(90 days)
The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.
The Exeter Intramedullary Bone Plug is a molded acrylic device that is designed to be placed in the femoral canal prior to the insertion of a femoral stem. The bone plug restricts the migration of bone cement down the femoral canal and permits cement pressurization within the canal. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.
The provided text describes a 510(k) submission for a medical device called the "Exeter Intramedullary Bone Plug." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device would.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of regulatory submission. The document explicitly states: "The substantial equivalence of the Exeter Bone Plug is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter II Distal Centralizer (K974054)."
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Substantial Equivalence: Equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to predicate devices. The device is described as having the "same design as the currently marketed device" and is stated to be substantially equivalent to K933077 and K974054 based on the criteria listed. No specific performance metrics (e.g., bone cement restriction percentage or pressurization values) are provided. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance data from a test set.
- Data Provenance: Not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth assessment by experts for a test set is not described in this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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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 not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" in this context is the performance and safety established for the predicate devices, which is what the new device is compared to for substantial equivalence. No new ground truth data is generated for this specific submission as it relies on equivalence.
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The sample size for the training set
- Not applicable. This is not a machine learning device.
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How the ground truth for the training set was established
- Not applicable.
§ 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.