Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

Device Description

The Aequalis Shoulder Fracture System is a typical 3 part system consisting of interchangeable humeral heads, a humeral stem and, if used as a total shoulder, a glenoid component.

The Aequalis Shoulder Open stem for Fracture is available in 3 diameters (6.5, 9 and 12), with the same length. The geometry of the meaphyseal part has been designed to allow the filling by bone graft and to improve the knitting of the bones. The goal of the metaphyseal shape is to make a "bony bridge" between the tuberosities. In order to allow extraction of the prosthesis in case of revision, two slits have been designed to break the bony bridge. Anterior-posterior fins extending from diaphyseal portion form a convex bearing area allowing adequate positioning and synthesis of the greater tuberosity. The stem is used cemented in the diaphyseal part.

Various heads may be assembled to the stem in different configurations thus accommodating large variations in patient size and anatomy. The head is fixed on the stem on a Morse taper. It is impacted onto the stem on an impacting support. Subsequent revisions may be accomplished if necessary by reoparetion and separation of the head and the stem. The taper fit heads may be rotated about the axis of the Morse taper. The reverse surface of the heads has series of holes drilled around the female Morse taper every 45°. Because the female Morse taper of the head is eccentric, rotation of the head before fully seating the male and female tapers produces eight possible offset combinations for the orientation of the humeral head radius. The rotational adjustability of the humeral articulating surface expands the surgical flexibility of the system. The articulating surface of each head is designed to mate with either the natural glenoid (hemi-shoulder applications) or the available glenoid implants (total shoulder applications).

The Aequalis glenoid components are pear-like in shape, to avoid friction with the deep surface of the rotator cuff.

Open Stem for fracture: 3 dia. (6.5. 9 and 12 mm) with 1 length

Humeral Heads:
37mm x 13.5mm
39mm x 14mm
41mm x 15mm
43mm x 16mm
46mm x 17
48mm x 18mm
50mm x 16mm
50mm x 19mm
52mm x 19mm
52mm x 23mm
54mm x 23mm
54mm x 27mm

Glenoid: 3 sizes (small, medium, large)

Each component of the system is individually part coded for ease identification. The offered combinations of stem, head and glenoid sizes accommodate a wide range of anatomical variations and circumstances.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Aequalis Shoulder Fracture System. This document focuses on establishing substantial equivalence to a predicate device and safety and effectiveness, rather than providing specific acceptance criteria and performance data for a new device's functional attributes in the way a clinical trial for an AI/medical device might.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially for AI or software-based devices) are not applicable to this type of regulatory submission for a shoulder fracture system.

However, I can extract information related to the device's classification, general standards it complies with, and the regulatory process.

Here's a breakdown of what can be inferred or is directly stated, and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than setting specific performance acceptance criteria for a new, innovative function and then reporting against them.

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

Not applicable. This device is a shoulder implant, and the submission does not detail "test sets" or data provenance in the context of performance studies for an AI/software device. The submission relies on a comparison to a predicate device and compliance with established standards.

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

Not applicable. Ground truth establishment with experts is not mentioned as part of this type of regulatory submission for a physical implant.

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

Not applicable. Adjudication methods are not mentioned.

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:

Not applicable. This is a physical shoulder implant, not an AI-assisted diagnostic or treatment device, so MRMC studies are not relevant.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used:

Not applicable in the context of AI/software performance. For a physical implant, the "ground truth" would be related to clinical outcomes, biomechanical testing, and material properties, which are generally not detailed as "ground truth" in this manner within a 510(k) summary. The submission focuses on substantial equivalence based on design, materials, and intended use.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

General summary of what the document does address regarding "safety and effectiveness":

The document states:

"This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Shoulder Fracture System."
It highlights compliance with various standards and regulations:
- Tornier, S.A. Standard Operating Procedures (SOP)
- Vendor certifications and qualification procedures
- Quality System Regulations (QSR)
- ISO9001 & EN46001 specifications
- European CE Marking
- FDA requirements for labeling (21 CFR 801 and 809.10)
- Good Manufacturing Practice requirement (21 CFR Part 820)
The sterilization method (gamma radiation, 2.5 Mrad, SAL of 10^-6) and its validation according to EN552 are described.
The FDA letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the core "acceptance criteria" for a 510(k) submission. This determination is based on the information provided in the submission, including device description, intended use, and comparison to existing legally marketed devices.

