The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis or correction of posttraumatic joint deformity
Where the use of a more conservative procedure has failed or is unacceptable.
All components are for cemented use.
Additional indications for use:
Whenever a cone is used, a revision stem is to be used as well.

Device Description

The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed.
The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee.
The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays.
The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone.
The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively.
The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation.
The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

AI/ML Overview

Here's an analysis of the provided text regarding the Symmetric™ Total Knee Augments and its associated study, structured according to your requested points:

The provided text describes a 510(k) premarket notification for the Symmetric™ Total Knee Augments, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than directly proving the device meets an explicit set of acceptance criteria through a specific performance study in the way a diagnostic AI might. The "performance" here refers to the physical and material characteristics of the implants and their intended use.

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

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI or diagnostic devices (e.g., sensitivity, specificity, accuracy thresholds) is not directly applicable here. This document is a 510(k) summary for a medical implant, which demonstrates substantial equivalence to existing devices rather than meeting a specific performance metric against a gold standard in a clinical study.

Instead, the "acceptance criteria" are implied by the similarities to predicate devices and the successful completion of non-clinical (mechanical) testing as outlined to the FDA for regulatory clearance. The "device performance" is therefore the demonstration of these similarities and the satisfactory results of the engineering tests.

Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (Symmetric Total Knee Augments)
Intended Use: Cemented application in total knee arthroplasty for osteoarthritis, rheumatoid arthritis, traumatic arthritis, or post-traumatic deformity where conservative methods failed. Whenever a cone is used, a revision stem is also used.	Meets: Same intended use as predicate devices. All components for cemented use.
Material Composition (e.g., Femoral Wedges): Titanium 6Al-4V, Titanium Plasma Spray coating.	Meets: Titanium 6Al-4V, Titanium Plasma Spray (ASTM F1580) for coatings.
Fixation Method (e.g., Femoral Wedges): Cemented to implant.	Meets: Cemented to implant.
Dimensional Characteristics (e.g., Femoral Wedges Thickness): Similar to predicate devices (e.g., 5-10mm posterior, 5-15mm distal).	Meets: Thickness characteristics are comparable to predicate devices.
Mechanical Performance: Withstand compressive fatigue, static, and torsional loads; proper assembly/disassembly.	Meets: Non-clinical testing included compressive fatigue and static testing, torsional testing, and assembly/disassembly testing of the offset trunnion with a tray and stem. Results stated to be "substantially equivalent to or better than those of at least one predicate device."
Compliance with Material Standards: ASTM F1472 (Titanium), ASTM F1580 (Plasma Spray Coating).	Meets: All components listed comply with ASTM F1472 and ASTM F1580 where applicable.

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

Test Set Sample Size: Not applicable in the context of a clinical test set as for diagnostic devices. The "testing" refers to mechanical and material characterization. The document does not specify sample sizes (e.g., how many wedges were fatigue-tested) but refers to "a writeup of the testing completed for this 510(k) is included in Section 18."
Data Provenance: The testing is non-clinical, likely conducted in a laboratory setting, not geographically specific patient data.

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 device is a mechanical implant. Ground truth is established through engineering design specifications, material standards (ASTM), and mechanical testing protocols, not expert consensus on medical images or patient outcomes.

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 establishing ground truth in clinical or diagnostic studies. This is a non-clinical, engineering-focused submission.

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 a knee implant, not an AI or diagnostic tool that assists human readers.

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

Not applicable. This is a knee implant.

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

The "ground truth" for this type of device is material specifications (ASTM standards), engineering design principles, and mechanical test results that demonstrate structural integrity and performance equivalent to or better than predicate devices. There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data) for this 510(k) process as "No clinical data was utilized for the basis of substantial equivalence."

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI or machine learning model.

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

Not applicable. This device does not involve a training set.

