(89 days)
The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement or with Biomet Compress®.
The Biomet Side Access Distal Femoral Expandable Knee is an additional component to Biomet's Orthopedic Salvage System (OSS) that gives the surgeon the ability to expand the prosthesis as the patient grows. All expansion takes place where natural bone has been removed. The device does not lengthen existing bones. The expandable device is available in standard and Reduced Size (RS) and is compatible with Biomet OSS system components and Compress (CPS) devices.
The provided text describes the Biomet Side Access Distal Femoral Expandable knee implant and a summary of its non-clinical performance data. Here's an analysis of the available information regarding acceptance criteria and the study proving it:
Summary of Acceptance Criteria and Reported Device Performance:
The document states that cyclic fatigue testing was conducted. However, specific quantitative acceptance criteria for this test (e.g., number of cycles, load levels, maximum allowable deformation or failure) are not detailed in this summary.
The reported device performance is a general statement:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adequate accuracy and performance for intended use | "Testing verified that the accuracy and performance of the system is adequate to perform as intended" |
| Substantial equivalence to predicate device | "and to demonstrate substantial equivalence to the predicate device." |
| Performance within intended use (based on mechanical testing) | "The results of mechanical testing indicated the devices performed within the intended use" |
| No new safety and efficacy issues | "did not raise any new safety and efficacy issues" |
| Substantial equivalence to predicate devices (based on mechanical testing) | "and were found to be substantially equivalent to the predicate devices." |
Detailed Information as Requested:
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Table of acceptance criteria and the reported device performance:
(As provided above) It's important to note the lack of specific, quantitative acceptance criteria in the summary. The performance is stated in qualitative terms related to adequacy, intended use, and equivalence. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size used for the cyclic fatigue testing or any other mechanical tests.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given it's non-clinical, the concept of "prospective" or "retrospective" as it applies to human clinical trials is less relevant; these would be controlled laboratory studies.
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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):
This information is not applicable to this submission. The tests described are "non-clinical" mechanical performance tests (cyclic fatigue). Ground truth, in the context of expert consensus, is typically established for diagnostic or clinical performance studies involving human readers or adjudicators, not for mechanical device testing. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are relevant for clinical studies where subjective assessments (e.g., image interpretation, clinical outcomes) require expert review to establish a ground truth. Mechanical testing relies on objective measurements and established engineering standards, not adjudication. -
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:
This information is not applicable. This submission describes a mechanical knee implant and its non-clinical performance testing. It does not involve AI, image analysis, human readers, or diagnostic performance evaluation. Therefore, an MRMC comparative effectiveness study is entirely outside the scope of this document. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As mentioned above, this device is a mechanical implant, not an algorithm or an AI-powered system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for mechanical performance tests like cyclic fatigue is typically established by engineering standards and specifications. The device is tested against predefined load conditions, cycles, and failure criteria (e.g., no fracture, no significant deformation, maintaining functional integrity) as outlined in relevant ASTM or ISO standards for orthopedic implants. The document implies compliance with these standards through the statement "Testing verified that the accuracy and performance of the system is adequate to perform as intended." -
The sample size for the training set:
This information is not applicable. There is no "training set" for a mechanical device as it does not involve machine learning or AI. -
How the ground truth for the training set was established:
This information is not applicable. Since there is no training set, there's no ground truth to establish for it.
In conclusion, the provided document focuses solely on the non-clinical mechanical performance of a knee implant. It confirms that cyclic fatigue testing was performed, and the results indicated the device met its intended use and demonstrated substantial equivalence to predicate devices. However, it lacks specific quantitative acceptance criteria, sample sizes for testing, and details about the testing methodology beyond stating "cyclic fatigue was conducted" and "mechanical testing." Information related to clinical studies, AI, human readers, or expert ground truth establishment is not relevant to this type of non-clinical device submission.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.