Summary

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MAR 1 C 200

K994392

510(k) Premarket Notification Aequalis Shoulder Fracture System September 2. 1999

Fig. 1 of 5

510(k) SUMMARY of Safety and Effectiveness Information

In accordance with the Food and Drug Administration Rule to implement provisions of the safe Medical devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Aequalis Shoulder Fracture System.

Manufacturer:	TORNIER, S.A.
	Rue du Doyen Gosse
	38330 SAINT-ISMIER / France
	Registration No : 9610667
US Representative:	Mr. David W. SCHLERF
	BUCKMAN Company, Inc.
	200 Gregory Lane, Suite C-100
	Pleasant Hill, CA 94523-3389
Date:	September 2, 1999
Contact Person:	Anne LE ROUZO
	Regulatory Affairs Manager
Classification Name:	Shoulder joint metal/polymer semi-constrained cementedprosthesis - 21CFR888.3660

1. Classification:

$888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as Titanium or cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §888.3.

The Orthopedic and Rehabilitation Devices Panel assigned the unique device classification Product Code 87KWS to this device.

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2. Voluntary standard:

pg 275

Various voluntary performance standards are utilized. They include Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures. Quality System Regulations (OSR). ISO9001 & EN46001 specifications, and European CE Marking,

3. Labeling / Packaging:

Labeling complies with all FDA requirements in effect at the time of device review and clearance. Warning and caution statements are displayed as appropriate. Professional information is available from Tornier and is supplied with all product ordered. Please obtain and review all product information before using the system. Only the information supplied with the product is to be considered current and complete.

The Aequalis Shoulder Fracture System offers all components in double blister-type peel packs. This is an industry typical package obtained from commercial suppliers of such packaging.

4. Device Description:

Overview. The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Though the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthrosplasty to a total shoulder replacement.

Device Description. The Aequalis Shoulder Fracture System is a typical 3 part system consisting of interchangeable humeral heads, a humeral stem and, if used as a total shoulder, a glenoid component.

shoulder applications) or the available glenoid implants (total shoulder applications).

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The Aequalis glenoid components are pear-like in shape, to avoid friction with the deep surface of the rotator cuff.

Open Stem for fracture: 3 dia. (6.5. 9 and 12 mm) with 1 length

Humeral Heads:	37mm x 13.5mm	50mm x 16mm
	39mm x 14mm	50mm x 19mm
	41mm x 15mm	52mm x 19mm
	43mm x 16mm	52mm x 23mm
	46mm x 17	54mm x 23mm
	48mm x 18mm	54mm x 27mm

3 sizes (small, medium, large) Glenoid:

Only surgeons fully experienced in total and hemi-Contraindications and Cautions. arthroplasty surgical technique of the shoulder should utilize the device. Please contact Tornier about available instructional course demonstrations and bio-skills workshops.

5. Packaging and Sterilization Information:

The prostheses are supplied sterile from Tornier. The technique used to achieve the sterilization is known as gamma radiation sterilization dose of at least 2.5 Mrad is utilized. The sterility assurance level (SAL) is 10°. The validation of the sterilization has been carried out according to the standard EN552.

The implant is contained in a double sealed blister pack in order to maintain sterility. Once the packaging is opened, the implant must never be resterilized. In case of packaging is damaged, the implant must be rejected.

The instruments required to properly use the device are provided non-sterile. They must be decontaminated, cleaned and sterilized prior to each surgery. All packaging, labeling and shipping materials must be removed from the instruments prior any operation. The recommended sterilization method is steam sterilization at 274°F for 18 minutes.

6. Summary of Safety and Effectiveness Information.

This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Shoulder Fracture System. A feature comparison table is used to graphically present important parameters of the available systems. The comparison table is identified as Table 1, located after the Class III Summary section.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Schlerf Representing Tornier, S.A. Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K994392 Trade Name: Æqualis® Shoulder Fracture System Regulatory Class: III Product Code: KWS Dated: November 21, 1999 Received: December 28, 1999

Dear Mr. Schlerf:

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 control provisions of the Act. The general control 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 Regulation (OS) 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.

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.

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Page 2 – Mr. David W. Schlerf

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) 594-4595. 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,

Kamil Mayer

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 994392

Equalis® Shoulder Fracture System Device Name:

Indications For Use:

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

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

Vuan Lazaro

Nhofr Jz

ion Sign-Off) of General Restorative I

Prescription Use X OR
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”