Summary

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SIGNAL MEDICAL CORPORATION

Image /page/0/Picture/1 description: The image shows a series of maritime signal flags, each corresponding to a letter of the alphabet. Below each flag is the corresponding letter, spelling out the word "ORTHOPAEDICS". The flags are arranged in a horizontal row, with each flag enclosed in a square frame. The letters are printed in a simple, sans-serif font.

Section 5:

1. Submitted by:
  Submitter's Name Address:

Establishment Registration#: Correspondent: Date:

2. Device Name:

Trade Name: Proprietary Name: Common Name: Classification Name:

3. Device Class

Regulatory Class: Product Code: Panel: Regulation Number:

4. Predicate Device:

510(k) Summary 21 CFR 807.92

Signal Medical Corporation 1000 Des Peres Road, Suite 140 St. Louis, MO 63131 P: 314-775-0518 F: 314-775-0524 1932213 Brian Katerberg; Leo Whiteside, MD; Louis Serafin, MD March 4, 2011

Symmetric™ Total Knee Augments Signal Medical Corp. Symmetric™ Total Knee Augments Knee Prosthesis - Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, metal/polymer (888.3560 - JWH)

Class II JWH Orthopedic 21 CFR 888.3560

SymmetricTM Total Knee System (K080199), Revision Knee System (K043440), Regenerex Ultra Porous Construct - Titanium Knee Augments (K053505), Regenerex Porous Titanium Sleeve Augments (K072336), Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments (K053340), Genesis II Total Knee System (K953274) Similarities to these components are based on design, indications for use, and materials.

MAR - 7 2011

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Category	Symmetric TotalKnee Augments	Symmetric TotalKnee System	Smith & NephewRevision KneeSystem	Regenerex™ UltraPorous Construct -Titanium KneeAugments	Regenerex™Porous TitaniumSleeve Augments	Trabecular Metal™Tibial and FemoralCone Augments	Genesis II TotalKnee System
510K #	K100370	K080199	K043440	K053505	K072336	K053340	K953274
Intended Use	Cemented	Cemented	Cemented	Cemented/less	Cemented/less	Cemented/less	Cemented
Femoral wedges	Thickness	5-10mm posterior,5-15mm distal	NA	Similar	Similar	NA	NA	NA
	Fixation Method	Cemented to implant	NA	Cemented to implant	Cemented or screwedto implant	Cemented or screwedto implant	NA	NA
	Material	Titanium 6Al-4V	NA	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V	NA	NA
	Coating	Titanium PlasmaSpray ASTM F1580	NA	NA	Regenerex™Titanium PorousCoating ASTM F1580	Regenerex™Titanium PorousCoating ASTM F1580	NA	NA
Femoral wedges	Thickness	5-10mm posterior,5-15mm distal	NA	Similar	Similar	NA	NA	NA
	Fixation Method	Cemented to implant	NA	Cemented to implant	Cemented or screwedto implant	Cemented or screwedto implant	NA	NA
	Material	Titanium 6Al-4V	NA	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V	NA	NA
	Coating	Titanium PlasmaSpray ASTM F1580	NA	NA	Regenerex™Titanium PorousCoating ASTM F1580	Regenerex™Titanium PorousCoating ASTM F1580	NA	NA
Femoral Cone	ML Width	47-77mm	NA	NA	NA	NA	Similar	NA
	Height	28-46mm	NA	NA	NA	NA	Similar	NA
	Fixation Method	Cemented ontofemoral component	NA	NA	NA	NA	Cemented ontofemoral componentRegenerex™	NA
	Material	Titanium 6Al-4V	NA	NA	NA	NA	Tantalum TrabecularMetal™	NA
	Coating	Titanium PlasmaSpray ASTM F1580	NA	NA	NA	NA	Regenerex™Titanium PlasmaSpray ASTM F1580	NA
Tibial Cone	ML Width	45-70mm	NA	NA	NA	NA	Similar	NA
	Height	18-30mm	NA	NA	NA	NA	Similar	NA
	Fixation Method	Cemented onto tibialcomponent	NA	NA	NA	NA	Cemented onto tibialcomponentRegenerex™	NA
	Material	Titanium 6Al-4V	NA	NA	NA	NA	Tantalum TrabecularMetal™	NA
	Coating	Titanium PlasmaSpray ASTM F1580	NA	NA	NA	NA	Regenerex™Titanium PlasmaSpray ASTM F1580	NA
Trunnion	Offset Distance	4mm	NA	NA	NA	NA	NA	NA
	Extension Length	50mm	NA	NA	NA	NA	NA	NA
	Fixation Method	Morse Taper	NA	NA	NA	NA	NA	NA
	Material	Titanium 6Al-4V	NA	NA	NA	NA	NA	NA
	Length	100, 150, 200mm	NA	NA	NA	NA	NA	NA
Stems	Diameter	10 through 26mm	NA	NA	NA	NA	Similar	NA
	Fixation Method	Morse Taper	NA	NA	NA	NA	Similar	NA
	Material	Titanium 6Al-4V	NA	NA	NA	NA	Morse TaperTitanium 6Al-4V	NA

