ACUMED MODULAR SHOULDER SYSTEM by ACUMED, INC.

The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Acumed Modular Shoulder System." This document is for a shoulder implant (prosthetic device), not an AI/ML-based device. Therefore, the questions related to AI/ML device performance (such as sample size for test sets, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices, primarily the Atlas Modular Shoulder (K961260) and the Select Shoulder System (K962224). The manufacturer's claim of safety and effectiveness is based on these similarities.

Here's the relevant information that can be extracted:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way typically seen for AI/ML performance. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use being similar to existing, legally marketed devices.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as presented in the 510(k) summary)
Similarity in Design: Components (head, body, stem), features (suturing holes), tapered stem.	"This device is most similar in design to the Atlas Modular shoulder in that both devices consist of a head, body, and stem components, have holes for suturing, and have a Morse tapered stem." "The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head." "Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire." "Targeting instrumentation is provided to allow accurate of the screws through the component."
Similarity in Material: Construction materials.	"All the devices mentioned above are manufactured from similar materials..." (referring to Atlas Modular Shoulder and Intermedics Select Shoulder). "It incorporates a cobalt chrome modular head, a titanium body..."
Similarity in Intended Use: Addresses proximal fractures and arthritis of the shoulder joint.	"The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement." "All the devices mentioned above... have the same intended use."
Adequate Locking Strength: The taper selected provides sufficient strength.	"Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength for this application." (No specific quantitative data for locking strength is provided in this summary).
Sterility Assurance: Device can be sterilized to appropriate levels.	"Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10⁻⁶." "On file at Acumed is data which shows that the instrumentation and implant can be successfilly steam sterilized under specific process parameters which will obtain a resulting SAL of 10⁻⁴."
Safety and Effectiveness: Expected to be similar to predicate devices based on the above similarities.	"Based on the similarities between the Acumed Modular System and the predicate devices studied, the safety and effectiveness of the Acumed Modular System is expected to be similar to the prodicate devices mentioned above."

2. Sample size used for the test set and the data provenance: Not applicable (this is not an AI/ML device study). The "test set" would be the device itself undergoing various engineering tests (e.g., sterilization, taper strength), but specific sample sizes for such tests are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/ML device).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to engineering and biocompatibility standards. The document mentions:
* Engineering Test Data: "Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength..." (specifics not detailed).
* Sterility Verification: "Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10⁻⁶."
* Similarity to Predicate Devices: The primary "ground truth" for regulatory approval here is the demonstrable substantial equivalence to devices already proven safe and effective through their market history.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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

K992525

FEB 4 2000

Appendix F - 510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

Classification Name:	Prosthetic, shoulder, humeral (hemi-shoulder), uncemented, metallic
Common Name:	Modular shoulder system
Proprietary Name:	Acumed Modular Shoulder System
Proposed Regulatory Class:	Class II
Device Product Code:	HSD
Manufacturing Facility:	Acumed, Inc.
	10950 SW 5th Street, Suite 170
	Beaverton, OR 97005 U.S.A.
Establishment Registration No .:	3025141
Contact:	Shari Jeffers
Labeling/Promotional Materials:	See Appendix D
Substantial Equivalence:	This device is similar in size, material, and intended use to the Atlas
	Modular Shoulder (K961260) and the Select Shoulder System
	(K962224). This device is most similar in design to the Atlas Modular
	shoulder in that both devices consist of a head, body, and stem
	components, have holes for suturing, and have a Morse tapered stem
	Literature on the Atlas and Select Shoulder Systems are included in
	Appendix E.

The Acumed Modular Shoulder System is provided both non-sterile. The sterile version is packaged in inner and outer PETO blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10 . We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation and implant can be successfilly steam sterilized under specific process parameters which will obtain a resulting SAL of 104. Information regarding has been provided. Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength for this application.

Predicate devices that are substantially equivalent to the Acumed Modular System are the Atlas Modular Shoulder and the Intermedics Select Shoulder. All the devices mentioned above are manufactured from similar materials and have the same intended use. The design of the Acumed Shoulder is most similar to the Atlas Shoulder in that both devices consist of a head, body, and stem components, have holes for suturing, and have a Morse rapered stem. The Acumed Shoulder and the Atlas Shoulder have similar surgical techniques. Based on the similarities between the Acumed Modular System and the predicate devices studied, the safety and effectiveness of the Acumed Modular System is expected to be similar to the prodicate devices mentioned above.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

Ms. Shari Jeffers Regulatory Affairs Manager Acumed. Inc. 10950 SW 5th Street, Suite 170 Beaverton, Oregon 97005

Re: K992525/S1

Trade Name: Acumed Modular Shoulder System Regulatory Class: II Product Code: HSD Dated: November 5, 1999 Received: November 8, 1999

Dear Ms. Jeffers:

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 Regulation (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.

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

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) 594-4595. 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 vours.

Neil R. Ogden
James E. Dillard III

James E. Di Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

S10(k) Number (if known):_K992 S Z S

Device Name: ___ Acumed Shoulder Implany

Indications For Use:

Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	NPO for JZD
(Division Sign-Off)Division of General Restorative Devices
510(k) Number	K992525

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

. •

(Optional Format 1-2-96)

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.