Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Palacos® R+G Bone Cement or Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the StageOne™ disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Palacos® R-G Bone Cement and Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

Device Description

The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are intended to be filled with Palacos® R+G Bone Cement or Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.

AI/ML Overview

The document describes the StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

This document is a 510(k) premarket notification for a medical device (a cement spacer mold), which is a physical product, not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and associated sample sizes for training and testing are not applicable to the information provided.

The performance data mentioned (mechanical performance and gentamicin elution testing) is for the physical characteristics of the cement spacer and the bone cement combination, comparing it to an existing predicate device.

Here's a breakdown of the information that is available, and why the requested information is largely absent based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy) for an AI/ML system. For this physical device, "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in terms of mechanical and elution characteristics.
Reported Device Performance:
- Mechanical performance testing: "StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical... characteristics comparable to those of the predicate device."
- Gentamicin Elution testing: "...and Gentamicin Elution testing of StageOne™ ... compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess... elution characteristics comparable to those of the predicate device."
- Design validation: "Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not mentioned. The "test set" here refers to the physical samples of the cement spacers and bone cement used for mechanical and elution testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested or the provenance of these physical samples.

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. This question pertains to expert review for AI/ML model ground truth. The "ground truth" for this device is based on laboratory testing of physical properties (mechanical strength, drug elution) and comparison to a predicate device, not expert interpretation of medical images or data.

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

Not applicable. This is relevant for resolving discrepancies in expert opinions for AI/ML ground truth. Not relevant for physical device testing.

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 study type is specific to evaluating AI/ML's impact on human performance in diagnostic tasks. The StageOne™ device is a physical medical device.

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

Not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

Ground Truth (for the physical device): The "ground truth" for this device's performance is established by objective, quantitative laboratory measurements of mechanical properties (e.g., strength, stiffness) and drug elution profiles, compared against established standards or performance of a legally marketed predicate device.

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this device.

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

Not applicable. There is no AI/ML training set for this device.

In summary, the provided document is a 510(k) submission for a physical medical device. The questions posed are primarily designed for AI/ML-enabled medical devices, and thus, most of them are not relevant to the information presented in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected or overlapping. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2016

Biomet, Incorporated Ms. Heidi Busz Global Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581

Re: K160071

Trade/Device Name: StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: April 15, 2016 Received: April 18, 2016

Dear Ms. Busz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160071

Device Name

StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the StageOne™ Shoulder Spacer Molds 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Heidi BuszRegulatory Affairs Associate
Phone:	574-372-4249
Fax:	574-372-4710
Date:	May 31, 2016
Subject Device:	Trade Name: StageOne™ Disposable Cement Spacer Molds forTemporary Hemi-Shoulder ProsthesisCommon Name: Bone Cement Shoulder Spacer Mold; DisposableCement Spacer Molds for Temporary Hemi-Shoulder Prosthesis;StageOne™ Shoulder Spacer Mold
Classification Name:	MBB-Polymethylmethacrylate (PMMA) bone cement (21 CFR 888.3027) HSD- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690) KWS-Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)

Legally marketed devices to which substantial equivalence is claimed:

K131135-StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ● Prosthesis
K112983-Tecres S.p.A. InterSpace® Shoulder

Device Description

Indications for Use

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Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a sans-serif font. The letters are all capitalized and appear to be a dark gray color. The letters are evenly spaced and the word is centered in the image. The overall impression is clean and professional.

Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Palacos® R+G Bone Cement or Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Palacos® R+G Bone Cement and Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

Summary of Technological Characteristics

The subject modifications include the removal Cobalt™ G-HV Bone Cement from the Instructions for Use and the addition of Palacos® R+G Bone Cement and Refobacin® Bone Cement R for use with the subject device.

The subject modification does not result in any changes to the StageOne™ Shoulder Spacer Mold design features, materials, sizes, sterilization method, manufacturing process, sterility assurance level, or shelf life of the StageOne™ Shoulder Spacer Molds.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- Mechanical performance testing and Gentamicin Elution testing of StageOne™ o Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical and elution characteristics comparable to those of the predicate device. Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use.
Clinical Tests
- o Clinical data was not required to establish substantial equivalence between the subject StageOne™ Shoulder Spacer Molds and the predicate device.

Substantial Equivalence Conclusion

Based on the similarities in design, function, indications for use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”