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The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of 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. It is intended to be used in a cementless mode.

The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.

The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.

This document is a 510(k) premarket notification for a medical device, the Foundation® Porous Hip Stem - Size 8mm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a diagnostic AI study would.

The provided text describes a submission for a hip stem prosthesis, which is a physical implant, not a diagnostic AI device. Therefore, a study focused on typical AI performance metrics like sensitivity, specificity, or reader improvement is not relevant to this type of medical device submission.

Instead, the "Test Results" section states: "Testing on this device included finite element analysis." This indicates that the evaluations done for this device likely focused on:

• Biocompatibility: Ensuring the materials are safe for implantation in the human body.
• Mechanical Strength and Durability: Assessing how well the implant can withstand the stresses of walking, running, and other activities over time. Finite Element Analysis (FEA) is a common method for this.
• Sterility: Verifying that the device is free from harmful microorganisms.
• Design Validation and Verification: Ensuring the device meets its design specifications and performs as intended.

Without a detailed engineering report or design validation plan, specific acceptance criteria for a hip stem (e.g., minimum fatigue life cycles, maximum stress under load, acceptable wear rates) and the explicit results proving these are met cannot be extracted from this summary.

Therefore, I cannot fulfill the request as it pertains to AI-specific acceptance criteria and studies. The document describes a traditional medical device (hip implant) submission, not an AI/ML device.

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The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of 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. It is intended to be used in a cementless mode.

The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.

The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.

The provided document is a 510(k) submission for a medical device (Foundation® Porous Hip Stem) to the FDA. It does not contain any information regarding acceptance criteria, device performance measures, or study details typically found in a clinical or performance evaluation for an AI/ML medical device.

The document focuses on:

• Device Description: Materials, porous coating, availability with/without calcar collar, and modular heads.
• Intended Use: Specific conditions for total hip arthroplasty (degenerative joint disease, rheumatoid arthritis, correction of deformity, revision procedures, fractures).
• Comparable Features to Predicate Devices: Geometry, material, and indications are the same.
• Test Results (mentioned briefly): "fatigue testing on the Morse type taper." This is a mechanical engineering test, not a study involving human subjects or AI performance.
• FDA Correspondence: Substantial equivalence determination, regulatory class, and general compliance information.

Therefore, I cannot provide the requested information based on the given text. The questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set information are not applicable to the content of this 510(k) submission. This document pertains to a traditional orthopedic implant, not an AI-powered device.

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