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The Instruments for LINK® MEGASYSTEM-C® Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:

The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.

The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:

1. Revision for loosened femoral prosthesis components involving extensive bone loss;
2. Surgical intervention for severe trauma;
3. Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;

The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.

For the use of the LINK® Endo-Model® SL® Rotating Hinge Knee System additional indications should be noted:

1. Bone necroses.
2. Bicondylar arthrosis by partly damaged collateral ligaments.
3. Revision surgery after primary total knee replacement.
4. Revision surgery after rotating or non-rotating hinged knee replacement.
5. Revision surgery by insufficient / inadequate bone mass.
6. Arthrosis of patella flange.
7. Valgus/Varus deformities

The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187).

This is a duplicate 510k and line extension in Link Bio Corp.'s name for the accessory instrument system previously cleared in K151008 by Waldemar Link GmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). It includes the same instruments as in K151008, and additional accessory instruments (line extension).

The provided text describes a 510(k) premarket notification for surgical instruments used in knee and hip replacement (Trade/Device Name: Instruments for LINK® MEGASYSTEM-C® Family). This submission is a duplicate 510(k) and line extension for accessory instruments previously cleared under K151008.

Based on the provided document, the device in question is a set of manual reusable surgical instruments, not an AI/ML-driven device or a device that generates diagnostic data that would typically have acceptance criteria related to sensitivity, specificity, or similar performance metrics. The document explicitly states:

"Extensive performance testing was provided in K151008 for the implant system, but is not required for the accessory instruments."

And regarding technological characteristics:

"The accessory instruments presented in K151008 are exactly replicated in this duplicate 510k. Additional reusable manual surgical instruments included as a line extension are for the same purpose (to support implantation of the same Waldemar Link GmbH implant systems) as the existing instrument system, with no significant differences in technological features, materials, or intended use."

Therefore, the following information cannot be extracted from this document as it pertains to AI/ML or data-driven diagnostic devices, which this product is not:

• Acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a predicate device (K151008) based on the instruments being identical or having minor design modifications that do not change their intended use or function. No "study" in the sense of a clinical trial or performance evaluation against specific diagnostic metrics is mentioned for these instruments.

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