The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

Device Description

Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.

Materials: Titanium; Ti-6A14V-ELI as per ASTM F136

Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and, as such, does not typically contain information about comprehensive clinical studies with detailed acceptance criteria and reported device performance metrics in the way a PMA (Premarket Approval) application or a clinical trial report would.

The provided text focuses on establishing substantial equivalence to a predicate device, which is the cornerstone of the 510(k) pathway. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not part of this type of submission.

However, I can extract the relevant information and explicitly state where information is not provided in the document.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance (Not applicable for this type of submission)

The provided document is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than demonstrating "acceptance criteria" and "reported device performance" through a novel clinical study with hard performance metrics. The "acceptance criteria" in this context are implicitly met by demonstrating technological characteristics and intended use that are substantially equivalent to a legally marketed predicate device.

Table 1: Acceptance Criteria and Reported Device Performance (N/A for 510(k) Summary)

Criteria Category	Description of Criteria (as typically found in PMAs/Clinical Trials)	Reported Device Performance (as typically found in PMAs/Clinical Trials)	Not Provided in 510(k) Summary
Safety	(e.g., Complication rate, adverse events)	(e.g., X% complication rate compared to predicate)	Yes
Effectiveness/Performance	(e.g., Fracture union rate, functional outcomes, specific biomechanical performance benchmarks)	(e.g., X% union rate, specific functional scores, biomechanical test results)	Yes
Biocompatibility	(e.g., ISO 10993 compliance)	(e.g., Passed all biocompatibility tests)	Yes
Sterility	(e.g., SAL of 10^-6)	(e.g., SAL of 10^-6 achieved)	Yes
Mechanical Reliability	(e.g., Fatigue life, pull-out strength, torque limits)	(e.g., Met or exceeded predicate's mechanical properties)	Yes
Substantial Equivalence	Device's technological characteristics and intended use are as safe and effective as the predicate.	The device is determined to be substantially equivalent to the predicate device (K002775).	No

Study Details (Information largely not provided in this 510(k) summary)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This 510(k) submission does not describe a clinical study with a "test set" of patient data for performance evaluation in the way a clinical trial would. It relies on a comparison of technological characteristics to a predicate device.
- Data Provenance: Not applicable. No clinical data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical study with a "test set" requiring expert-established ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical study requiring adjudication of a "test set" is described.
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:
- No. This device is a metallic bone fixation appliance, not an AI software/diagnostic device, and thus an MRMC study is not relevant to its regulatory pathway.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm, so standalone performance in this context is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no clinical study for performance evaluation is described. The "ground truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are fundamentally similar to a previously cleared device.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. No "training set" or establishment of ground truth for such a set is relevant to this submission.

Summary of what the document does provide regarding "proof" and "acceptance criteria":

Substantial Equivalence Pathway: The entire submission serves as proof that the device is "substantially equivalent" to a legally marketed predicate device (Hand Innovations Distal Volar Radius Fracture Repair System, K002775).
Technological Characteristics Comparison: The document states that there are "no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product." It explicitly mentions the use of "the same basic mechanical features as the predicate."
Material Equivalence: The material (Titanium; Ti-6A14V-ELI as per ASTM F136) is specified, implying it's a known, safe, and effective material for this application, likely consistent with the predicate.
Intended Use Equivalence: The "Indications for Use" of the KMI Distal Volar Radius Plate are aligned with the general use of similar devices for distal radius fracture fixation, indicating it serves the same clinical purpose as the predicate.
Regulatory Acceptance: The letter from the FDA (AUG 16 2004) explicitly states: "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." This FDA determination serves as the "acceptance" that the device meets the substantial equivalence criteria.

Summary

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APPENDIX I: SUMMARY OF SAFETY AND EFFECTIVENESS

For

KMI Distal Volar Radius Plate System

1. Submitter:

Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Carlsbad. CA 92009

Contact Person:

John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road Carlsbad, CA 92009 (448) 760 1706 FAX (448) 760 1739

Date Prepared: May 29, 2004

KMI Distal Volar Radius Plate System 2. Trade Name: Distal Volar Radius Fracture Repair System Common Name: Single, multiple component Metallic Bone Fixation Appliances Classification Name: and Accessories, per 888.3030
Predicate or legally marketed devices which are substantially equivalent 3.

-Hand Innovations Distal Volar Radius Fracture Repair System (K002775)

Description of Device 4.

Materials: Titanium; Ti-6A14V-ELI as per ASTM F136

Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.

5. Intended Use

The use of the KMI Distal Volar Radius Plate is generally indicated for the reduction and fixation of fractures of the distal radius bone. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product. The KMI Distal Volar Radius Plate employs the same basic mechanical features as the predicate, legally marketed device specified in section I in that the essential configuration consists of a plate and sets of bone screws intended for use in the reduction of fractures of the distal proximal radius bone.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John G. Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc 6005 Hidden Valley Road Carlsbad, California 92009

Re: K041461

Trade/Device Name: KMI Distal Volar Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 29, 2004 Received: June 2, 2004

Dear Mr. Spampinato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premained is substantially equivalent (for the indications ferenced above and nave acterimined and marketed predicate devices marketed in interstate for use stated in the encrosale) to regary regary the Medical Device Amendments, or to continered price to May 20, 1978, the exactions of the Federal Food, Drug, devices mat nave been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (110) that to her request to the general controls provisions of the Act. The r ou may, merelore, mance of the Act include requirements for annual registration, listing of general controls provisions proctice, 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 If your device is elassified (vor a controls. Existing major regulations affecting your device can may be subject to suen additions. Title 21, Parts 800 to 898. In addition, FDA may be found in the OUD acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least be advised that I Drivination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 comply with an the 11ct 621 CFR Part 801); good manufacturing practice requirements as set CT N Fart 607); adomig (DT CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John G. Spampinato

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDF miding of cation 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 If you desire specific acvice for Jour ac (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Comphaliso at (537) 777 Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mikkelsen

Celia M. Witten, Ph.D., M.D. 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):_K041461

Device Name: KMI Distal Volar Radius Plate

Indications For Use:

The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mak

Davision Sign-Off)

vision of General, Restorative,

Wological Devices

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Stock Number K04146/

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.