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Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics' World Total Knee System and its cleared indications for use.

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions:

• · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• · Inflammatory degenerative joint disease including rheumatoid arthritis.
• · Functional deformity such as varus, valgus or flexion deformities.
• · Revision procedures where other treatments or devices have failed.
• · Fractures that are unmanageable using other techniques.

The Imboki Knee Instrument System is a simplified instrument set containing accessory devices that are intended to assist in the implantation of Signature Orthopaedics' previously cleared World Total Knee System (K180750).

The Imboki Knee Instrument System consists of manual orthopaedic surgical instruments which are either device-specific or non-device specific. The World Smart Card is a device-specific component which varies in geometry to match the specific dimensions of a particular sized World Knee component. It is a rectangular guide manufactured from acetal polymer as per ASTM F1855 which is assembled with the IM rod to assist with femoral alignment and distal resection. The Imboki Knee Instrument System also includes the same trial instruments as the World Knee previously cleared under 510(k) submission K180750 for the femoral, tibial and patella components. The non-device specific instruments are manufactured from 630 stainless steel as per ASTM A269 or 420 stainless steel as per ASTM F899. All instruments are supplied non-sterile.

The provided text is a 510(k) summary for the Imboki Knee Instrument System, which is an accessory device intended to assist in the implantation of a previously cleared knee system. It explicitly states that clinical data is not required to support the safety and effectiveness of the Imboki Knee Instrument System. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a primary therapeutic or diagnostic device.

The basis for clearance is substantial equivalence to a predicate device (Signature Orthopaedics' World Total Knee System instruments, K180750). The document argues that this new instrument system falls within the scope of validation and verification conducted on the previously cleared system.

Because clinical data was not required for this submission, the following sections will be largely empty or marked as "Not applicable" based on the provided text's explicit statement.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. Clinical test data was not required for this 510(k) submission. The device's substantial equivalence was based on its similarity to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Clinical test data was not required for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. Clinical test data was not required for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Imboki Knee Instrument System is a set of manual orthopedic surgical instruments, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

Not applicable. Clinical performance data or ground truth for diagnostic accuracy was not required for this submission. The "ground truth" used for clearance was the established safety and effectiveness of the predicate device, to which the new device was demonstrated as substantially equivalent.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set with established ground truth.

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The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following conditions:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• . Inflammatory degenerative joint disease including rheumatoid arthritis.
• . Functional deformity such as varus, valgus or flexion deformities.
• . Revision procedures where other treatments or devices have failed.
• . Fractures that are unmanageable using other techniques.

Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intended for cementless use by checking the package label.

The World Knee system is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and tibial baseplate components are manufactured from cast cobalt chromium alloy and are intended for use with or without bone cement. The cementless variants are additionally coated with cobalt chromium beads and hydroxyapatite. The cemented femoral components are also available as a symmetrical variant. The femoral component may be used with modular pegs. The modular femoral peg is manufactured from wrought cobalt chromium allov. The femoral component, meniscal inserts and all polyethylene tibias are available as postererior stabilized or cruciate retaining variants.

Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the all polyethylene tibia, meniscal insert and patella are manufactured from UHMWPE. The patella components are available in a spherical or non-symmetrical designs.

The provided text describes the regulatory clearance of the "World Total Knee System" by Signature Orthopaedics. This document is a 510(k) premarket notification letter from the FDA, and it focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study or standalone performance testing in the way an AI/software device would.

Therefore, the requested information components (1, 2, 3, 4, 5, 6, 7, 8, 9) regarding acceptance criteria, sample sizes, ground truth establishment, expert validation, and MRMC studies are not applicable to this type of device clearance document.

Instead, the document details:

• Non-clinical testing and engineering evaluations were conducted to verify performance. These included:

  • Range of motion analysis
  • Component contact area and stress testing
  • Porous coating characterization, shear strength, tensile strength, and shear fatigue testing

• The company claims substantial equivalence to several predicate devices based on:

  • Same intended use and indications for use.
  • Similar materials (cast cobalt chromium alloy, UHMWPE, hydroxyapatite, wrought cobalt chromium alloy).
  • Similar geometry for specific components (e.g., Symmetrical World Knee femur to Total Joint Orthopedics Klassic Knee System, World Knee All Poly Tibia to Smith & Nephew Genesis II Knee System's All Poly Tibia, World Knee patellas to Signature Orthopaedics World Knee System, Signature Orthopaedics Genius Knee System, and Smith & Nephew Genesis II Knee System's patellas).

In summary, this document is for a medical device (knee prosthesis) seeking 510(k) clearance, which relies on demonstrating substantial equivalence through non-clinical performance and material comparisons, not typically through clinical trials with acceptance criteria, ground truth, or expert review like a digital health or AI-driven device would.

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