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The Orthopedic Source Hip Stem is intended for treating 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 non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.

Indications for Use:

• 1. noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;
• 4. revision procedures where other treatments or devices have failed; and,
• 5. treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This implant is intended for cementless use.

The Orthopedic Source stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is a collarless flat wedge-shaped implant that provides excellent durability and stability in a design that is relatively simple and predictable to implant. The use of a collarless designity the Orthopedic Source hip tends to allow for self seating of the implant and achievement of optimal rotational stability, immediately after implantation. The incorporation of standard and lateralized offset options provides the surgeon the ability to reconstruct a stable joint with proper leg length in virtually all patient anatomies. The Orthopedic Source Stem has a 135° rack shaft angle and a standard 12/14 Morse type taper is incorporated in to the geometry to receive modular heads. The proximal body is circumferentially coated with commercially pure titanium plasma spray. Femoral heads are manufactured from wrought CoCrMo alloy conforming to ASTM F799 and are available in 22m, 28mm and 32mm diameters and multiple neck lengths.

This document is a 510(k) summary for a premarket notification for a hip implant, specifically the Orthopedic Source Press-fit Hip. This is a medical device approval for a physical product and not a software device, therefore, the requested information about acceptance criteria and studies (test set, ground truth, expert involvement, etc.) is not applicable in the context of AI/software performance.

The document describes the device, its intended use, and compares its technological characteristics to a predicate device (Taperloc Hip). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified.

The "testing" mentioned in this document is in the context of mechanical engineering analysis for the hip implant's strength and durability, not for a software algorithm's performance.

Therefore, I cannot populate the table or provide details on the study types (MRMC, standalone), sample sizes for test/training sets, or methods for establishing ground truth, as these concepts are relevant to software/AI device evaluation and not to the mechanical device described in this 510(k) summary.

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Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:

1. Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
2. Inflammatory degenerative joint disease including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head Involvement that are unmanageable using other techniques.

The Avalon cup is manufactured from Titanium 6AL 4V Eli (ASTM F136). The Avalon Cup is porous coated with commercial pure (CP) titanium sintered beads (ASTM F67) to promote fixation. The Avalon Cup is a low profile cup available in three versions: [No-hole], [Three hole], and a [Multi-hole]. The holes are to allow for added fixation with bone screws. The Avalon Cup's outer geometry consists of a 14° flared rim and 8 external cutouts, which are machined into the peripheral exterior of the cup.

The provided document, K022711 for the Avalon Cup System, is a 510(k) premarket notification for an orthopedic implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, a dedicated study proving performance against those criteria, or an AI/algorithm-related evaluation.

The document states:

"The proposed device modification has been tested and meets and exceeds the requirements provided in the Draft Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement."

and

"The Avalon Acetabular cup system demonstrated adequate performance in design control activities."

However, it does not provide the acceptance criteria, the specific study results, or any of the detailed information about sample size, ground truth, expert involvement, or AI performance as requested. The "modification" is a "line extension" to add a sintered beaded coated option, which is explicitly stated to have no changes to any other aspect of the cup. The basis of substantial equivalence relies on the new device being "identical (except for sintering process)" to the previously cleared device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and AI evaluation based on the information provided in this 510(k) summary. The document is about demonstrating equivalence for a minor material change, not about proving device performance against detailed statistical acceptance criteria or evaluating an algorithm.

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Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:

• 1. Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
• 2. Inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA for the "Avalon Cup System." This document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not contain this type of data.

Specifically:

• It does not contain a table of acceptance criteria or reported device performance.
• It does not describe any study, sample sizes, data provenance, expert qualifications, or adjudication methods.
• It does not mention MRMC comparative effectiveness studies, standalone algorithm performance, or ground truth types.
• It does not discuss training sets or how ground truth for training sets was established.

This document solely indicates that the FDA has reviewed the submission for the Avalon Cup System and determined it is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It lists the indications for use but does not delve into the specific performance data that led to this determination.

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