ECLIPSE TOTAL ANKLE IMPLANT

• K Number: K061749
• Device Name: ECLIPSE TOTAL ANKLE IMPLANT
• Manufacturer: KINETIKOS MEDICAL, INC.
• Date Cleared: 2006-11-22 ( 154 days)
• Product Code: HSN
• Regulation Number: 888.3110
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K020541

Intended Use

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:

1. 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.

2. 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.

3. 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.

4. 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.

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 not an AI/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/CADe device.

7. 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.

8. The sample size for the training set: Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.

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.