STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.

Device Description

STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants. The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.

AI/ML Overview

This document describes the STOMA Bone Screws, a medical device used for the fixation of bone fractures and transplanted bone blocks in oral and maxillomandibular surgery. The provided text is a 510(k) premarket notification and subsequent FDA letter, which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria and a dedicated study to prove device performance is not explicitly available in the provided text. The submission relies on demonstrating that the STOMA Bone Screws are substantially equivalent to predicate devices, implying that if the predicates are safe and effective, then the new device, being substantially equivalent, also meets safety and effectiveness requirements.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics for the STOMA Bone Screws. The primary "performance" reported is its substantial equivalence to predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The core acceptance criterion for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This implies that the device will perform similarly to the predicate in terms of safety and effectiveness.	STOMA Bone Screws are "substantially equivalent to other legally marketed bone screws from different manufacturers."
Biological compatibility (no adverse reactions)	"All requirements of biocompatibility are met through the composition of the used material. The used titanium alloy is also used in many other medical devices, especially implants."
Material properties	Made from "substantially equivalent or identical material" (titanium alloy) compared to competitors.
Sterilization efficacy	Can be sterilized by the user using a validated steam-sterilization process according to DIN EN 554 / ISO 11134 (137°C / 280°F, 3 bar, for min. 15 minutes).

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

Not applicable/Not provided. The 510(k) submission does not describe a performance study with a test set of data. The submission focuses on a comparison of device characteristics (design, materials, indications for use) to predicate devices.

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

Not applicable/Not provided. Since no performance study with a test set generating a ground truth is described, information on experts is not available.

4. Adjudication method for the test set

Not applicable/Not provided. There is no described test set or adjudication method.

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. This device is a physical bone screw and not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical bone screw, not an algorithm.

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

Not applicable/Not provided. No specific clinical performance study requiring a "ground truth" for a test set is described. The "ground truth" in a 510(k) substantial equivalence submission, in a broader sense, is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this information is not relevant or provided.

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

Not applicable/Not provided. See answer to #8.

Summary of the "Study" (510(k) Submission):

The "study" presented here is a Substantial Equivalence Comparison (as stated in Section 4 of the document). This is a regulatory pathway where the applicant demonstrates that their new device is as safe and effective as a legally marketed predicate device, without needing to conduct extensive new clinical trials.

The basis for proving substantial equivalence for the STOMA Bone Screws includes:

Comparison of Indications for Use: The STOMA Bone Screws are indicated for "treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field." This would have been compared to the indications of the predicate devices.
Comparison of Device Properties/Technology: The physical characteristics, materials, and method of sterilization are compared. STOMA Bone Screws are made of titanium alloy, similar to the predicate devices.
Biocompatibility: The material (titanium alloy) used is noted to be "also used in many other medical devices, especially implants," and meets biocompatibility requirements. This implies reliance on established knowledge and data for this material.
Predicates Referenced: The document explicitly lists examples of predicate devices: OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760), and/or Synthes (USA) 1.3 Craniofacial Screws (K021850). The FDA's decision letter confirms that the device was found substantially equivalent to the indications referenced against legally marketed predicate devices.

In essence, the "study" is a regulatory comparison, not a direct performance study of the STOMA Bone Screws themselves.

Summary

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STOMA Bone Screws

510(k) Notification

stoma Storz am Mark GmbH

K051871

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN AC-CORDANCE WITH SMDA OF 1990

DATE: 2005-08-22

APPLICANT: Storz am Mark GmbH Emminger Str. 39 D-78576 Emmingen-Liptingen Germany Phone: +49 (7465) 9260-0 Fax: +49 (7465) 9260-50 Email: info@stoma.de

Official Correspondent: Gunther Schanz

Device Name 1.

Trade Name: STOMA Bone Screw Common Name: Bone Screw

Classification 2.

