014

Dear Mr. Furr:

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 10 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 device-related adverse events} (21 CFR 803): good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 -Mr. David Furr

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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K140962 page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013
Indications for Use	See PRA Statement on last page.

510(k) Number ( if known )	K140962
Device Name	Normed Vario Subtalar Screw
Indications for Use (Describe)

The Normed® Vario Subtalar Screw System is indicated for adult, children and adolescent patients.

The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Adult - additive subtalar alignment for flat foot.

Children - flexible flat foot treatment in children and adolescents.

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)

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

PO, Pass ar Servator (J61) 413-678

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.

510(k) Summary Pursuant to 21 CFR 807.92

General Company Information

Class:

Device Description:

Technological Characteristics:

510(k) Premarket Notification Normed Vario Subtalar Screw

Performance Data (Nonclinical and/or Clinical):

DEPARTMENT OF HEALTH & HUMAN SERVICES

Page 2 -Mr. David Furr

K140962 page 1 of 1

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

Elizabeth|© Brank -S

§ 888.3040 Smooth or threaded metallic bone fixation fastener.