Sec 5: Page 2 of 4

3/4/11

K100370

K100370 #²/₄

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5. Device Description:

The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee.

The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays.

The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone.

The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively.

The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation.

The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

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KVO0320 *Mly

6. Device Intended Use:

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
1. Rheumatoid Arthritis
1. Traumatic Arthritis or correction of posttraumatic joint deformity
Where the use of a more conservative procedure has failed or is unacceptable. 4.

All components are for cemented use.

Additional indications for use:

Whenever a cone is used, a revision stem is to be used as well. .

Material Characteristics:

COMPONENT	CLEARED DEVICE	NEW DEVICE
Femoral Wedges	ASTM F1472	ASTM F1472
Tibial Wedges	ASTM F1472	ASTM F1472
Femoral and Tibial Cones	ASTM F1472	ASTM F1472
Offset Trunnion	ASTM F1472	ASTM F1472
(Partially) Coated Stems	ASTM F1472	ASTM F1472
Rectangular Revision Stems	ASTM F1472	ASTM F1472
Plasma Spray Coating	ASTM F1580	ASTM F1580

7. Performance Summary:

Non-Clinical Testing:

A writeup of the testing completed for this 510(k) is included in Section 18. Testing included compressive fatigue and static testing, torsional testing, and assembly/disassembly testing of the offset trunnion with a tray and stem.

Clinical Testing:

No clinical data was utilized for the basis of substantial equivalence.

Conclusions:

Based on the Symmetric Total Knee System having the same intended use, the results of the non-clinical tests being substantially equivalent to or better than those of at least one predicate device, and the indications for use being similar, we feel that there are no new questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is black and white.

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

Signal Medical Corporation % Mr. Brian Katerberg Engineer 1000 Des Peres Road, Suite 140 Saint Louis, Missouri 63131

MAR - 7 2011

Re: K100370

Trade/Device Name: 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 Dated: February 25, 2011 Received: March 2, 2011

Dear Mr. Katerberg:

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 r reade or actived 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 or uny I vithe Act's requirements, including, but not limited to: registration and listing (21

{5}------------------------------------------------

Page 2 - Mr. Brian Katerberg

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

AZ. B. R.L.
fer

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

Enclosure

{6}------------------------------------------------

Section 4:

Indications for Use

510K Number: K100370

Device Name: SymmetricTM Total Knee Augments

Indications For Use:

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
1. Rheumatoid Arthritis
1. Traumatic Arthritis or correction of posttraumatic joint deformity
1. Where the use of a more conservative procedure has failed or is unacceptable.

All components are for cemented use.

Additional indications for use:

Whenever a cone is used, a revision stem is to be used as well. .
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for m melkerson

(Division Sign-Off) (Division Sign-of Surgical, Orthopedic, Division of Restorative Devices

K100370

510(k) Number

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.