A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

When used as a component of the Consensus Revision Knee System:

The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.

The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
C. Failed osteotomy or unicompartmental replacements.
D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
F. Moderate valgus, varus, or flexion deformities

Device Description

The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.

AI/ML Overview

This document describes the 510(k) premarket notification for the Consensus Orthopedics VitalitE Tibial Insert & Patellar Components. This is a medical device, and the evaluation for such devices often focuses on substantial equivalence to existing legally marketed predicate devices, rather than a direct clinical performance study that proves specific acceptance criteria for a new AI/software device.

Therefore, the requested information elements (especially those related to AI/software performance metrics like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and specific ground truth establishment methods) are not applicable in the context of this 510(k) submission for a physical medical implant.

However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text, reinterpreting some of your categories to fit the context of a physical implant's regulatory review.

Here's the breakdown:

Acceptance Criteria and Device Performance for Consensus Orthopedics VitalitE Tibial Insert & Patellar Components

The core "acceptance criteria" for this device, within the scope of a 510(k) submission, revolve around demonstrating substantial equivalence to existing predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on Substantial Equivalence)	Reported Device Performance/Evidence Provided
Design Equivalence: New device has the same design/form as predicate devices.	The VitalitE tibial insert "is the exact same design" as cleared for use with the Consensus Knee System (K932837, K953443 & K110950) and Consensus Revision Knee System (K100542). It is compatible with all metallic femoral and tibial components from those systems. The proprietary locking mechanism design on the underside remains unchanged.
Material Equivalence: New device uses materials that are either identical or demonstrably equivalent to predicate devices, especially regarding the key differentiating feature (Vitamin E).	The UHMWPE (GUR 1020) with α-tocopherol (Vitamin E) is the "same polymer" as cleared in K130652 for the Consensus VitalitE Acetabular Insert (with a slightly lower radiation dose). The use of Vitamin E infused UHMWPE tibial inserts for knee systems has been cleared for use in DJO/Encore systems via K091956 and K103223. The UHMWPE used in the current Consensus tibial inserts is GUR 1050 (implying the new GUR 1020 with Vitamin E is being compared for equivalence).
Performance Equivalence: The new device performs equivalently to predicate devices in critical functional aspects.	Non-Clinical Performance Data (Bench Testing): Included wear testing of the worst-case tibial insert. Included anterior disassembly testing of the locking mechanism (push-out testing) on a range of various sizes and types of inserts. The report states: "All of the observed results indicate that the VitalitE Tibial Inserts and Patellas are substantially equivalent to devices currently marketed." Biocompatibility Testing: Performed. Material Characterization: Performed.
Processing and Shelf-Life Equivalence: Manufacturing, packaging, and sterilization processes maintain equivalence.	The VitalitE inserts are "cleaned, packaged, and sterilized using the same validated processes as the current inserts." They will also have a "5 year shelf-life" (implicitly equivalent to or validated as acceptable for existing products).
Intended Use Equivalence: Indications for Use are consistent with predicate devices.	The "Indications for Use" statement (on page 5) lists specific primary intervention scenarios (rheumatoid arthritis, osteoarthritis, etc.), failed osteotomies, replacement of unsatisfactory components, and various deformities, which are standard for these types of knee systems and align with predicate devices.
Safety and Effectiveness: Overall safety and effectiveness is comparable to legally marketed predicates.	The FDA's final letter of substantial equivalence determination indicates that "the device is substantially equivalent... to legally marketed predicate devices." And the company states: "Therefore, the devices are as safe, as effective, and perform at least as safely and effectively as legally marketed predicates."

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

Sample Size for Test Set: Not specified in terms of specific number of units for each bench test. For physical implant testing, "worst-case" scenarios are typically selected rather than a large statistical sample of every size/type. The document mentions "a range of various sizes and types of inserts" for the disassembly testing.
Data Provenance: The data appears to be from internal bench testing and analysis conducted by Consensus Orthopedics, Inc. The document doesn't specify country of origin for the data, but the company is based in El Dorado Hills, CA, USA, implying the testing likely occurred in the US or at a certified lab. The data is retrospective in the sense that it was generated for this specific submission to demonstrate equivalence to already marketed devices.

