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The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - · Those patients with failed previous surgery where pain, deformity or dysfunction persists. - · Revision of a previously failed hip arthroplasty. - · Patients who require a total hip replacement.

The Total Joint Orthopedics Klassic HD® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.

The provided text describes a 510(k) premarket notification for a medical device, the Klassic HD® Hip System, specifically focusing on the Klassic HD® Acetabular Insert with XLPE. This filing addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria in a clinical setting in the way an AI/ML medical device might.

Therefore, the information required to answer your specific questions about acceptance criteria and a study that proves the device meets the acceptance criteria regarding AI/ML device performance (e.g., sensitivity, specificity, expert ground truth, MRMC studies) is not present in the provided document.

The document discusses non-clinical bench testing to support substantial equivalence. While it mentions "pre-determined acceptance criteria" for this bench testing, it does not specify what those criteria are or provide detailed results from a clinical study.

Here's an breakdown of why your questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document states that "bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices." It also says the device "met the pre-determined acceptance criteria." However, it does not list these specific criteria (e.g., thresholds for wear, strength, etc.) nor does it present the quantitative results against those criteria.
2. Sample sizes used for the test set and the data provenance: This refers to clinical data for performance evaluation. The document only mentions "non-clinical bench testing" and "extensive material characterization." There is no mention of a human test set, data provenance (country, retrospective/prospective), or data collection methods for a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts for the test set: Not applicable as no clinical test set using expert judgment is described.
4. Adjudication method for the test set: Not applicable as no clinical test set using expert judgment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The study described is non-clinical bench testing, not a study involving human readers or cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would relate to engineering standards, material properties, and mechanical performance metrics (e.g., ultimate tensile strength, wear rates). The specific metrics are not detailed, but the document mentions "material characterization," "sterility validation," "Push Out, Lever Out, Axial Torque Disassembly and Impingement testing."
8. The sample size for the training set: Not applicable. This document describes a physical medical device (hip implant), not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML model or training set discussed.

In summary, the provided document details a 510(k) submission for a physical medical device (hip implant), focusing on non-clinical bench testing for substantial equivalence. It does not provide the kind of information typically found in an AI/ML device submission regarding clinical performance, expert readers, or ground truth establishment relevant to AI algorithm validation.

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This device is intended for use in total hip arthroplasty. The device is intended for uncemented, biological fixation only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The proposed subject device Escalade Legend® Acetabular Shell is a line extension to the Escalade Acetabular Cup System (K103384). The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articular surface of the hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.

The Escalade Legend® Acetabular Shells are hemispherical in shape and are designed for press-fit, cementless, surgical applications. The subject device differs from the shell in K103384 device in the use of sintered titanium beads instead of titanium plasma spray for bone fixation.

The provided document is a 510(k) summary for the Escalade Legend® Acetabular Shell. It describes a medical device and its equivalence to a predicate device. The information provided does not include the specifics of acceptance criteria for software performance or a study proving a device meets such criteria for AI/software.

The document discusses non-clinical testing for certain physical characteristics of the device, but this is not related to software performance or AI.

Therefore, I cannot extract the requested information concerning acceptance criteria for device performance related to AI/software, as the document pertains to a physical medical implant (an acetabular shell) and its material and mechanical properties, not an AI or software-based device.

Specifically, there is no mention of:

1. A table of acceptance criteria and reported device performance for software.
2. Sample sizes for test sets or data provenance for software.
3. Number of experts or their qualifications for establishing ground truth for software.
4. Adjudication methods for software test sets.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
6. Standalone performance studies for an algorithm.
7. Type of ground truth for software performance.
8. Sample size for the training set of an AI.
9. How ground truth for a training set was established for AI.

The document states: "No clinical studies were performed." and the non-clinical testing performed is for material and connecting strength properties.

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