The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Description

The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Humeral Head Plate with Angular Stability." This document focuses on demonstrating the device's substantial equivalence to previously approved devices, rather than conducting a de novo study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study details, and AI-related performance metrics is not directly present in the provided text.

Specifically:

Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which means it aims to demonstrate substantial equivalence to predicate devices already on the market. The provided text doesn't define specific quantitative acceptance criteria for performance; instead, it focuses on the device's design, materials, and intended use being similar to existing, legally marketed devices. Therefore, a table of acceptance criteria and reported device performance as would be found in a performance study is not available here.
Sample Size for Test Set and Data Provenance: Not applicable, as this is not a clinical performance study with a test set of data. The document focuses on regulatory approval based on equivalence.
Number of Experts and Qualifications: Not applicable. There is no information on expert review for ground truth establishment for a test set.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done or is described. The device is a bone plate, so AI assistance for human readers is not relevant in this context.
Standalone (Algorithm Only) Performance: Not applicable. This is a physical implant, not an AI algorithm.
Type of Ground Truth Used: Not applicable, as there's no performance data being evaluated against a ground truth.
Sample Size for Training Set: Not applicable. There is no AI model or training set involved.
How Ground Truth for Training Set Was Established: Not applicable.

However, based on the information provided, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission:

1. Acceptance Criteria (for 510(k) Substantial Equivalence):

Acceptance Criterion	Reported Device Performance (as per 510(k) Summary)
Material Composition	Plate: CP titanium (ASTM F 67-00). Screws: 6-4 alloyed titanium (ASTM F 136-02). Surface conditioned with TIODIZE, Type II preparation.
Device Design	Low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws.
Intended Use / Indications for Use	Stabilize fracture(s) of the proximal humerus bone in the shoulder, including fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. This is congruent with predicate devices.
Substantial Equivalence (Safety & Effectiveness)	The device is deemed substantially equivalent to the Synthes LCP Proximal Humerus Plates (K041860 & K011815), Hand Innovations Shoulder Fixation System (K042059), Arthrex Humeral Fracture Plates and Screws (K041965), DePuy ACE TIMAX® Meta Plate (K983853), and ACE Humerus & Radius Plates (K955472). This implies that its safety and effectiveness are comparable to these legally marketed devices based on non-clinical data and existing knowledge of these device types.

2. The "Study" (in the context of 510(k)):

The "study" that proves the device meets the acceptance criteria is the 510(k) Premarket Notification process itself, specifically the provided Summary of Safety and Effectiveness. In this context, the "study" is a comparative assessment against legally marketed predicate devices, and it relies on non-clinical data (e.g., material testing, mechanical testing, design comparisons, and adherence to recognized standards for bone plates).

Data Provenance: The nature of a 510(k) implies that the "data" is primarily based on engineering analysis, material specifications, and comparative design reviews against established predicate devices. There is no mention of clinical data or patient outcomes in this summary. The materials comply with ASTM standards (F 67-00, F 136-02), indicating adherence to recognized engineering and material specifications.
Ground Truth: For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness profile of the predicate devices. The new device aims to demonstrate that it is as safe and effective as these already approved devices.
Sample Size for Test/Training set & Ground Truth Establishment: These concepts are not directly applicable since this is a regulatory submission for a physical implant based on substantial equivalence, not a clinical trial or an AI performance study. The "evidence" is the comprehensive documentation submitted to the FDA demonstrating that the device is comparable to predicates in terms of intended use, technological characteristics (materials, design), and performance (implied by material and design similarity, and adherence to standards).

Summary

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K05/4/2

JUL 1 1 2005

510(k) Summary of Safety and Effectiveness Section XII:

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:	I.T.S. Impiantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoehe A-8301AUSTRIA
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372
TRADE NAME:	Humeral Head Plate with Angular Stability
COMMON NAME:	Bone Plate System
CLASSIFICATION:	Plate, Fixation, Bone
	(see 21 CRF, Sec. 888.3030).
DEVICE PRODUCT CODE: HRS
SUBSTANTIALLYEQUIVALENT DEVICES	Synthes LCP Proximal Humerus Plates (K041860 & K011815)Hand Innovations Shoulder Fixation System (K042059)Arthrex Humeral Fracture Plates and Screws (K041965)DePuy ACE TIMAX® Meta Plate (K983853)ACE Humerus & Radius Plates (K955472)
DEVICE DESCRIPTION:	The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate withvarious length cancellous self-tapping stabilization screws. Thehumeral head plate is made from CP titanium according to ASTMF 67-00 and the screws are made from 6-4 alloyed titaniumaccording to ASTM F 136-02. The plate and screws are surfaceconditioned with a TIODIZE, Type II preparation.
INTENDED USE:	The I.T.S. Humeral Head Plate with Angular Stability is used tostabilize fracture(s) of the proximal humerus bone in the shoulder.
BASIS OF SUBSTANTIALEQUIVALENCE:	The I.T.S. Humeral Head Plate with Angular Stability issubstantially equivalent to the Synthes, Hand Innovations, Arthrex,and DePuy ACE proximal humerus bone plate systems.
SUMMARY OF SAFETYAND EFFECTIVENESS:	The I.T.S. Claviculplate with Angular Stability is shown to be safeand effective for use in fracture fixation of the proximal humerusin the shoulder.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile or a wave-like design. The image is in black and white.

JUL 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implantat-Technologie-Systeme GmbH C/o Mr. Al Lippincott U.S. Agent and Official Correspondent. Engineering Consulting Services Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K051412

K031412
Trade/Device Name: Humeral Head Plate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliance Regulatory Class: II Product Code: HRS Dated: May 25, 2005 Received: May 31, 2005

Dear Mr. Lippincott:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(tr) prematice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated to fithe Medical Device Amendments, or to commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosment Act (Act) that to not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, salgoer to the general registration, listing of
general controls provisions of the Act include requirements for annual registration an general controls of the rice list. Increases of the start of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into .. Existing major regulations affecting your device. EDA if may be subject to such additional controls: Extreman, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feasta. Rogerming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies of the May must that FDA has made a decemination and regulations administered by other Federal and light or any Federal statures and regulations daminities to: registration and listing (21 little comply with all the Act STEquilements, moradian and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000) 11 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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Page 2 – Mr. Al Lippincott

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manieans your antial equivalence of your device to a legally premarket notification. "The PDT Inturing of booses on the spermits your device and thus, 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 If you desire specific advice for your act (240) 276-0120 . Also, please note the regulation entitled, Comaci the Office of Compuner an (21 transmit (21CFR Part 807.97). You may obtain Misoraliung by relevelee to promanson ibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-204, or Manufacturers, international and Oolisanhttp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Implant-Technology-Systems GmbH

Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter

Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 office@its-implant.com

Indications for Use

510(k) NUMBER:	____________________________
DEVICE NAME:	HUMERAL HEAD PLATE
	WITH ANGULAR STABILITY
INDICATIONS FOR USE:

The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder.

Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Prescription Use

AND/OR

Over-The-Counter-Use __

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Stupt Churde

Divisions of Comerals Restitute Profitistion (ODE) and Neurological Devices

510(k) Numb

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.