The products are classified according following Device Names and Product Codes:

Device:	Screw, Fixation, Intraosseous
Medical Specialty:	Dental
Product Code:	DZL
Regulation Number:	872.4880
Device Class:	2
Description acc. 21 CFR 872.4880:Subpart E -- Surgical DevicesSec. 872.4880 Intraosseous fixation screw or wire.(a) Identification. An intraosseous fixation screw or wire is a metal device intended tobe inserted into fractured jaw bone segments to prevent their movement.(b) Classification. Class II.

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K051871

STOMA Bone Screws

stoma. Storz am Mark

GmbH

510(k) Notification

Description of the Device 3.

Indication for Use 3.1.

3.2. Properties

The bolt head of the STOMA Bone Screw is either self tapped by a square, hexagon or cross slot. The screws will be delivered in a cassette / container including accordingly screw driver and pilot drill. The bone screws are available in 1.3mm in length 4 mm to 1.6mm and 2.0mm diameter and lengths ranging from 4mm to 16mm.

Substantial Equivalence Comparison 4.

STOMA Bone Screws are substantially equivalent to other legally marketed bone screws from different manufacturers, e.g. OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760) and/or Synthes (USA) 1.3 Craniofacial Srews (K021850).

5. Biocompatibility

All requirements of biocompatibility are meet through the composition of the used material. The used titanium alloy is also used in many other medical devices, especially implants.

Compared with competitors devices, STOMA Bone Screws are made out of substantially equivalent or identical material.

ં. Sterilization by User

STOMA Bone Screws are delivered in non-sterile conditions. The user may sterilize these devices by using a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes.

7. Conclusion

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that STOMA Bone Screws are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

Date of Issue: 2005-06-30

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2005

Storz am Mark GmbH C/O Mr. Franz Menean Managing Director Medagent GMBH & Co. KG Griesweg 47 Muehlheim GERMANY 78570

Re: K051871

Trade/Device Name: STOMA BONE SCREW Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous fixation screw or wire Regulatory Class: II Product Code: DZL Dated: August 22, 2005 Received: August 30, 2005

Dear Mr. Menean:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section 910(x) premained instally equivalent (for the indications referenced above and nave decemblicated the acresed predicate devices marketed in interstate for use stated in the encrosure to regally manatical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Ecolors of the Ecoderel Good. Drug commerce prior to May 28, 1970, the chaeanters with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance water approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P and Cosmetic Act (Act) that do not require approvide on trols provisions of the Act. The
You may, therefore, market the device, subject to the generation, lightestion, ligh You may, merelore, market the de rece, booject of the more
general controls provisions of the Act include requirements for annual registration disassed general controls provisions of the Fiel herdares and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) not existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such adultional controlist Extremig and of of 998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 Parts of be found in the Code of I ederal regaranting your device in the Federal Register.

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Page 2 - Mr. Menean

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a substitive requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a deciclimation administered by other Federal agencies. You must or any Federal statules and regulations daministered or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, mendants, was its requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fart on ); good manation (21 CFR Part 200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 14 CF forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (occions 55 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to 1egal This letter will anow you to begin mancemis requiredice of your device to a legally
premarket notification. The FDA finding of substantial equivaliae and thus, permits vour premarket notification. The PDA imaling of substanced on this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the latest of the support on 101 and 14 for the regulation entitled If you desire specific advice for your ac no not on success note the regulation entitled, the regulation entitled, the move obtain contact the Office of Compliance at (210) 217 - 10 (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obt "Misbranding by reference to premarkst notheation" (er the Act from the Division of Small other general information on your responsion its toll-free number (800) 638-2041 or 14 Manufacturers, International and Consumer rebets http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K_05187 |

Device Name: STOMA Bone Screw

Indications for Use:

STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of surgery implanted bone blocks during the augmentation process and / or in combination with transplantou bette brome the oral cavity and maxillomandibular surgical field.

Prescription Use YES_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 SFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punds

", Asion Sign-Off) Chision Sign-Om)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number:_

Page 1 of 1

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.