(23 days)
Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.
The device is a single use implant intended for implantation with bone cement.
The Repicci II® Unicondylar Knee System consists of a femoral and tibial component. The Repicci™ tibial bearing is used with the Repicci™ femoral components (K971938).
The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a face with fixation holes and a keel.
The provided document does not describe acceptance criteria for a device, nor does it detail a study that proves a device meets such criteria.
Instead, this document is a Summary of Safety and Effectiveness and a 510(k) clearance letter for a medical device called the "Repicci™ Locked Keel Tibial Bearing." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific performance acceptance criteria through detailed studies.
Here's a breakdown of why this information is not present in the provided text, and what is present:
Key Takeaways from the Document:
- Device: Repicci™ Locked Keel Tibial Bearing (part of a unicompartmental knee system).
- Purpose of Submission: Seek 510(k) clearance from the FDA by demonstrating substantial equivalence to a predicate device (Worland Unicondylar All Poly Tibial Bearing -- K011795).
- Basis for Substantial Equivalence:
- Non-Clinical Testing: An engineering justification determined that the Repicci™ Locked Keel tibial component presented no new risks and was substantially equivalent. This suggests design and material comparisons, but no specific performance metrics or studies are detailed. The change from the predicate device is a modification to the keel and removal of a waffle pattern.
- Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical trials or studies were conducted to prove the device meets specific performance criteria.
- FDA Decision: The FDA granted 510(k) clearance, concluding that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
Addressing your specific points based on the absence of the requested information in the text:
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A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify any quantitative acceptance criteria or report device performance against them. The basis for clearance was "engineering justification" and "substantial equivalence" to a predicate, not performance against defined metrics.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available. No specific test set or data from a study is mentioned, as clinical testing was not provided for substantial equivalence. The "engineering justification" would involve design comparisons and possibly bench testing, but details on sample size, provenance, or type are not 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 (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available. There was no clinical study described that would require experts to establish ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. No test set or related adjudication method 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 knee implant, not an AI-powered diagnostic tool. MRMC studies involving human readers and AI are irrelevant to this product type.
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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 orthopedic implant, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. No clinical study result requiring ground truth is presented.
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The sample size for the training set
- Not Applicable/Not Available. No algorithm or machine learning component is involved in this device, therefore no training set exists.
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How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set or ground truth for one is relevant here.
In summary, the provided document is a regulatory submission demonstrating "substantial equivalence" based on engineering justification and comparison to a predicate device, rather than a study proving performance against defined acceptance criteria.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.