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The LINK GEMINI SL Total Knee System is indicated for patients suffering from disability due to:

• · Degenerative, post-traumatic or rheumatoid arthritis;
• · Avascular necrosis of the femoral condyle;
  · Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
  · Moderate valgus, varus or flexion deformities.
  This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented use. Only cementless labeled modular stems are indicated for uncemented use

The SPAR-K instruments are a line extension to the instrument system cleared in 510(k) #K182872 with the Gemini SL Total Knee System. The SPAR-K instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the Gemini SL Total Knee System (K182872). The SPAR-K Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique. Both the original and modified (SPAR-K) instruments accommodate tibia first or femur first workflows according to surgeon preference. The modifications do not change the intended use, or involve any change in technology. The Class II accessory instruments within the SPAR-K Instrument system that are the subjects of this 510(k) are the femoral, tibial, and patellar resection guides.

The provided text is a 510(k) premarket notification for the SPAR-K Instruments, which are accessory instruments for the LINK GEMINI SL Total Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with novel AI/ML device approvals.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance (i.e., algorithm only without human-in-the-loop performance).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the submission focuses on comparing the design and features of the SPAR-K Instruments to their predicate device (LINK GEMINI SL Total Knee System Gemini SL Instruments, 510(k) #K182872).

Key information from the document related to substantial equivalence:

• Device Description: The SPAR-K instruments are a line extension to the instrument system cleared in 510(k) #K182872. They are manual orthopedic surgical reusable instruments designed to aid the implantation of the Gemini SL Total Knee System.
• Modifications: The SPAR-K Instruments incorporate design changes for simplicity of use. These modifications "do not significantly alter the surgical workflow or technique." They accommodate both tibia-first or femur-first workflows. The specific accessory instruments subject to this 510(k) are the femoral, tibial, and patellar resection guides.
• Technological Characteristics and Substantial Equivalence Justification: The modified instruments have the "same intended use, operating principle, basic device designs and purposes, and materials as the unmodified instruments." The modified cutting guides "create the same bone cuts, but feature minor design changes for simplicity and ease of use."
• Study Data: "Non-clinical and clinical performance testing were not required to demonstrate substantial equivalence."

In summary, the document states that the device meets the acceptance criteria for substantial equivalence because its design changes are minor, do not alter the intended use or fundamental technology, and non-clinical/clinical testing was deemed unnecessary for this demonstration.

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