(118 days)
The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.
The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadnium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidfy around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.
This document describes a medical device, the Stryker Cement Removal System (CRS), and its intended use, contraindications, and a summary of its safety and effectiveness. However, it does not contain the specific information requested regarding acceptance criteria, a detailed study proving device performance, or the methodologies for establishing ground truth, sample sizes, and expert qualifications.
The provided text is a summary of safety and effectiveness, likely from a regulatory submission document (e.g., 510(k) summary). It broadly states that "data collected at the University of Michigan and Michigan State University demonstrated that the CRS does not raise any new safety issues..." but does not detail the nature of this data, the study design, or its specific findings against acceptance criteria.
Therefore, I cannot fulfill your request for the specific information points because the provided text does not contain them.
Here's a breakdown of the requested information and why it cannot be provided from the input:
- A table of acceptance criteria and the reported device performance: Not present. The document states the device "does not raise any new safety issues" and "does not produce a greater amount of fumes," but these are general statements, not quantifiable criteria with reported performance.
- Sample sizes used for the test set and the data provenance: Not present. The locations (University of Michigan and Michigan State University) are mentioned, but no details on sample size, retrospective/prospective nature, or data origin (country) are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Neither the concept of "ground truth" for this type of device (a cement removal system) nor expert involvement in establishing it is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
- 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 present. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study and AI assistance are not applicable.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not present. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. The nature of "data collected" is vague. For a surgical instrument, "ground truth" might relate to successful cement removal, avoidance of adverse events, or objective measurements like temperature control or material strength, but these are not specified.
- The sample size for the training set: Not present. This is not an AI/machine learning device with a training set in the conventional sense.
- How the ground truth for the training set was established: Not present, as it's not an AI/ML device.
In summary, the provided text offers a regulatory overview of a medical device but lacks the detailed study design, acceptance criteria, and performance metrics typically found in clinical study reports or comprehensive efficacy analyses.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.