(29 days)
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.
The Vanguard™ CR Stem Housings are comprised of Co-Cr-Mo and enhance fixation of prosthesis to bone. The device is to be used with the appropriate Vanguard™ knee components and is available in 10 sizes.
This submission {0} does not contain information about acceptance criteria or a study proving that a device meets such criteria to the extent requested. The document is a 510(k) Summary for the Vanguard™ CR Stem Housings, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance criteria or clinical trial results.
Here's why the requested information cannot be fully provided based on the given text:
- No specific acceptance criteria are listed: The document states "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device is functional within its intended use," but it does not specify what those acceptance criteria were (e.g., specific thresholds for fatigue strength, wear rates, etc.).
- No detailed study report is provided: While non-clinical testing was performed, the document does not detail the methodology, results, or how these results specifically "proved" the device met unstated acceptance criteria.
- No clinical testing was performed as a basis for substantial equivalence: The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." This means there would be no data related to human readers, ground truth established by experts, or multi-reader multi-case studies.
Therefore, many of the specific points requested (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or extractable from this document.
Based on the available text, here's what can be inferred or directly stated regarding testing:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion Reported Device Performance Not specified "functional within its intended use" (based on non-clinical laboratory testing) -
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for non-clinical testing.
- Data Provenance: Non-clinical laboratory testing. No geographical origin or retrospective/prospective status is mentioned, as it's not clinical data.
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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. No human expert review for establishing ground truth is mentioned in relation to the non-clinical tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human review or adjudication process is mentioned for the non-clinical tests.
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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. No clinical or MRMC study was performed; the device is a knee implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm. The non-clinical testing likely involved mechanical testing of the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for non-clinical lab testing of a mechanical implant, "ground truth" would likely refer to engineering specifications, material properties, and mechanical performance standards, rather than clinical outcomes or expert consensus.
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The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable. No training set mentioned.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.