Biomet Comprehensive Vault Reconstruction System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Vault Reconstruction System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.

Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Interlok finish humeral stems are intented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Description

The Comprehensive Vault Reconstruction System (VRS) is a glenoid baseplate for reverse shoulder arthroplasty designed to match the anatomy of an individual patient.

AI/ML Overview

The provided text describes the regulatory clearance (K152754) for the Biomet Comprehensive Vault Reconstruction System (VRS). However, it does not include detailed acceptance criteria or a study proving performance against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data with specific acceptance criteria.

Key takeaway: The document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence." Therefore, it does not contain the information requested regarding acceptance criteria and performance studies.

Despite the absence of the requested information, here's a breakdown of what can be inferred or directly stated from the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific quantitative performance metrics comparing the device to such criteria. The performance data section only lists the types of non-clinical tests conducted.

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified quantitatively against criteria in the document
Non-clinical tests performed:
Compressed Shear Load to Failure Testing	"performed within the intended use"
Baseplate Fixation Testing	"performed within the intended use"
Axial Separation Testing	"performed within the intended use"
Torsional Separation Testing	"performed within the intended use"
Software Validation	"performed within the intended use"
Cadaver Validation	"performed within the intended use"

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 specified for any of the listed non-clinical tests.
Data Provenance: Not specified. The tests are non-clinical (mechanical, software, cadaveric), so country of origin for patient data is irrelevant. Whether the tests were retrospective or prospective is not mentioned, but for mechanical and cadaveric testing, this distinction is less common than for clinical studies.

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):

This information is not applicable as the submission is for a medical device (a shoulder prosthesis) and relies on non-clinical testing for substantial equivalence, not expert-adjudicated clinical data to establish ground truth in the context of image interpretation or diagnosis.

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

Not applicable. As noted above, this submission focuses on non-clinical testing for a device, not on diagnostic performance where expert adjudication for ground truth would be required.

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 device is a shoulder prosthesis, not an AI-powered diagnostic tool. No MRMC study was performed or required for this type of submission.

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

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

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

For the non-clinical tests, the "ground truth" would be established by engineering standards and validated physical measurements or simulations, rather than clinical consensus or pathology. For example:

Compressed Shear Load to Failure Testing: Ground truth would be the mechanical properties of the materials and design under load, validated by destructive testing.
Software Validation: Ground truth would be the specified functional requirements and expected outputs of the software, validated through testing.
Cadaver Validation: Ground truth would relate to the anatomical fit, surgical procedure, and stability of the implant within a cadaveric model, evaluated by anatomists or orthopedic surgeons.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.

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

Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582

May 16, 2016

Re: K152754

Trade/Device Name: Comprehensive Vault Reconstruction System (VRS) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: March 29, 2016 Received: March 31, 2016

Dear Ms. Beres:

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 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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K152754

Device Name

Comprehensive Vault Reconstruction System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

✖ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Comprehensive Vault Reconstruction System (VRS) 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.

SUBMITTER INFORMATION
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveWarsaw, IN 46582
Phone number	(574) 267-6639
Fax number	(574) 371-1027
Establishment Registration Number	1825034
Name of contact person	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.
Date prepared	May 10, 2016
NAME OF DEVICE
Trade or proprietary name	Comprehensive Vault Reconstruction System (VRS)
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint, metal/polymer, semi-constrained, cementedprosthesis
Classification panel	Orthopedics
Regulation	21 CFR 888.3660
Product Code(s)	PHX
Legally marketed device(s) to which equivalence is claimed	Comprehensive Reverse Shoulder510(k) K120121
Reason for 510(k) submission	New Device
Device description	The Comprehensive Vault Reconstruction System (VRS) is aglenoid baseplate for reverse shoulder arthroplasty designedto match the anatomy of an individual patient.
Intended use of the device	Shoulder Replacement
Indications for use	Biomet Comprehensive Vault Reconstruction System is indicatedfor use in patients whose shoulder joint has a grossly deficientrotator cuff with severe arthropathy and/or previously failedshoulder joint replacement with a grossly deficient rotator cuff.The patient must be anatomically and structurally suited toreceive the implants and a functional deltoid muscle isnecessary.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE GLENOSPHERE BASEPLATE
primary, fracture, or revision total shoulder replacement for therelief of pain and significant disability due to gross rotator cuffdeficiency.
The Comprehensive Vault Reconstruction System glenoidbaseplate components are intended for cementlessapplication with the addition of screw fixation in patients withunusual anatomy and/or extensive bone loss which precludesthe use of a standard glenoid baseplate component.
Titanium glenospheres are intended for patients with CobaltAlloy material sensitivity. The wear of these devices has notbeen tested but, based on pin on disk testing, the wear rate isinferior to that of cobalt alloy glenospheres. A Cobalt Alloyglenosphere is the recommended component for reverseshoulder arthroplasty patients without material sensitivity tocobalt alloy.
Interlok finish humeral stems are intended for cemented use andthe MacroBond coated humeral stems are intended for press-fitor cemented applications. Humeral components with porouscoated surface coating are indicated for either cemented oruncemented biological fixation applications.

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COMPARED TO THE PREDICATE

The new device is identical or similar in design, materials and intended use as the predicate device. Design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.

	Proposed Device	Predicate Device - K120121
Glenoid BaseplateMaterials	same	Titanium Alloy per ASTM F136Titanium Alloy plasma spray coatingper ASTM F1580Hydroxyapatite coating per ASTMF1185
Glenoid Baseplate SizeRange	Envelope of sizesM/L and A/P dimension ≥ 25mmvaried thickness 4.5mm to 50mm	Round25mm diametersingle thickness of 4.5mm
Manufacturing Process	Same	Machined from wrought Titaniumwith Plasma Spray and HA coating
Other Design Feature	Patient matched tray back3-10 peripheral screw holes toaccept locking and non-lockingscrewsMedial Boss with 6.5mm screw	Flat tray back4 peripheral screw holes to acceptboth locking and non-lockingscrewsMedial Boss with 6.5mm screw
Glenosphere attachment	same	Mini Taper, requires taper adapter
Other	Pre-assembled with F.A.S.T. GuideInserts

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PERFORMANCE DATA

Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence

Performance Test Summary-New Device

Compressed Shear Load to Failure Testing

Baseplate Fixation Testing

Axial Separation Testing

Torsional Separation Testing

Software Validation

Cadaver Validation

Summary of clinical tests conducted for determination of substantial equivalence and/or of clinical information

No clinical data submitted

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the device performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

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.”