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The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.
This document is a 510(k) summary for a medical device: a 22 mm CoCr Head and Polyethylene Acetabular Shell Liner. It is from 1996. The information provided is insufficient to answer your detailed questions about acceptance criteria and a study proving device meets those criteria in the context of modern AI/machine learning device evaluation.
Here's why and what information is available:
This document describes a traditional orthopedic implant, not an AI or machine learning-driven device. Therefore, many of your questions, such as those regarding ground truth, sample sizes for training/test sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable.
Here's a breakdown of what can be gleaned from the provided text according to your request, with an explanation of why other points are not applicable:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit from the text):
- Manufactured from biocompatible materials (Co-Cr-Mo alloy and UHMWPE).
- Fatigue testing of stem and 22 mm head satisfied under previously released 510(k)s.
- Liner testing satisfied under previous 510(k)s (since only I.D. changed).
- Increase polyethylene minimal thickness in smaller diameter acetabular cups (this is a design goal, not a direct performance metric here).
- Be considered "substantially equivalent" to predicate devices.
- Reported Device Performance: The document states that these materials are "in current use in numerous hip systems and their use has been established through many years of successful clinical application." It also mentions "Fatigue testing...was satisfied" and "liner testing was satisfied." There are no numerical performance metrics detailed in this summary.
- Acceptance Criteria (Implicit from the text):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device. Testing for orthopedic implants typically involves bench (mechanical) testing, not "test sets" in the AI sense. The document refers to "fatigue testing" and "liner testing" which are standard biomechanical tests. No human patient data is mentioned for performance evaluation in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment in the AI/radiology sense for this device. Ground truth for an implant involves material properties, mechanical strength, and clinical outcomes over time, evaluated by engineers and orthopedic surgeons.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This applies to expert review of medical images/diagnoses, not mechanical implant testing.
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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 is for AI-assisted diagnostic tools.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for algorithmic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicitly: For mechanical properties, the "ground truth" would be established by validated engineering standards and testing protocols. For biocompatibility and clinical success, it's based on long-term clinical use and literature for the materials. No "expert consensus" on imaging or pathology is relevant here.
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The sample size for the training set
- Not applicable. No training set for an algorithm is involved.
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How the ground truth for the training set was established
- Not applicable. No training set is involved.
In summary: This document is a regulatory submission for a physical medical implant from 1996, focusing on material biocompatibility and mechanical testing in comparison to previously approved devices. It pre-dates and does not involve AI or machine learning, rendering most of your detailed questions about AI device evaluation inapplicable.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.