The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.

Device Description

The materials utilized for the construction of the external elements of the Wristore Fixator are medical grade polyetherimide resin. This material is the identical material utilized to construct the Articulating Distal Radius Fixator (K984498). The materials utilized in the instruments and pin guides are instrument grade stainless steel. The pins and K-wires used to fix the fractured bones are produced from implant grade stainless steel (316L). The Wristore Fixator utilizes legally marketed commercially available fixation pins and/or K-wires. Once the provided K-wires and pins have been properly placed, the poly-resin external frame is tightened and the fracture(s) stabilized. Typical orthopaedic instrumentation is provided to place, tighten and adjust the fixator.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Wristore Fixator," an external fixator for upper extremity fractures. The focus of the document is on demonstrating substantial equivalence to legally marketed predicate devices, rather than on a clinical study proving specific performance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The document focuses on comparing design, materials, and intended use with predicate devices to establish substantial equivalence, not on pre-defined performance acceptance criteria and their fulfillment through a study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. As no clinical study is detailed, there is no mention of a test set, sample size, or data provenance.

3. 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):

This information is not provided. There is no mention of a test set requiring ground truth established by experts.

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

This information is not provided. There is no test set or adjudication method described.

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:

This information is not provided. No MRMC study or AI component is mentioned.

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

This information is not provided. The device is a physical external fixator, not an algorithm.

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

This information is not provided. There is no clinical study described that would require a ground truth.

8. The sample size for the training set:

This information is not provided. There is no mention of a training set as this is not a machine learning device.

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

This information is not provided. There is no mention of a training set.

Summary of what is provided regarding the device:

Device Name: Wristore Fixator
Intended Use: External fixation of the upper extremity for Colles, mid, and proximal fractures. Allows for three-plane control (axial, AP & medio/lateral) over fractures and bone segments.
Classification: Class II
Substantially Equivalent Devices:
- K003397, Colles C Series Frame (DePuy, Inc.)
- K984498, Articulating Distal Radius Fixator (Synthes, Inc.)
Materials: Polyetherimide resin (external elements), stainless steel (instruments, pin guides, pins, K-wires).
Sterilization: Supplied NON-STERILE; validated steam sterilization cycle: Gravity, 250° F (121° C) for 30 minutes.

The document primarily serves to demonstrate that the Wristore Fixator is substantially equivalent to existing devices based on its design, materials, and intended use, rather than presenting data from a performance study against specific acceptance criteria.

Summary

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0122994

(k) Premarket Notification ummary of Safety and Effectiveness Information

Device Name:

Wristore Fixator Trade Name: Common Name: External Fixator Classification Name: Single/multiple component metallic bone fixation appliance and accessories.

Establishment Name & Registration Number:

Millennium Medical Technologies, Inc. Name: Number: Pending

Classification:

§ 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.

Device Class: Class II for all requested indications.

Classification Panel: Physical Medicine Devices Panel

Product Code: 87KTT/HRS

Substantially Equivalent Device(s):

Millennium Medical Technologies, Inc. believes that the Wristore is substantially equivalent to the following legally marketed upper extremity external fixators marketed by DePuy, Inc and Synthes, Inc. respectively.

K003397, Colles C Series Frame Sterile Pack. ●
K984498, Articulating Distal Radius Fixator. ●

Both referenced equivalent fixators are legally marketed. Both fixators have the same indications for use as the Wristore and, in the case of the Synthes fixator, is made from the identical material. All three systems utilize the same type of fixation pins. All three systems are clinically equivalent in terms of design, materials, indications, cautions, precautions and adverse events. A feature comparison chart is included at the end of the summary that graphically depicts substantial equivalence.

Description of the Device:

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Each Wristore Fixator is supplied with:

Main Body Fixator 1.
Radial Triangle 2.
Double K-wire Clamp (up to 1.0mm) 3.
1. Single K-wire Clamp
Universal Inserter stainless steel ഗ
Pin Guide stainless steel 6.
K-wires 316L SS, 0.08, 3 each 7.
Threaded Half Pins 316L SS, (2.5, 3.0, 3.5 & 4.0mm) 4 each. 8.

is supplied with standard, commercially available orthopaedic instruments. No The Wristore Fixator proprietary or specialized instruments are needed to use the system.

