The Humerus Locking Plating System consists of plates designed for various fracture modes of the humerus bone. The system is used with locking screws, smooth locking pegs, threaded locking peg, locking cortical screws and standard cortical screws. The locking screws, threaded pegs and pegs could be supplied cannulated or not. Each device is manufactured from titanium alloy Ti-6A1-V4 ELI (conforms to ASTM F 136-02a and/or ISO 5832-3) or stainless steel (conforms to ASTM F 138 and/or ISO 5832-1). Each device can be supplied color anodized or non-anodized. The Humerus Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

AI/ML Overview

This looks like a 510k submission for a medical device. These types of submissions typically don't include studies demonstrating device performance against specific acceptance criteria in the way a clinical trial or AI/software validation study would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, the information requested in your prompt (especially regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software) is not present in this 510(k) summary.

A 510(k) summary focuses on:

Device Description: What the device is.
Intended Use: What the device is meant to do.
Predicate Device: A legally marketed device with similar characteristics and intended use.
Technological Comparison: How the new device is similar to (and sometimes different from) the predicate device.
Performance Data: Often bench testing (mechanical, material, sterilization efficacy) to ensure the device meets established standards or performs comparably to the predicate, but not necessarily clinical performance against specific acceptance criteria with expert ground truth.

If you are looking for details on studies proving device performance against acceptance criteria, that information would be found in a more comprehensive premarket approval (PMA) application or a different type of regulatory submission, or in a separate clinical study report, depending on the device's risk class and novelty.

To directly answer your prompt based only on the provided text, I must state that the requested information is not available in the given document.

However, I can extract the information that is present:

Key Information from the Document:

Device Name: Humerus Locking Plating System
Intended Use: For fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Predicate Devices:
- Modified Shoulder Fixation System of HAND INNOVATIONS (K051728)
- SYNTHES LCP® Proximal Humerus Plates, long of SYNTHES (K041860)
- Proximal Humerus Plate of ACUMED (K012655)
- Stryker Plating System of HOWMEDICA OSTEONICS CORP. (K060798)
Materials: Titanium alloy Ti-6A1-V4 ELI (ASTM F 136-02a and/or ISO 5832-3) or stainless steel (ASTM F 138 and/or ISO 5832-1).

Regarding your specific questions, as they relate to AI/software performance, none of the following can be answered from this document:

A table of acceptance criteria and the reported device performance: Not provided. This is a mechanical orthopedic implant, not typically evaluated with "performance criteria" in the AI sense for a 510(k). The "performance" would be related to mechanical strength, biocompatibility, and sterilization, which are confirmed through engineering tests, not clinical studies in this context.
Sample sized used for the test set and the data provenance: Not applicable in the AI/software sense. Bench testing would have its own sample sizes.
Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for an orthopedic implant refers to its physical and material properties, not diagnostic accuracy by experts.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for an orthopedic implant, not a diagnostic imaging device or AI assistance tool.
If a standalone performance was done: "Standalone performance" in this context would refer to mechanical testing (fatigue, torsion, bending), not AI algorithm-only performance. Such tests are usually part of the submission to demonstrate compliance with standards, but specific results and acceptance criteria are not detailed in this summary.
The type of ground truth used: For a mechanical implant, ground truth typically refers to scientific standards (e.g., ASTM/ISO for material properties, mechanical load capabilities).
The sample size for the training set: Not applicable (no AI/ML component).
How the ground truth for the training set was established: Not applicable (no AI/ML component).

In summary, the provided document is a 510(k) summary for an orthopedic implant, not an AI/software device. The regulatory pathway is based on substantial equivalence, and the detailed performance study information you're asking for, especially regarding AI-specific validation, is not part of this type of submission summary.

Summary

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K063095

Image /page/0/Picture/1 description: The image shows the word "NEWCLIP" in bold, sans-serif font. Above the word is a curved line that resembles a paperclip. The word is likely the name of a company or product.

DEC 2 2 2006

4. 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter's Name and adress

NEWCLIP TECHNICS Z.A du Pâtis Rue de la fontaine grillée F-44 690 La Haye-Fouassiere France Tele : (33) 2 28 21 37 12 Fax : (33) 2 40 63 68 37

Summary preparation date: October 6, 2006

B. Official Contact Person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 Tele/Fax - 512-388-0199 Email - ortho.medix@sbcglobal.net

C. Establishment registration number : Applied for

D. Device name

Humerus Locking Plating System

E. Device Classification Name

Plate, fixation, bone (21 CFR 888.3030) Screw, fixation, bone (21 CFR 888.3040)

F. Proposed regulatory Class

Class II

G. Device Product Code

HRS HWC

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H. Panel Code

Orthopedic

I. Device Description

The Humerus Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

J. Intended use:

The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

K. Predicate device:

. Modified Shoulder Fixation System of HAND INNOVATIONS (K051728)
SYNTHES LCP® Proximal Humerus Plates, long of SYNTHES (K041860) .
Proximal Humerus Plate of ACUMED (K012655) .
Stryker Plating System of HOWMEDICA OSTEONICS CORP. (K060798) .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newclip Technics % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

DEC 2 2 2006

Re: K063095 Trade/Device Name: Humerus Locking Plating System 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: September 29, 2006 Received: October 13, 2006

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara buelum
to

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K663095

Device Name: Humerus Locking Plating System

Indications for Use:

The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Prescription Use
AND/OR
Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Barbara Buchin

(Division Sign-Off) Division of General. Restorative, and Neurological Devices

510(k) Number K03095

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.