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The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

The DePuy Sigma Femoral Adapters are a modification to the previously cleared DePuy PFC Sigma Femoral Adapters included in K040281. The devices consist of a selection of adapters and bolts that attach to Sigma TC3 and C/S femoral components' intracondylar boxes. When assembled to a femoral component, they provide a construct for the attachment of additional fixation extensions such as metaphyseal sleeves or cemented and fluted stem extensions. The Sigma Femoral Adapters are available in five and neveous degree valgus angle options and +2 mm, 0 mm, and -- 2 mm anterior/posterior offset options.

This document describes a 510(k) premarket notification for a medical device called the "DePuy Sigma Knee Prosthesis Femoral Adapter." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics (like those for AI/standalone algorithms) is not applicable to this type of regulatory submission.

Here's why and what information is provided:

• 510(k) Premarket Notification: This regulatory pathway focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.
• Basis for Substantial Equivalence (as described in the document):
  • Design Similarity: The design of the PFC Sigma Knee Prosthesis Femoral Adapter is stated to be "substantially equivalent" to two predicate devices: the LPS Metaphyseal Sleeve (K040281) and the Darwin Knee System (TC3) (K952830).
  • Material Identity: The materials used for the subject device components are identical to those of the predicate devices.
  • Attachment Mechanism: The attachment mechanism incorporates similar adapter, retaining ring, and bolt components.
  • Offset Options: The available offset options (+2mm anterior, neutral, -2mm posterior) are the same as the predicate devices.
  • Valgus Angle Options: While both the PFC Sigma and Darwin Knee systems offer 5 and 7-degree valgus angle components, the LPS system offers only a 5-degree component. This difference is deemed acceptable within the substantial equivalence framework.
  • Mechanical Testing: The document mentions "results from the mechanical testing of the PFC Sigma Femoral Adapter" as a basis for substantial equivalence. However, no specific performance metrics or acceptance criteria for this testing are provided in the excerpt. It's implied that these tests demonstrated the new device performed equivalently or acceptably compared to the predicate, likely according to industry standards for mechanical properties of knee implants.

In summary, the provided document does not contain the information requested in points 1-9 because it is a 510(k) submission focused on substantial equivalence rather than a study designed to meet specific performance acceptance criteria for a novel device or AI algorithm.

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