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

Not applicable in the context of this 510(k) for a physical implant. "Ground truth" as a concept with expert consensus is typically used for AI/software devices where human interpretative judgment is being compared to an algorithm's output. For physical implants, "ground truth" is established through engineering and material science standards, validated testing methods, and regulatory requirements (e.g., ISO standards, ASTM standards, FDA guidance).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in human expert interpretations, especially in clinical image analysis for AI. For engineering bench testing, results are typically quantitative and compared against predefined pass/fail criteria or against control/predicate device performance.

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. MRMC studies are specific to evaluating inter-reader variability and the impact of AI assistance on human performance, primarily in imaging diagnostics. This submission is for a physical knee implant.

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

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

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

For physical implants demonstrating substantial equivalence, the "ground truth" is typically a combination of:
- Validated engineering standards: e.g., ASTM standards for mechanical properties and wear.
- Biocompatibility standards: demonstrating the material is safe for implantation.
- Performance of legally marketed predicate devices: The "known good" performance of existing devices serves as the benchmark.
- Material characterization: Chemical composition, physical properties, and manufacturing integrity are verified against specifications.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a 510(k) for a physical medical device. This concept is relevant for machine learning algorithms.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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K133919 Page 1 of 3

2014

2. 510(k) SUMMARY

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95762	JUL 1
510(k) Contact:	Matthew M. Hull, RACPhone: (916) 355-7156/ Fax: (916) 355-7190mhull@consensusortho.com
Date Prepared:	20 December 2013
Trade Name:	VitalitE Tibial Insert & Patellar Components
Common Name:	Total Knee Arthroplasty System
Classification Name:	Knee joint patellofemorotibial Polymer/metal/polymer semi-constrained cemented prosthesis is a Class 2 device per 21 CFR888.3560 (Product Code JWH/OIY)
	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis is a Class II device per 21 CFR888.3565 (Product Code MBH)

Device Description:

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

Indications for Use:

When used with the components of the Consensus Knee System:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

When used as a component of the Consensus Revision Knee System:

The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
C. Failed osteotomy or unicompartmental replacements.
D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
F. Moderate valgus, varus, or flexion deformities

Substantial Equivalence:

Technological Characteristics/ Substantial Equivalence:

The new VitalitE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & K110950 and also with the Consensus Revision Knee in K 100542 and is compatible with all of the metallic femoral and tibial components from those systems. The UHMWPE (GUR 1020) with a-tocopherol is the same polymer as that cleared in K 130652 for the Consensus VitalitE Acetabular Insert with the exception of the slightly lower radiation dose. The use of Vitamin E infused UHMWPE tibial insert for knee systems has been cleared for use in DJO/ Encore systems via K091956 and K103223. The UHMWPE used in the current

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

K133919

Page 3 of 3

Consensus tibial inserts is GUR 1050. The VitalitE inserts are cleaned, packaged, and sterilized using the same validated processes as the current inserts and will also have a 5 year shelf-life.

Non-Clinical Performance Data:

Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new insert material included wear testing of the worst case tibial insert, and anterior disassembly testing of the locking mechanism (push-out testing) on a range of various sizes and types of inserts.

All of the observed results indicate that the VitalitE Tibial Inserts and Patellas are substantially equivalent to devices currently marketed. Therefore, the devices are as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a black and white picture of the address.

July 14, 2014

Consensus Orthopedics, Incorporated Mr. Matthew M. Hull QS & RA Director 1115 Windfield Way, Suite 100 El Dorado Hills. California 95762

Re: K133919

Trade/Device Name: VitalitE Tibial Inserts & Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: June 10, 2014 Received: June 12, 2014

Dear Mr. Hull:

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

{4}------------------------------------------------

Page 2 - Mr. Matthew M. Hull - .

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

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

Enclosure

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1. INDICATIONS FOR USE STATEMENT

510(k) Number: K133919

Device Name: VitalitE Tibial Inserts & Patellar Components

Indications for Use:

When used with the components of the Consensus Knee System:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of theumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

When used as a component of the Consensus Revision Knee System:

The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or B. prior patellectomy )
C. Failed osteotomy or unicompartmental replacements.
D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized u at the time of surgery
Moderate valgus, varus, or flexion deformities F.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1/1

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.