(57 days)
The Exeter II Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended to be used with bone cement.
The Exeter II Distal Centralizer is a molded acrylic device that is fitted to the distal portion of a hip stem and used to centralize the stem within the femoral canal. The centralizer's design consists of three wing-like projections that extend outwards from the base of the centralizer. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal.
I'm sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.
The document is a 510(k) summary and an FDA clearance letter for the Distal Centralizer, Exeter II Hip System. Its primary purpose is to establish "substantial equivalence" to predicate devices already on the market, not to present a detailed study on specific performance acceptance criteria.
Here's a breakdown of why I cannot fulfill your request for each point:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document focuses on demonstrating equivalence to existing devices rather than defining and meeting specific performance metrics with quantitative results.
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Sample size used for the test set and the data provenance: Not mentioned. There is no description of a specific test set or data collection for performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No test set or ground truth establishment process is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned. No test set or adjudication process is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical orthopedic implant (hip stem centralizer), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. As mentioned, this is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. No ground truth is discussed as there's no performance study to establish it. The "ground truth" for this 510(k) submission is the pre-existing predicate devices and their established safety and effectiveness.
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The sample size for the training set: Not applicable. This is a mechanical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable. No training set is involved.
The document states that "The substantial equivalence of the centralizer is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to Howmedica's currently marketed centralizers." This indicates that the FDA clearance was primarily based on a comparison to existing, cleared devices rather than a de novo performance study against specific acceptance criteria.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.