When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: - Degenerative arthritis in the distal femur and patella; . - A history of patellar dislocation or fracture; . - Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis; - Post-traumatic loss of knee joint confiquration and function: . - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability; - Revisions of previous unsuccessful knee replacement or other procedure. . Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint: . - Absent or non-functioning posterior cruciate ligament. . The patella components are single use only and intended for implantation with bone cement.

Device Description

The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE with pegs on the non-articulating surface. The surgeon uses the components to resurface the patella during either a patella-femoral replacement or a total knee replacement. The device is designed for cemented fixation only.

AI/ML Overview

The provided text describes a Premarket Notification Submission (510(k)) for the Cardo Medical Align 360® Medialized Patella Component. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity for diagnostic imaging devices).

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, and intended use, and by confirming that the device meets general guidance documents for knee implants. The "tests" mentioned are likely mechanical or biocompatibility tests, rather than clinical performance studies.

Therefore, the following information is derived from the context of a 510(k) submission for a medical implant, where "acceptance criteria" and "study" typically refer to adherence to established standards and comparison to predicate devices, rather than a clinical trial with performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in Design: Same articulating surface	"The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE have the same articulating surface as the current dome patella." (The only difference is additional material around the edge of the dome.)
Equivalence in Material: Manufactured from UHMWPE	"The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE..."
Equivalence in Intended Use: Resurfacing patella	Intended for cemented use in resurfacing the patella during patellofemoral disease or total knee replacement. (Same as predicate)
Compliance with FDA Guidance:	"Testing has shown that the proposed device meets the requirements of the current FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
Safety and Effectiveness: No negative impact from differences	"Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the Align 360° Medialized patella components for their intended use."
Equivalency to Predicate Device for all performed testing.	"Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed." (Specific test results not provided, but claims equivalence.)

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

Sample Size for Test Set: Not explicitly stated. The description mentions "tests were performed" and "testing has shown," which typically refers to mechanical and material testing rather than a patient-based test set or clinical trial. Hence, "sample size" in a clinical sense is not applicable here.
Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a medical device implant, the data would typically come from in-house mechanical testing or accredited laboratory testing on device prototypes/units. It would not typically involve patient data unless a clinical trial was specifically required, which is not indicated here for substantial equivalence.

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

Not applicable. This submission is for a medical implant and relies on mechanical and material testing, as well as comparison to predicate devices and adherence to regulatory guidance. It does not involve a diagnostic test where expert-established ground truth is required.

4. Adjudication method for the test set:

Not applicable. This concept relates to studies where multiple readers or experts assess cases to establish a ground truth or resolve discrepancies. This submission pertains to device design, material, and mechanical performance, not diagnostic interpretations.

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 medical implant (patella component for knee replacement), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. As mentioned, this device is a physical implant, not an algorithm or software.

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

For the equivalence claim, the "ground truth" is the performance and characteristics of the legally marketed predicate devices (Cardo Medical Dome Patella, Scorpio Knee System) and the requirements outlined in the FDA Guidance document. The device aims to demonstrate it is "substantially equivalent" to these established benchmarks.
For the mechanical/material testing, the ground truth would be engineering specifications, material science standards, and performance metrics defined by relevant ISO standards or FDA guidance for knee implants.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device implant and does not involve machine learning or AI, and thus no "training set" in that context.

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

Not applicable. (See #8)

Summary

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Cardo Medical Align 360 Medialized Patella Component Premarket Notification Submission - 510(k)

Submitter:	Dave LambCardo Medical Corporation10 Clifton Blvd., Suite B1Clifton, NJ 07011	Summary of Safety and EffectivenessDEC 2 3 2009
Date Prepared:	November 18, 2009
Device:	Cardo Medical Align 360® Medialized Patella Component
Classification:	87KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented,21CFR 880.3540, Class II; and 87JWH Prosthesis, knee, patellofemorotibial,semi-constrained cemented polymer/metal/polymer, 21 CFR 888.3560, Class II.
Predicate Device:	Cardo Medical Dome Patella - K073120 (used with patellofemoral joint), CardoMedical Dome Patella - K081127 (used with Total Knee System), and ScorpioKnee System - K962152 and K972967.
Device Description:	The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPEwith pegs on the non-articulating surface. The surgeon uses the components toresurface the patella during either a patella-femoral replacement or a total kneereplacement. The device is designed for cemented fixation only.
Intended Use:	The Cardo Medical Align 360® Medialized Patella Component is intended for cementeduse in resurfacing the patella during patellofemoral disease or during total kneereplacement. Patient's with patellofemoral disease may have Degenerative arthritis in thedistal femur and patella; a history of patellar dislocation or fracture; or failed previoussurgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity ordysfunction persists; whereas patients obtaining a total knee arthroplasty may havepainful, disabling joint disease of the knee resulting from degenerative arthritis,rheumatoid arthritis, or post-traumatic arthritis; post-traumatic loss of knee jointconfiguration and function; moderate varus, valgus or flexion deformity in which theligamentous structures can be returned to adequate function and stability; or revisions ofprevious unsuccessful knee replacement or other procedure. Additional indications forposteriorly stabilized components include ligamentous instability requiring implant bearingsurfaces with increased constraint; or absent or non-functioning posterior cruciateligament

Comparison to Predicates:

The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE have the same articulating surface as the current dome patella. The only difference is the additional material around the edge of the dome. Therefore, the devices are equivalent to the current Cardo Medical Dome Patella. In addition the Stryker, Scorpio Knee System has an oval patella component, which is a similar shape to the Cardo Medialized Patella proposed in this submission.

Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the Align 360° Medialized patella components for their intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.

Synopsis of Test Methods and Results:

Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 3 2009

Cardo Medical Corporation % Mr. David Lamb 10 Clifton Boulevard, Suite B1 Clifton, New Jersey 07011

Re: K092803

Trade/Device Name: Cardo Medical Align 360® Medialized Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, KRR Dated: December 7, 2009

Received: December 14, 2009

Dear Mr. Lamb:

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.

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 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.

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Page 2 - Mr. David Lamb

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/CDRH/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.fdai.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

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

Enclosure

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Indications for Use Form

510(k) Number (if known):	K042803
---------------------------	---------

Device Name: Cardo Medical Align 3600 Medialized Patella

Indications for Use:

When used with the Patello-femoral System:

The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with:

Degenerative arthritis in the distal femur and patella; .
A history of patellar dislocation or fracture; .
Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists.

When used with the Total Knee System:

The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of:

Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis;
Post-traumatic loss of knee joint confiquration and function: .
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
Revisions of previous unsuccessful knee replacement or other procedure. .

Additional indications for posteriorly stabilized components:

Ligamentous instability requiring implant bearing surfaces with increased constraint: .
Absent or non-functioning posterior cruciate ligament. .

The patella components are single use only and intended for implantation with bone cement.

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

(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) Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092803

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.