NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM by OSTEOMEDICS, INC.

Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Device Description

Normed Distal Radius Reconstruction System consists of a series of titanium plates in various shape and length in left and right curved configurations, which are attached to the bone using 2,7 mm diameter titanium bone screws. The plates are available in 8, 11, and 13 holes with 2.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.7 mm screw diameters will be available in hex-lock screw head designs, in sixteen length 8 through 38 mm long in 2mm intervals. A hand fixation table system is also available for the surgeon to rest the injured hand during the surgery.

AI/ML Overview

It appears there might be a misunderstanding of the provided text. The document is a 510(k) summary for the Normed Distal Radius Reconstruction System, which is a metallic bone fixation appliance.

This type of device is a physical medical implant, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they would apply to the performance of an AI or diagnostic algorithm do not directly apply in the same way.

The 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:

Design comparison: Showing the new device has similar materials, design, and intended use as a predicate.
Mechanical testing: Demonstrating that the device meets established engineering standards for strength, fatigue, material biocompatibility, etc.
Clinical use (if necessary, but often not for 510(k)s): Sometimes, if there are significant differences or new indications, clinical data might be required, but it's not the primary route for most 510(k)s.

The provided document does not contain information about:

Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC).
A "study" in the sense of an effectiveness trial for an AI model.
Sample sizes for test or training sets for an algorithm.
Expert involvement in establishing ground truth for an algorithm.
MRMC studies, standalone algorithm performance, or different ground truth types for an AI.

To answer your request based on the provided document, I can only state what is present and what is absent:

The document describes a medical device (bone plate and screws) and its intended use, along with the FDA's clearance (510(k)) based on substantial equivalence. It does not pertain to an AI or diagnostic algorithm.

Therefore, most of the fields you requested cannot be filled from the provided text.

Here's an attempt to address your points by clarifying their applicability or lack thereof:

A table of acceptance criteria and the reported device performance:
- Applicability: Not applicable in the context of an AI/diagnostic algorithm performance.
- What's in the document: The document states the device is "substantially equivalent" to predicate devices, implying it meets criteria for safety and effectiveness for its intended use, typically through design and material comparisons, and potentially mechanical testing, though those specific results are not detailed here.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Applicability: Not applicable. There is no "test set" for an algorithm performance evaluation described.
- What's in the document: N/A.
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):
- Applicability: Not applicable. There is no "ground truth" for an algorithm described.
- What's in the document: N/A.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Applicability: Not applicable. No test set or adjudication method is described.
- What's in the document: N/A.
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:
- Applicability: Not applicable. This is a physical implant, not an AI assistance tool for human readers.
- What's in the document: N/A.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Applicability: Not applicable. This is a physical implant, not an algorithm.
- What's in the document: N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Applicability: Not applicable. No ground truth is described in this context. Substantial equivalence for this device would rely on established engineering standards and predicate device characteristics rather than "ground truth" in an AI sense.
- What's in the document: N/A.
The sample size for the training set:
- Applicability: Not applicable. No training set for an algorithm is described.
- What's in the document: N/A.
How the ground truth for the training set was established:
- Applicability: Not applicable. No training set or ground truth for it is described.
- What's in the document: N/A.

In summary, the provided text is about the regulatory clearance (510(k)) of a conventional surgical implant, not an AI or diagnostic algorithm, and thus the specific questions about algorithm performance, test sets, training sets, and expert evaluations are not relevant to this document.

Summary

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510 (k) Summary

Device Name: Normed Distal Radius Reconstruction System

Device Identification: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Class II

Product Code: 87 HRS (21 CFR - 888.3030)

Official Contact Person:

Albert Enayati President Osteomedics Inc. 809 Carter Lane Paramus, NJ 07652 Tel: (201) 444-7306 Fax: (201) 444-7395 E-mail: osteomedics@aol.com

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol resembling a stylized human figure or bird, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2002

Osteomedics, Inc. Albert Enayati President 809 Carter Lane Paramus. New Jersey 07652

Re: K022231

Trade/Device Name: Normed Distal Radius Reconstruction System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 8, 2002 Received: July10, 2002

Dear Mr. Enayati:

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. Albert Enayati

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 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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

K. Mark A. Millman

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): K022231

Device Name: Normed Distal Radius Reconstruction System.

Indications for use:

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription use _________________

OVER - THE - COUNTER USE

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Milkeren

leneral, Restorative and Neurole

510(k) Number K022231

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.