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Total and partial hip replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint diseasc including osteoarthritis and avascular necrosis of the . natural femoral head;
• . rheumatoid arthritis;
• . correction of functional deformity;
• femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts.

The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.

The modification consists of use of a ceramic femoral head with the hip stem. The material used in the ceramic femoral head is the same as other legally marketed predicate devices.

. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.

The provided document is a 510(k) premarket notification for a medical device manufacturer seeking clearance to market a modified hip stem product. It describes the device, its intended use, predicate devices, and the FDA's clearance letter. However, this document does not contain information related to acceptance criteria, device performance metrics, or a study proving that a device meets such criteria as would be expected for an AI/ML-based medical device.

The product in question is a ceramic femoral head used in conjunction with existing hip stems (Vitality, Keystone, Alfa II, R120, R120PC). The clearance is based on substantial equivalence to predicate devices, and the manufacturer explicitly states "Clinical Testing: None provided." The type of testing performed was "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions."

Therefore, I cannot provide the requested information. The document focuses on mechanical properties and material compatibility, not on the performance metrics of an AI/ML system.

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The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Zirconia ceramic heads for use with Foundation® Forged (K952191), Textured (K935263) and Porous Stems (K952297), the Encore® Vitality™ Stem (K962560) and the SL and SLR PLUS (K932481) Hip Stems which have been cleared for commercial distribution.

This document is a 510(k) premarket notification for a medical device: Zirconia ceramic femoral heads for use with specific hip stems. The content is primarily a summary of safety and effectiveness used to demonstrate substantial equivalence to predicate devices, rather than a detailed study report with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth cannot be fully extracted from the provided text. The document focuses on demonstrating that the new Zirconia ceramic heads are comparable in material, design, and clinical indications to existing, cleared devices.

Based on the provided text, the following information can be stated:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The filing is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with detailed performance metrics.
• Sample Size Used for the Test Set and Data Provenance: Not applicable. This document is not a report of a clinical trial or a test set evaluation. It's a regulatory submission demonstrating equivalence.
• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable. This document does not describe a ground truth establishment process for a test set.
• Adjudication Method for the Test Set: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (femoral head), not an algorithm or AI system.
• The type of ground truth used: Not applicable in the context of an AI/algorithm. For a physical device, "ground truth" would relate to material properties, wear performance, or clinical outcomes, which are not detailed as a "ground truth" for a specific test set in this document. The "truth" in this context is established through a body of evidence including material testing and comparable clinical performance of predicate devices.
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Summary of the document's relevance to the request:

The document outlines an intention to market Zirconia ceramic heads for hip replacement prostheses. The core of the submission is to establish substantial equivalence to predicate devices. This means that instead of presenting a new study with explicit acceptance criteria for performance, the submission argues that the device is "equivalent in material, design and clinical indications" to already cleared devices. This equivalency is the "proof" that the device meets regulatory requirements.

The predicate devices mentioned are Zirconia heads manufactured by Demarquest for Zimmer (K944601), DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). The "acceptance criteria" are effectively that the new device performs sufficiently similar to these cleared predicate devices according to established material and design standards for hip prostheses.

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