The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.

Device Description

The Eclipse Total Ankle implant is intended for use in total ankle joint replacement arthroplasty. The system consists of various size range components to accommodate variations in human ankle anatomy. Materials: -Cobalt Chrome, per ASTM F75, with Titanium Plasma Spray Coating per ASTM 1580 (Tibia Plates / Talar components) -U.H.M.W.Pe., per ASTM 648-00 (Bearing) -Titanium Alloy per ASTM F-136 (Bone screws) Function: The Eclipse Total Ankle system functions as a replacement for the ankle joint.

AI/ML Overview

This document is a 510(k) premarket notification for the Eclipse Total Ankle Implant, a medical device for ankle joint replacement. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device, demonstrating its substantial equivalence to previously marketed devices.

Based on the provided text, there is no study described that establishes acceptance criteria or reports device performance against such criteria in the way typically expected for an AI/CADe device. This document is for a physical orthopedic implant seeking FDA clearance as a Class II device. The information provided focuses on demonstrating substantial equivalence to a predicate device (DePuy Agility Total Ankle Orthopedic Implant).

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI/CADe device. However, I can extract the general information pertinent to this 510(k) submission:

Interpretation for a traditional medical device (not AI/CADe):

In the context of traditional medical devices like the Eclipse Total Ankle Implant, "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity) against a ground truth as they would be for an AI algorithm. Instead, acceptance criteria are generally met by demonstrating:

Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing similar indications for use, technological characteristics (materials, basic mechanical features), and safety and effectiveness.
Compliance with Standards: The materials used (Cobalt Chrome, U.H.M.W.Pe., Titanium Alloy) are specified to meet ASTM standards, which are a form of acceptance criteria for material properties.
Intended Use and Contraindications: The clear definition of intended use and contraindications is part of establishing the device's safe application.

The "study" or justification for meeting these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence.

Specific answers based on the provided text, re-interpreting the questions for a physical implant:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (implicit for 510(k) of a physical implant):
  - Substantial Equivalence to legal predicate device.
  - Use of materials compliant with recognized standards (e.g., ASTM F75, ASTM 1580, ASTM 648-00, ASTM F-136).
  - Similar indications for use, technological characteristics, and safety/effectiveness profile as the predicate.
- Reported Device Performance: The document states, "There are no significant differences between the Eclipse Total Ankle Implant and other total ankle joint replacement systems currently being marketed which would adverselv affect the use of the product. The Eclipse Total Ankle Implant employs the same materials and basic mechanical features as the predicate, legally marketed device specified in section 3 (DePuy Agility total ankle arthroplasty system)." This statement is the "reported device performance" in the context of a 510(k) for substantial equivalence – meaning its performance is considered equivalent to the predicate. No specific performance data (e.g., durability, range of motion in patients) is provided in this summary.
Sample size used for the test set and the data provenance: Not applicable. This is not an AI/CADe device being tested on image data. The "test set" would implicitly refer to the device itself and its components as compared to the predicate. The document doesn't detail a clinical study with a patient sample size.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would generally relate to clinical outcomes, which are not detailed in this 510(k) summary. The "ground truth" for substantial equivalence is regulatory comparison.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication is described. The "adjudication" is essentially the FDA's review of the substantial equivalence claim.
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 not an AI/CADe device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/CADe device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a traditional orthopedic implant's 510(k), the "ground truth" for demonstrating safety and effectiveness implicitly relies on:
- Predicate Device History: The established safety and effectiveness of the predicate device (DePuy Agility Total Ankle Orthopedic Implant).
- Material Standards: Compliance with recognized ASTM material standards.
- Design Principles: Sound biomechanical and engineering principles, assumed to be similar to the predicate.
  No specific pathology or outcomes data from a prospective study for this specific device is presented in this document for clearance.
The sample size for the training set: Not applicable. This is not an AI/CADe device.
How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.

Summary

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APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS

For

Eclipse Total Ankle Implant

1. Submitter:	Contact Person:	NOV 22 2005
Kinetikos Medical, Inc.6005 Hidden Valley Rd. Suite 180Carlsbad, CA 92011	John G. SpampinatoV.P., Quality AssuranceKinetikos Medical, Inc.6005 Hidden Valley Road Suite 180Carlsbad, CA 92011

(760) 448 1706

FAX (760) 448 1739

Date Prepared: June 15, 2006

1. Proprietary Name: Eclipse Total Ankle Implant Common Name: Ankle Prosthesis Classification Name Ankle joint metal/polymer semi-constrained Regulatory Class: Cemented prosthesis; Class II, per 21 CFR 888.3110 Device Product Code: 87 HSN

3. Predicate or legally marketed devices which are substantially equivalent:

-Depuy Agility Total Ankle Orthopedic Implant (K020541) cleared May 20, 2002

4. Description of Device

Materials: -Cobalt Chrome, per ASTM F75, with Titanium Plasma Spray Coating per ASTM 1580 (Tibia Plates / Talar components) -U.H.M.W.Pe., per ASTM 648-00 (Bearing) -Titanium Alloy per ASTM F-136 (Bone screws)

Function: The Eclipse Total Ankle system functions as a replacement for the ankle joint.

5. Intended Use

The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients effected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement. The Eclipse Total Ankle replacement system is contraindicated for patients with:

-active sepsis or infection

-insufficient bone or osteonecrosis

-insufficient blood supply such that healing activity may be compromised -Charcot's neuropathy or other peripheral neuropathy

-age, weight or activity levels that introduce unnecessary risk of failure

-insufficient bone or musculature such that proper component positioning or alignment is not possible.

Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:

There are no significant differences between the Eclipse Total Ankle Implant and other total ankle joint replacement systems currently being marketed which would adverselv affect the use of the product. The Eclipse Total Ankle Implant employs the same materials and basic mechanical features as the predicate, legally marketed device specified in section 3 (DePuy Agility total ankle arthroplasty system).

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kinetikos Medical, Inc. % Mr. John G. Spampinato Vice President, Quality Assurance 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92011

NOV 2 2 2006

Re: K061749

Trade/Device Name: Eclipse Total Ankle Implant Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: October 30, 2006 Received: October 31, 2006

Dear Mr. Spampinato:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. John G. Spampinato

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buettner

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Eclipse Total Ankle

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Congurrence of CDRH, Office of Device Evaluation (ODE)

Oabare thulmp for msm,

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K061749

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.