The Marchetti-Vicenzi Humeral Intramedullary Nail is a single-use device intended for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 cm proximal to the olecranon fossa.

Device Description

The Marchetti-Vicenzi Humeral Intramedullary Nail is an intramedullary rod made up of several pins that provide elastic fixation of humeral fractures. The cylindrical, rod-like base of the nail is tapered and is preloaded with either four or five pins. A bolt system holds the tips of the pins together until the nail is properly inserted, at which time the bolt is removed back through the canal and the pins diverge and return to their preconditioned position. The cylindrical base that holds the pins contains a screw hole through which a screw can be inserted for distal locking. Distal locking is required for the humeral nail.

AI/ML Overview

The provided text describes a medical device, the Marchetti-Vicenzi Intramedullary Nail, Humeral, and its 510(k) submission to the FDA. However, it does not contain the detailed information typically found in a study proving acceptance criteria for an AI/software device, as requested in the prompt.

The document is a traditional 510(k) submission for a physical medical device (an intramedullary nail), which relies on physical testing and comparison to predicate devices, rather than AI-driven performance metrics. Therefore, many of the requested fields (like sample size for test set, number of experts, adjudication method, AI assistance in MRMC, standalone algorithm performance, training set details) are not applicable or not present in this type of submission.

Here's an attempt to answer based only on the provided text, indicating where information is not available or not applicable for an AI device.

Acceptance Criteria and Study for Marchetti-Vicenzi Intramedullary Nail, Humeral

Based on the provided document, the acceptance criteria and study focus on mechanical performance and substantial equivalence to predicate devices, rather than acceptance criteria for an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Clinical Indications	Fixation of fractures of the humerus, including all types of fractures and pseudoarthroses between the surgical neck and 3 cm proximal to the olecranon fossa.
Bending Strength (vs. predicate)	Statistically higher bending strength (in both 4-pin and 5-pin configurations) when compared to Rush Pins.
Rigidity (vs. predicate)	Statistically higher rigidity (in both 4-pin and 5-pin configurations) when compared to Rush Pins.
Substantial Equivalence to Predicate	Deemed "substantially equivalent" to predicate devices (Rush Pins marketed by Zimmer) by the FDA for the stated indications for use.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for a clinical or performance study involving human subjects or a large dataset. The "performance data" refers to mechanical testing.
Data Provenance: Not applicable in the context of an AI device's test set. The performance data is from laboratory mechanical testing of the physical nail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This information is for AI/software device validation. The "ground truth" for this physical device's performance would be derived from biomechanical testing standards and measurements.

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

Not applicable. This information is for AI/software device validation.

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:

No, an MRMC study was not done. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to the physical device's design and materials.

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

The "ground truth" for the performance claims ("statistically higher bending strength and rigidity") is derived from mechanical testing data comparing the Marchetti-Vicenzi Humeral Nail to its predicate device (Rush Pins).

8. The sample size for the training set:

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set with established ground truth.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, lowercase font.

SEP 1 9 1997

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

K972692

Summary of Safety and Effectiveness Marchetti-Vicenzi Intramedullary Nail, Humeral

Submitted by:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Prepared by: ●
Ralph H. Larsen Manager Global Regulatory Affairs Telephone: 219-372-4129 Telefax: 219-372-4605
. Date:
June 27, 1997
Trade Name: .
Marchetti-Vicenzi Intramedullary Nail, Humeral
Common Name: .
Intramedullary Rod
Classification Name: .
Intramedullary Fixation Rod
Predicate Devices: .
Rush Pins, marketed by Zimmer

{1}------------------------------------------------

K972612

Summary of Safety and Effectiveness Marchetti-Vicenzi Intramedullary Nail, Humeral (Continued)

Device Description

Intended Use

Performance Data

The Marchetti-Vicenzi Humeral Nail exhibited statistically higher bending strength and rigidity in both the 4-pin and 5-pin configurations when compared to Rush Pins.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ralph H. Larsen, RAC ·Manager Global Requlatory Affairs Zimmer P.O. Box 708 46581-0708 Warsaw, Indiana

SEP 1 9 1997

Re: K972692 Marchetti-Vicenzi™ Intramedullary Nail, Humeral Requlatory Class: II Product Code: HTY Dated: July 16, 1997 Received: July 17, 1997

Dear Mr. Larsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ralph H. Larsen, RAC

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page _ 1 __ of __ l __

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Marchetti-Vincenzi™ Intramedullary Nail, Humeral

Indications for Use:

The Marchetti-Vicenzi Humeral Intramedullary Nail is indicated for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 centimeters proximal to the olecranon fossa.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

RA06701K.510

(Division Sign-Off) Division of General Restorative Devi 510(k) Number

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.