The Equinoxe™ Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
congenital abnormalities in the skeletally mature
primary and secondary necrosis of the humeral head.
humeral head fracture with displacement of the tuberosities
pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
displaced three-part and four-part upper humeral fractures
spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
revision of failed previous reconstructions when distal anchorage is required
to restore mobility from previous procedures (e.g. previous fusion)

Device Description

Exactech Equinoxe® Shoulder System. The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. All components are supplied sterile.

AI/ML Overview

The provided text is a 510(k) Summary for the Exactech Equinoxe Shoulder Stem Size Scope Extension. This document does not contain acceptance criteria or study data in the way one would find for an AI/ML device.

This is a submission for a device modification (addition of new size stems and increased lateral offset) to an existing shoulder prosthesis system. The "study" mentioned is "Engineering evaluations," which are typically mechanical tests and analyses to demonstrate that the new sizes and modifications are equivalent in performance to the predicate devices.

Therefore, many of the requested points are not applicable to this type of medical device submission.

Here's a breakdown based on the provided text, indicating where information is not present or not applicable for an AI/ML device:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated as acceptance criteria in the AI/ML sense. The general acceptance criterion is "substantial equivalence" to predicate devices.	"Engineering evaluations were conducted verifying the proposed Equinoxe Press-Fit Humeral Stems and the Equinoxe Cemented Revision Humeral Long Stems are appropriate for anticipated in vivo use and are substantially equivalent to the predicate devices."

2. 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 in the context of clinical trials for AI/ML. The "engineering evaluations" would involve a number of physical samples of the device components being tested for mechanical properties (e.g., strength, fatigue). The specific number of physical samples is not detailed in this summary.
Data Provenance: Not applicable. These are engineering tests, not clinical data from patients.

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)

Not applicable. Ground truth as understood for AI/ML (e.g., expert labels on medical images) is not relevant for this type of mechanical device evaluation. The "ground truth" here would be the physical properties and performance characteristics determined through engineering tests.

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

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or clinical outcomes, not for engineering evaluations.

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 comparative effectiveness study was not done. This type of study is specific to AI/ML assistive devices or diagnostic tools.

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

Not applicable. This is a physical prosthetic device, not an algorithm.

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

The "ground truth" for this device's evaluation is based on engineering standards, mechanical testing results, and established performance characteristics of the predicate devices. This demonstrates that the modified stems meet the necessary physical and mechanical requirements for their intended use and are comparable to existing, legally marketed devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

Not applicable. See point 8.

Summary

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2320 NW 66TH COURT GAINESVILLE, FL 32653

2-377-1140

Exactech, Inc.® Equinoxe Shoulder Stem Size Scope Extension Special 510(k) Summary of Safety and Effectiveness

JUN 1 2 2006

1. Submitted By: Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653

Contact: Chris Roche Product Development Engineer Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617

Exactech Equinoxe® Shoulder System 3. Product:
21 CFR Section 888.3660 Product Code 87 KWS Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented

21 CFR Section 888.3690 Product Code 87 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented

Class II

Rev 04/24/06

Section 4 Page 1 of 2

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Image /page/1/Picture/0 description: The image shows the word "Exactech" in a stylized font. The word is white and the background is black. There is a circle with a "C" in it to the left of the word. There is a registered trademark symbol to the right of the word.

352-377-1140 FAX 352-378-2617

Exactech, Inc. ® Equinoxe" Shoulder Stem Size Scope Extension Special 510(k) Summary of Safety and Effectiveness

Trade or Proprietary or Model Name(s):

Equinoxe Press-Fit Primary Humeral Stems (size17x125 and 19x130) Equinoxe Cemented Revision Humeral Long Stems (size 10x200mm, 12x200mm)

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
#K042021	Equinoxe Press-Fit Primary Humeral Stems(Size 7x100mm, 9x105mm, 11x110mm, 13x115mm,15x120mm)	Exactech, Inc.
#K042021	Equinoxe Cemented Revision Humeral Long Stems(Size 8x175mm, 8x215mm)	Exactech, Inc.

Intended Use:

The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. All components are supplied sterile.

Special 510(k) Modifications:

Addition of 17 x 125 and 19 x 130mm Press-Fit Primary Humeral Stem size ●
Addition of 10 x 200 and 12 x 200 Cemented Revision Humeral Long Stems .
. Increased lateral offset for sizes 11,12,13,15

Conclusions:

Engineering evaluations were conducted verifying the proposed Equinoxe Press-Fit Humeral Stems and the Equinoxe Cemented Revision Humeral Long Stems are appropriate for anticipated in vivo use and are substantially equivalent to the predicate devices.

Rev 04/24/06

Section 4 Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

Exactech, Inc. % Ms. Maritza Elias Regulatory Representative 2320 NW 66th Court Gainesville, Florida 32653

Re: K061454

Trade/Device Name: Exactech Equinoxe® Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: April 24, 2006 Received: May 25, 2006

Dear Ms. Elias:

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

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Page 2 - Ms. Maritza Elias

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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Helmut Remensno

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech, Inc.® Equinoxe® Shoulder Stem Size Scope Extension Special 510(k) Indications for Use

510(k) Number: ______________________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE

Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:

P	L/R	F	Indications
√	√		rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
√	√		congenital abnormalities in the skeletally mature
√			primary and secondary necrosis of the humeral head.
√		√	humeral head fracture with displacement of the tuberosities
√	√		pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
√	√		revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
		√	displaced three-part and four-part upper humeral fractures
√	√		spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
√	√		revision of failed previous reconstructions when distal anchorage is required
√	√	√	to restore mobility from previous procedures (e.g. previous fusion)

Prescription Use	X
or	Over the Counter Use

(Division Sign-Off)

Please do not write below this line - use another page if needed.

Division of General, Restorative,

Concurrence of CDRH, Office of Device Evaluation (ODE)

and Neurological Devices

06/06/06	510(k) Number K061454
	Section 3 Page 1 of 1

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.