Sterilization, Packaging and Storage:

The Wristore Fixator is supplied NON-STERILE. The Wristore Fixator and instruments must be sterilized before use. The device is supplied clean and has been processed to remove debris and manufacturing residue. Before using, all labels and packaging materials must be removed and the device and instruments thoroughly washed before sterilization and use. Cleaning and rinsing should be conducted in accordance with accepted hospital practice using hot water and a commercial instrument detergent or soap. Once cleaned, the Wristore Fixator may be sterilized according the following validated steam sterilization cycle:

Saturated steam at 250° F for 30 minutes. This cycle will provide a Sterility Assurance Level (SAL) of at least Validation of the recommended cleaning protocol and sterilization cycle is complete. Validation was 10°. achieved in accordance with a modified AAMI ST32 Method 3, Protocol B as recommended by the biological testing laboratory. Validation for the following cycle is on file at Millennium Medical Technologies, Inc.:

Method:	Steam
Cycle:	Gravity
Temperature:	250° F (121° C)
Exposure Time:	30 minutes

Applicant / Sponsor Name / Address:

Millennium Medical Technologies, Inc. · 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 - 505.988.7234 fax

Contact Person:

Mr. Fred Kolb Millennium Medical Technologies, Inc. 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 - 505.988.7234 fax

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 / 925.356.2654 FAX

Manufacturing Facility:

At the present time, the Wristore Fixator is manufactured under contract for Millennium Medical Technologies, Inc.

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Image /page/2/Picture/1 description: The image shows a string of alphanumeric characters. The characters are 'KOLDJ94'. The characters are written in a handwritten style. The background of the image is white.

Feature Comparison Table:

FEATURE	Wristore Fixator	DePuy Colles C series frame	Synthes USA - ArticulatingDistal Radius Fixator	SE?
Intended Use:	Colles, mid & proximalfractures of the upper extremity	Same	Same	Yes
Design:	Single frame, transfixing pinbased external fixator	Same	Same	Yes
SuppliedSterile:	No	Yes	Yes	No
Single Use:	Yes	No	Yes	Yes
SterilizationMethod:	Steam	Unknown	Unknown	???
Materials:	Polyethermide resin, stainlesssteel	Metallic	Polyethermide resin,stainless steel	No/Yes
Product Code:	KTT/HRS	KTT	HRS	Yes
K-Number	K012294	K003397	K984498	Yes

and the comments of the comments of

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2002

Millenium Medical Technologies, Inc c/o Mr. David Schlerf Buckman Company, Inc 200 Gregory Lane Suite C-100 Pleasant Hill, California 94523-3389

Re: K012294 Trade Name: Wristore Fixator Regulatory Number: 888.3030 and 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories; and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: KTT and NDK Dated: December 14, 2001 Received: January 24, 2002

Dear Mr. Schlerf:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaon 310(x) premised the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) (c 10gm) and ment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been rochasined in assee approval of a premarket approval application (PMA). alla Cosmetic Act (Fee) market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rist 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 classified (500 abor of als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to sublications: voulations, Title 21, Parts 800 to 898. In addition, FDA may ov found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Dri of issuaires swour device complies with other requirements of the Act that I Dri has made a colorized by other Federal agencies. You must of any I cuchar statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA ratt 807); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Schlerf

This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket notification. The FDA finding of substantial equivalence of your device to a legally promation holicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance alease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

for Mark N. Millenson

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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510(k) Number: K012294

Wristore Fixator Device Name(s):

Intended Use(s) of the Device:

The Wristore Fixator is intended to provide external fixation of the upper External fixation devices allow for three plane (axial, AP & extremity. medio/lateral) control over fractures and bone segments.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Millman

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

510(k) Number ___ K012294

Over-The-Counter Use (Optional format 1-2-96)

Prescription Use (Per 21 CFR 801.109)

Wristore.doc

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.